LL-C (Certification) · 17021-1 (up to date version), ... EN ISO/IEC 17065 - General Requirements...

LL-C (Certification)®

Czech Republic s.r.o.

Rule 03

CERTIFICATION PROCEDURE

1) MANAGEMENT SYSTEMS

2) PRUDUCTS, PROCESSES AND SERVICES

Revision No. 20 from 06. 10. 2016

Owner and Publisher: Head of CB, MUDr. Michal Krutský

LL-C (Certification)

RULE 03, Revision 20, (total 22)

LL-C (Certification) Czech Republic s.r.o., Pobřežní 620/3, Praha 8 - Karlín 186 00

M.C., section C, inset 97630, IC 27118339

Content

List revisions and motivations ...................................................................... 3

I. Supporting Statements .......................................................................... 3

II. Scope and Objectives ......................................................................... 5

III. Definitions and Abbreviations .............................................................. 5

Abbreviations used: ................................................................................. 6

Documents mentioned: ............................................................................ 6

IV. Selection and Use .............................................................................. 6

A. Selection and use of Certification Standard ......................................... 6

B. Selection and Use of Certification Scheme .......................................... 7

V. Certification processes ........................................................................ 9

A. Management Systems Certification .................................................... 9

B) Process of Product Certification ........................................................... 14

VI. Suspension or termination of certification ............................................ 18

VII. Responsibility of Certification Body ..................................................... 19

VIII. Responsibilities of Certified Client .................................................... 20

(holder of certification) ............................................................................. 20

A. Management Systems certification .................................................. 20

B. Product certification ....................................................................... 20

IX. Application of Certification Rules modifications ..................................... 22

X. Certification fees and other expenses ................................................. 22

XI. Complaint and Appeal Procedure ........................................................ 22





List revisions and motivations

Rev. Date Motivation Insert Approved by

1 4.1.2004 First publication M.Krutský M.Krutský

2 15.6.2004 Page 8 M.Krutský M.Krutský

3 27.9.2004 Page 3-8, 10 M.Krutský M.Krutský

4 30.5.2005 Page 3-8, 12-13 M.Krutský M.Krutský



7 1.7.2008 Page 3-12 M.Krutský M.Krutský



10 29.11.2010 Page 3-12 I.Angelovski M.Krutský

11 10.12.2012 Page 2- 12 I.Angelovski M.Krutský

12 22.05.2013 Page 2, 4, 5, 7 I.Angelovski M.Krutský

13 1.12.2013 Revision of all document B.Kuchtová M.Krutský

14 10.2.2014 Page 2,20 L.Holub M.Krutský

15 18.2.2014 Page 19 B.Kuchtová M.Krutský

16 25.4.2014 Pages 12, 13 D.Tokar M.krutský

17 9.4.2015 Revision of all document B.Kuchtová M.Krutský

18 5.11.2015 Page 7 D.Tokar M.Krutský

19 13.1.2016 Page 22 L. Holub L. Holub

20 06.10.2016 Page 3, 7, 11, 12, 13, 21 M.K., I.A M.Krutský

I. Supporting Statements

The LL-C (Certification) Czech Republic s.r.o. (hereinafter LL-C) is a certification body

offering a national and international wide range of certification services in the field of

Management Systems, e.g. Quality Management Systems (as per ISO 9001),

Environmental Management Systems (as per ISO 14001), Occupational Health & Safety

Management Systems (as per ISO 18001) and Information Security Management

Systems (as per ISO/IEC 27001). Further, certification services are offered in

Management of Critical Control Points in the Food Industry with requirements of

Food/Feed Safety Management Systems (as per ISO 22000, FSSC 22000 and GMP+)





with the requirements of HACCP, IT Service Management Systems (as per ISO 20000-1),

both in production and service companies.1

LL-C offers certification of products according to EN ISO 3834, EN 15085-2, EN 17660-1,

EN 17660-2, EN 14554-1, EN 14554-2 and ISO 22716 in the scope of its accreditation

and in a conformity with ISO/IEC 17065, EA-6/02 as well as valid Guidelines for

accreditation.

Further, LL-C offers certification of products (Construction Products REG EU 305/2011,

Medical Devices and Machinery Devices) in the scope of its accreditation and in

conformity with ISO/IEC 17065.

The legal status of LL-C is a limited liability company with 100% foreign investments.

LL-C company was established as a subsidiary in the Czech Republic. The company is

registered with the Municipal Court in Prague, section C inset 97630 IN 271 18 339. The

company operates in the EU and beyond.

Certification services offered by LL-C are available to all candidates who adopt rules laid

down in this Directive (Rule 03) and officially demand any certification from LL-C.

The policy of LL-C and its management is to offer certification of Management Systems

and Products only within its own certification system while ensuring impartiality,

confidentiality and independence for the Certified Client (hereinafter Client). All policies

applied to LL-C employees, such as knowledge, skills or relevant experiences are equally

applicable to LL-C´s external Auditors, Assessors, Decision Makers, Evaluators and

Technical Experts.

