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KOREA ACCREDITATION BOARD

KAB Accreditation Advisory (2) : IAF Criteria

Document No.: KAB-A-02

Issue No.: 4

Issue Date: April 26, 2016

ISSUE No.4 April 26, 2016 2 / 77

KAB Accreditation Advisory (2) : IAF Criteria KAB-A-02

Contents

1. Certification of Multiple Sites Based on Sampling (MD 1:2007)

2. The Transfer of Accredited Certification of Management Systems (IAF MD 2:2007)

3. Advanced Surveillance and Recertification Procedures (IAF MD 3:2008)

4. The use of Computer Assisted Auditing Techniques (“CAAT”) for Accredited Certification of

Management Systems (IAF MD 4:2008)

5. Duration of QMS and EMS Audits (IAF MD 5: 2015)

6. Harmonization of Sanctions to be applied to Conformity Assessment Bodies (MD 7:2010)

7. Assessment of certification body management of competence in accordance with

ISO/IEC17021:2011 (MD 10:2013)

8. The application of ISO/IEC 17021 for audits of integrated management systems (MD

11:2013)

9. Assessment of certification activities for cross frontier accreditation (MD 12:2016)

[Annexes]

A. IAF-ILAC JGA Sydney Resolution 7 – Certification to accreditation standards

B. (INFORMATIVE) Examples of intended results from certification functions

C. Reduction of audit time

D. (INFORMATIVE) Examples of the type of relationships a CAB may have with its foreign

entities and subsidiaries

E. QMS audit time

F. EMS audit time

Additional Clause

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Foreword

1. This guide prepared by KAB to supplement requirements for bodies that provide audits and certification services provides details necessary for KAB’s accreditation activities in accordance with ISO/IEC 17011 (Conformity assessment -- General requirements for accreditation bodies accrediting conformity assessment bodies) and IAF documents.

2. Certification bodies that wish to be accredited by KAB or maintain accreditation shall comply with the following criteria as well as the applicable accreditation criteria based on ISO/IEC 17021:2011(Conformity assessment -- Requirements for bodies providing audit and certification of management systems) or ISO/IEC 17024 (Conformity assessment -- General requirements for bodies operating certification of persons):

KAB Accreditation Advisory (1) : KAB Criteria (KAB-A-01)

KAB Accreditation Advisory (2) : IAF Criteria (KAB-A-02)

3. IAF published IAF Guidance Documents (GD) and Mandatory Documents (MD) to ensure that accreditation programs are conducted in a consistent and equal way when accreditation bodies accredit certification bodies. Certification bodies accredited by KAB which is an IAF signatory member shall comply with IAF GDs and MDs for the consistent application of international standards.

4. The term “shall” is used throughout this document are mandatory. Although not mandatory, the term “should” is used to indicate recognised means of meeting the requirements of Mandatory documents set out by IAF.

5. If a certification body does not follow the criteria developed by KAB or IAF exactly, it may obtain or maintain accreditation only when it can justify its measures satisfy the intention of the criteria. This criteria can be revised anytime as international standards or IAF’s criteria are revised.

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Chapter 1. Certification of Multiple Sites Based on Sampling (MD 1:2007)

This document is mandatory for the consistent application of Clause 9.1.5. of ISO/IEC

17021:2006 and this document does not supersede any of the requirements in that standard.

1.0 INTRODUCTION

1.0.1 This document is for the audit and, if appropriate, the certification of management

systems in organizations with a network of sites to ensure that the audit provides adequate

confidence in the conformity of the management system to the relevant standard across all

sites listed and that the audit is both practical and feasible in economic and operative terms.

1.0.2 Normally initial audits for certification and subsequent surveillance and recertification

audits should take place at every site of the organization that is to be covered by the

certification. However, where an organization’s activity subject to certification is carried out in a

similar manner at different sites, all under the organization’s authority and control, a

certification body may put into operation appropriate procedures for sampling the sites at the

initial audit and subsequent surveillance and recertification audits. This document addresses

the conditions under which this is acceptable for accredited certification bodies including the

calculation of sample size and audit duration.

1.0.3 This document does not apply to the audits of organizations that have multi-sites where

fundamentally dissimilar processes or activities are used at the different sites, or a combination

of sites, even though they may be under the same management system. The conditions under

which certification bodies can make any reduction in the normal full audit of every site in these

circumstances have to be justified at each site where a reduction is proposed.

1.0.4 This document is applicable to accredited certification bodies that employ sampling in

their audit and certification of multi-site organizations. Nevertheless an accredited

certification body may exceptionally deviate from this document under condition it is able to

produce relevant justifications. These justifications shall, under evaluation by the

accreditation body, demonstrate that the same level of confidence in the conformity of the

management system across all the sites listed can be obtained.

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1.1 DEFINITIONS

1.1.1 Organization

The term organization is used to designate any company or other organization owning a

management system subject to audit and certification.

1.1.2 Site

A site is a permanent location where an organization carries out work or a service.

1.1.3 Temporary Site

A temporary site is one set up by an organization in order to perform specific work or a service

for a finite period of time and which will not become a permanent site. (eg. construction site).

1.1.4 Additional Sites

A new site or group of sites that will be added to an existing certified multi-site network.

1.1.5 Multi-site Organization

A multi-site organization is defined as an organization having an identified central function

(hereafter referred to as a central office – but not necessarily the headquarters of the

organization) at which certain activities are planned, controlled or managed and a network of

local offices or branches (sites) at which such activities are fully or partially carried out.

1.2 APPLICATION

1.2.1 Site

1.2.1.1 A site could include all land on which activities under the control of an organization at

a given location are carried out including any connected or associated storage of raw materials,

by-products, intermediate products, end products and waste material, and any equipment or

infrastructure involved in the activities, whether or not fixed. Alternatively, where required by

law, definitions laid down in national or local licensing regimes shall apply.

1.2.1.2 Where it is not practicable to define a location (e.g. for services), the coverage of the

certification should take into account the organization’s headquarters activities as well as

delivery of its services. Where relevant, the certification body may decide that the certification

audit will be carried out only where the organization delivers its services. In such cases all the

interfaces with its central office shall be identified and audited.

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1.2.2 Temporary Site

1.2.2.1 Temporary sites that are covered by the organization's management system may be

subject to audit on a sample basis to provide evidence of the operation and effectiveness of

the management system. They may, however be included within the scope of a multi-site

certification subject to agreement between the certification body and the client organization.

Where included in the scope, such sites shall be identified as temporary.

1.2.3 Multi-site Organization

1.2.3.1 A multi-site organization need not be a unique legal entity, but all sites shall have a

legal or contractual link with the central office of the organization and be subject to a common

management system, which is laid down, established and subject to continuous surveillance

and internal audits by the central office. This means that the central office has rights to

require that the sites implement corrective actions when needed in any site. Where applicable

this should be set out in the formal agreement between the central office and the sites.

Examples of possible multi-site organizations are:

ㆍOrganizations operating with franchises

ㆍManufacturing companies with a network of sales offices (this document would apply to the

sales network)

ㆍService companies with multiple sites offering a similar service

ㆍCompanies with multiple branches

1.3 ELIGIBILITY OF AN ORGANIZATION FOR SAMPLING

1.3.1 The processes at all the sites have to be substantially of the same kind and have to be

operated to similar methods and procedures. Where some of the sites under consideration

conduct similar, but fewer processes than others, they may be eligible for inclusion under

multi-site certification providing that the sites(s) which conduct the most processes, or critical

processes are subject to full audit.

1.3.2 Organizations which conduct their business through linked processes in different

locations are also eligible for sampling providing all other provisions of this document are met.

Where processes in each location are not similar but are clearly linked, the sampling plan shall

include at least one example of each process conducted by the organization (eg. fabrication of

electronic components in one location, assembly of the same components – by the same

company in several other locations).

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1.3.3 The organization’s management system shall be under a centrally controlled and

administered plan and be subject to central management review. All the relevant sites

(including the central administration function) shall be subject to the organization’s internal

audit program and all shall have been audited in accordance with that program prior to the

certification body starting its audit.

1.3.4 It shall be demonstrated that the central office of the organization has established a

management system in accordance with the relevant management system standard under

audit and that the whole organization meets the requirements of the standard. This shall

include consideration of relevant regulations.

1.3.5 The organization should demonstrate its ability to collect and analyse data (including but

not limited to the items listed below) from all sites including the central office and its authority

and also demonstrate its authority and ability to initiate organizational change if required:

ㆍSystem documentation and system changes;

ㆍManagement review;

ㆍComplaints;

ㆍEvaluation of corrective actions;

ㆍInternal audit planning and evaluation of the results;

ㆍChanges to aspects and associated impacts for environmental management systems (EMS)

and

ㆍDifferent legal requirements.

1.3.6 Not all organizations fulfilling the definition of “multi-site organization” will be eligible for

sampling.

1.3.7 Not all management systems standards are suitable for consideration for multi-site

certification. For example, multi-site sampling would be unsuitable where the audit of variable

local factors is a requirement of the standard. Specific rules apply also for some schemes, for

example those including automotive (TS 16949) and aerospace (AS 9100 series) and the

requirements of such schemes shall take precedence.

1.3.8 Certification bodies should have documented procedures to restrict such sampling where

site sampling is inappropriate to gain sufficient confidence in the effectiveness of the

management system under audit. Such restrictions should be defined by the certification body

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with respect to:

ㆍScope sectors or activities (i.e. based on the assessment of risks or complexity associated

with that sector or activity);

ㆍSize of sites eligible for multi-site audit;

ㆍVariations in the local implementation of the management system such as the need for

frequent recourse to the use of plans within the management system to address different

activities or different contractual or regulatory systems;

ㆍUse of temporary sites that operate under the management system of the organization and

which are not to be included within the scope of certification.

1.4 RESPONSIBILITY OF THE CERTIFICATION BODY

1.4.0.1. The certification body shall provide information to the organization about the

application of this document and the relevant management system standards before starting

the audit process, and should not proceed if any of the provisions are not met. Before starting

the audit process, the certification body should inform the organization that the certificate will

not be issued if during an initial audit nonconformities are found.

1.4.1 Contract Review

1.4.1.1 The certification body’s procedures should ensure that the initial contract review

identifies the complexity and scale of the activities covered by the management system

subject to certification and any differences between sites as the basis for determining the level

of sampling.

1.4.1.2 The certification body shall identify the central function of the organization with which

it has a legally enforceable agreement for the provision of certification activities.

1.4.1.3 The certification body shall check, in each individual case, to what extent sites of an

organization operate substantially the same kind of processes according to the same

procedures and methods. See clause 1.3.1 for sites which conduct fewer, but similar

processes than other sites and clause 1.3.2 for sites involving linked processes. Only after a

positive examination by the certification body that all the sites proposed for inclusion in the

multi-site exercise meet the eligibility provisions may the sampling procedure be applied to the

individual sites.

1.4.1.4 If all the sites of a service organization where the activity subject to certification is

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performed are not ready to be submitted for certification at the same time, the organization

shall be required to inform the certification body in advance of the sites that it wants to be

included in the certification and those which are to be excluded.

1.4.2 Audit

1.4.2.1 The certification body shall have documented procedures to deal with audits under its

multi-site procedure. Such procedures shall establish the way the certification body satisfies

itself that the same management system governs the activities at all the sites, is actually

applied to all the sites and that all the eligibility criteria for the organization in clause 1.3 above

are met. This requirement also applies to a management system where electronic documents,

process control or other electronic processes are used. The certification body shall justify and

record the rationale for proceeding with a multi-site approach.

1.4.2.2 If more than one audit team is involved in the audit or surveillance of the network, the

certification body should designate a unique audit leader whose responsibility is to consolidate

the findings from all the audit teams and to produce a synthesis report.

1.4.3 Nonconformities

1.4.3.1 When nonconformities, as defined in ISO/IEC 17021 clause 9.1.15 (b), are found at

any individual site, either through the organization’s internal auditing or from auditing by the

certification body, investigation should take place to determine whether the other sites may be

affected. Therefore, the certification body should require the organization to review the

nonconformities to determine whether they indicate an overall system deficiency applicable to

other sites or not. If they are found to do so, corrective action should be performed and verified

both at the central office and at the individual affected sites. If they are found not to do so, the

organization should be able to demonstrate to the certification body the justification for limiting

its follow-up corrective action.

1.4.3.2 The certification body shall require evidence of these actions and increase its

sampling frequency and/or the size of sample until it is satisfied that control is re-established.

1.4.3.3 At the time of the decision making process, if any site has a nonconformity, as

defined in ISO/IEC 17021 clause 9.1.15 (b), certification shall be denied to the whole network

of listed sites pending satisfactory corrective action.

