Guide for

HKAS Lead Assessors,

Assessors and

Technical Experts

HKAS 008

(SECOND EDITION)

Hong Kong Accreditation Service

HKAS 008 (Second Edition)

Guide for HKAS

Lead Assessors,

Assessors

and

Technical Experts

Hong Kong Accreditation Service November 2004

Published by Innovation and Technology Commission, The Government of

the Hong Kong Special Administrative Region

36/F., Immigration Tower, 7 Gloucester Road,

Wanchai, Hong Kong.

© Copyright The Government of the Hong Kong Special Administrative Region 2004

ISBN 962-86584-2-5

Second Edition : November 2004

TABLE OF CONTENTS Page No.

1. INTRODUCTION 1 1.1 Objectives 1 1.2 Definitions 1 1.3 Accreditation 2 1.4 The HOKLAS / HKIAS Approach to Accreditation 2 1.5 Nature of Service provided by Lead Assessors, Assessors and Technical Experts 3

2. ORGANISATION STRUCTURE OF HOKLAS / HKIAS 4 2.1 The HKAS Executive 4 2.2 The Accreditation Advisory Board 5 2.3 Lead Assessors, Assessors and Technical Experts 5

3. APPOINTMENT, TRAINING, SUPPORT, PERFORMANCE MONITORING 6 AND REAPPOINTMENT 3.1 Assessors 6 3.2 Lead Assessors 6 3.3 Technical Experts 7 3.4 Support to Lead Assessors, Assessors and Technical Experts 7 3.5 Performance Evaluation and Reappointment 8

4. ASSESSMENT OBJECTIVES 9 4.1 Competence Evaluation 9 4.2 Advisory Activities 9

5. THE ASSESSMENT TEAM 11 5.1 Composition 11 5.2 Duties of the Assessment Team 12 5.3 Teamwork 12

6. THE ASSESSMENT PROCESS 14 6.1 Types of Assessment 15 6.2 Arranging the Assessment 15 6.3 Briefing of Assessors 15 6.4 The Assessment Visit 17 6.4.1 Arriving at the Organisation's Premises 17 6.4.2 The Opening Meeting 17

6.4.3 Assessment of Quality System and Testing (and/or Calibration) / 17 Inspection

6.4.4 Grading of Non-conformities 19

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6.4.5 Team Discussions 19 6.4.6 Interview of Signatories, Inspectors and other Personnel 20 nominated for Approval 6.4.7 Concluding the Assessment 20 6.4.8 The Closing Meeting 21

6.5 After the Visit 22 6.5.1 HKAS Accreditation Officer as Team Leader of the Assessment 22 6.5.2 Lead Assessor as Team Leader of the Assessment 23 6.5.3 Other Follow-up Actions 24

7. ASSESSMENT TECHNIQUES AND TACTICS 25 7.1 Approach to Assessment 25 7.2 Professional Image 25 7.3 Information Gathering Techniques 28 7.3.1 Observation of the Organisation's Practices 28 7.3.2 Inspection of the Organisation's Facilities and Documents 29 7.3.3 Review of Proficiency Testing or Calibration / Inspection Programme 29

Results 7.3.4 Questioning of Staff 30 7.4 Organisation Diversionary Tactics 32 7.4.1 Time Wasting Techniques 32 7.4.2 Sidetrack Tours 33 7.4.3 Preselected Documents 33

8. OBLIGATIONS OF LEAD ASSESSORS, ASSESSORS AND 34 TECHNICAL EXPERTS

8.1 Contact with Organisations 34 8.2 Confidentiality 34 8.3 Undue Influence 35

9. COMMENTARY ON ACCREDITATION CRITERIA 36 9.1 Management Requirements 36 9.1.1 Organisation and Quality System 36 9.1.2 Technical Records 37 9.2 Technical Requirements 37 9.2.1 Personnel 37 9.2.2 Accommodation and Environmental Conditions 39

Page No.

9.2.3 Test (or Calibration) / Inspection Methods 41 9.2.4 Equipment 42 9.2.5 Measurement Traceability 43 9.2.6 Sampling 44 9.2.7 Handling of Test (or Calibration) / Inspection Items 45 9.2.8 Assuring the Quality of Test (or Calibration) / Inspection Results 46 9.2.9 Reporting Results 47

APPENDIX 1 LIST OF PUBLISHED DOCUMENTS 48 APPENDIX 2 LIST OF SUPPLEMENTARY CRITERIA 50 APPENDIX 3 LIST OF INFORMATION NOTES 53 APPENDIX 4 LIST OF FORMS USED IN ASSESSMENT 54

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1. INTRODUCTION

The Hong Kong Laboratory Accreditation Scheme (HOKLAS) is a voluntary scheme established in May 1985 with the initial objective to support the testing for export needs of Hong Kong. Its accreditation activities have since been considerably extended to include testing for domestic needs. In 1998, the scheme was expanded to form the Hong Kong Accreditation Service (HKAS) which currently operates, in addition to HOKLAS, two accreditation schemes, viz. the Hong Kong Certification Body Accreditation Scheme (HKCAS) and the Hong Kong Inspection Body Accreditation Scheme (HKIAS). This document is intended for use by HOKLAS and HKIAS assessment team members, including Lead Assessors, Assessors and Technical Experts. It specifies the requirements for their roles and appointments and includes details on the assessment process as well as techniques and tactics to be used for assessment. For HKCAS assessors, the relevant HKCAS documents on the operational requirements should be referred.

1.1 Objectives

The primary objectives of HOKLAS / HKIAS are to:

(a) upgrade the standard of management and testing and calibration / inspection

of Hong Kong laboratories / inspection bodies, (b) identify and recognise officially competent testing and calibration

laboratories / inspection bodies in Hong Kong, and (c) promote local and international acceptance of test and calibration / inspection

data from accredited laboratories / inspection bodies HOKLAS / HKIAS is an independent or "third party" accreditation scheme and is designed not only to be as flexible as possible to allow widening of the scope of accreditation when needs are identified, but also to conform to relevant international standards and practice e.g. ISO/IEC 17011.

1.2 Definitions

Definitions and abbreviations of terms are given in Section 1 of HKAS 002 - Regulations for HKAS Accreditation.

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1.3 Accreditation

Accreditation is defined in HKAS 002 as a formal recognition given by an authoritative body to an organisation or person competent to carry out specific tasks. HKAS is such an authoritative body which gives formal recognition to competent laboratories for testing or calibrations under HOKLAS and competent inspection bodies for specific inspections or specific types of inspection activity under HKIAS.