Auditors, Assessors, Evaluators, Decision Makers or Technical Experts involved in

certification process shall carry out their obligations without any unfair advantage; no

influence by any third party. Further, all of them are bound by strict rules of impartiality

and independence of the certification body. Performed activities are an act carried out

based on following principles:

- Access maintenance to all certified entities, ensure non-discrimination of any

organization or an individual;

- Exclusion from participation in an audit and a decision-making granting a certificate

for a specific Client where personally involved in consulting of management systems

activities (above mentioned standards); impartiality and independence of the

assessment for a particular Client is ensured;

- Exclusion from participation in an evaluation process/conformity assessment, and on

decision on certification granting, where activities of personnel might be considered

as violating obligation of impartiality;

- Strict separation of Audit/Expert advice and decision on certification granting;

- Strict separation of Evaluation/Conformity assessment and decision on certification

granting;

- Respect for confidentiality of all personnel involved in any certification process.

LL-C services are based on following policies and principles:

- Philosophy to promote confidence in certification as an effective instrument to

improve the quality of products and services and as a more careful approach to the

environment and other risk prevention;

- Information system security improvement;

- Ensuring the highest possible level of integration during assessment of management

systems according to various established standards and regulations;

- Ensuring territorial and term availability of Auditors and Assessors;

1 All standards mentioned are in up to date version.





- Ensuring personnel with relevant experiences and competence – Auditors and

Assessors regarding expertise required, Auditor experience, conformity assessment

experiences and of equal existence of ethical behaviour and empathy;

- Strict respect for confidentiality;

- Effective preference of precautions prior to formality of meeting the requirements of

standards;

- Use of the most modern techniques for testing, as well as an adoption of

organizational measures preventing conflicts of interest and challenging the legality of

tests.

II. Scope and Objectives

Objectives

The present Rule defines:

A) Procedures used for Management Systems Certification. Further, the Rule

explains substances and procedures of certification process relevant for organizations

with an interest for certification. Instructions are based on the requirements of ISO

17021-1 (up to date version), MPA 50-01-07, ČSN EN ISO 19011 (up to date

version).

B) Procedures used for Product Certification. Further, the Rule explains

substances and procedures of certification process relevant for organizations with an

interest for certification. Instruction are based on the requirements of ISO/IEC 17065.

Scope

This definition of scope applies to Management Systems Certification of organizations

active in manufacturing, non-state or government sectors in areas for which LL-C is

accredited for.

This definition of scope applies to Product Certification of organizations active in

manufacture of products for which LL-C is accredited for.

Regulations or standards specific for a particular field, not designated here in detail, are

adequately regarded and applied according to inherent requirements if needed. Any non-

conformities or deviations will be presented to any Client case by case pursuant inherent

requirements.

III. Definitions and Abbreviations

The present Rule contains definitions from:

EN ISO 17021 (up to date version) - General requirements for certification bodies for

Management System Certification (including MPA 50-01-07 of Czech accreditation

institute)

EN ISO 19011 - Guidelines for Auditing of Management Systems





EN ISO/IEC 17065 - General Requirements for Bodies Operating Product Certification

Systems

Abbreviations used:

CB – Certification Body

CBP – CB for Product Certification

HCB – Head of CB

DHCB – Deputy Head of CB

QM – Quality Manager

A – Assessor which provides Conformity Assessment

LA – Lead Assessor

DM – Decision Maker on Certification

TE – Technical Expert

Certified Client - Client

Documents mentioned:

F30 -

F31 -

F32 -

F46 -

Rule 01 -

Rule 02 -

Rule 03 -

Rule 05 -

Rule 12 -

IV. Selection and Use

A. Selection and use of Certification Standard

Quality Management System (QMS)

For Quality Management System certification ISO 9001 standards (up to date version) is

used. Further, quality management system must meet expectations of the relevant field

and customers.





Environmental Management System

For Environmental Management System certification standard ISO 14001 is used.

Further, management system must meet expectations of the relevant field and

customers.

Information Security Management System

For Information Security Management System certification standard ISO 27001 is used.

Further, quality management system must meet expectations of the relevant field and

customers. Currently, IT Service Management System is currently often used in ICT

sector; as per ISO 20000-1. This standard contains elements of IT services outsourcing

management, quality management of ICT services and security management system

information.

Critical Control Points Management

Food Industry is certified in accordance to HACCP regulation (FAO/WHO Codex

Alimentarius). Further, quality management system must meet expectations of the

relevant field and customers. This standard gives basis for a more comprehensive Food

Safety Management System (ISO 22000 and FSSC 22000), which integrates feedback

and process management, as well as quality compatibility.

As well as GMP+ (B2, B4, B4.3) feed safety certification scheme

Occupational Health & Safety Management System

For Occupational Health & Safety Management System certification ISO 18001 OHSAS

standard is used. Further, management system must meet expectations of the relevant

field and customers.

Other management systems

When other standards are used, additional requirements according to relevant

accreditation body or contractual entity might occur. These additional requirements will

be provided to interested parties upon request.

B. Selection and Use of Certification Scheme

Products/Processes as per EN ISO 3834-2/3/4, EN 1090-2/3, EN 15085-2, EN

17660-1, EN 17660-2, EN 14554-1, EN 14554-2 and IS0 22716,

The conformity assessment is based on system certification audit methodology in the

scope of accreditation, in accordance with EN 45011, EA-6/02 and a valid accreditation

entity prescription. The quality assurance of welding processes in manufacturing,

execution of steel/aluminium construction, welding work on railway vehicle and ensuring

GMP-cosmetics products are generally controlled during the certification procedure.

Machinery Devices

Machinery devices certification means conformity assessment and evaluation procedures

are provided based on EC type-examination. In this regard, CB ascertains and certifies

that a sample of machinery devices (product concerned) meets provisions and

requirements of Directive 2006/42/EC.