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1.4.3.4 It shall not be admissible that, in order to overcome the obstacle raised by the

existence of a nonconformity at a single site, the organization seeks to exclude from the scope

the "problematic" site during the certification process. Such exclusion can only be agreed in

advance (See clause 1.4.1.4).

1.4.4 Certification Documents

1.4.4.1 Certification documents can be issued covering multiple sites provided that each site

included in the scope of certification has either been individually audited by the certification

body or audited using the sample approach outlined in this document.

1.4.4.2 The certification body shall provide certification documents to the certified client by

any means it chooses. Such certification documents shall comply in all respects with ISO/IEC

17021.

1.4.4.3 These documents shall contain the name and address of the central office of the

organization and a list of all the sites to which the certification documents relate. The scope or

other reference on these documents shall make clear that the certified activities are performed

by the network of sites on the list. If the certification scope of the sites is only issued as part of

the general scope of the organization, its applicability to all the sites shall be clearly stated. .

Where temporary sites are included in the scope, such sites shall be identified as temporary in

the certification documents.

1.4.4.4 Certification documents may be issued to the organization for each site covered by

the certification under condition that they contain the same scope, or a sub-scope of that

scope, and include a clear reference to the main certification documents.

1.4.4.5 The certification documentation will be withdrawn in its entirety, if the central office or

any of the sites does not fulfill the necessary provisions for the maintenance of the certification.

1.4.4.6 The list of sites shall be kept updated by the certification body. To this effect, the

certification body shall request the organization to inform it about the closure of any of the sites

covered by the certification. Failure to provide such information will be considered by the

certification body as a misuse of the certification, and it should act consequently according to

its procedures.

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1.4.4.7 Additional sites can be added to an existing certification as the result of surveillance

or recertification activities or enhancement of scope. The certification body shall have

documented procedures for the addition of new sites.

1.5 SAMPLING

1.5.1 Methodology

1.5.1.1 The sample should be partly selective based on the factors set out below and partly

non-selective, and should result in a representative range of different sites being selected,

without excluding the random element of sampling.

1.5.1.2 At least 25% of the sample should be selected at random.

1.5.1.3 Taking into account the provisions mentioned below, the remainder should be selected

so that the differences among the sites selected over the period of validity of the certificate is

as large as possible.

1.5.1.4 The site selection may include among others the following aspects:

ㆍResults of internal site audits and management reviews or previous certification audits;

ㆍRecords of complaints and other relevant aspects of corrective and preventive action;

ㆍSignificant variations in the size of the sites;

ㆍVariations in shift patterns and work procedures;

ㆍComplexity of the management system and processes conducted at the sites;

ㆍModifications since the last certification audit;

ㆍMaturity of the management system and knowledge of the organization;

ㆍEnvironmental issues and extent of aspects and associated impacts for environmental

(EMS) management systems;

ㆍDifferences in culture, language and regulatory requirements; and

ㆍGeographical dispersion.

1.5.1.5 This selection does not have to be done at the start of the audit process. It can also

be done once the audit at the central office has been completed. In any case, the central office

shall be informed of the sites to be included in the sample. This can be on relatively short

notice, but should allow adequate time for preparation for the audit.

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1.5.2 Size Of Sample

1.5.2.1 The certification body shall have a documented procedure for determining the sample

to be taken when auditing sites as part of the audits and certification of a multi-site

organization. This should take into account all the factors described in this document.

1.5.2.2 The certification body shall have records on each application of multi-site sampling

justifying it is operating in accordance with this document.

1.5.2.3 The following calculation is an example based on the example of a low to medium risk

activity with less than 50 employees at each site. The minimum number of sites to be visited

per audit is:

ㆍInitial audit: the size of the sample should be the square root of the number of remote sites:

(y=√x ), rounded to the upper whole number.

ㆍSurveillance audit: the size of the annual sample should be the square root of the number of

remote sites with 0.6 as a coefficient (y=0.6 √x), rounded to the upper whole number.

ㆍRe-certification audit: the size of the sample should be the same as for an initial audit.

Nevertheless, where the management system has proved to be effective over a period of three

years, the size of the sample could be reduced by a factor 0.8, i.e.: (y=0.8 √x), rounded to the

upper whole number.

1.5.2.4 The certification body should define within its management system the risk levels of

activities as applied above

1.5.2.5 The central office shall be audited during every initial certification and recertification

audit and at least annually as part of surveillance.

1.5.2.6 The size or frequency of the sample should be increased where the certification body’s

risk analysis of the activity covered by the management system subject to certification

indicates special circumstances in respect of factors such as:

ㆍThe size of the sites and number of employees (eg. more than 50 employees on a site);

ㆍThe complexity or risk level of the activity and of the management system;

ㆍVariations in working practices(eg. shift working);

ㆍVariations in activities undertaken;

ㆍSignificance and extent of aspects and associated impacts for environmental management

systems (EMS);

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ㆍRecords of complaints and other relevant aspects of corrective and preventive action;

ㆍAny multinational aspects; and

ㆍResults of internal audits and management review.

1.5.2.7 When the organization has a hierarchical system of branches (e.g. head (central) office,

national offices, regional offices, local branches), the sampling model for initial audit as defined

above applies to each level.

Example:

1 head office: visited at each audit cycle (initial or surveillance or recertification) 4 National

offices: sample = 2: minimum 1 at random

27 regional offices: sample = 6: minimum 2 at random

1700 local branches: sample = 42: minimum 11 at random.

1.5.3 Audit Times

1.5.3.1 The audit time to spend for each individual site is another important element to

consider, and the certification body shall be prepared to justify the time spent on multi-site

audits in terms of its overall policy for allocation of audit time.

1.5.3.2 The number of man-days per site, including the central office, should be calculated for

each site using the most recently published IAF document for the calculation of man-days for

the relevant standard.

1.5.3.3 Reductions can be applied to take into account the clauses that are not relevant to the

central office and/or the local sites. Reasons for the justification of such reductions shall be

recorded by the certification body.

Note: Sites which carry out the most or critical processes are not subject to reductions (clause

1.3.1).

1.5.3.4 The total time expended on initial assessment and surveillance is the total sum of the

time spent at each site plus the central office and should never be less than that which would

have been calculated for the size and complexity of the operation if all the work had been

undertaken at a single site (i.e. with all the employees of the company in the same site).

1.5.4 Additional Sites

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1.5.4.1 On the application of a new group of sites to join an already certified multi-site network,

each new group of sites should be considered as an independent set for the determination of

the sample size. After inclusion of the new group in the certificate, the new sites should be

cumulated to the previous ones for determining the sample size for future surveillance or

recertification audits.

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Chapter 2. The Transfer of Accredited Certification of Management

Systems (IAF MD 2:2007)

This document is mandatory for the consistent application of Clause 9.1.1. of ISO/IEC

17021:2006 and this document does not supersede any of the requirements in that standard.

2.0 INTRODUCTION

2.0.1 This document provides normative criteria on the transfer of accredited management

system certification between certification bodies. The criteria may also be applicable in the

case of acquisitions of certification bodies accredited by an IAF MLA signatory.

2.0.2 The objective of this document is to assure the maintenance of the integrity of accredited

management system certifications issued by one certification body if subsequently transferred

to another such body.

2.0.3 The document provides minimum criteria for the transfer of certification. Certification

bodies may implement procedures or actions which are more stringent than those contained

herein provided that a client organization's freedom to choose a certification body is not unduly

or unfairly constrained.

2.1 DEFINITION

2.1.1 Transfer of Certification

The transfer of certification is defined as the recognition of an existing and valid management

system certification, granted by one accredited certification body, (hereinafter referred to as the

“issuing certification body”), by another accredited certification body, (hereinafter referred to as

the “accepting certification body”) for the purpose of issuing its own certification.

Note: Multiple certification, (concurrent certification by more than one certification body), does

not fall under the definition above, and is not encouraged by IAF.

2.2 MINIMUM REQUIREMENTS

2.2.1 Accreditation

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Only certifications which are covered by an accreditation of an IAF MLA signatory shall be

eligible for transfer. Organizations holding certifications that are not covered by such

accreditations shall be treated as new clients.

2.2.2 Pre-Transfer Review

A competent person from the accepting certification body shall carry out a review of the

certification of the prospective client. This review shall be conducted by means of a

documentation review and should, normally, include a visit to the prospective client. Reasons

for not conducting a visit shall be fully justified and documented and a visit shall be conducted

if no contact can be made with the issuing certification body. The review should cover the

following aspects and its findings shall be fully documented:

• confirmation that the client’s certified activities fall within the accredited scope of the

accepting certification body;

• the reasons for seeking a transfer;

• that the site or sites wishing to transfer certification hold an accredited certification that

is valid in terms of authenticity, duration and scope of activities covered by the

management system certification. If practical, the validity of certification and the status

of outstanding nonconformities should be verified with the issuing certification body

unless it has ceased trading. Where it has not been possible to communicate with the

issuing certification body, the accepting certification body shall record the reasons;

• A consideration of the last certification or recertification audit reports, subsequent

surveillance reports and any outstanding nonconformities that may arise from them.

This consideration shall also include any other available, relevant documentation

regarding the certification process i.e. handwritten notes, checklists. If the last

certification, recertification or subsequent surveillance audit reports are not made

available or if the surveillance audit is overdue then the organisation shall be treated

as a new client;

• complaints received and action taken;

• the stage in the current certification cycle. See Clause 2.2.3.4 of this document; and

• any current engagement by the organisation with regulatory bodies in respect of legal

compliance.

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2.2.3 Certification

2.2.3.1 Normally, only valid accredited certification should be transferred. In cases where

certification has been granted by a certification body which has ceased trading or whose

accreditation has expired, been suspended or withdrawn, the accepting certification body may

consider such a certification for transfer at its discretion. In such cases, before it proceeds with

the transfer, the accepting certification body shall obtain agreement from the accreditation

body, whose mark it intends to place on the certificate. In the case of acquisitions the acquiring

certification body should, where practical, fulfil the contractual obligations of the acquired

certification body.

2.2.3.2 Certification which is known to have been suspended or under threat of suspension

shall not be accepted for transfer. If the accepting certification body has not been able to verify

the status of the certification with the issuing certification body, the organisation shall be

required to confirm that the certificate is not suspended or under threat of suspension.

2.2.3.3 Outstanding nonconformities should be closed out, if practical, with the issuing

certification body, before transfer. Otherwise they shall be closed out by the accepting

certification body.

2.2.3.4 If no further outstanding or potential problems are identified by the pre-transfer review

a certification may be issued following the normal decision making process. The programme of

ongoing surveillance should be based on the previous certification regime unless the

accepting certification body has conducted an initial or recertification audit as a result of the

review.

2.2.3.5 Where doubt continues to exist, after the pre-transfer review, as to the adequacy of a

current or previously held certification, the accepting certification body shall, depending upon

the extent of doubt, either:

ㆍtreat the applicant as a new client

or

ㆍconduct an audit concentrating on identified problem areas.

The decision as to the action required will depend upon the nature and extent of any problems

found and shall be explained to the organization and the justification for the decision shall be

documented and the records maintained by the certification body.

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Chapter 3. IAF Mandatory Document for Advanced Surveillance and

Recertification Procedures (IAF MD 3:2008)

This document provides normative criteria for advanced surveillance and recertification

procedures (ASRP) for consistent application of clause 9.1.1 of ISO/IEC 17021:2006 for

determining subsequent adjustments to the audit program. This document addresses only

Quality Management Systems (QMS) and Environmental Managements Systems (EMS), in

which IAF members have had experience of implementing ASRP or its predecessor

methodologies. The use of ASRP is not mandatory, but if an accreditation body wishes to

permit their accredited certification body and its client(s) to opt for the use of ASRP, it is a

requirement of IAF that the certification body and its client(s) conform to this document and be

able to demonstrate conformity to the accreditation body.

3.0 INTRODUCTION

3.0.1 For a client organization that has established confidence in its management system

(QMS and/or EMS) by consistently demonstrating effectiveness over a period of time, the

certification body, in consultation with the organization, may choose to apply the Advanced

Surveillance and Recertification Procedures (ASRP) provided for in this document. Such an

advanced surveillance and recertification program may place greater (but not total) reliance on

the organization’s internal audit and management review processes, include targeted

surveillance topics, take into account specific design input from the organization and/or use

other methods as appropriate, to demonstrate conformity of the management system.

3.0.2 The objective of this document is to assure the provision of more effective and efficient

audits to organizations that have a proven performance record while at the same time

maintaining the integrity of the accredited management system certificates they hold.