By gaining accreditation, organisations achieve formal and public recognition of their expertise, demonstrating to their clients and to appropriate regulatory bodies that they are capable of working in accordance with currently accepted standards and practice. Those who must make important decisions on the basis of test (and/or calibration) / inspection results, receive an assurance that the organisation is capable of reliable and professional testing (and/or calibration) / inspection. Thus, both the organisation and its clients, and through them the community at large, benefit from the schemes.

1.4 The HOKLAS / HKIAS Approach to Accreditation

HOKLAS / HKIAS accredits laboratories (both medical and non-medical) / inspection bodies based on the accreditation regulations set out in HKAS 002 and the technical criteria given in HOKLAS 003 or HOKLAS 015 / HKIAS 003 which are respectively based on the international standards ISO/IEC 17025 or ISO 15189 / ISO/IEC 17020. Detailed requirements specific to certain administrative and technical aspects are set out in the relevant HKAS, HOKLAS and HKIAS Supplementary Criteria. This approach to accreditation aims to raise standards by helping laboratories / inspection bodies to meet the requirements and provides an unbiased evaluation which will assure users of these laboratories / inspection bodies of the confidence in test and calibration / inspection reports endorsed under HOKLAS / HKIAS.

Assessment team members are expected to be firm in checking conformity and to give general advice, where necessary, on how to achieve conformity, without forcing their own preferences on the organisation.

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1.5 Nature of Service provided by Lead Assessors, Assessors and Technical Experts

Accreditation is useful for enhancing the competitiveness of Hong Kong amongst economies in the world. Domestically, it is used to improve quality of life of fellow citizens and efficiency of the community. Therefore, acting as a HKAS assessor and taking part in the delivery of accreditation service is a service to the community. When a Lead Assessor, Assessor or Technical Expert performs accreditation work for HKAS, he/she is an independent expert working as an independent service provider for HKAS Executive and is not a representative of any other organisation, including one which may employ him/her on a full time basis.

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2. ORGANISATION STRUCTURE OF HOKLAS / HKIAS

The organisation of HKAS in respect of HOKLAS / HKIAS and the relationships between the elements of the two schemes are shown diagrammatically below:

2.1 The HKAS Executive

The HKAS Executive comprises (a) the Commissioner for Innovation and Technology who is the Head of HKAS; (b) the Assistant Commissioner for Innovation and Technology (Quality Services)

who is the Deputy Head of HKAS; (c) the Executive Administrator; and (d) the professional staff.

The HKAS Executive is given the authority to implement and run the schemes on behalf of the Government of the Hong Kong Special Administrative Region (HKSAR). It handles all enquiries on accreditation, offers initial advice to applicant organisations and prepares the background documentation for assessment team members. The authority and administration of the HKAS Executive are described in Section 2 of HKAS 002.

Panel of Lead Assessors,

Assessors, and

Technical Experts

HKAS Executive

Accreditation Advisory Board

(AAB)

AAB Working PartiesHOKLAS HKIAS

Laboratories Inspection Bodies Task Forces

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2.2 The Accreditation Advisory Board

The HKAS Executive is advised by the Accreditation Advisory Board (AAB) on policy matters relating to HOKLAS / HKIAS accreditation and decides, with advice from AAB if needed, whether or not HOKLAS / HKIAS accreditation should be granted, reaffirmed or terminated, based on the report of the assessment team. AAB also makes recommendations on appointment of Lead Assessors and Assessors. The terms of reference of AAB are set out in Section 3 of HKAS 002.

AAB Working Parties are set up to deal with policy and technical matters relating to a specific category or area of tests or calibrations / inspections, and, if necessary, form various Task Forces to undertake specific tasks.

2.3 Lead Assessors, Assessors and Technical Experts

HOKLAS / HKIAS Lead Assessors, Assessors and Technical Experts are drawn from the ranks of government establishments, academic institutions, research associations and commercial consultant firms or laboratories. They are selected on the basis of their professional knowledge of, and expertise in, a particular area of testing or calibration / inspection technology and their ability to investigate and evaluate an organisation's standard of management and operation. Lead Assessors, Assessors and Technical Experts are paid a honorarium to honour their service. It is expected that HOKLAS / HKIAS Assessors, Lead Assessors and Technical Experts would, in addition to evaluate the competence of organisations to be assessed, support the concept of accreditation and the principles of good laboratory / inspection practice embodied within the HOKLAS / HKIAS criteria for accreditation. Any reservations they may have on HOKLAS / HKIAS requirements should be discussed with the HKAS Executive. Such feedback is an essential element in the development of HOKLAS / HKIAS criteria.

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3. APPOINTMENT, TRAINING, SUPPORT, PERFORMANCE MONITORING AND REAPPOINTMENT

3.1 Assessors

A person identified as a suitable HOKLAS / HKIAS Assessor will be invited to fill out a Potential Assessor Information form and to attend at the earliest opportunity an assessor training course recognised by HKAS. The training course will be focussed on the operation of HKAS, interpretation of accreditation criteria, assessment procedure, assessment techniques and code of conduct. An examination will be included in the training course and the candidate is required to pass the examination before being qualified as an Assessor. In general, the AAB Chairman and the Chairman of the relevant AAB Working Party will consider the appointment of an Assessor for a particular test (calibration) / inspection category or area and make recommendation to the HKAS Executive. If accepted, the Assessor will be formally appointed by the HKAS Executive. A HOKLAS / HKIAS Assessor would normally be required to attend at least one assessment as an observer or Technical Expert before taking part in any assessment as an Assessor. He / She will be given the latest editions of all relevant HKAS and HOKLAS / HKIAS publications, supplementary criteria and guidance documents listed in Appendices 1 and 2. It is expected that the Assessor would have read and understood the given documents prior to the assessment.

3.2 Lead Assessors

HOKLAS / HKIAS Assessors who have conducted at least ten relevant assessments may be appointed as Lead Assessors and take the role of leader of assessment team or, where appropriate, the combined roles of the team leader and Assessor, usually for reassessments, assessments for extension of scope of accreditation within the existing test (and/or calibration) / inspection categories, or surveillance visits. For initial assessments, a HKAS Accreditation Officer normally acts as the assessment team leader.

Lead Assessors are selected from the cadre of Assessors on the basis of their experience, expertise and previous performance. Candidates for Lead Assessors shall have successfully completed a lead assessor training course recognised by HKAS, passed its examination and have been formally assessed by HKAS Executive to be a competent Lead Assessor.

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Lead Assessors are appointed by the HKAS Executive, with endorsement from AAB where necessary.