Medical Devices (MDD)

MDD certification means that conformity assessment and evaluation procedures are

provided based on EC Declaration of Conformity assessment procedures of Full Quality

Assurance System (Annex II of Directive 93/42/EEC), Production Quality Assurance

(Annex V of Directive 93/42/EEC) and Production Quality Assurance (Annex VI of

Directive 93/42/EEC), by which CB ascertains and certifies that a sample of MDD

(product concerned) meets provisions and requirements of this Directive.

Construction Products (CPR)

The procedure provides an evaluation based on conformity assessment and durability

verification in accordance with Regulation (EU) No 305/2011 of the European Parliament

and of the Council, Annex V (System 2+).

CB conducts Factory Production Control (FPC) certification based on factory´s initial

inspection, factory production control and continuous surveillance and factory production

control (FPC) approval.

Toys

Evaluation of Toys means conformity assessment procedure is provided based on EC

Declaration of Conformity by procedure EC type-examination. In this regard, CB

ascertains and certifies that a toy sample (product concerned) meets provisions and

requirements of Directive 2009/48/EC, Regulation of Government No. 86/2011.

Software for MDD

The conformity assessment is based on system certification audit methodology in

accordance with ISO 13485 and efforts to fulfil individual chapters of Directive 93/42/EEC

related to MDD and Directive 98/79/EC related to IVVD. The assessment model is based

on other Annexes of Directives and Client requests. LL-C provides assessment of MDD

class III based on Annex II of Directive 93/42/EEC; including examination of product

design.





V. Certification processes

A. Management Systems Certification

Certification process diagram

CLIENT

LL-C

Process participants:

SUBCONTRACTOR

CLIENT INQUIRY

INQUIRY DETAILS

TELEPHONE

E-MAIL

APPLICATION REGISTRATION

APPLICATION FORM (F30)

APPLICATION EVALUATION

CERTIFICATION STANDARDS

INTEGRATION

OTHER NORMATIVE DOCS.

ASSESSMENT SCOPE DEFINITION

STAGE 2 AUDIT - ON SITE

STAGE 1 AUDIT - OFF SITE /ON SITE

NON-CONFORMITY REPORTS

(F46)

AUDIT RECORD (F44)

AUDIT REPORT (F43)

QUESTIONNAIRE (F42 I+II.)

COMPILATION OF FINAL DOCUMENTS

(Certificates)

COMMENTS AND ACCEPTANCE BY

CLIENT

f

AUDIT REPORT (F 43)

CERTIFICATE (F 49)

EVALUATION

Successful

evaluation

Evaluation failed due to incorrect audit/assessment procedure

ACCEPTANCE BY CLIENT

Unsuccessful evaluation

NON-CONFORMING

REJECTION NOTICE OF

CERTIFICATE ISSUE (F 48 V)

APPOINTMENT OF AUDITORS

(F40) AUDIT PLAN (F41)

OFFER/AGREEMENT (F31)

BUSINESS CONDITIONS (F32)

STAGE I QUESTIONNAIRE

(F42 I.) – GMP+ temporary

acceptance (max 4th months)

GMP+

AUDIT OUTCOME EVALUATION





The certification process mainly consists of:

- Inquiry – completion of Application F30 (Questionnaire for Proposal – Management

System certification);

- Verification of required documentation;

- Identification of aspects, risks and processes of manufacture or services provided

(Stage 1 Audit - On-site/Off-site);

- On-site audit of implementation and application at both, the contractors Head Office

and active operational site (branches), to demonstrate capabilities (Stage 2 Audit);

- Audit evaluation results.

Certification cycle:

- Certification audit - Initial audit and evaluation;

- Surveillance audits as per IAF requirement; the first surveillance shall be carried out

within 12 months from the last day of Stage II Audit;

- Recertification audit (audit re-assessment) with the frequency of 3 years after initial

certification and before the expiry of valid certificate; to maintain a valid certification.

The following articles describe details of individual steps of Certification cycle.

Inquiry/ Offer /Offer Submission and Application Registration

Inquiry of any new Client for Management System certification may be personally

discussed with a responsible LL-C persona, send via email at [email protected] or by mail to

company address, as well as send via electronic form available at LL-C website www.ll-

c.cz. Based on written inquiry or a face-to-face meeting, the LL-C coordinator conducts a

review of obtained information and verifies whether the CB has a competence and

abilities to perform the certification demanded (based on the scope of accreditation).

Further, reviews whether specific processes (e.g. welding, sterilization) should be

considered is conducted; in cooperation with the Head of CB.

Based on Inquiry, Questionnaire data and a current tariff, LL-C issues F31 form (Proposal

on a management system certification according to the standard(s) …) in written form,

which is send to the address of the Applicant. Further, every Offer must be accompanied

by Business Conditions (F32 form) as this document is its integral and mandatory annex.

Client who accepts an Offer for certification has to confirm the F31 form and Business

Conditions (F32 form). Only an Offer that is signed by an authorised persona and

submitted with signed Business Conditions is taken as a valid contract/agreement for

Management System certification.

By the Application confirmation, following process is initiated:

- Offer is registered to the internal system of LL-C, including information about the

Applicant;

- Lead Auditor is appointed; Lead Auditor starts to plan the audit (contact person

authorised by the Applicant, additional conditions, creation of audit team, fix an audit

date);

- The Applicant is requested to submit the management manual or other document(s)

describing the management system at least 14 days before the audit starts (first date

of audit).