3.0.3 This document states minimum requirements for the application of the ASRP.

Certification bodies may implement procedures or actions which are more stringent than those

contained herein provided that an organization's justifiable request for the ASRP is not unduly

or unfairly constrained.

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3.1 MINIMUM REQUIREMENTS

3.1.1 Prerequisite

In order to utilize the ASRP, the certification body shall first demonstrate to an IAF MLA

signatory accreditation body:

a) That it has been operating an accredited certification scheme for the relevant management

system (QMS and/or EMS) for a minimum of one complete accreditation cycle.

b) That it is competent to design an ASRP program for each individual organization in the

relevant management system (QMS and/or EMS), in accordance with the requirements of ISO

9001:2000 clause 7.3 and using the design input criteria mentioned in clause 3.1.3.2 below.

NOTE: Reference is made here to ISO 9001 since this specifies the requirements for the

certification body to design a program for ASRP regardless of whether it is operating

certification of QMS or EMS.

3.1.2 Accreditation Scope

The competence of the certification body to meet clause 3.1.1 (b) above shall be assessed by

the accreditation body after which, if successful, specific reference to the approval for ASRP

for QMS and/or EMS, as appropriate, shall be included in the certification body’s accreditation

scope.

3.1.3 Eligibility and Design Input Criteria

The certification body shall inform the accreditation body prior to every new utilization of ASRP

for each specific organization, and shall be able to demonstrate that the following criteria in

clauses 3.1.3.1 and 3.1.3.2 have been satisfied:

3.1.3.1 Eligibility Criteria

a) The certification body shall confirm that the organization’s management system has been in

demonstrated conformity with the requirements of the applicable standard(s) for a period of at

least one complete certification cycle including initial, surveillance and recertification audits.

NOTE: The certification body may base this confirmation of demonstrated conformity on the

outcome of the first recertification audit (non-ASRP) of the organization conducted at the end

of a three-year certification cycle.

b) All nonconformities raised during the certification cycle immediately prior to the utilization of

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ASRP shall have been successfully resolved.

c) For an EMS, the certification body shall confirm that the organization has established

compliance with applicable legal requirements and has not had any sanctions imposed by the

relevant regulatory authority(ies) for the period of a) above.

d) The certification body shall have agreed suitable performance indicators with the

organization, on which to judge the ongoing effectiveness of the management system, and

shall ensure that the organization is consistently meeting agreed performance targets.

(i) For a QMS, these performance indicators shall address, as a minimum, the organization’s

demonstrated ability to consistently provide product that meets customer and applicable

regulatory requirements (see ISO 9001:2000 clause 1.1), and shall incorporate requirements

for the continual improvement of the effectiveness of the QMS. NOTE: For a QMS, “indicator”

means the characteristic to be measured and “target” means the quantitative/qualitative

requirements to be met.

(ii) For an EMS, these performance indicators shall address, as a minimum, the organization’s

demonstrated ability to achieve its environmental policy, objectives and targets and comply

with applicable legal and other requirements related to its environmental aspects (see ISO

14001:2004 clause 4.3.2), and shall incorporate requirements for the continual improvement

and prevention of pollution.

NOTE: For an EMS, “indicator” means the characteristic to be measured and “target” used in

the context of performance target means the quantitative/qualitative requirements to be met,

which is considered to be identical with “environmental target” as defined in ISO 14001.

e) The certification body shall have enforceable arrangements with the organization to provide

for access to relevant information. For a QMS, this information is all customer satisfaction data

collected or otherwise available. For an EMS, this information is all relevant communication

from external interested parties, and in particular the relevant regulatory authority(ies). When it

becomes necessary for the certification body to communicate directly with the source of such

information in order to validate the information, mutually agreed confidentiality policies and

procedures shall be applied.

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f) The certification body shall verify that the organization’s internal audit process is being

managed in accordance with the guidance of ISO 19011, with particular reference to auditor

competence defined in clause 7. The internal audit process shall be sufficiently coordinated

and integrated so as to provide an evaluation of the management system as a whole, not only

the performance of individual components.

g) The certification body shall have contractually enforceable arrangements to enable it to

increase the scope, frequency and duration of its audits in the event of a deterioration of the

organization’s ability to meet agreed performance targets.

3.1.3.2 Design Input Criteria

In addition to organization-specific input criteria, the design of each individual ASRP shall

address the following:

a) The frequency and duration of the certification body audits shall be sufficient to allow the

certification body to conform with this criteria document including the following b) and c),

among others.

For each proposed utilization of ASRP, the certification body shall determine the base level

(non-ASRP) auditor time using relevant IAF Guidance or Normative Criteria Documents, and, if

applicable, IAF MD 1 for sampling of multi-sites. If the certification body plans an individual

ASRP program that reduces the auditor time to less than 70% of this base-level, the

certification body shall justify such reductions and seek specific approval from the accreditation

body prior to its implementation.

NOTE: IAF Mandatory Documents applicable to auditor time for QMS and EMS are under

development. Until such documents become available, Annex 2 of IAF GD2 (and, where

applicable, Annex 3) and Annex 1 of IAF GD6 (and, where applicable, clause G5.3.6) should

continue to be applied to define the total audit time (Phase 1 + Phase 2).

b) In addition to auditing a statistically significant number of samples of the organization’s

management system processes to confirm the adequacy and effectiveness of the internal audit

process, the certification body itself shall continue to carry out the following activities at each

on-site surveillance and recertification audit, as a minimum (with other activities defined by the

ASRP; see clause 4.1.4 below):

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ㆍinterview top management and the management representative;

ㆍevaluate management review inputs and outputs, including a verification of the

organization’s ability to meet the agreed performance targets;

ㆍreview the internal audit process, including the procedures and records of internal audits,

and the competence of internal auditors; and

ㆍreview corrective and preventive actions plans, and verify their effective implementation.

c) The certification body shall ensure that all the requirements for accredited certification

(including the requirements of ISO/IEC 17021:2006 and any applicable sector scheme)

continue to be met.

3.1.4 Design Output

The design output for each application of the certification body’s ASRP program shall include

the following (a) – (f):

a) The extent to which the certification body will utilize the organization’s internal audit and

management review processes to complement the certification body’s activities;

b) Criteria for witnessing the organization’s internal audits, including sampling of both auditors

and processes to be audited;

c) Criteria for accepting and monitoring the competence of the organization’s internal auditors

and the method of reporting internal audit results;

d) Criteria for ongoing adjustments to the audit program, taking into account the organization’s

demonstrated ability over time to meet the agreed performance targets;

e) The components of the management system that will necessarily be audited by the

certification body at each surveillance and recertification audit (see clause 3.1.3.2 b); and

f) Specific competence criteria for certification body auditors and, where applicable, for

technical experts.

3.1.5 Certificates

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The certification body shall not differentiate between ASRP and non-ASRP methodologies on

the certificates it issues.

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Chapter 4. The use of Computer Assisted Auditing Techniques (“CAAT”)

for Accredited Certification of Management Systems (IAF MD 4:2008)

This mandatory document is to provide for the consistent application of ISO/IEC 17021:2006

when computer assisted auditing techniques are used as part of the audit methodology. The

use of CAAT is not mandatory, but if a certification body and its client opt to use CAAT, it is

mandatory that they conform to this document and are able to demonstrate conformity to the

accreditation body.

4.0 INTRODUCTION

4.0.1 As information and communication technologies become ever-more sophisticated, it is

important for certification bodies to be able to use “Computer Assisted Auditing Techniques” to

enhance audit effectiveness and efficiency, and to support and maintain the integrity of the

audit process.

NOTE: Guidance on the use of Computer Assisted Auditing Techniques can be obtained from

the website of the ISO/IAF Auditing Practices Group

www.iso.org/tc176/ISO9001AuditingPracticesGroup

4.0.2 Such “Computer Assisted Auditing Techniques” (“CAAT”) may include, for example:

ㆍTeleconferencing,

ㆍWeb meetings,

ㆍInteractive web-based communications,

ㆍRemote electronic access to the management system documentation and/or management

system processes.

4.0.3 The objectives for the effective application of CAAT are:

a) To provide a methodology that is sufficiently flexible and non-prescriptive in nature to satisfy

the needs of industry, by allowing client organizations and their respective certification bodies

to use CAAT to enhance the conventional audit process, and

b) To ensure that adequate controls are in place with sufficient accreditation body oversight to

avoid abuses and to prevent excessive commercial pressures that could compromise the

integrity of the certification process.

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4.1 REQUIREMENTS

4.1.1 Confidentiality

In accordance with ISO/IEC 17021, clause 8.5.1, the security and confidentiality of electronic

or electronically-transmitted information is particularly important when a certification body is

using CAAT. The certification body should agree on mutually acceptable information security

measures with its client before using CAAT.

4.1.2 Process requirements

4.1.2.1 In addition to the requirements in ISO/IEC 17021, clause 9.1.2, the audit plan shall

identify any computer-assisted auditing techniques that will be utilized.

4.1.2.2 In addition to the requirements in ISO/IEC 17021, clause 9.1.3, when using CAAT,

specific attention shall be given to the auditors’ ability to understand and utilize the information

technologies employed by the client organization to manage its management system

processes.

4.1.2.3 In addition to the requirements in ISO/IEC 17021, clause 9.1.4, if a certification body

uses CAAT, it may be considered as partially contributing to the total on-site auditor time. If

remote auditing activities represent more than 30% of the planned on-site auditor time, the

certification body shall justify the audit plan and obtain specific approval from the accreditation

body prior to its implementation.

NOTES:

1) It is expected that this "specific approval" will initially be done on a case-by-case basis, but

does not preclude a "blanket approval" from the accreditation body for the certification body to

go over a 30% reduction once the certification body has demonstrated that its process is

robust.

2) On-site auditor time refers to the on-site auditor time allocated for individual sites. Electronic

audits of remote sites are considered to be remote audits, even if the electronic audit is

physically carried out from another of the client organization’s premises.

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4.1.2.4 In addition to the requirements in ISO/IEC 17021, clause 9.1.10, audit reports shall

indicate the extent to which CAAT has been used in carrying out the audit, and how it

contributes to audit effectiveness and efficiency.

4.1.2.5 In addition to the requirements in ISO/IEC 17021, clause 9.2.2.1 (a) when the

certification body is proposing to use CAAT for part of the audit, the application review shall

include verification that the client organization has the necessary infrastructure to support this

approach.

4.1.2.6 In addition to the requirements in ISO/IEC 17021, clause 9.3.2.2, regardless of the use

of CAAT, the organization shall be physically visited at least annually.

4.1.2.7 In addition to the requirements in ISO/IEC 17021, clause 9.9.2, records shall indicate

the extent to which CAAT has been used in carrying out the audit and certification.

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Chapter 5. Duration of QMS and EMS Audits (IAF MD 5: 2015)

This document is mandatory for the consistent application of Clause 9.1.4.1 of ISO/IEC

17021:2011 for audits of quality and environmental management systems and is based upon

guidance previously provided in IAF GD2:2005 Annex 2 and GD6: 2006 Annex 1. All clauses

of ISO/IEC 17021:2011 continue to apply and this document does not supersede any of the

requirements in that standard. Although personnel numbers (permanent, temporary and part

time) of the client are used as the starting point when considering the audit duration, this is not

the sole consideration and account shall be taken of other factors affecting audit duration.

5.0 INTRODUCTION

5.0.1 The correct determination of the audit time for an initial audit (Stage 1 plus Stage2) is an

integral part of the application review for any client organization.

5.0.2 This document provides mandatory provisions and guidance for CABs to develop their

own processes for determining the amount of time required for the auditing of clients of

differing sizes and complexity over a broad spectrum of activities. It is intended that this will

lead to consistency of the determination of audit time of management systems between CABs,

as well as between similar clients of the same CAB.

5.0.3 CABs shall identify the audit time of the Stage 1 and Stage 2 initial audit and of

surveillance and re-certification audits for each applicant and certified client.

5.0.4 This mandatory document provides a framework that shall be utilized within a CAB’s

processes to determine appropriate audit time of management systems, taking into account

the specifics of the client to be audited.

5.0.5 Although this document is set up for EMS/QMS certification, a number of elements may

be used for other 17021-1 based certification schemes. Examples of these elements are the

application of audit time duration or audit day and effective personnel.

5.0.6 Notwithstanding the guidance provided by this document, the time allocated for a specific

audit should be sufficient to plan and accomplish a complete and effective audit of the client's

management system.

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5.1 DEFINITIONS

5.1.1 Management Systems Certification scheme

Conformity assessment system related to management systems to which the same specified

requirements, specific rules and processes apply.