3.3 Technical Experts A person identified as a potential HOKLAS/HKIAS Technical Expert will be invited to fill in a Potential Technical Expert Information Form. If he/she is found to be suitable, HKAS Executive will formally invite him/her to register as a Technical Expert. Prior to assessment, the responsible HKAS accreditation officer will provide the Technical Expert with the necessary documents and brief him/her on the assessment process and the role of each assessment team member. A Technical Expert may be invited by the HKAS Executive to join the cadre of Assessors after he/she has successfully completed an assessor training course and has taken part in or observed at least one assessment.

3.4 Support to Lead Assessors, Assessors and Technical Experts HKAS Executive endeavours to provide Lead Assessors, Assessors and Technical Experts with all the necessary assistance in carrying out their duties. Briefing notes including all the information needed for the assessment are provided for each assessment. Relevant HKAS published documents, e.g. HKAS regulations for accreditation, supplementary criteria and standard assessment forms (see appendices) are available at HKAS website www.info.gov.hk/itc/hkas for download. Appropriate training courses, seminars and workshops for Lead Assessors / Assessors / Technical Experts are also organised and held on a regular basis or when required. To share the assessment experience among Lead Assessors / Assessors / Technical Experts and to seek their views on possible improvements in HKAS accreditation processes, annual assessor seminars normally held in the first quarter of each year are arranged. Lead Assessors / Assessor / Technical Experts are welcome to contact HKAS Executive for any queries and assistance, if required, in relation to assessment.

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3.5 Performance Evaluation and Reappointment

The performance of Assessors and Technical Experts during assessments is evaluated and reported to HKAS Executive by the team leader after each assessment. As for Lead Assessors, their performance will be assessed and recorded by the responsible HKAS Accreditation Officers on the basis of their preparation, overall management and coordination, reports on assessment and assessor performance and follow-up of individual assessments, and, where necessary, on the observations made during their on-site assessments conducted in the presence of the Accreditation Officers. Should there be doubts on the performance and integrity of any Lead Assessor / Assessor / Technical Expert, the responsible Accreditation Officer will inform the HKAS Executive Administrator and provide him with all the necessary evidence for investigation and decision to retain, suspend or terminate the services of the concerned Lead Assessor / Assessor / Technical Expert. Where appropriate, advice and assistance for improvement will be provided to them. The appointments of all Lead Assessors, Assessors and Technical Experts are reviewed and either re-confirmed in writing or terminated by the HKAS Executive Administrator every three years.

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4. ASSESSMENT OBJECTIVES

The main objective of an assessment is to examine and evaluate the competence of an organisation in performing the specific activities listed in the scope of accreditation. A secondary function is to provide, where necessary, general advice to the organisation on correction of perceived deficiencies in its operations. These are discussed separately below, but in practice the evaluation and provision of advice are concurrent during an assessment.

4.1 Competence Evaluation

The competence of an organisation to perform the tests (and/or calibrations) / inspections for which it holds or is seeking accreditation shall be evaluated. This requires assessing the management, staff, facilities, operations, etc. of the organisation against the HOKLAS / HKIAS criteria and any additional requirements for the particular area(s) of testing (or calibration) / inspection for which the organisation is seeking accreditation, as detailed in:

(a) HKAS 002, HOKLAS 003 or HOKLAS 015 / HKIAS 003 (b) HKAS and HOKLAS / HKIAS Supplementary Criteria (c) standard test (or calibration) / inspection methods

The assessment shall be a thorough and critical evaluation of all aspects of the organisation's operations and facilities which will affect the validity and reliability of its test (or calibration) / inspection results. The assessment team shall report the results of its investigation and give its opinion as to whether the organisation complies with the criteria for accreditation.

4.2 Advisory Activities Almost every assessment will reveal some non-conformities. Even in an accredited organisation, it is common to find aspects of its operations or facilities which do not fully conform to accreditation criteria. In providing advice to the organisation, Lead Assessors / Assessors should be very careful not to dictate how a non-conformity should be rectified but simply refer to the accreditation requirements and the usual ways in which the fields concerned normally address the deficiencies. As long as a non-conformity is corrected, the manner in which it is corrected is entirely up to the organisation.

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Assessors' / Lead assessors' personal preferences should not be allowed to influence judgement. Giving any perceived “consultative advice” should be avoided.

Written recommendations on further improving already adequate aspects of the organisation's operations may also be provided but a clear distinction from non-conformity should be made. The advisory activities should not be allowed to take up too much time at the expense of thoroughly examining the organisation’s activities.

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5. THE ASSESSMENT TEAM 5.1 Composition

An assessment team comprises normally a team leader and one or more assessors. It may also include Technical Experts and observers. The role of the team leader is to assign duties to team members, give them support and manage the progress of the on-site assessment. The team leader will usually chair the opening and closing meetings and prepare the assessment report. He/she is usually responsible for assessing the quality system of the organisation but may also assess specific technical areas. Assessors are responsible for assessing specific technical areas, or other areas assigned by the team leader. A Technical Expert, if present in an assessment team, will give technical advice to the team leader. Observers are not members of assessment teams. They do not have any role in assessing the organisation and are not allowed to interfere with the assessment process. The extent to which an observer is allowed for observing the assessment is determined by the team leader. The HOKLAS / HKIAS regulations concerning accreditation procedures are described in Section 4 of HKAS 002. The composition of the assessment team will depend upon the purpose of the particular assessment and the scope and nature of the testing (and/or calibration) / inspection to be examined. More than one assessor may be required if the tests (and/or calibrations) / inspections to be examined are not within the area of expertise of a single assessor.

For initial assessments, a HKAS Accreditation Officer is normally present as the leader of the team. For routine reassessments, assessments for extension of scope of accreditation within the existing test (and/or calibration) / inspection categories and surveillance visits, a Lead Assessor may assume the role of the assessment team leader.

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5.2 Duties of the Assessment Team

The duties of the assessment team are:

(a) examine all aspects of the quality system of the organisation relevant to the scope of accreditation sought;

(b) assess the appropriateness of the test (and/or calibration) / inspection methods used, adequacy of qualifications, experience and competence of the staff, soundness of the organisation's operations and other aspects relevant to the accreditation e.g. suitability of the environment provided for testing (and/or calibration) / inspection, adequacy of equipment, etc.

(c) provide as appropriate a written report which includes: i. both positive and negative comments on the aspects covered by HKAS

002, HOKLAS 003 or HOKLAS 015 / HKIAS 003; ii. a list of non-compliances identified during the assessment;

iii. a list of persons recommended for approval as Approved Signatories and, in case of HKIAS, Approved Inspectors and other types of approved personnel as required by the relevant discipline;

iv. a list of the tests (and/or calibrations) and, for HKIAS, a report on the inspections witnessed.