Auditors

The Lead Auditor, Auditors, members of Audit team, Technical Expert and DM (Decision

Maker) are appointed by Head of CB LL-C. The appointment process must comply with

general qualification of Auditors, including their competence and experience, reflecting

mailto:[email protected]

http://www.ll-c.cz/

http://www.ll-c.cz/





applicant activity and any specific processes (e.g. welding) if any occur, impartiality and

independence. The Applicant must be notified in advance about the Lead Auditor

appointment.

Client´s documentation submitted

Documentation submitted must reasonably depict the organizational structure of

Applicant company as well as it shall include a precise description of company´s

activities. Above the system management manual, the documentation may include

procedures and work instructions. Documentation must take into account both, direct

and indirect, requirements based on standard(s) applied and Client business scope.

Documentation assessment

LL-C considers all information and documentation of the Applicant/Client to be

confidential.

Lead Auditor shall examine documentation presented in adherence to completeness and

conformity to the requirements of selected standard. In case of major nonconformities,

the applicant receives a Protocol of nonconformities (F46 form). The applicant shall

accept corrective actions to nonconformities which occurred and specify the date for their

compliance. Major nonconformities must be corrected before Stage II Audit. Insignificant

nonconformities and other anomalies may be clarified during the Stage II audit.

Stage I Audit - Initial certification

Stage I Audit is an obligatory part and is carried out as a part of the initial certification

audit (Stage I Audit). Stage I Audit is performed to determine the preparedness of Client

location, status and the main conditions for Stage II Audit.

Results are documented in I. stage Questionnaire, Protocol of nonconformities (F46 form)

and other forms.

In certain cases, and under specific circumstance (particularly standard ISO 9001) Stage

I Audit may be carried out as an offsite audit of the Applicant location via questionnaires

and telecommunication technology (RAP – remote auditing procedures).

In case of GMP+ certification temporary acceptance for max 4 month can be issued.

Audit planning and preparation

Lead Auditor in cooperation with the Applicant draw up an Audit plan and inform the

Applicant about its final version in an appropriate way. The Audit plan shall contain all

information needed for the Applicant to prepare for audit. If necessary, Lead Auditor may

visit the Applicant to plan details.

In case of an integrated audit only one Audit plan is created. Lead Auditor prepares the

Audit plan in order to avoid repeated verification of the common requirements of

individual standards.

AUDIT ON SITE

Opening meeting

The Opening meeting stands for an interview of Auditors with an Applicant and person

responsible for management system in the Applicant company. The goal of Opening

meeting is to:

- Reach a consensus of both parties (Applicant and CB) on the content and procedures

of certification;

- Discuss results of Stage I Audit;

- Determine a manner of communication between both parties;





- Verify whether the extent of audit shall provide sufficient results for further

assessment carried out by the Auditors;

- A declaration of confidentiality and impartiality of audit team.

Stage 2 Audit - Audit performance

Auditors with an assistance from company management or its representatives shall

examine whether the organization unit system is in accordance with the plan; including

amendments adopted during the Opening meeting. During the assessment Auditors can

use questionnaires (for specific standards) and verify whether the management system is

introduced and applied in conformity with requirements of the selected standard as well

as with Client´s documentation. Lead Auditor shall communicate a preliminary report on

results after the audit is done. Audit team is not authorized to release the final result of

certification. A written Audit report containing results of an audit and other important

information shall be received by an Applicant within 14 days. The Applicant may raise

objections and comments within following 14 days. If any nonconformities (major or

minor) are found in the system, the Applicant must propose appropriate corrective

actions and the date of their implementation; the date depends on specific findings.

In case of GMP+ the period between Stage I and II. must not be longer than 4 months.

Evaluation of Audit results

Lead Auditor shall forward all necessary documentation from audit performed to a

responsible persona for an impartial evaluation and decision on certification.

Criteria for evaluation of audit results are as follows:

- Verification of compliance with the relevant standard;

- Verification of compliance with the LL-C Rules;

- Submission and completeness of audit results in the documentation of audit (f.e.

report, questionnaire, reports of nonconformities).

If any uncertainties occur, they shall be clarified by a responsible Evaluator and Lead

Auditor.

If any nonconformities occur an additional audit is needed to verify that corrective

actions were taken successfully before the certificate will be granted.

Information for Applicant

If an Evaluator decides that an outcome of an audit assessment authorizes the CB to

grant a new certificate or maintain a current certificate, the Applicant will receive a

certificate (in case of an initial audit) as well as the Audit report.

If an Evaluator decides that an outcome of an audit assessment does not allow the CB to

grant a new certificate or maintain current certificate, the final decision is notified to the

Applicant including reasons for the decision.

The Applicant has the right to appeal to the Head of CB with a request to challenge the

decision.

Certification contract

The certification contract on management systems dealing with rights and obligations of

any Applicants and CB is concluded by a confirmation of Offer of Management System

Conditions (F31 form) and Business Conditions (F32 form). The Applicant must confirm

both documents (sign), before the Stage I Audit starts. Signed contract is mandatory for

the certification and follow up/ surveillance period.