5.1.2 Client organization

Entity or defined part of an entity operating a management system.

5.1.3 Permanent site

Location (physical or virtual) where a client organization (5.1.2) performs work or provides a

service on a continuing basis.

5.1.4 Virtual Site

Virtual location where a client organization performs work or provides a service using an on-

line environment allowing persons irrespective of physical locations to execute processes.

Note 1: A virtual site cannot be considered where the processes must be executed in a

physical environment, e.g., warehousing, manufacturing, physical testing laboratories,

installation or repairs to physical products.

Note 2: A virtual site (e.g. company intranet) is considered a single site for the calculation of

audit time.

5.1.5 Temporary site

Location (physical or virtual) where a client organization (5.1.2) performs specific work or

provides a service for a finite period of time and which is not intended to become a permanent

site (5.1.3).

5.1.6 Audit time

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Time needed to plan and accomplish a complete and effective audit of the client organization’s

management system (ISO IEC 17021-1).

5.1.7 Duration of management system certification audits

Part of audit time (5.1.6) spent conducting audit activities from the opening meeting to the

closing meeting, inclusive.

Note: Audit activities normally include:

• conducting the opening meeting

• performing document review while conducting the audit

• communicating during the audit

• assigning roles and responsibilities of guides and observers

• collecting and verifying information

• generating audit findings

• preparing audit conclusions

• conducting the closing meeting

5.1.8 Audit Day

The duration of an audit day is normally 8 hours and may or may not include a lunch break

depending upon local legislation.

5.1.9 Effective Number of Personnel

The effective number of personnel consists of all personnel involved within the scope of

certification including those working on each shift. When included within the scope of

certification, it shall also include non-permanent (e.g. contractors) and part time personnel.

Refer to 5.2.3 for calculation of effective number of personnel.

5.1.10 Risk Category (QMS only)

For QMS, the provisions in this document are based on three categories, dependant on the

risks posed by failure of the product or service of the client organization. These categories can

be considered as high, medium or low risk. High risk activities (e.g. nuclear, medical,

ISSUE No.4 April 26, 2016 30 / 77


pharmaceutical, food, construction) normally require more audit time. Medium risk activities

(e.g., simple manufacturing) are likely to require the average time to carry out an effective

audit and low risk activities less time. (See Annex E, Table QMS 2)

5.1.11 Complexity Category (EMS only)

For environmental management systems, the provisions specified in this document are based

on five primary complexity categories of the nature, number and gravity of the environmental

aspects of an organization that fundamentally affect the audit time. (See Annex F, Table EMS

2)

5.2 APPLICATION

5.2.1 Audit Time

5.2.1.1 The audit time for all types of audits includes the total time on-site at a client's location

(physical or virtual) (5.1.7) and time spent off-site carrying out planning, document review,

interacting with client personnel and report writing.

5.2.1.2 The duration of a management system certification audit (5.1.7) should typically not be

less than 80% of the audit time calculated following the methodology in Section 3. This applies

to initial, surveillance and recertification audits.

5.2.1.3 Travel (en-route or between sites) and any breaks are not included in the on-site

duration of management system certification audits.

Note: See 5.1.8. There may be a local legal requirement to include lunch breaks.

5.2.2 Audit Day(s)

5.2.2.1 Tables QMS 1 and EMS 1 present the average audit time of management systems

certification audits calculated in audit days. National adjustments on the number of days may

be needed to comply with local legislation for travel, lunch breaks and working hours, to

achieve the same total number of days of auditing from Tables QMS 1 and EMS 1.

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5.2.2.2 The number of audit days allocated shall not be reduced at the planning stages by

programming longer hours per working day. Consideration can be made to allow efficient

auditing of shift activities which may require additional hours in a working day.

5.2.2.3 If after the calculation the result is a decimal number, the number of days should be

adjusted to the nearest half day (e.g. 5.3 audit days becomes 5.5 audit days, 5.2 audit days

becomes 5 audit days).

5.2.2.4 To help ensure the effectiveness of the audit, the CAB should also consider the

composition and size of the audit team (e.g. ½ day with 2 auditors may not be as effective as a

one day audit with 1 auditor or 1 audit day with one lead auditor and one technical expert is

more effective than 1 auditor day without the technical expert).

Note 1: ABs may require a CAB to demonstrate that the average audit time of specified clients

is neither significantly more nor less than the audit time calculated from tables QMS1 and

EMS1.

Note 2: CABs that work primarily in high risk or complex industries are likely to have an

average higher than the tables and CABs that work primarily in low risk industries are likely to

have an average lower than the tables.

5.2.3 Calculation of the Effective Number of Personnel

5.2.3.1 The effective number of personnel as defined above is used as a basis for the

calculation of audit time of management systems. Considerations for determining the effective

number of employees include part-time personnel and employees partially in scope, those

working on shifts, administrative and all categories of office staff, repetitive processes and the

employment of large numbers of unskilled personnel in some countries.

5.2.3.2 The justification to determine the effective number of personnel shall be available to

the client organization and to the Accreditation Body for review during their assessments and

on request from the Accreditation Body.

5.2.3.3 Part time personnel and employees partially in scope

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Dependent upon the hours worked, part time personnel numbers and employees partially in

scope may be reduced or increased and converted to an equivalent number of full time

personnel. (e.g. 30 part time personnel working 4 hours/day equates to 15 full time personnel.)

5.2.3.4 Repetitive process within scope

When a high percentage of personnel perform certain activities/positions that are considered

repetitive (e.g. cleaners, security, transport, sales, call centers, etc) a reduction to the number

of personnel which is coherent and consistently applied on a company to company basis within

the scope of certification is permitted. The methods incorporated for the reduction shall be

documented to include any consideration of the risk of the activities/positions.

5.2.3.5 Shift work employees

The CAB shall determine the duration and timing of the audit which will best assess the

effective implementation of the management system for the full scope of the client activities,

including the need to audit outside normal working hours and various shift patterns. This shall

be agreed with the client.

5.2.3.6 Temporary unskilled personnel

This issue normally only applies in countries with a low level of technology where temporary

unskilled personnel may be employed in considerable numbers to replace automated

processes. Under these circumstances a reduction in effective personnel may be made, but

the consideration of processes is more important than employee numbers. This reduction is

unusual and the justification for doing so shall be recorded and made available to the AB at

assessment.

5.3 3 METHODOLOGY FOR DETERMINING AUDIT TIME OF MANAGEMENT SYSTEMS

5.3.1 The methodology used as a basis for the calculation of audit time of management

systems for an initial audit (Stage 1 + Stage 2) involves the understanding of tables and figures

in Annex E and Annex F for QMS and EMS audits respectively. Annex E (QMS) is based upon

the effective number of personnel (see Clause 2.3 for guidance on the calculation of the

effective number of personnel) and the level of risk, but does not provide minimum or

ISSUE No.4 April 26, 2016 33 / 77


maximum audit time. In addition to effective number of personnel, Appendix F (EMS) is based

also on the environmental complexity of the organization and does not provide minimum or

maximum audit time.

Note: Normal practice is that time spent for Stage 2 exceeds time spent for Stage 1.

5.3.2 Using a suitable multiplier, the same tables and figures may be used as the base for

calculating audit time for surveillance audits (Clause 5) and recertification audits (Clause 6).

5.3.3 The CAB shall have processes that provide for the allocation of adequate time for

auditing of relevant processes of the client. Experience has shown that apart from the number

of personnel, the time required to carry out an effective audit depends upon other factors for

both QMS and EMS. These factors are explored in more depth in Clause 5.8.

5.3.4 This mandatory document lists the provisions which should be considered when

establishing the amount of time needed to perform an audit. These and other factors need to

be examined during the CAB’s application review process and after Stage 1 and throughout

the certification cycle and at recertification for their potential impact on the determination of

audit time regardless of the type of audit. Therefore the relevant tables, figures and diagrams

for both QMS and EMS which demonstrate the relationship between effective number of

personnel and complexity, cannot be used in isolation. These tables and figures provide the

framework for audit planning and therefore required adjustments for the determination of audit

time for all types of audits.

5.3.5 For QMS audits, Figure QMS 1 provides a visual guide to making adjustments from

the audit time calculated from Table QMS 1 and provides the framework for a process that

should be used for audit planning by identifying a starting point based on the total effective

number of personnel for all shifts.

5.3.6 For an EMS audit it is appropriate to base audit time on the effective number of

personnel of the organization and the nature, number and gravity of the environmental aspects

of the typical organization in that industry sector. Tables EMS 1 and EMS 2 provide the

framework for the process that should be used for audit planning. The audit time of

management systems should then be adjusted based on any significant factors that uniquely

apply to the organization to be audited.

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5.3.7 The starting point for determining audit time of management systems shall be

identified based on the effective number of personnel, then adjusted for the significant factors

applying to the client to be audited, and attributing to each factor an additive or subtractive

weighting to modify the base figure. In every situation the basis for the establishment of audit

time of management systems including adjustments made shall be recorded. The CAB should

ensure that any variation in audit time does not lead to a compromise on the effectiveness of

audits. Where product or service realization processes operate on a shift basis, the extent of

auditing of each shift by the CAB depends on the processes done on each shift, and the level

of control of each shift that is demonstrated by the client. To audit effective implementation, at

least one of the shifts shall be audited. The justification for not auditing the other shifts (e.g.

those outside of regular office hours) shall be documented.

5.3.8 The audit time of management systems determined using the tables or figures in

Annexes E and F shall not include the time of “auditors-in-training”, observers or the time of

technical experts.

5.3.9 The reduction of audit time of management systems shall not exceed 30% of the times

established from Tables QMS 1 or EMS 1.

Note: Clause 5.3.9 may not apply to the situations described in IAF MD1 for the individual sites

in multi-site operations where sampling of sites is permitted. In this situation a limited number

of processes may be present in such sites and the implementation of all relevant requirements

of the management system standards(s) can be verified.

5.4 4 INITIAL MANAGEMENT SYSTEMS CERTIFICATION AUDITS (STAGE 1 PLUS

STAGE 2)

5.4.1 Determination of audit time of management systems involved in combined offsite

activities (Clause 5.2.1) should not reduce the total on-site duration of management systems

audits to less than 80% of the audit time calculated from the tables following the methodology

in Section 3. Where additional audit time is required for planning and/or report writing, this will

not be justification for reducing the on-site duration of management systems certification

audits. .

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5.4.2 Table QMS 1 and Table EMS 1 provide a starting point for estimating the audit time of

an initial audit (Stage 1 + Stage 2) for QMS and EMS respectively.

5.4.3 The audit time determined by the CAB and the justification for the determination shall

be recorded. This calculation shall include details on the time to be allocated to cover the

entire scope of certification.

5.4.4 The CAB shall provide the audit time determination and the justification to the client

organization as part of the contract and make it available to its Accreditation Body upon

request.

5.4.5 Certification audits may include remote auditing techniques such as interactive web-

based collaboration; web meetings, teleconferences and/or electronic verification of the client’s

processes (see IAF MD4). These activities shall be identified in the audit plan, and the time

spent on these activities may be considered as contributing to the total duration of

management systems audits. If the CAB plans an audit for which the remote auditing activities

represent more than 30% of the planned on-site duration of management systems audits, the

CAB shall justify the audit plan and maintain the records of this justification which shall be

available to an Accreditation Body for review (see MD4).

Note 1: Duration of management system certification audits refers to the audit time allocated

for individual sites. Electronic audits of remote sites are considered to be remote audits, even if

the electronic audit is physically carried out on the client organization’s location (physical or

virtual).

Note 2: Regardless of the remote auditing techniques used, the client organization shall be

physically visited at least annually where such a physical location exists.

Note 3: It is unlikely that the duration of a Stage 2 audit will be less than one (1) audit day.

5.5 SURVEILLANCE

During the initial three year certification cycle, audit time for surveillance audits for a given

organization should be proportional to the audit time spent on the initial certification audit

(Stage 1 + Stage 2), with the total amount of time spent annually on surveillance being about

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1/3 of the audit time spent on the initial certification audit. The CAB shall obtain an update of

client data related to its management system as part of each surveillance audit. The planned

audit time of a surveillance audit shall be reviewed at least at every surveillance and

recertification audit to take into account changes in the organization, system maturity, etc. The

evidence of review including any adjustments to the audit time of management systems audits

shall be recorded.

Note: It is unlikely that a surveillance audit will take less than one (1) audit day.