The team may also comment on any other aspect of the function, management or operation of the organisation pertinent to its accreditation.

5.3 Teamwork

Teamwork is important to the success of any assessment, especially if the assessment becomes difficult. Members of the team should travel to the organisation premises together and do everything possible to give the impression that they are a team. There might be occasions in which their opinions differ but such differences should not be aired in the presence of the staff of the organisation. If the matter cannot be resolved tactfully at the time, the assessment team should leave the issue unresolved, discuss the matter in private and achieve consensus later, if possible.

Team members should have no hesitation in asking the team leader for assistance if they feel that the assessment process is being disrupted or if they do not get the full co-operation of the staff of the organisation.

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Similarly, the team leader has a duty to ensure that the assessment process is thorough and complete. He / She may need to alert the team members to aspects of the organisation's operation which need to be probed further, but this should be done as unobtrusively as possible.

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6. THE ASSESSMENT PROCESS 6.1 Types of Assessment

An assessment of an organisation can normally be categorised under one of the following types:

(a) initial assessment of an applicant organisation; (b) reassessment of an accredited organisation; (c) assessment of an accredited organisation for extension of its scope of

accreditation; (d) follow-up visit as a result of either of the above; (e) surveillance visit.

The reassessments and surveillance visits are conducted to monitor the competence of accredited organisations. The procedure and coverage of reassessments are same as that for initial assessments while only selected aspects of the organisation’s operations are examined in surveillance visits. For HOKLAS, reassessments of accredited laboratories are scheduled one year after initial accreditation and every two years thereafter. Between reassessments, surveillance visits, announced or unannounced, are made whenever necessary to confirm the organisation’s continuing compliance with the accreditation requirements, particularly in cases where there is:

i. a significant change in the circumstances of the organisation; ii. a complaint against the organisation; iii. an inter-laboratory / inter-inspection body dispute; iv. poor performance by the organisation in a proficiency testing (or calibration)

/ inspection programme; or v. a need to check on the performance of newly accredited tests (and/or

calibrations) / inspections vi. no visit made in the last 12 months.

For HKIAS, the accredited inspection bodies are reassessed once every two years and routine surveillance visits are made usually every six months.

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6.2 Arranging the Assessment

The HKAS Accreditation Officer to whom the assessment is assigned shall select a suitable team leader, either a HKAS Accreditation Officer or a Lead Assessor, Assessor(s) and Technical Expert(s) for the task and obtain their agreement to participate and the Executive Administrator’s approval for their appointment. The Accreditation Officer will

(a) determine in consultation with the team members the required time, a

tentative plan and mutually convenient date(s) for the assessment; (b) obtain agreement from the Authorised Representative of the organisation to

the selected team members and the proposed assessment plan and dates(s) (c) confirm in writing with the team members and the Authorised Representative

of the assessment details including the purpose, date(s) and time as well as the names and capacity of members of the assessment team

(d) make arrangements for the transport to the organisation, if required.

6.3 Briefing of Assessors

The HKAS Accreditation Officer will prepare briefing documents which may contain some or all of the following once the arrangements for the assessment have been confirmed:

(a) the purpose of the assessment, and any relevant information on previous

visits; (b) the scope of accreditation to be assessed and the test (and/or calibration) /

inspection procedures; (c) the operational procedures in use in the organisation, including where

necessary a copy of the organisation's quality manual; (d) the names, qualifications and experience of senior staff officers of the

organisation, including those approved or nominated as Approved Signatories;

(e) the facilities available, including where appropriate significant items of equipment;

(f) results obtained by the organisation in any proficiency testing (or calibration) / inspection programmes;

(g) any other information on the organisation or its operations which might assist the assessors in their task.

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In case where Assessors and Technical Experts are required for surveillance visits, only those documents relating to the aspects to be covered in the visits will be provided to them. The briefing notes and a letter confirming the assessment arrangements will be sent to all team members well in advance of the assessment. Team members should read the briefing notes thoroughly prior to the assessment.

In addition to the technical criteria given in HOKLAS 003 / HOKLAS 015 / HKIAS 003 for non-medical laboratories / medical laboratories / inspection bodies, there may be other specific requirements that have to be met, e.g. those stipulated in particular test (or calibration) / inspection methods for which the organisation wishes to be accredited. A list of the methods to be assessed should be included in the briefing notes.

Team members should examine the test (and/or calibration) / inspection methods prior to the on-site assessment of the organisation and prepare any specific technical questions in advance of the visit. It is not acceptable to leave examination of the documented methods until the assessment is underway, as this considerably reduces the time available to examine the actual operations. After reading the briefing notes, team members should prepare a list of deficiencies identified, either using the checklist included in the briefing notes or using his own system. He / She should contact the team leader if any additional information about the organisation is required, or if he / she would like the organisation to demonstrate any particular test (and/or calibration) / inspection within the scope of accreditation to be assessed.

The team leader will arrange a meeting or telephone discussion a few days prior to the assessment. To assist both the assessment team and the organisation to schedule their work, the assessment team should agree on a programme for carrying out the assessment in sequence which does not have to be rigidly adhered to. The assessment team should discuss any items which may cause problems and make arrangements for performance of tests (and/or calibrations) / inspections where prior warning is necessary. The plan may have to be modified to fit in with the organisation's lunch break etc. but prior planning avoids wasting time during the assessment. The team leader should record details of discussion in relevant forms e.g. WD-9.11 for HOKLAS.

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6.4 The Assessment Visit

6.4.1 Arriving at the Organisation's Premises

The team leader will, as far as possible, arrange to meet with the other team members and any observers and travel to the organisation premises together. This enables the team to plan its approach and to confirm the part that each member will play in the assessment process. If the team does not travel together, the team members should meet somewhere near the organisation and spend a little time in private discussion before entering the organisation premises together.

6.4.2 The Opening Meeting

The assessment team leader will introduce the team members to the senior staff of the organisation, outline the assessment procedure and clarify any administrative matters related to the accreditation itself, the terms of accreditation, the list of nominees for approved signatories, etc. Agreement on a time-table for the assessment, interview of the nominees, assessment team meeting and closing meeting should be made with consideration given to the organisation's working times. The team leader will also attempt to put the organisation staff at their ease, reduce any tension and allay any nervousness they may feel. To aid other team members in assuming a more active role in this introductory phase, the leader will draw them into the flow of discussion. A good starting point is to request for inspection of training records and to establish which personnel are qualified to perform the various tests (and/or calibrations) / inspections within the scope of accreditation to be assessed.