Certification





Ones all criteria are met; LL-C grants a certification in the form of a certificate. The

Applicant receives official certificates, two original sets in Applicant national language as

well as two original sets in English. Additional fee might be charged if additional copies or

the foreign language version(s) of certificate are required. All issued certificates are valid

for a period of three years under certain conditions; follow up / surveillance audits are

performed as well as compliance with conditions of the relative standard are confirmed.

Use of LL-C logo and other marks

The use of LL-C logo and marks is regulated in compliance with Business Conditions (F32

form). Any certified entity must comply with the terms in F32 form.

Certification maintenance

In order to maintain the valid certificate LL-C provides an annual surveillance audit to

determine the effectiveness of the system. Surveillance audits are carried out in

compliance with the certification cycle; surveillance audit shall not be later than 1 year

from the last day of Stage II Audit or no later than last day of first surveillance audit.

If surveillance audit findings show nonconformities in Client´s management system

according to the standards, the Client is allowed to take corrections and corrective

actions and implement them by the established deadline. LL-C verifies and decides if the

relative corrective action(s) is/are sufficient enough to maintain the current certification.

The recertification audit shall be done prior to the expiry date of the certification if Client

wishes to continue certification with LL-C. Therefore, recertification audits shall be

planned ahead of time and Client shall be informed. Recertification audits evaluate and

confirm the continued conformity and effectiveness of the management system, further

its commitment to maintain the effectiveness and improvement, and its continued

relevance and applicability for the scope of certification. The recertification audit shall be

planned and conducted in due time to enable for timely renewal before the certificate

expiry date.

Procedures and guidelines for recertification audits are consistent with procedures and

guidelines for an initial audit. If any important changes, e.g. object of activity or

documentation, in Client´s organization occur they shall be submitted to LL-C at least 14

days before the audit starts.

Additional audits (in GMP+ schemes are carried out in accordance with GMP+C12

document.





B) Process of Product Certification

Certification process diagram – certification of product, process or service*

* The Certification process diagram (above) does not apply to Medical Devices Certification process;

Medical Devices Certification process described separately in Technical Guide for Product certification - Medical Devices MDD (Rule 15.11).

CLIENT

LL-C

PROCESS PARTICIPANT SUBCONTRACTOR

OWN EQUIPMENT YES

CLIENT INQUIRY

INQUIRY DETAILS

TELEPHON

EMAIL

APPLICATION

APPLICATION REGISTRATION

APPLICATION

FORM F30 V

APPLLICATION EVALUATION

REGULATIONS OF GOVERN.

HARMONISED STANDARDS

LIST OF SUBCONTRACTORS EVALUATION

SCOPE DEFINITION

PLAN OF EVALUATION F41 V

EXECUTION OF TESTS IN LABORATORY ,

CALCOLATIONS

EXECUTION OF TESTS IN LABORATORY ,

CALCOLATIONS

OWN EQUIPMENT NO

EVALUATION OF THE RESULTS OF

TESTS

EVALUATION QUESTIONNAIRE

(F 42 V) RECORDS FROM

ASSESSMENT( F44)

COMPILATION OF FINAL DOCUMENTS

COMMENTS AND ACCEPTANCE BY

CLIENT

f

EVALUATION REPORT (F 43 V)

DECISION ON CERTIFICATIO (F 47 V) CERTIFICATION OF CONFORMITY (F 49 V)

DM

Successful evaluation

EVALUATION FAILED DUE TO INCORRECT EVALUATION PLAN

ACCEPTANCE BY CLIENT

Unsuccessful evaluation

CERTIFICATE ISSUE

REJECTION NOTICE (F 48 V)

TECNICAL

EXPERT





The Certification process mainly consists of:

- Inquiry and completion of application Questionnaire for Proposal – Product

certification (F30V form);

- Verification of required documentation;

- Documentation assessment and creation of Certification Offer – Product certification

(F31V)

- Evaluation process;

- Certification review and;

- Decision on certification.

Certification cycle:

- Initial audit, review and decision on certification by DM (decision maker);

- Surveillance assessment as per IAF requirement; if requested by certification

scheme;

- Recertification (repetitive evaluation and conformity assessment) before the expiry of

valid certificate; to maintain a valid certification.

Inquiry / Offer / Offer Submission and Application Registration

Inquiry of any new Client for Product certification may be personally discussed with a

responsible LL-C persona, send via email at [email protected] or by mail to company´s

address, as well as send via electronic form available at LL-C website www.ll-c.cz. Based

on written inquiry or a face-to-face meeting, the LL-C coordinator conducts a review of

obtained information and verifies whether the CB has a competence and abilities to

perform the certification demanded (the scope of accreditation).

Documentation received at the stage of Application for certification must adequately

define the organizational structure of the Applicant. Further, it has to describe

Applicant´s activities essential for certification for which Application was made.

Documentation may include, in addition to the manual, procedures and work instructions.

Documentation must take into account both, direct and indirect, requirements based on

standards used and the business scope.

Coordinator reviews documentation received to assure that a product certified is covered

by the LL-C accreditation, and whether the CB has competences and capabilities to

perform certification itself. If evaluated positively, based on Inquiry, data from

Questionnaire and a current tariff, LL-C issues Certification Offer – Product certification

(F31V) in written form, which is send to the address of the Applicant. Further, every offer

must be accompanied by Business Conditions – Product certification (F32V) as this

document is its integral and mandatory annex.