5.6 RECERTIFICATION

The audit time for the recertification audit should be calculated on the basis of the updated

information of the client and is normally approximately 2/3 of the audit time that would be

required for an initial certification audit (Stage 1 + Stage 2) of the organization if such an initial

audit were to be carried out at the time of recertification (i.e. not 2/3 of the original time spent

on the initial audit). The audit time of management systems shall take account the outcome of

the review of system performance (ISO/IEC 17021-1). The review of system performance does

not itself form part of the audit time for recertification audits.

Note: It is unlikely that a recertification audit will be less than one (1) audit day.

5.7 INDIVIDUALIZED SECOND AND SUBSEQUENT CERTIFICATION CYCLES

For the second and subsequent certification cycles, the CAB may choose to design an

individualized surveillance and recertification program (see IAF MD3 for Advanced

Surveillance and Recertification Procedures – ASRP) with approval by the Accreditation Body.

If an ASRP approach is not chosen the audit time of management systems should be

calculated as indicated in Clauses 5.5 and 5.6.

5.8 FACTORS FOR ADJUSTMENTS OF AUDIT TIME OF MANAGEMENT SYSTEMS (QMS

AND EMS)

The additional factors that need to be considered include but are not limited to:

Increase in audit time of management systems:

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• Complicated logistics involving more than one building or location where work is

carried out. e.g., a separate Design Centre must be audited.

• Staff speaking in more than one language (requiring interpreter(s) or preventing

individual auditors from working independently).

• Very large site for the number of personnel (e.g., a forest).

• High degree of regulation (e.g. food, drugs, aerospace, nuclear power, etc.).

• System covers highly complex processes or relatively high number of unique activities.

• Activities that require visiting temporary sites to confirm the activities of the permanent

site(s) whose management system is subject to certification.

• Outsourced functions or processes.

Increase in audit time of management systems for QMS only:

• Activities considered to be of high risk (see Annex E, Table QMS 2).

Increase in audit time of management systems for EMS only:

• Higher sensitivity of receiving environment compared to typical location for the industry

sector.

• Views of interested parties.

• Indirect aspects necessitating increase in audit time.

• Additional or unusual environmental aspects or regulated conditions for the sector.

• Risks of environmental accidents and impacts arising, or likely to arise, as

consequences of incidents, accidents and potential emergency situations, previous

environmental problems that the organization has contributed to.

Decrease in audit time of management systems:

• Client is not "design responsible" or other standard elements are not covered in the

scope (QMS only).

• Very small site for number of personnel (e.g. office complex only).

• Maturity of management system.

• Prior knowledge of the client management system (e.g., already certified to another

standard by the same CAB).

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• Client preparedness for certification (e.g., already certified or recognized by another

3rd party scheme).

• Note: if audit is conducted in accordance with IAF MD 11 this justification is invalid as

reduction will be calculated from the level of integration.

• High level of automation.

• Where staff include a number of people who work “off location” e.g. salespersons,

drivers, service personnel, etc. and it is possible to substantially audit compliance of

their activities with the system through review of records.

• Activities considered to be of low risk (see Annex E, Table QMS 2 for examples and

Table EMS 1). Low complexity activities, e.g.:

- Processes involving similar and repetitive activities (e.g., Service only).

- Identical activities of low complexity performed on all shifts with appropriate

evidence of equivalent performance on all shifts.

- Where a significant proportion of staff carry out a similar simple function.

Repetitive process within scope (when employees perform repetitive activities).

All attributes of the client’s system, processes, and products/services should be considered

and a fair adjustment made for those factors that could justify more or less audit time for an

effective audit. Additive factors may be off-set by subtractive factors.

Note 1: Subtractive factors may be used once only for each calculation for each client

organization.

Note 2: Additional factors to consider when calculating the audit time of integrated

management systems are addressed in IAF MD 11.

5.9 TEMPORARY SITES

5.9.1 In situations where the certification applicant or certified client provides their product(s)

or service(s) at temporary sites, such sites shall be incorporated into the audit programs.

5.9.2 Temporary sites could range from major project management sites to minor

ISSUE No.4 April 26, 2016 39 / 77


service/installation sites. The need to visit such sites and the extent of sampling should be

based on an evaluation of the risks of the failure of the QMS to control product or service

output or the EMS to control environmental aspects and impacts associated with the client's

operations. The sample of sites selected should represent the range of the client’s scope of

certification, competency needs and service variations having given consideration to sizes and

types of activities, and the various stages of projects in progress and associated environmental

aspects and impacts.

5.9.3 Typically on-site audits of temporary sites would be performed. However, the following

methods could be considered as alternatives to replace some on-site audits:

- Interviews or progress meetings with the client and/or its customer in person or by

teleconference.

- Document review of temporary site activities.

- Remote access to electronic site(s) that contains records or other information that is

relevant to the assessment of the management system and the temporary site(s).

- Use of video and teleconference and other technology that enable effective auditing to

be conducted remotely.

5.9.4 In each case, the method of audit should be fully documented and justified in terms of

its effectiveness.

5.10 AUDIT TIME OF A MULTI-SITE MANAGEMENT SYSTEM

5.10.1 In the case of a management system operated over multiple sites it is necessary to

establish if sampling is permitted or not.

5.10.2 For certification of multiple sites where sampling is not permitted, detailed

requirements will be covered in more detail in a new IAF MD when it is available. The starting

point for calculating audit time of the management system is the total involved on all of the

sites, consistent with Table QMS 1 and Table QMS 2 for quality management systems and

Table EMS 1 and Table EMS 2 for environmental management systems.

The proportion of the total time spent on each site shall take into account situations where

certain management system processes are not relevant to the site.

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5.10.3 For certification of multiple sites where sampling is permitted, detailed requirements

are covered in more detail in IAF MD1. The starting point for calculating audit time of the

management system is the total involved on each of the sampled sites. MD1 shall be used to

select sites to be sampled prior to applying MD5 to each selected site. The total time should

never be less than that which would have been calculated for the size and complexity of the

operation if all the work had been undertaken at a single site (MD1 – clause 5.3.4).

5.11 CONTROL OF EXTERNALLY PROVIDED FUNCTIONS OR PROCESSES

(OUTSOURCING)

5.11.1 If an organization outsources part of its functions or processes, it is the responsibility of

the CAB to obtain evidence that the organization has effectively determined the type and

extent of controls to be applied in order to ensure that the externally provided functions or

processes do not adversely affect the effectiveness of the MS, including the organization’s

ability to consistently deliver conforming products and services to its customers or to control its

environmental aspects and commitments to compliance with legal requirements.

5.11.2 The CB will audit and evaluate the effectiveness of the client's management system in

managing any supplied activity and the risk this poses to the delivery of objectives, customer

and conformity requirements. This may include gathering feedback on the level of

effectiveness from suppliers. However auditing the supplier’s management system is not

required, considering that it is included in the scope of the organization’s management system

only the control of the supplied activity, and not the performance of the activity itself. From this

understanding of risk any additional audit time shall be determined.

5.12 Reference

[Annex E] QUALITY MANAGEMENT SYSTEMS

[Annex F] ENVIRONMENTAL MANAGEMENT SYSTEMS

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Chapter 6. IAF Mandatory Document for Harmonization of Sanctions to

be applied to Conformity Assessment Bodies (MD 7:2010)

This document is mandatory for the consistent application of Clause 7.13 of

ISO/IEC17011:2004 under specific circumstances described in this document. This document

does not supersede any of the requirements of that standard.

6.0 INTRODUCTION

6.0.1 Under ISO/IEC 17011, Accreditation Bodies (ABs) are required to have procedures for

suspension, withdrawal or reduction of the accreditation scope (refer to ISO/IEC 17011 Clause

7.13.1).

6.0.2 The intention of this document is to clarify the situations where the sanctions shall be

applied to applicant or accredited Conformity Assessment Bodies (CABs) and the subsequent

necessary communication which shall be taken by ABs.

6.0.3 The following are applicable not only to the scope of the IAF MLA but also to any other

IAF accreditation activities, not just the management system certification. Other situations are

at individual AB’s discretion.

6.0.4 Clause 6.2 states some situations that frequently lead to sanctions by an AB and Clause

3 describes sanctions that are normally applied progressively by an AB.

6.0.5 6.4 and 6.5 describe specific instances in which there shall be a harmonized approach

by all ABs.

1) ISO/IEC 17011 Conformity assessment – General requirements for accreditation

bodies accrediting conformity assessment bodies.

2) IAF-ILAC JGA 2007 Sydney Resolution 7 (Refer to Annex A)

6.2 INITIATION OF SANCTIONS

Situations that lead to sanctions being applied to applicant or accredited CABs include, but are

ISSUE No.4 April 26, 2016 42 / 77


not limited to the following:

ㆍFailure to resolve nonconformities in accordance with an AB’s procedures;

ㆍNegative outcome of a complaint investigation;

ㆍMisuse/misrepresentation of an accreditation symbol (see ISO/IEC 17011 clause 8.3.3 and

NOTE);

ㆍNon-payment of fees.

6.3 SANCTIONS AVAILABLE

Sanctions available include, but are not limited to:

ㆍIntensification of surveillance (office, witness or document review);

ㆍReduction of accreditation scope (including geographical scope);

ㆍSuspension;

ㆍWithdrawal;

ㆍPublic notice of scope reduction/suspension/withdrawal/misrepresentation of accreditation;

ㆍLegal actions.

NOTE 1: Application of sanctions outlined in this document does not preclude legal action by

third parties, regulators, public authorities or any other interested parties.

NOTE 2: Under ISO/IEC 17011 Clause. 8.1.1.(g), there is provision for an AB to refuse

services if an AB perceives that any known violation of laws and regulations by the CAB would

bring the AB into disrepute.

6.4. SPECIFIC HARMONIZED SANCTIONS

The following are situations requiring specific sanctions by the AB:

6.4.1 Where there is proven evidence of fraudulent behavior, or the CAB intentionally

provides false information, or the CAB deliberately violates accreditation rules, the AB shall

initiate its process for withdrawal of accreditation.

6.4.2 Where a CAB is providing certification to any standard used as a basis for accrediting

CABs (e.g. ISO/IEC 17025 or ISO 15189), the AB shall initiate its process for suspension of

accreditation, as this behaviour of the CAB will put the AB, against its will, in the condition of

ISSUE No.4 April 26, 2016 43 / 77


providing the same service that a CAB performs, in violation of Clause 4.3.6 of ISO/IEC 17011.

Further decisions shall be based on the actions taken by the CAB.

NOTE: The action detailed in this mandatory document does not override the CABs right to

appeal against a decision as described in ISO/IEC 17011 Clause 7.10

IAF MD 7:2010 International Accreditation Forum, Inc. IAF Mandatory Document for

Harmonization of Sanctions Page 7 of 9 Issue 1, Ver 2

to be applied to Conformity Assessment Bodies

6.5 COMMUNICATION

In each of the situations mentioned in Clauses 6.4.1 and 6.4.2 that lead to suspension or

withdrawal of accreditation and after any appeal decision in accordance with the AB’s appeals

procedures, the AB shall notify the IAF Secretariat of this decision and the reasons. The IAF

Secretary shall then communicate the decision and status to all IAF Member ABs in the

following format:

“[Name of AB] [state the action as ‘withdrew’ or ‘suspended’] accreditation of [Name of CB] on

[date] for [state the proven offence]”.

6.6 Reference

Annex A. IAF-ILAC JGA Sydney Resolution 7 – Certification to accreditation standards

ISSUE No.4 April 26, 2016 44 / 77


Chapter 7. ASSESSMENT OF CERTIFICATION BODY MANAGEMENT OF

COMPETENCE IN ACCORDANCE WITH ISO/IEC17021:2011 (MD 10:2013)

7. 1 INTRODUCTION

The aim of this document is to provide a harmonised approach to how Accreditation Bodies

assess a Certification Body (CB)’s management of competence in accordance with ISO/IEC

17021:2011.

7. 2 DEFINITIONS

For the purposes of this document the following definitions shall apply:

7.2.1 Certification process

the entirety of functions relating to certification from receipt of application to the granting and

maintenance of certification

7.2.2 Certification function

a stage of the certification process, for example, application review, audit, certification decision

(ref; ISO/IEC 17021:2011 Annex A)

7.2.3 Intended results

the outputs of a certification function that comply with the requirements of ISO/IEC 17021:2011

and the objectives of the CB’s certification process

7.3 GENERAL

7.3.1 The AB shall verify that the CB can demonstrate that all personnel involved in performing

certification functions have the required competence.