6.4.3 Assessment of Quality System and Testing (and/or Calibration) /

Inspection

A familiarisation tour of the organisation may be useful if any members of the team have not visited the organisation previously. However, the tour should be kept short. The team members may split up in order to cover more aspects during the available time or they may stay together for part of the time, particularly in case for new assessors.

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The team leader is normally responsible for assessment of the organisation’s quality system and, where specified, the technical aspects. He / She shall ensure that:

(a) on-site activities are co-ordinated and monitored; (b) advice to the team members on HKAS criteria is provided; (c) a uniform assessment quality is maintained; (d) all operations relating to the tests (and/or calibrations) /

inspections within the scope of accreditation to be assessed are adequately covered.

Assessor should examine the technical aspects of organisation operation, including assessment of :

i. technical competence of testing (and/or calibration) / inspection

staff; including their theoretical knowledge and practical techniques;

ii. all aspects of testing (and/or calibration) / inspection process including sample preparation, equipment and methods used, environmental conditions under which the tests (or calibrations) / inspections are conducted, method validation, standards, calibration, reference materials, data recording and analysis, and reporting procedures;

iii. verification practices; iv. performance in proficiency tests

Assessors may also be assigned to assess specified quality system operation, including vertical audits e.g. tracing a test sample from receipt to issue of test report, or visa versa. The checklist in the briefing notes provides a good aide-memoir to the items the assessors need to look at. Assessors should concentrate their efforts on

those items marked with a "•" and spend as much time as possible observing the organisation's actual practice. Request for a particular person to perform specific tests (and/or calibrations) / inspections should be made instead of letting the organisation select them.

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Suspected non-conformities should be recorded in the standard forms AF01 / AF04 / IF01 as they are observed. Scribbling notes and filling out the forms later could waste a lot of time at the end of the day. Attempt to decide whether the recorded observations are really non-conformities at this stage should be avoided. Further advice to assessors on various assessment aspects is given in Section 7. In case of HKIAS, Assessors may be assigned to witness and to evaluate the performance of the inspection process and technical competence of the inspectors on-site. In addition, particular attention should be paid to the integrity of the whole inspection process, including the arrangements for maintaining an appropriate relationship between the inspector and the staff of the organisation being assessed, and the mechanism for prevention of bribery. The findings of the assessment should be recorded in IF04 forms. Technical Experts should work closely with the assessor. They will advise the assessor on whether the observed activities are acceptable. They may propose the activities to be witnessed, observe the activities and interact with the staff of the organisation in the presence of the assessor. If any suspected non-conformity is identified, the Technical Expert should inform and discuss with the assessor who should raise a non-conformity where appropriate.

6.4.4 Grading of Non-conformities

Non-conformities identified during assessments may range from relatively minor to very serious. To ensure their significances are understood, a classification of non-conformities into three grades viz. minor, significant and critical has been adopted for HOKLAS and HKIAS, the details of which can be referred to HKAS Supplementary Criteria No. 2.

6.4.5 Team Discussions

The purpose of team discussions is to allow the team to review the progress of the assessment, resolve any differences, decide whether apparent non-conformities are really non-conformities, and agree to any advice which can be offered on improvement of the operation of the organisation. These discussions also enable the team to discover any aspect of the organisation's operation which may have been overlooked or have not been investigated sufficiently.

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Team discussions should be held prior to the closing meeting. Additional discussions may be necessary, particularly when there are several Assessors and Technical Experts. For HKIAS, as Assessors may be assigned to assess inspections carried out at sites away from the office of the inspection body, they are encouraged to, whenever in doubt, discuss with the team leader through telephone or other means of communication.

6.4.6 Interview of Signatories, Inspectors and other Personnel nominated for

Approval

Sufficient time should be allocated for this task as it usually takes longer than anticipated. It can be carried out at any stage but is probably convenient be done towards the end of the assessment. Where it is necessary to assess the nominees’ familiarisation with the quality system, the assessment is usually carried out by the team leader while the Assessors are responsible for assessing the candidates' knowledge of test (and/or calibration) / inspection procedures and limitations, calibration requirements, etc. Relevant forms e.g. AF02 / AF05 / IF02 should be used to record the results and signed by the team leader and the Assessors. A formal interview may not be needed if discussion with the nominees on other occasions during the assessment is sufficient to enable both the team leader and Assessors to make judgement on the nominees' suitability. For HKIAS, the interview for approved inspectors may be conducted by an Assessor for technical operation alone and the results should be recorded in IF05 forms.

In case where an organisation requests for interviews of their nominees in

between scheduled visits, the interviews may be conducted at the premises of the organisation, the HKAS Executive office or any other convenient location. Where necessary, Assessors and Technical Experts may be invited to conduct such interviews.

6.4.7 Concluding the Assessment

Once the team members are satisfied that they have completed their assessment of the organisation, they should review in private all observations and decide not only whether the apparent non-conformities are really non-conformities, if this has not been done.

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To classify an observation as a non-conformity, it is necessary to identify the clause of HKAS 002, HOKLAS 003 or HOKLAS 015 / HKIAS 003 or the relevant Supplementary Criteria with which it does not comply. This process may sometimes take a considerable amount of time.

The team leader, after finalising the assessment findings, will complete the assessment report AF03 or AF 06 / IF03 which shall be signed by each team member present at the closing meeting. The team leader will ask for input from other team members when compiling the assessment report. The original copy and attachments, if any, of the report will be given to the organisation representative who will be asked to make a photocopy of the report and attachments for the assessment team before the closing meeting is held.

6.4.8 The Closing Meeting

The closing meeting may be attended by the organisation representative and any personnel of the organisation he or she may choose. In the closing meeting, the team leader will be the spokesman for the team but may call upon other team members to contribute on specific matters if deemed necessary.

The efficient conduct of this final meeting will leave a lasting impression of the professionalism of the assessment team and the value of the assessment process. The meeting should not therefore be conducted hastily and a suitable provision for the meeting in the assessment timetable should be included.

The team leader will advise the organisation representative of the outcome of the assessment and may try to get the organisation staff to suggest corrective action to solve any non-conformities if time allows. Where appropriate, advice on improvement in the organisation's operations may also be given. During this meeting it should be emphasised to the organisation staff that any assessment is a sampling exercise and that not every aspect of its activities has been covered. It does not follow, therefore, that no problems exist in areas where none have been reported.