Client who accepts an offer for certification has to confirm the Certification Offer –

Product certification (F31 form) and Business Conditions (F32). Only an Offer that is

signed by an authorised persona and submitted with signed Business Conditions is taken

as a valid contract/agreement for Product Certification. The contract is generally

governed by the provisions of the Civil Code Nr. 89/2012 Sb. § 2652 - § 2661 in Czech

Republic and accreditation criteria.

By the Application confirmation, following process is initiated:

- Offer is registered to the internal system of LL-C, including information about the

Applicant;

- Lead Assessor is appointed; Lead Assessor starts to plan the assessment (contact

person authorised by the Applicant, additional conditions, creation of Assessor team,

fix a date of assessment);

- The Applicant is requested to submit Product technical documentation (product

documents, design drawings, validation test reports, instruction manual, risk analysis,

mailto:[email protected]

http://www.ll-c.cz/





investigations, technical test, etc.) at least 14 days before the assessment starts (first

date of assessment).

Assessors

The Lead Assessor, Assessment team members, Technical Experts and person

responsible for the review and Certification decision are appointed by Head of CB LL-C.

The appointment process must comply with general qualification of Assessors, including

their competence and experience, reflecting specificities of the product – its

assessment/evaluation, impartiality and independence. An Applicant must be notified in

advance about the Lead Assessor appointment.

Evaluation activities/processes

Conformity assessment of requirements covered by the scope of certification and other

requirements of certification scheme.

Conformity assessment shall be governed by different procedures depending on the type

of product and consists mainly of:

- Verification of supporting documents, requirements and provisions of the

manufacturer for his quality system, documented in a systematic and orderly

manner in the form of written policy statements, procedures, further a uniform

interpretation of quality policy and procedures such as quality programmes, plans,

manuals and records is granted;

- Conformity assessment of Quality Assurance system to determine whether

requirements set by documentation structure are met;

- Inspection on the manufacturer premises, where technical documentation is

verified, to ensure health and safety requirements are met;

- Verification of Technical documentation submitted by the Applicant, further

conformity assessment of product type (demonstrated) with technical

documentation;

- Appropriate inspection, measurements and tests verifying the compliance with

basic technical requirements for health and safety;

- Appropriate inspection whether harmonised standards were applied.

If any nonconformities occur, the Applicant receives a Report of Nonconformities (F46

form) to which corrective actions must be accepted and a date for their compliance must

be specified. These nonconformities shall be removed before the assessment is done.

Irrelevant nonconformities and anomalies shall be clarified during the assessment period,

if any.

During the evaluation DMs use Questionnaire and verify whether there is a conformity of

documents; relevant standards, Applicant documentation, government regulation and

directives. Lead Assessor shall communicate a preliminary report on the results of

evaluation. The team of Assessors is not authorized to release the final result. A written

Evaluation report containing results of evaluation and other important information shall

be received by the Applicant within 14 days. The Applicant may rise objections and

comments within following 14 days. If any nonconformities (major or minor) are found,

the Applicant must propose appropriate corrective actions and the date of their

implementation; the date depends on specific findings.

Review of certification decision

Lead Assessor shall forward all necessary documentation related to evaluation to DM

(e.g., Head of CB or his deputy) for an impartial assessment and decision on certification.

Criteria for an assessment and a review of evaluation results are as follows:





- Test records/questionnaires;

- Theoretical calculation records and reports (if requested);

- Evaluation Report (F43V);

- Verification of compliance with the LL-C Rules;

- Submission and completeness of evaluation results in the documentation (report,

questionnaire, reports of nonconformities)

- Corrective actions list including response actions and a date of implementation.

If any uncertainties occur, they shall be clarified by a responsible DM and Lead Assessor.

If any nonconformities occur additional tests may be needed to verify that corrective

actions were taken successfully before the certificate will be granted.

Based on findings review the Applicant is informed if additional tests will be needed to

verify the effectiveness of the corrective action(s) taken before granting the Certificate.

The DM reviews the results of additional evaluation. In relation, DM reviews the final

results of evaluation and assessment.

Information for Applicant

If DM decides that outcome of a conformity assessment authorizes the CB to grant a new

Certificate or maintain a current Certificate, the Applicant will receive a Certificate (in

case of an initial evaluation) as well as the Evaluation report, further a report with

additional conditions to be fulfilled before issuing a Certificate (maintaining in case of

surveillance audits).

If a Decision Maker decides that an outcome of conformity assessment does not allow the

CB to grant a new Certificate or maintain a current Certificate, the final decision is

notified to the Applicant including reasons for the decision.

The Applicant has the right to appeal to the Head of CB with a request to challenge the

decision.

Certificate Issuance

Ones all criteria are met; the LL-C grants a certification in the form of a Certificate. The

Applicant receives official Certificates, two original sets in Applicant´s office national

language as well as two original sets in English. Additional fee might be charged if

additional copies or foreign language version(s) of Certificate are required. All issued

certificates are valid for a period of three years under certain conditions; surveillance

audits are performed as well as compliance with conditions of the relative standard are

confirmed.

Use of LL-C logos ad marks

The use of LL-C logo and marks is regulated in compliance with Business Conditions (F32

form). Any certified entity must comply with the terms in F32 form.

Certification maintenance

If required by the certification scheme, to maintain the valid certificate LL-C provides an

annual surveillance assessment to determine that product requirements are fulfilled.