7.3.2 The AB shall verify that the CB has defined its certification process and the intended

results to be achieved for each certification function. The AB’s evaluation of the CB’s

competence shall be based on:

(a) the CB’s documented process for determining competence criteria;

(b) the outcomes of the process for determining competence criteria;

ISSUE No.4 April 26, 2016 45 / 77


(c) the CB’s evaluations of its personnel; and

(d) taking account of the intended results of each certification function and whether, or not,

these have been achieved.

7.3.3 The certification functions for which the AB shall verify that the CB has determined

competence criteria, include, but are not limited to, the following:

(a) Application review (see example in 3.5 below);

(b) Establishing the audit program;

(c) Scheduling of audits;

(d) Allocation of audit teams;

(e) Auditing and reporting;

(f) Report reviews and certification decisions; and

(g) Maintenance of certification.

Annex B of this document is informative and provides examples of intended results from the

above certification functions. The CB may identify other intended results from these

certification functions.

7.3.4 The AB shall verify that the CB has determined competence criteria for:

(a) Management overseeing the certification process;

(b) Members of its committee for safeguarding impartiality;

(c) Personnel performing internal audits; and

(d) Personnel responsible for evaluating and monitoring the competence and performance of

personnel performing certification functions.

7.3.5 The AB shall regard objective evidence of the CB achieving the intended results for all

certification functions (see Annex A of this document) as an indication of the effectiveness of its

processes for determining and evaluating competence. The AB shall regard objective evidence

of the CB failing to achieve intended results for any certification functions as an indication that

the processes for determining and evaluating competence may be ineffective.

Note: The failure of the CB to achieve the intended results for a particular certification function

could also be an indication that the CB’s procedures for that function are ineffective or have

not been implemented.

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For example, in the case of the application review, to determine that the CB has competent

audit team members, it can allocate and to determine the audit time, the AB shall verify that

the CB:

a) has defined the intended results (see (d) below) for this function of the certification process;

b) has defined effective competence criteria for the personnel performing this function;

c) can provide objective evidence that the staff performing this function have demonstrated

that they meet the competence criteria; and

d) that the output from this function of the certification process has achieved the intended

results, by:

i) providing evidence that the technical area(s) of the organisation to be audited has/have

been correctly allocated;

ii) providing evidence that the assigned auditors have the required competence for the

appropriate technical area(s); and

iii) providing evidence that adequate time has been allocated for the audit, based on the

review of information provided by the applicant/certified client and from previous audits.

7.3.6 The AB shall assess the process and procedures established by the CB to determine

competence criteria and to evaluate competence to verify that personnel evaluated as

competent consistently achieve the intended results for all certification functions.

7.3.7 The AB shall verify that the CB has appropriate records of the implementation of its

processes for determining and evaluating competence and that the CB can demonstrate its

evaluation methods are effective and achieve intended results consistently.

4. TECHNICAL AREAS

7.4.1 The AB shall verify that the CB has defined the technical areas for which it provides

accredited certification and that these cover the total scope of the CB’s accreditation. It is the

responsibility of the CB to determine the technical areas in which it operates, based on

commonality of processes, environmental impacts and aspects, risk, etc.

(a) Technical areas do not necessarily need to be defined using scopes of accreditation. It is

possible that a single scope of accreditation may comprise more than one technical area, for

ISSUE No.4 April 26, 2016 47 / 77


example QMS scope 38* Health and Social Work could comprise:

- Veterinary services

- Hospital services

- Medical and dental practices

- Care services

- Social work

Similarly, QMS scope 28* Construction may need to take account that it comprises activities

ranging from painting and decorating to major construction and civil engineering projects.

* See IAF ID1:2010 Informative Document for QMS Scopes of Accreditation

(b) In some cases, a single technical area may relate to more than one scope of accreditation

For example, the manufacture of plastic bags for use in packaging could relate to both QMS

scope 9 printing companies and QMS scope 14 rubber and plastics products.

7.4.2 The AB shall verify whether the documented technical area competence criteria of the

CB:

(a) have been formulated in terms of competence (i.e. what are the required knowledge and

skills for that technical area);

Note: In certain instances, for example in the case of a medical doctor, evidence of

qualification and professional registration with the relevant national authority may be

considered as part of the evidence of technical area competence.

(b) cover all the relevant aspects of that technical area; i.e. has all relevant knowledge (for

example, legal requirements, processes, products, control techniques) for that technical area

been identified.

7.4.3 The AB shall seek evidence that the CB is able to demonstrate competence in all

certification functions across the whole of a technical area, by achieving the intended results

for each certification function. The AB shall seek evidence that the CB has processes in place

to ensure it can do so consistently.

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7.5 DETERMINATION OF COMPETENCE CRITERIA

7.5.1 The AB shall verify that the CB has documented the expertise needed to establish and

maintain the competence criteria for each technical area. This expertise may be provided by

an external resource.

7.5.2 The AB shall verify that the CB’s process for determining competence criteria identifies

the knowledge and skills necessary for personnel performing all certification functions in each

of its technical areas and for each management system standard or specification.

(a) For some certification functions allocated to particular individuals, competence may be

embedded in the design of the process. For example, the CB’s IT system may contain details

of auditors and the technical areas for which they have been evaluated as competent and can

nominate which auditors are competent to perform an audit of a particular organisation. Where

this is the case, the AB shall verify that the CB’s process is appropriately controlled and

capable of achieving intended results.

Note: Appropriate controls may include defining authority levels, password control etc.

(b) It is not necessary for personnel involved in reviewing applications, selecting audit teams,

determining audit times, reviewing reports and making certification decisions to have the same

depth of competence, in all areas, as auditors. For example, referring to Annex A of ISO/IEC

17021, personnel reviewing reports and making certification decisions are required to have

equivalent competence to that of auditors in knowledge of the CB’s processes, but not in

knowledge of the client’s business sector or knowledge of audit principles, practices and

techniques.

(c) Individuals assigned to perform certification functions need not necessarily each have all

the required competencies, providing the CB can demonstrate that it has the collective

competence to perform those functions. For example, the certification decision maker may not

be competent in all of the client’s business sector, but if the report has been reviewed by an

independent technical expert the collective competence may be evident.

(d) The competence required in an audit team may differ depending on the scope of the audit.

For example, the scope of a surveillance visit may be narrower than that for an initial

ISSUE No.4 April 26, 2016 49 / 77


assessment. The AB shall verify that the CB has a process which ensures audit teams have

the collective competence necessary to audit for particular visits.

7.6 EVALUATION PROCESSES

7.6.1 The AB shall verify that the CB has documented processes for initially evaluating the

competence and evaluating the continued competence of all personnel involved in the

management and performance of all certification functions. The AB shall seek objective

evidence that the CB has evaluated these personnel in accordance with its own documented

processes.

(a) Annex B of ISO/IEC 17021, being informative and not normative, provides useful guidance

on some methods that may be used by a CB to evaluate competence. However, the CB is free

to use other methods of evaluating competence. Whichever methods the CB uses to evaluate

competence, the AB shall verify that the CB can demonstrate that these methods are effective

in demonstrating competence.

(b) The CB may take into account, but not solely rely on, a history of proven ability of

personnel achieving intended results for the tasks they have been assigned. The AB shall

verify that this proven ability is based on the CB performing an evaluation of the outputs from

the appropriate certification function, for example, records, reports or other information, which

can contribute to the evidence that personnel have the knowledge and skills required by the

documented competence criteria.

7.6.2 The AB shall verify that where the CB employs external and new personnel who may

have been evaluated as competent by another accredited CB, it performs its own evaluation of

those personnel against its own competence criteria. However, the CB may take the evaluation

(when the complete records of the evaluation are available) by the other accredited CB into

account, but not solely rely on it, when performing its own evaluation.

7.6.3 Certification in a personnel certification scheme, accredited to ISO/IEC 17024 may be

used as demonstrating the competence of personnel, to the extent covered by the scope of

the scheme. The AB shall seek evidence that the CB has determined which of its competence

criteria are not covered by the scope of the personnel certification scheme and that the CB has

performed its own evaluation against these criteria.

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7.6.4 Where a personnel certification scheme is not accredited it may be used only as an

indication that personnel have certain knowledge and skills, and the AB shall verify that the CB

has performed its own evaluation of competence against the criteria covered by the scheme.

7.6.5 The AB shall verify the CB is able to identify where an individual ceasing to be available

to the CB has an impact on the overall competence of the CB. For example, it is possible that

an auditor, competent in a specific technical area, leaving the employment of a CB could result

in it no longer being able to demonstrate competence in a particular technical area. Under

such circumstances the AB shall seek evidence that the CB has identified the limitations to its

overall competence and the effect on existing certifications.

7.7. Reference

ANNEX B. Examples of intended results from certification functions – INFORMATIVE

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Chapter 8. IAF MANDATORY DOCUMENT FOR THE APPLICATION OF

ISO/IEC 17021 FOR AUDITS OF INTEGRATED MANAGEMENT SYSTEMS

(MD 8:2011)

This document is mandatory for the consistent application of ISO/IEC 17021 by Cer-tification

Bodies (CBs) for planning and delivery of Audits of Integrated Management Systems (IMS).

8.0 INTRODUCTION

8.0.1. This document provides requirements for the application of ISO/IEC 17021 for the

planning and delivery of audits of IMS and, if appropriate, the certification of an organization’s

management system(s) against two or more sets of audit crite-ria/standards. All clauses of

ISO/IEC 17021 continue to apply and this document does not add to or supersede any of the

requirements in that standard.

8.0.2 This document may not be applicable to ISO 9001 based sector-specific standards.

8.0.3 It shall be noted that the Annex at the end of this document is also part of the

requirements and shall be read as such.

1. DEFINITIONS

For the purposes of this document, the following definitions apply:

8.1.1 Audit of Integrated Management System

An audit of an organization’s management system against two or more sets of audit

criteria/standards conducted at the same time.

8.1.2 Integrated Management System

A single management system managing multiple aspects of organizational performance to

meet the requirements of more than one management standard, at a given level of integration

(8.1.3). A management system may range from a combined system adding separate

management systems for each set of audit criteria/standard, to an Integrated Management

System, sharing in single system documentation, management system elements, and

responsibilities.

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8.1.3 Level of Integration

The level to which an organization uses one single management system to manage multiple

aspects of organizational performance to meet the requirements of more than one

management system standard. Integration relates to the management system being able to

integrate documentation, appropriate management system elements and responsibilities in

relation to two or more sets of audit criteria/standards.

Note: Audit criteria are intended to mean management system standards used as a ba-sis for

conformity assessment and certification (e.g. ISO 9001, ISO 14001, ISO/IEC 20000, ISO

22000, ISO/IEC 27001, etc.).

8.2. APPLICATION

8.2.1 The Certification Body shall ensure that:

8.2.1.1 In establishing the audit program the level of integration of the management

system(s) is considered.

8.2.1.2 Audit plans cover all areas and activities applicable to each management system

standard/specification covered by the scope of the audit and are addressed by competent

auditor(s).

8.2.1.3 The audit team as a whole shall satisfy the competence requirements, established by

the Certification Body, for each technical area, as relevant for each management system

standard/specification covered by the scope of the audit of an IMS.

8.2.1.4 The audit shall be managed by a team leader, competent in at least one of the

audited standards/specifications.

8.2.1.5 Sufficient time is allocated to accomplish a complete and effective audit of the

organization’s management system for the management system stand-ards/specifications

covered by the scope of the audit.

8.2.1.5.1 To determine the audit time for an audit of an IMS covering two or more

management system standards/specifications, e.g. A + B + C, the Certification Body shall:

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a) calculate the required audit time for each management system standard/specification

separately (applying all relevant factors provided for by the relevant application documents

and/or scheme rules for each standard, e.g., IAF MD5, ISO/TS 22003, ISO/IEC 27006);

b) calculate the starting point T for the duration of the audit of the IMS by adding the sum of

the individual parts (e.g. T = A + B + C);

c) adjust the starting point figure by taking into account factors that may increase or reduce

(see Annex 1) the time required for the audit.

The factors for reduction shall include but are not limited to:

i) The extent to which the organization’s management system is integrated;

ii) The ability of the organization’s personnel to respond to questions concerning more than

one management systems standard; and

iii) The availability of auditor(s) competent to audit more than one management system

standard/specification.

The factors for increases shall include but are not limited to:

i) The complexity of the audit of an IMS compared with single management system audits.

d) inform the client that the duration of an IMS audit based on the declared level of integration

of the organisation’s management system may be subject to adjustment on the basis of

confirming the level of integration at stage one and subsequent audits.

8.2.1.5.2 Audit of an IMS could result in increased time, but where it results in re-duction, it

shall not exceed 20% from the starting point T (2.1.5.1b).