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In presenting the assessment report the team should not be drawn into debating the validity of their recommendations concerning the accreditation of the organisation or the validity of the accreditation requirements. The organisation has an opportunity to refer these matters directly to HKAS in its subsequent response correspondence to the assessment report. Advice should also be given to the organisation that the assessment report will be subject to review and that the organisation will be informed of the amendments, if any, in writing within 10 days following the assessment. For assessments to be referred to AAB, for example, initial assessments or assessments of new test / calibration categories or inspection fields, a formal outcome letter which supersedes the assessment report issued at the closing meeting will be forwarded to the organisation usually within 20 working days from the last date of the assessment visit.

6.5 After the Visit

After an assessment, the team leader shall evaluate the performance of other team members, complete the Lead Assessor/Assessor/Technical Expert evaluation forms (WD-9.4/9.4A/9.26) as appropriate and ensure that any additional assessment reports of the assessors after conclusion of the visit are submitted to HKAS within 3 days of the assessment.

6.5.1 HKAS Accreditation Officer as Team Leader of the Assessment

Being the team leader, the HKAS Accreditation Officer will acknowledge receipt of assessor's report if any, amend the assessment report as appropriate and notify the organisation of the amendments and the reasons for such amendments within 10 working days following the visit. When response to the assessment findings is received from the assessed organisation, the responsible accreditation officer may seek advice from team members before giving a recommendation on the granting or reaffirmation of accreditation.

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6.5.2 Lead Assessor as Team Leader of the Assessment

As team leader, the Lead Assessor shall provide within 3 working days following the on-site assessment the assessment report including AF01, AF02, AF03 (for HOKLAS non-medical laboratories), AF04, AF05 and AF06 (for HOKLAS medical laboratories) or IF01, IF02, IF03, IF04, IF05 (for HKIAS), the scope of accreditation assessed, the list of recommended signatories, inspectors or other type of personnel and any additional assessment report subsequently received from the assessor to the responsible Accreditation Officer. The completed assessor evaluation form (WD-9.4) should also be provided together with the assessment report. The responsible Accreditation Officer will review those documents, amend them where necessary and inform the organisation in writing of the details of and reasons for the amendments within 10 working days following the on-site assessment. The responsible Accreditation Officer will redirect the organisation’s response letter and attachments, if any, upon receipt together with a copy of the assessment report to the Lead Assessor for evaluation. The Lead Assessor shall evaluate the organisation’s response, record his comments in the "Checklist for Mandatory Requirement(s)" WD-9.21 on the remedial actions taken by the organisation against each mandatory requirement. Where necessary, advice may be sought from other team members responsible for the relevant areas. If the Lead Assessor considers that the remedial actions taken are inadequate or inappropriate to address particular mandatory requirements, the Lead Assessor shall inform the responsible Accreditation Officer who will request the organisation in writing to take further actions.

When being satisfied with all the remedial actions taken by the organisation, the lead assessor shall forward the duly completed WD-9.21 and related documents to the responsible Accreditation Officer.

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6.5.3 Other Follow-up Actions

In certain circumstances, it may be necessary for a team member to obtain further information from the organisation in order to clarify matters which could not be examined fully during the visit. Usually the need for such contact will have been recognised during the visit and mutually acceptable arrangements will have been made between the assessment team and the concerned staff of the organisation. Should such a need arise, the contact shall be arranged through the team leader. If any staff member of the organisation contacts any other team member on matter related to the assessment, especially its outcome, the team member shall advise the organisation to contact the team leader. Based on the assessment findings, the HKAS Executive will consider the further action to take, including submission of a report to AAB if required.

If AAB requires clarification of any aspect of the report, further discussions with the assessors will be arranged by the responsible HKAS Accreditation Officer. If, for reasons of policy or practice, any particular recommendation arising from an assessment is not acceptable, the HKAS Accreditation Officer will contact the assessors concerned and give reasons for the decision. The assessment team may decide on the basis of the assessment findings to conduct a follow-up visit or another assessment to evaluate the implementation of remedial actions against non-conformities. Such additional visits will be arranged by the responsible Accreditation Officer when he, where appropriate, together with the team leader if the team leader is a Lead Assessor, has determined that the organisation is ready for the additional visit based on the remedial actions taken or planned. Members of the assessment team for the additional visit may be the same as or different from those for the original assessment.

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7. ASSESSMENT TECHNIQUES AND TACTICS

7.1 Approach to Assessment

Assessment team members should take the approach that they are there to help the organisation being assessed and consider its staff as being partners in the delivery of the accreditation service. They are expected to be firm in discharging their main duty of checking conformity with accreditation criteria and are recommended to offer, where appropriate, advice on how to achieve conformity without comprising their primary role or imposing on the organisation. Such advice should be of a general nature without disclosing confidential information of any third party.

7.2 Professional Image

One of the most valuable tactics for the assessment team to employ is to project professional image of itself and HKAS. To facilitate the projection of such image, the team members should:

(a) be prepared Being caught out because of not having read the documents destroys the

professional image. Since assessment time is very limited, the assessment team members should, prior to the assessment, identify and spend more time on aspects which are critical to the validity of the activities to be assessed.

(b) be precise in questioning Loosely phrased questions or requests cause confusion and waste time. (c) remain calm and courteous Efforts should be made not to become flustered, emotional or argumentative.

"Please" and "thank you" are amongst the most powerful words in a team member’s vocabulary.

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(d) appropriately manage the assessment time and focus on critical issues Every assessment will reveal examples of human error and trivial discrepancies

but evidence of fallibility should be of far less interest than evidence of real deficiencies in the organisation's management and quality systems. The magnitude and significance of a deficiency is the vital issue. To pursue every minor error wastes time and alienates the organisation personnel. Critical comment on minor deficiencies dilutes the effectiveness of critical comment on the major deficiencies. Time management is crucial to the quality of an assessment.

(e) distinguish between chronic and isolated incidences Making an issue out of trivial deficiencies, human errors or isolated mistakes

should be avoided. However, it should be aware that apparently minor problems may be in reality symptoms of a major system fault.

A large number of non-conformities will indicate the absence of an effective system. If only a few minor non-conformities are identified then the system may be in a development phase or staff may not be fully familiar with the system. Should there be no non-conformities observed after tracing the testing / inspection process by a random selection of records and reports, it can reasonably be presumed that an effective quality management system is in place and is being implemented by the organisation personnel.

(f) make allowances

The circumstances surrounding each non-conformity should be considered. Unreasonable levels of diligence or reliability should not be expected from the organisation staff.

(g) be sensitive Assessment team members should try to put the organisation staff at their ease

and should not be afraid to admit that they also make mistakes occasionally.