Surveillance assessments are carried out in compliance with the certification cycle;

surveillance assessment shall not be later than 1 year from the last day of Stage II Audit

or no later than the last day of first surveillance assessment.

If surveillance assessment findings show nonconformities, product requirements do not

comply with the standard, the Client is allowed to take corrections and corrective actions

and implement them by the established deadline. LL-C verifies and decides if the relative

corrective action(s) is/are sufficient enough to maintain the current certification.





Certification renewal

The recertification assessment shall be done prior to the expiry date of the certification if

the Client wishes to continue product certification with LL-C. Therefore, recertification

assessment shall be planned ahead of time and the Client shall be informed.

Recertification assessment evaluates and confirms the continued conformity and

effectiveness of the product requirements. The recertification assessment shall be

planned and conducted while taking into consideration time necessary for the renewal

before the certificate expiry date; new Certificate shall be issued before the expiry of the

old one.

If any important changes, e.g. object of activity or documentation, in Client´s

organization occur they shall be submitted to LL-C at least 14 days before the

reassessment starts.

VI. Suspension or termination of certification

Certificate Suspension

In case a breach of certification contract or an infringement by Client occurs and is

followed by a subsequent re-examination of severity violation, the Certificate may be

suspended for a period specified by LL-C.

Certificate suspension may arise for example in following cases:

- Surveillance findings show that the manufacturer does not fulfil obligations imposed

by Management System, further agreed corrective actions were not properly

implemented in time specified and in a way agreed;

- Surveillance audit could not be conducted on time (e.g. entity certified refuses to

perform surveillance);

- Entity certified is in an insolvency or in an anticipation of bankruptcy.

- Entity certified has been using the certificate in an unauthorised way.

The Certificate suspension shall be communicated to the Client by a registered letter and

published on the website of the CB. The holder may appeal to Head of CB within 30 days.

The suspension is withdrawn immediately if the Certified Client demonstrates that

corrective action(s) was/were taken and sufficiently implemented; a breach of

certification contract was removed.

Withdrawal/Termination of certification

If the Certified Client, despite the instructions from LL-C fails to fulfil contract obligations,

e.g. does not take corrective actions or fails to comply with the above mentioned

shortcomings, LL-C immediately terminates the validity of the certificate. Following, the

Client is notified and asked to return all original certificates by registered mail and to

publish information about certificate withdrawal. Other reasons for Termination of

certification may be, for example:

- Surveillance audit shows that essentials Management System requirements are not

met;

- The Certified Client requested a withdrawal;

- Certified products are no longer offered by Client (technical parameters of the product

have changed, therefore the product does not conform with current requirements

anymore);

- The Client fails to meet financial obligations to LL-C





- Any other violations of Business Conditions (F32 form) by the Client.

VII. Responsibility of Certification Body

Confidentiality

LL-C considers all information and documentation of the Applicant/Client to be

confidential.

Appointment of Auditors and their qualification (Management System certification)

Auditors with an appropriate qualification and relevant professional experiences are

appointed for Management System certification. Required skills and knowledge of

Auditors are continuously updated by internal and external trainings.

Auditors or appointed Evaluators involved in certification of a certain Client must not

participate in any consultancy, introduction of management system or to be in any other

way connected to the Applicant/Certified client; impartiality needs to be guaranteed.

Appointed Auditors are presented to the Applicant; Applicant has the right to refuse

individual Auditors. However, the Client/Applicant must explain his motivation for the

refusal of an individual Auditor. On those bases Head of LL-C considers and adopts final

decision. If a complaint from a Client arises, Head of LL-C acts in accordance with the

internal Quality Manual (Rule 01) – mentioned bellow. Further, external Experts and

Auditors are also bound by confidentiality pursuant to the contract with LL-C.

Appointment of Evaluators and their qualification (Product certification)

Assessors with an appropriate qualification and relevant professional experience are

appointed by Head of CB for Product certification. Required skills and knowledge of

Assessors are continuously updated by internal and external trainings.

Assessors or appointed Decision Makers for certification assessment and review shall be

only CB employees, who have not participated in any consultancy, further have no work

relationship to the Applicant/Certified client at least for 2 years and have not participated

on the development of a product certified; impartiality needs to be guaranteed. Unless

appointed Assessor/Decision Maker and/or Technical Expert is a permanent full-time

employee of CB, the assessment is provided under conditions written in the Act and

Behaviour of CB personnel (Rule 05); confidentiality and conflict of interest avoidance are

ensured.

Applicant/Certified client has the right to refuse individual Assessors. However, the

Applicant/Certified client must explain his motivation for the refusal of an individual

Assessor. On those bases the Head of LL-C considers and adopts final decision. If a

complaint from a Client arises, the Head of LL-C acts in accordance with the internal

Quality Manual (Rule 01) – mentioned bellow. Further, external Experts and Assessors

are also bound by confidentiality pursuant to the contract with LL-C.

Records (documents stored)

For the purpose of Market Surveillance Authority (CAI in CZ) and Medical Devices

Surveillance Authority (SÚKL – State Institute for Drug control in CZ), complete

documentation, a part of MDD conformity assessment shall be kept by the manufacturer

or authorised representative for minimum of 5 years from the manufacture of the last

product (in case of implantable MDD for 15 years).

In case of critical nonconformity (annex 1 GMP+ C12 document) certification body is

obligate to inform the GMP+ International.