8.2.1.5.3 The starting point figure and justification for increase or reduction shall be

documented.

8.2.2 Existing application documents (e.g., IAF Mandatory Documents) relating to audits of

ISSUE No.4 April 26, 2016 54 / 77


management systems standards/specifications need to be considered when developing audit

program and audit plans for an IMS.

8.2.3 All applicable requirements of each management system stand-ard/specification relevant

to the scope of the IMS shall be audited.

8.2.4 Audit reports can be integrated or separate, with respect to the management systems

audited. Each finding raised in an integrated report shall be traceable to the applicable

management system standard(s)/specification(s).

8.2.5 The Certification Body shall consider the impact that a nonconformity found for one of the

management system standard(s)/specification(s) has on the compliance with the other

management system standard(s)/specification(s).

8.3. INITIAL AUDIT AND CERTIFICATION

8.3.1 Client Application

This shall include information relating to the level of integration, including the level of

integration of documents, management system elements and responsibilities (see Annex C).

8.3.2 Stage One Audit

During a Stage One Audit, the audit team shall confirm the level of integration of the IMS. The

Certification Body shall review and modify, as necessary, the audit dura-tion that was based on

information provided at the application stage.

8.4. SURVEILLANCE AND RECERTIFICATION ACTIVITIES

The Certification Body shall confirm that the level of integration remains unchanged throughout

the certification cycle to ensure that the established audit durations are still applicable.

8.5. SUSPENSION, REDUCTION, WITHDRAWAL

If certification to one or more management system standard(s)/specification(s) is subject to

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suspension, reduction or withdrawal the Certification Body shall investi-gate the impact of this

on the certification to other management system stand-ard(s)/specification(s).

8.6 Reference

Annex C. Reduction of audit time

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Chapter 9. IAF MANDATORY DOCUMENT FOR Accreditation

Assessment of Conformity Assessment Bodies with Activities in

Multiple Countries

(MD 12:2016)

9.1. INTRODUCTION

9.1.1 This document is mandatory for the consistent application of Clause 7 of ISO/IEC

17011:2004 regarding an Accreditation Body (AB)’s assessment of Conformity Assessment

Bodies (CAB)’s that provide certification in countries outside the country in which their head

office is located. Aspects of accreditation relating to cooperation between IAF Multilateral

Recognition Arrangement (MLA) AB’s are covered by IAF ML 4.

9.1.2 Clauses 7.5.7 and 7.5.8 of ISO/IEC 17011 prescribe requirements for ABs assessment

of locations from which key activities are performed. Key activities are defined in IAF/ILAC A5

Clause 7.5. This document takes account of the AB’s responsibility for establishing that all of

the CAB’s activities, within its scope of accreditation with that AB, not only key activities,

conform to all requirements of the relevant conformity assessment standards, irrespective of

where in the world these activities are performed.

9.1.3 This document takes account of the fact that some activities may not be performed at

fixed office locations, but by remote personnel using the CAB Information Technology (IT)

system.

9.2 DEFINITIONS

9.2.1 Accreditation Body

An accreditation body that is a member of IAF.

9.2.2 Fixed Office Location

The permanent premises where certification activities are performed and/or managed for the

CAB, regardless of location and relationship with the CAB.

9.2.3 Other Activities

Certification functions that are not key activities.

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9.2.4 Remote Personnel

The individuals, who may be internal or external that perform certification activities for a CAB

and do not work at a fixed office location.

9.3. IMPLEMENTATION

9.3.1 Data Collection

The AB shall require its accredited CAB’s to identify:

• Countries into which accredited certificates are issued and the number of certificates

issued in each country;

• Countries in which the CAB operates from a fixed office location that performs any

certification activities;

• Countries in which the CAB has remote personnel that perform any certification

activities;

• Which fixed office locations are responsible for performing and/or managing key

activities as defined in IAF/ILAC A5, or from where remote personnel performing key

activities are managed; and

• The CAB’s arrangements for managing all activities that are performed from a foreign

fixed office location or by remote personnel.

Note: The recording of this information is not for the purpose of granting prior permission to the

CAB to issue certificates in a particular country, but to enable the AB to plan its assessment

program for the CAB based on up-to-date knowledge of the full geographic scope of the CAB’s

accredited activities.

9.3.2 Assessment Program

The AB shall have an assessment program, covering the current accreditation period that

enables it to confirm the CAB’s conformity with the requirements of the relevant conformity

assessment standard(s), within the CAB’s scope of accreditation, irrespective of where

certification activities are performed.

Note: As a consequence of the assessment output, the AB may decide to limit or restrict the

ISSUE No.4 April 26, 2016 58 / 77


scope of a CAB’s accreditation to certain geographical areas or fixed office locations.

The program shall be developed to identify the activities and key activities to be assessed and

the countries where these are performed and/or managed, taking account of the following:

• The relationship between the CAB and its foreign entities and subsidiaries;

• The CAB’s arrangements for managing its foreign certification activities;

• Whether the CAB holds accreditation from the local AB;

• The number of fixed office locations, undertaking certification activities, in each

country;

• The number of remote personnel, undertaking certification activities, in each country;

• Where key activities are performed and managed or from where remote personnel

performing key activities are managed;

• The range of certification activities performed, where they are performed and from

where remote personnel are managed;

• The effectiveness of the CAB’s management controls of its certification activities;

• The accessibility of the CAB’s records;

• The availability of selected CAB personnel (internal and external) for interview;

• The number of certificates issued through a particular fixed office location;

• Schemes for which certification is granted through a particular fixed office location;

• Where a fixed office location manages other fixed office locations or remote personnel

outside of their national boundaries;

• The number of different countries covered by remote personnel and how they are

managed;

• The risks posed by the activities performed and/or managed and where they are

performed and/or managed (Note: these may be non-key activities);

• The capability of the AB to conduct remote assessments;

• Social and cultural aspects of each country;

• The number and type of complaints;

• The effectiveness of the CAB’s oversight in controlling its foreign certification activities,

including internal audits it performs on fixed office locations; and

• Where there is evidence of malpractice, such as misrepresentation by sales personnel,

inappropriate relationships with consultants or ineffective oversight by the CAB.

The AB’s assessment program shall be reviewed annually to take account of changes to the

ISSUE No.4 April 26, 2016 59 / 77


information in 9.3.1 and changes to the above factors.

The personnel performing and managing certification activities are more important than where

they are performed. The assessment program should include provision for interviews with a

representative sample of the CAB’s personnel (internal and external) to enable the AB to

confirm that the CAB’s certification activities, irrespective of where they are performed, meet

the requirements of the relevant conformity assessment standard(s).

Remote assessment can be used instead of conducting on-site assessments, provided the

outcomes of such assessments are equivalent to those of on-site assessments.

9.3.3 Initial Assessment

The initial assessment of the CAB shall include assessment of all fixed office locations,

whatever the relationship with the CAB, where key activities are performed and/or managed,

or from which remote personnel performing key activities are managed, and/or where records

are maintained.

Where appropriate, the initial assessment shall also include assessment of selected fixed

office locations, whatever the relationship with the CAB, where other activities covered by the

requirements of the relevant conformity assessment standard(s) are performed, or from which

personnel performing these activities are managed.

For extensions of scope, the AB shall determine an assessment program taking account of the

factors in 9.3.2 and whether the extension is for a new main scope, a new sub-scope or within

an accredited sub-scope. The assessment program does not necessarily need to include visits

to each fixed office location.

9.3.4 Surveillance and Reassessment

For surveillance and reassessment, each fixed office location, whatever the relationship with

the CAB, at which key activities are performed and/or managed or from which remote

personnel performing key activities are managed and/or records are maintained, shall be

assessed at least once in each accreditation cycle and in accordance with the AB’s

assessment program.

ISSUE No.4 April 26, 2016 60 / 77


The AB shall have the procedure for sampling fixed office locations, including remote

personnel, where other activities are performed or from which personnel performing these

activities are managed. The procedure shall ensure that a repres

9.4 Reference

D. Examples of the type of relationships a CAB may have with its foreign entities and

subsidiaries – INFORMATIVE

ISSUE No.4 April 26, 2016 61 / 77


[Annex A] IAF-ILAC JGA Sydney Resolution 7 – Certification to accreditation standards

The IAF and ILAC Joint General Assembly, acting on the recommendation of the JCCC,

resolves that when a Conformity Assessment Body (CAB), accredited by an Accreditation

Body (AB), is providing certification to any standard used as a basis for accrediting CABs (e.g.

ISO/IEC 17025 or ISO 15189), the AB shall initiate its process for suspension of accreditation,

as this behaviour of the CAB will put the AB, against its will, in the condition of providing the

same service that a CAB performs, in violation of clause 4.3.6 of ISO/IEC 17011. Further

decisions shall be based on the actions taken by the CAB.

All IAF and ILAC AB members shall include a suitable provision on such a possibility in their

contracts with CABs.

Note: It is accepted that a CAB may have to assess subcontractors to confirm that they

meet the CABs’ requirements, which may include accreditation standards e.g. ISO/IEC

17025. Documentation issued to subcontractors as a result of a successful

assessment should clearly state that this is only for the purposes of the subcontract

and is not certification or accreditation in accordance with ISO/IEC 17011.

ISSUE No.4 April 26, 2016 62 / 77


[Annex B] Examples of intended results from certification functions – INFORMATIVE

CERTIFICATION FUNCTION INTENDED RESULTS

Application review · the scope falls within the competence of the CB;

· the proposed scope is accurately defined consistent with the

products/service of the applicant and the management system;

· the technical area(s) of the organisation to be audited

has/have been correctly identified and allocated;

· sufficient auditors have been assigned;

· the assigned auditors have the required competence for:

i) the audit functions they are

assigned, e.g. audit team leader;

ii) the processes and operations they are assigned;

iii) the relevant management system standard(s);

iv) the certification scheme, where appropriate.

· adequate time has been allocated and justified for the audit,

in line with IAF MD1 and IAF MD5 (for QMS and EMS) or other

specific requirements for particular certification schemes,

based on the review of information provided by the

applicant/certified client.

· applications for transfer of certification are processed in line

with the requirements of IAF

MD 2.

Establishing the audit

programme

· the schedule for surveillance and recertification audits is in

line with ISO/IEC 17021;

· correct application of IAF MD 1 for multiple sites.

Scheduling of audits · the audit program complies with ISO/IEC 17021;

· audit duration and dates have been agreed with the client.

Allocation of audit teams · the collective competence of the audit team is consistent with

the products and processes of the client.

Audit planning · the audit plan is consistent with the proposed scope of

certification and the type of audit and reflects the client’s

organisation, processes and operation;

· the audit plan allocates sufficient time for a thorough audit;

· the audit team members are allocated tasks appropriate to

their competence.

ISSUE No.4 April 26, 2016 63 / 77


CERTIFICATION FUNCTION INTENDED RESULTS

Auditing and reporting · audit execution is performed effectively:

o opening and closing meetings are held;

o audit evidence collection techniques are effective;

o audit team members take adequate notes of audit evidence;

o sampling techniques are used effectively;

o audit team members reach conclusions consistent with the

audit evidence.

· the content of the audit report fulfills the requirements of

ISO/IEC TS 17022:2012.

· reaudits are performed when necessary.

· the certification recommendation is consistent with the audit

findings, the audit scope and the scope of certification.

Report reviews and

certification decisions

· checking for any changes since the application

review;

· confirming that the audit duration was correct;

· confirming that audit team members have been allocated

audit tasks appropriate to their competence;

· confirming that the audit report fulfills the requirements of

ISO/IEC TS 17022:2012;

· confirming that the recommendation is consistent with the

audit findings;

· documentary evidence is available where the independent

reviewer has had cause to discuss/clarify any aspect of the

report content. or associated recommendation.

Maintenance of certification · the audit program has been followed and surveillance and

recertification functions have been performed in a timely

manner;

· adequate sampling of surveillance reports for review;

· any changes have been reviewed and verified as not

adversely affecting the certification;

· demonstrated escalation in the event of nonconformities that

could lead to suspension or withdrawal of certification;

· timely recertification audits and recertification decisions prior

to expiry.