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(h) be determined and decisive Once sufficient information has been gathered to form the basis of a sound

judgement, there is no point in going over the same ground again. (i) get on with the job Efforts should be made not to be side-tracked into irrelevant conversations. (j) remember that assessment is an information collection process Most of the assessment time should be spent on observing and listening

(allowing the organisation staff to do most of the talking). (k) know who's who Team members should be aware at all times of the relationships between the

organisation personnel. Not only the formal staff structure but also the more important informal structure should be determined.

(l) bear in mind staff sensitivities Criticising staff in front of their subordinates or their seniors and becoming

involved in intra-personnel problems should be avoided. (m) discuss problems on the spot Any non-conformity identified should be discussed fully with the organisation

staff escort. There may be a valid reason for what the organisation is doing.

(n) be prepared to return Team members should keep returning to areas of the organisation's operations

until the conformity to the specified criteria is established. More time should be spent on areas if there are second thoughts or other queries.

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(o) be aware of the time As time begins to run short, it is better to assess the next aspect if all the critical

issues for an aspect have been adequately covered.

(p) avoid too many escorts It is not necessary to have a large number of organisation staff for company. A

large group slows down the progress.

7.3 Information Gathering Techniques

An assessment is an evaluation of information submitted with the organisation's application and those gathered by the assessment team from a variety of sources as listed below :

7.3.1 Observation of the Organisation's Practices

Observation of the activities in the organisation will provide an insight into the level of competence of organisation staff and the manner in which the organisation functions.

The assessment team should witness some or all of the tests (and/or calibrations) / inspections within the scope of accreditation. This allows assessors to evaluate the manipulative skills of testing (and/or calibration) / inspection staff and detect faults in the operation of equipment, facts which cannot be established in the questioning process.

Even if a particular test (or calibration) / inspection is too lengthy to be performed in its entirety during the visit, it should be possible for at least the most critical phases of the test (or calibration) / inspection to be performed in the presence of the assessment team. Depending upon the circumstances, samples or specimens used in such tests (or calibrations) / inspections may be conveniently drawn from the normal work throughput of the organisation or provided by a member of the assessment team through arrangement with the team leader.

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When arranging the assessment, the team leader will request the organisation to assume, as far as possible, its normal operations throughout the assessment visit. Team members should recognise that observation of the routine work performed by the organisation will often yield just as much information on the standard of competence and expertise of the testing (and/or calibration) / inspection personnel as the tests (and/or calibrations) / inspections being witnessed.

7.3.2 Inspection of the Organisation's Facilities and Documents

Thorough examination of facilities and records is essential to the success of any assessment. Depending upon the volume and variety of testing (and/or calibration) / inspection being undertaken in the organisation, the assessment team should select several examples of the types of samples or tests (or calibrations) / inspections being performed and trace through the testing (or calibration) / inspection process from start to finish, or in the reverse direction. The records should be examined for clarity, completeness and consistency. The assessment team should be especially alert to any anomalies or discontinuities; anomalies for which there is no explanation may sometimes be a symptom of a much deeper problem in the operation of the organisation.

7.3.3 Review of Proficiency Testing or Calibration / Inspection Programme Results

Proficiency testing is an established technique commonly adopted by laboratories for quality assurance. It may also, in certain cases, be applied to inspection bodies. The details of any participation by the organisation in external proficiency testing (and/or calibration) / inspection programmes should be included in the briefing documents for consideration during the assessment.

In the course of the assessment, the results obtained in these proficiency testing (and/or calibration) / inspection programmes should be reviewed with the organisation's manager or supervisors. Aspects to be covered include:

i. adherence to the programme instructions ii. difference in testing between the proficiency samples and the normal

samples

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iii. acceptability of the results obtained in relation to the assigned value or consensus mean and the uncertainty of measurement claimed by the laboratory;

iv. appropriateness of action taken by the organisation to determine the causes of and rectify unsatisfactory results

v. use of the results of the programme to improve the general standard of testing (and/or calibration) / inspection undertaken by the organisation.

7.3.4 Questioning of Staff

Effective questioning of the organisation staff is vital to the success of any assessment. Questioning should not be aggressive but must be thorough, and on occasions persistent, if the real facts are to be established. The assessment team should try to put the organisation staff at ease at the start of any questioning or interview session. Knowing that they are under investigation, the organisation staff may react in a variety of ways, for example, by becoming withdrawn or defensive or at the other extreme by responding aggressively. While this reaction may be due to nothing more than nervousness, it may result in evasive answers which make it more difficult for the assessment team to establish the facts. In general terms, indirect questions requiring a substantial response are more useful than direct questions which permit yes / no answers. For example, it is better to ask:

"What interferences have you encountered in analysis by this method?"

and continue this line of questioning rather than simply ask: "Do you correct for the manganese interference?"

Similarly, it is better to say: "Tell me about your experience in.......

rather than

"The briefing notes state that you have 5 years' experience in.......

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Direct questions have a role in the questioning process, but they tend to evoke a defensive reaction in the recipient and may be interpreted as being critical or aggressive. They are best used to clarify particular points during the discussion.

The art of questioning also involves listening for what is not said as much as what is being said. Team members should be alert to answers which appear to be superficial or evasive and be prepared to continue the line of questioning if they sense that any response is incomplete.

Hypothetical questions of the "what if" variety often help in understanding the organisation's systems and in determining whether they can cover all reasonable eventualities.

Team members should not be afraid to admit that they do not understand if the organisation's explanation or response is unclear or unsatisfactory. They should keep questioning, rephrasing the question if necessary, until the answer is clear.

When junior staff are being interviewed there is sometimes a tendency for senior organisation staff to answer on the junior's behalf. This practice must be politely but firmly discouraged.

When interviewing the organisation staff, the team members should never talk down to the staff member. Such an attitude of superiority is unlikely to elicit co-operation. It is important to speak clearly and carefully, phrasing questions using terminology likely to be understood by the staff member in question. Credit should be given where it is due. An occasional compliment and the use of ‘please’ and ‘thank you’ are effective in developing communication.

Finally, team members should be alert to differences in information presented to them from different sources, for example, conflicting answers from different staff members, or differences between what is said and what is observed. Any such differences should be probed until the true situation is established.

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7.4 Organisation Diversionary Tactics

Prior to the assessment, and once it is finished, the organisation would probably acknowledge the benefits of the exercise. However, at the time the assessment is being carried out the majority of the staff would probably prefer the assessment team was not there. The staff are likely to be tense and nervous in what can be a very stressful situation. Nobody likes having his or her work subjected to careful and detailed scrutiny.

The following tactics are occasionally adopted by the organisation staff, sometimes deliberately, but often unwittingly under stress.