Publication of Certification

LL-C publishes Certificate holders (Certified clients) at regular intervals on the LL-C

website – www.ll-c.info – on the basis of Validity Code. In case of a suspension or a

withdrawal of Certificate, information is published immediately.

In private certification schemes (FSSC 22000, GMP+) the information about clients and

certification dates etc. are uploaded to specific IS held by scheme owner within 14 days

after every event.

VIII. Responsibilities of Certified Client

(holder of certification)

A. Management Systems certification

Management System supervision

The System Management certification shall be regularly reviewed by documented internal

audits to prove the effectiveness of the system. By acquiring a management certification

Client´s obligation is to uphold to the regular reviews. In case any non-compliance with

the specific standard occur, the Client shall uphold to the commitment to take his own

corrective actions. This commitment shall remain despite the regular monitoring by LL-C.

Assistance for LL-C Auditors

The Certified client is obliged to allow LL-C to perform audit on time, further to provide

any assistance needed to LL-C Auditors performing the audit. The Certified client shall

ensure an access to all premises, inducing scope of certification for Auditors as well as an

access to inspect all relevant documents.

Management System Modifications of Certified Client

The Certified client is obliged to immediately inform LL-C if any changes or modifications

to management system occur and might affect its validity, e.g.:

- Organisational changes occur (change of name/place of cooperation, sale or

undertaking of business or its part, bankruptcy, scope of certification, etc.);

- Substantial changes of product, business activity or services occur;

- In case of product recall (FSSC 22000 scheme, GMP+ FSA)

- Substantial changes in documentation occur.

LL-C shall examine occurred changes. In relation to their character and extent and

extraordinary audit may be scheduled.

B. Product certification

The Certified client (manufacturer) shall affix the EC Declaration of Conformity in

accordance with the Directive.





The Certified Client, holder of Machinery Device Certificate must constantly ensure that

the machinery meets the current technical state of art.

The Certified client, holder of construction product certificate must ensure that the

construction product correspond with the manufacturing technical parameters indicated

in the report and on the valid Certificate. If any changes to the manufacturing process or

to product construction technical parameters occur, the Client is obliged not to include

the existing Certificate with the changed product. Further, the Client is obliged to

communicate any changes with CB, LL-C.

The Certified Client undertakes to ensure fulfilment of obligations arising from the

approved Quality System Management, further to ensure its appropriateness and

effectiveness.

Assistance for the LL-C Evaluators

The Certified Client is obliged to allow LL-C to perform an assessment on time, further to

provide any assistance needed to LL-C Assessors performing the assessment. The

Certified Client shall ensure an access to all premises, inducing scope of certification for

Assessors as well as an access for the inspection of all relevant documents.

Product Modifications of Certified Client

The Certified Client is obliged to inform LL-C if any intended changes in quality assurance

occur. LL-C access changes and decides, whether changes caused a need for a new

conformity assessment to be held.

The Certified Client shall inform LL-C (CB) about all modifications to the approved

proposal. Additional assessment of above mentioned modifications is required. The

additional approval is in a form of a supplement to the EC Design-examination

Certificate. The Certified Client is obliged to immediately inform LL-C if any changes or

modifications, which might affect the certificate validity occur, e.g.:

- Organisational changes occur (change of name/place of cooperation, sale or

undertaking of business or its part, bankruptcy, scope of certification, etc.);

- Substantial changes of product, business activity or services occur;

- Substantial changes in documentation.

LL-C shall examine occurred changes. In relation to their character and extent and

extraordinary audit may be scheduled.





IX. Application of Certification Rules modifications

The certification system of LL-C is based on the requirements of applicable standards and

accreditation requirements. All Certified Clients shall be informed if

changes/modifications requiring certification system modification occur. This situation

may occur in the following cases:

- Revision and/or modification of certification standards;

- Modification of accreditation rules (e.g. changes in surveillance period, expenses

related to accreditation and audits, etc.).

If the Certified Client does not agree with occurred changes, the certification contract will

terminate by the entry of modifications/changes into force.

X. Certification fees and other expenses

Certification fees are set by the Common Customs Tariff of LL-C, which is in accordance

with methodical guidelines of ISO/EN 17021-1. LL-C must follow these requirements,

especially requirements considering audit timeframe.

Certification fees or any other additional costs are a subject of the certification Offer.

A pro forma invoice shall be paid by the Applicant prior to the beginning of the

audit/assessment; payment shall not be bound by the decision on certification, see F32

form.

XI. Complaint and Appeal Procedure

Appeal

Clients may appeal to the LL-C Head of CB within following 30 days. In relation, CB shall

establish an Appeals Committee consisting of 3 Auditors/Assessors or Experts who were

not involved in certification activities related to a Complaint or an Appeal. This

Committee reviews and verifies all necessary information and decides by simple majority

vote.

Complaints

Any third party has the right to complain about certification decision to LL-C. If such a

situation occurs, similar procedure as with “Appeal” (above mentioned) is applied;

depending on the type of a Complaint.

If an extraordinary audit is ordered, the Appeals Committee is convened after the

outcomes are disputed.

The precise procedure for receiving Complaints and Appeals, their evaluation and

implementation is documented in Rules of Appeals Committee (Rule 12).

LL-C (Certification) · 17021-1 (up to date version), ... EN ISO/IEC 17065 - General Requirements...

Documents

Transcript of LL-C (Certification) · 17021-1 (up to date version), ... EN ISO/IEC 17065 - General Requirements...