ISSUE No.4 April 26, 2016 64 / 77


[Annex C] REDUCTION OF AUDIT TIME

Figure C.1

Level of

inte

gra

tion %

100 0 0 10 15 20

80 0 5 10 15 15

60 0 5 10 10 10

40 0 5 5 5 5

20

0

0 0 0 0 0

0 20 40 60 80 100

Ability to perform combined audit %

Figure C.1: This figure illustrates the reduction (%) in integrated audit duration and its

relationship to:

Vertical axis: the level of integration of an organization’s management system (see below),

which should include a consideration of the auditee’s ability to respond to multi-aspect

questions. An Integrated Management System results when an organization uses one single

management system to manage multiple aspects of organizational performance. It is

characterized by (but not limited to):

1. An integrated documentation set, including work instructions to a good level of development,

as appropriate;

2. Management Reviews that consider the overall business strategy and plan;

3. An integrated approach to internal audits;

ISSUE No.4 April 26, 2016 65 / 77


4. An integrated approach to policy and objectives;

5. An integrated approach to systems processes;

6. An integrated approach to improvement mechanisms, (corrective and preventive action;

measurement and continual Improvement); and,

7. Integrated management support and responsibilities.

The Certification Body must decide the percentage level of integration based upon the extent

to which the organization’s management system meets the above criteria.

And

Horizontal axis: The extent, given as a ratio to be multiplied by a factor of 100 in order to

achieve the extent given as percentage, to which individual audit team members are qualified:

100 ((X1-1) + (X2-1) + (X3-1) + (Xn-1))

Z(Y-1)

Where

X1, 2, 3…n is the number of standards for which an auditor is qualified relevant for the scope

of the integrated audit;

Y is the number of management system standards to be covered by integrated audit;

Z is the number of auditors.

Example:

An integrated audit team of three auditors covering three different management system

standards. One auditor is qualified for all three standards; one auditor is qualified for two of the

standards and the other auditor is qualified for one standard.

The percentage figure to be used for the horizontal axis is:

100 ((3-1) + (2-1) + (1-1)) = 50 %

3(3-1)

Due to available competence of each auditor to more than one set of audit criteria/standards,

ISSUE No.4 April 26, 2016 66 / 77


efficiencies are gained and go into the calculation of the possible reduction of time in the

formula above. These include:

1. Time saved due to one opening and one closing meeting;

2. Time saved as one integrated audit report is produced;

3. Time saved in optimized logistics;

4. Time saved in auditor team meetings; and,

5. Time saved auditing common elements simultaneously, e.g. document control.

ISSUE No.4 April 26, 2016 67 / 77


[Annex D] Examples of the type of relationships a CAB may have with its foreign

entities and subsidiaries – INFORMATIVE

This informative Annex provides some examples of the type of relationships a CAB may

have with its foreign entities and subsidiaries:

- A wholly or majority (partly) owned regional subsidiary which controls and manages a

number of subsidiaries;

Note: This may be a separate entity which is wholly or majority (partly) owned by the

CAB.

- A wholly or majority (partly) owned subsidiary or branch of the CAB, either in its own

country or in another country;

Note: This may be a separate entity which is wholly or majority (partly) owned by the

CAB.

- A joint venture company, in which the CAB is a partner;

- A wholly or majority (partly) owned subsidiary of a joint venture company;

Note: This may be a separate entity which is wholly or majority (partly) owned by the joint

venture company.

- A representative, agency, franchisee or sales office of the CAB, a wholly or majority

(partly) owned subsidiary of the CAB or a joint venture company;

- Any separate entity that has contractual relationship with the CAB for performing

certification activities.

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[Annex E] QUALITY MANAGEMENT SYSTEMS

Table QMS 1 – Quality Management Systems Relationship between Effective Number of

Personnel and Audit Time (Initial Audit only)

Effective Number

of Personnel

Audit Time

Stage 1 + Stage 2

(days)

Effective

Number of

Personnel

Audit Time Stage

1 + Stage 2

(days) 1-5 1.5 626-875 12

6-10 2 876-1175 13

11-15 2.5 1176-1550 14

16-25 3 1551-2025 15

26-45 4 2026-2675 16

46-65 5 2676-3450 17

66-85 6 3451-4350 18

86-125 7 4351-5450 19

126-175 8 5451-6800 20

176-275 9 6801-8500 21

276-425 10 8501-10700 22

426-625 11 >10700 Follow progression

above

Note 1: The numbers of personnel in Table QMS 1 should be seen as a continuum rather than

a stepped change. I.e. if drawn as a graph, the line should start with the values in the lower

band and end with the endpoints of each band. The starting point of the graph should be

personnel of 1 attracting 1.5 days. See clause 2.2 for dealing with parts of a day.

Note 2: The CAB’s procedure may provide for calculation of audit time for a number of

personnel exceeding 10700. Such time should follow the progression in Table QMS 1 in a

consistent fashion.

Note 3: See also clause 1.9 and 2.3.

ISSUE No.4 April 26, 2016 69 / 77


Figure QMS 1 – Relationship between Complexity and Audit Time

Large Simple

Multi-site

Few processes

Repetitive

processes

Small scope

Large Complex

Multi-site

Many processes

Large scope

Unique

processes

Design

responsible

Starting point from

Table QMS 1

Few processes

Small scope

Repetitive

processes

Small Simple

Many processes

Design responsible

Large scope

Unique processes

Small Complex

Client System

Complexity

- O

rgan

izatio

n D

istr

ibutio

n

ISSUE No.4 April 26, 2016 70 / 77


Table QMS 2 – Examples of Risk categories

These risk categories are not definitive, they are examples only that could be used by a CB

when determining the risk category of an audit.

High risk

Where failure of the product or service causes economic catastrophe or puts life at risk.

Examples include but are not limited to:

Food; pharmaceuticals; aircraft; shipbuilding; load bearing components and structures;

complex construction activity; electrical and gas equipment; medical and health services;

fishing; nuclear fuel; chemicals, chemical products and fibres.

Medium risk

Where failure of the product or service could cause injury or illness. Examples include but are

not limited to:

Non load bearing components and structures; simple construction activities; basic metals and

fabricated products; non-metallic products; furniture; optical equipment; leisure and personal

services.

Low risk

Where failure of the product or service is unlikely to cause injury or illness. Examples include

but are not limited to:

Textiles and clothing; pulp, paper and paper products; publishing; office services; education;

retailing, hotels and restaurants.

Note 1: It is expected that business activities defined as low risk may require less audit time

than the time calculated using Table QMS1, activities defined as medium risk will take the time

calculated using Table QMS 1, and activities defined as high risk will take more time.

ISSUE No.4 April 26, 2016 71 / 77


Note 2: If a company is providing a mixture of business activities (eg: construction company

that builds simple construction – medium risk - and bridges – high risk), it is up to the CAB to

determine the correct audit time, taking into consideration the number of personnel involved in

each of the activities.

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[Annex F] ENVIRONMENTAL MANAGEMENT SYSTEMS

Table EMS 1 – Relationship between Effective Number of Personnel,

Complexity and Audit Time (Initial Audit only- Stage 1 + Stage 2)

Effective

Number of

Personnel

Audit Time

Stage 1 + Stage 2

(days)

Effective

Number of

Personnel

Audit Time

Stage 1 + Stage 2 (days)

High Med Low Lim High Med Low Lim

1-5 3 2.5 2.5 2.5 626-875 17 13 10 6.5

6-10 3.5 3 3 3 876-1175 19 15 11 7

11-15 4.5 3.5 3 3 1176-1550 20 16 12 7.5

16-25 5.5 4.5 3.5 3 1551-2025 21 17 12 8

26-45 7 5.5 4 3 2026-2675 23 18 13 8.5

46-65 8 6 4.5 3.5 2676-3450 25 19 14 9

66-85 9 7 5 3.5 3451-4350 27 20 15 10

86-125 11 8 5.5 4 4351-5450 28 21 16 11

126-175 12 9 6 4.5 5451-6800 30 23 17 12

176-275 13 10 7 5 6801-8500 32 25 19 13

276-425 15 11 8 5.5 8501-10700 34 27 20 14

426-625 16 12 9 6 >10700 Follow progression above

Note 1: Audit time is shown for high, medium, low and limited complexity audits.

Note 2: The numbers of personnel in Table EMS 1 should be seen as a continuum rather than

a stepped change. I.e. if drawn as a graph, the line should start with the values in the lower

band and end with the endpoints of each band. The starting point of the graph should be

personnel of 1 attracting 2.5 days. See clause 2.2 for dealing with parts of a day.

Note 3: The CAB’s procedure may provide for calculation of audit time for a number of

personnel exceeding 10700. Such time should follow the progression in Table EMS 1 in a

consistent fashion.

Table EMS 2 – Examples of Linkage between Business Sectors and Complexity

Categories of Environmental Aspects

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Complexity

Category

Business Sector

High

– mining and quarrying

– oil and gas extraction

– tanning of textiles and clothing

– pulping part of paper manufacturing, including paper recycling processing

– oil refining

– chemicals and pharmaceuticals

– primary productions – metals

– non-metallics processing and products covering ceramics

and cement – coal-based electricity generation

– civil construction and demolition

– hazardous and non-hazardous waste processing, e.g.

incineration, etc. – effluent and sewerage processing

Medium

– fishing/farming/forestry

– textiles and clothing except for tanning

– manufacturing of boards, treatment/impregnation of wood and wooden products

– paper production and printing, excluding pulping

– non-metallics processing and products covering glass, clay,

lime, etc. – surface and other chemically-based treatment for metal

fabricated products, excluding primary production

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Complexity

Category

Business Sector

– surface and other chemically-based treatment for general

mechanical engineering

– production of bare printed circuit boards for electronics

industry

– manufacturing of transport equipment – road, rail, air, ships

– non-coal-based electricity generation and distribution

– gas production, storage and distribution (note: extraction is

graded high)

– water abstraction, purification and distribution, including river

management (note: commercial effluent treatment is graded

as high)

– fossil fuel wholesale and retail

– food and tobacco processing

– transport and distribution by sea, air, land

– commercial estate agency, estate management, industrial

cleaning, hygiene cleaning, dry cleaning normally part of

general business services

– recycling, composting, landfill (of non-hazardous waste)

– technical testing and laboratories

– healthcare/hospitals/veterinary

– leisure services and personal services, excluding

hotels/restaurants

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Complexity

Category

Business Sector

Low – hotels/restaurants

– wood and wooden products, excluding manufacturing of

boards, treatment and impregnation of wood

– paper products, excluding printing, pulping, and paper

making

– rubber and plastic injection moulding, forming and assembly,

excluding manufacturing of rubber and plastic raw materials

that are part of chemicals

– hot and cold forming and metal fabrication, excluding surface

treatment and other chemical-based treatments and primary

production

– general mechanical engineering assembly, excluding surface

treatment and other chemical-based treatments

– wholesale and retail

– electrical and electronic equipment assembly, excluding

manufacturing of bare printed circuit boards

Limited – corporate activities and management, HQ and management of

holding companies

– transport and distribution management services with no actual

fleet to manage

– telecommunications

– general business services, except commercial estate agency,

estate management, industrial cleaning, hygiene cleaning, dry

cleaning

– – education services

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Complexity

Category

Business Sector

Special

Cases

– nuclear

– nuclear electricity generation

– storage of large quantities of hazardous material

– public administration

– local authorities

– organizations with environmental sensitive products or services, financial institutions

Complexity Categories of Environmental Aspects

The provisions specified in this document are based on five primary complexity categories of

the nature and gravity of the environmental aspects of an organization that fundamentally

affect the audit time. These are:

High – environmental aspects with significant nature and gravity (typically manufacturing or

processing type organizations with significant impacts in several of the environmental

aspects);

Medium – environmental aspects with medium nature and gravity (typically manufacturing

organizations with significant impacts in some of the environmental aspects);

Low – environmental aspects with low nature and gravity (typically organizations of an

assembly type environment with few significant aspects);

Limited – environmental aspects with limited nature and gravity (typically organizations of an

office type environment);

Special – these require additional and unique consideration at the audit planning stage.

Table EMS 1 covers the above four top complexity categories: high, medium, low and limited.

Table EMS 2 provides the link between the five complexity categories above and the industry

sectors that would typically fall into that category.

The CAB should recognise that not all organizations in a specific sector will always fall in the

same complexity category. The CAB should allow flexibility in its application review procedure

ISSUE No.4 April 26, 2016 77 / 77


to ensure that the specific activities of the organization are considered in determining the

complexity category. For example, even though many businesses in the chemical sector

should be classified as “high complexity”, an organization which would have only a mixing free

from chemical reaction or emission and/or trading operation could be classified as “medium” or

even “low complexity”. The CAB shall document all cases where they have lowered the

complexity category for an organization in a specific sector.

Table EMS 1 does not cover the “special complexity” category and the audit time of

management systems audits shall be developed and justified on an individual basis in these

cases.

Additional Clause

1. This document takes effect from the announcement date.

Additional Clause <Notification no.2015-29, 2015.04.15>

1. This guide shall come into effect from April 15, 2015