7.4.1 Time Wasting Techniques (a) The waffler The organisation staff may speak at length but say nothing. Questions

are never answered directly. (b) The long lunch break

The organisation staff may arrange to take the assessment team to lunch. If this is at a restaurant some distance away, over two hours can be wasted. A light working lunch at the organisation premises is preferable. Long lunches could also potentially be construed as providing opportunity for excessive entertainment contrary to the Prevention of Bribery Ordinance.

(c) Interruptions The organisation staff may be constantly interrupted during the

assessment to take telephone calls, etc. In such circumstances, a request to have these calls held until the assessment is finished should be made politely.

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(d) Unavailability of Key Staff The organisation has plenty of notice of the assessment so there should

be no excuse, other than sickness, for the absence or lateness of key staff members. If they are absent, the assessors should ask the team leader to consider stopping the assessment and rescheduling it.

7.4.2 Sidetrack Tours

Some organisations may present the assessment team with their version of the assessment programme which may include a lengthy tour of the organisations and other areas of interest. Such tours should be politely declined until the assessment is finalised.

7.4.3 Preselected Documents

The assessment team may be presented with sets of test / inspection records and reports for inspection. Team members should not spend too much time looking at these. Instead they should tactfully select more records and reports of their own choice from the organisation's filing system.

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8. OBLIGATIONS OF LEAD ASSESSORS, ASSESSORS AND TECHNICAL EXPERTS On initial appointment, HOKLAS and HKIAS Assessors, Lead assessors and Technical Experts are required to sign a formal agreement to commit themselves to complying with HKAS regulations specified in HKAS 002 and those related to confidentiality, independence from commercial or other interests and acceptance of advantages. They are completely free to decline invitation from HKAS to participate in any particular assessment and should not hesitate to exercise this right if their participation could be a source of inconvenience, a conflict of interest or an embarrassment to themselves, to their employers or to the organisation to be assessed. To avoid potential conflict of interest, Assessors, Lead Assessors and Technical Experts are required to inform HKAS Executive prior to the assessment of any existing, former or envisaged link or competitive position between them, their organisations and the organisation to be assessed. They are also free to withdraw from the HOKLAS / HKIAS panel of Assessors / Lead Assessors / Technical Experts at any time.

8.1 Contact with Organisations

HOKLAS / HKIAS regulations require any contact between the organisations or AAB and an assessor to be through the HKAS Executive. It is particularly important that organisations being assessed do not make direct contact with the relevant assessors prior to or after the on-site assessment. However, provision is given for lead assessors who assume the team leader’s role, to contact the organisations for arrangement and clarification of matters in relation to assessments. Nevertheless, the HKAS Executive takes responsibility for review of all recommendations and observations arising out of assessments and for decision as to the granting of accreditation.

8.2 Confidentiality All information provided by a testing (and/or calibration) / inspection organisation in relation to its accreditation and all information obtained in the course of, or in connection with, an assessment shall be treated in strictest confidence. Even the fact that a particular organisation has applied for accreditation or has been assessed is regarded as being confidential. Assessment team members shall not disclose such information to any person other than an officer of HKAS Executive.

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Briefing notes including any related documents shall be either returned to the HKAS Executive or disposed of in a proper manner (e.g. by shredding) promptly after the assessment. If a follow-up visit is needed, the briefing notes should be retained by the team members until completion of the follow-up visit. There should be no need for team members to retain copies of the briefing notes, but if they do, the briefing notes shall be kept in a secure place. Furthermore, the briefing notes shall not be incorporated into the general record system of the team members’ employers in a manner which would allow unauthorised access by others. Should a technical matter arise during an assessment on which an assessor wishes to undertake further research or seek advice and submit an additional report, such investigation should be undertaken in a manner that will maintain HKAS principles of confidentiality.

8.3 Undue Influence

While undue influence from accredited or applicant organisations on team members is considered unlikely, it is nevertheless possible that the managers or staff members of the organisation may attempt, through the use of corrupt or unethical practices, to influence a team member’s evaluation of the organisation and affect his/her recommendations. If such situation arises, the team member to whom the attempt is made shall immediately report the full details of the incident to the team leader and to the HKAS Executive Administrator who shall then take appropriate action. Team members should refer to Section 5 of HKAS 002 for details on the obligations of accredited organisations.

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9. COMMENTARY ON ACCREDITATION CRITERIA

HKAS does not require any particular sequence or format to be followed in assessment of an organisation. The assessment team is allowed to adopt what it considers to be the most appropriate approach in the circumstances. HKAS does require, however, the assessment team to examine thoroughly all aspects that could affect the reliability of the test or calibration / inspection results the organisation produces.

Assessment shall be conducted against the regulations detailed in HKAS 002, the technical criteria in HOKLAS 003 / HOKLAS 015 / HKIAS 003 and applicable HKAS and HOKLAS / HKIAS Supplementary Criteria. Although the technical criteria for inspection bodies are similar to that for laboratories, the requirements on environmental conditions, equipment, test methods and test records for inspection bodies generally need not be as stringent as for laboratories in view of the lower precision and accuracy for measurements and tests conducted as part of inspection. However, more emphasis should be placed on the supervision and competence of inspectors and the system for protecting the integrity of inspectors and the inspection process. Client requirements, according to which inspections are conducted, should also be taken into consideration when interpreting certain accreditation requirements.

9.1 Management Requirements

9.1.1 Organisation and Quality System

The manner in which an organisation is organised and functions shall be fully documented in some form of manual. Such a manual may be variously referred to as the Quality Manual or Quality Assurance Manual which should detail all the policies, procedures and practices of the organisation or make reference to documents in which they are given.

The team leader or an assigned team member shall examine the manual and establish if both the management and technical requirements stipulated in HOKLAS 003 / HOKLAS 015 / HKIAS 003 are adequately addressed and whether the manual is used as a working document representing the actual manner the organisation is organised and functions.

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Team members should also refer to the manual throughout the course of the assessment. Any differences between its provisions and the actual manner in which the organisation is organised and functions should be brought to the attention of the team leader.

Since inspections are performed on-site in most cases, supervision of inspectors might be difficult. The common practices adopted by inspection bodies to ensure effective supervision of their inspectors include : (a) unannounced on-site supervision by supervisors (b) solicitation of clients’ feedback on performance of the inspectors (c) provision of detailed records including photographs and videos on the

inspection to enable a meaningful review of the inspection results by supervisors.

9.1.2. Technical Records

As part of the accreditation requirements for control of records, test (or calibration) / inspection records shall be clear and unambiguous, be complete in respect of the performance of the test (or calibration) / inspection, and permit the tracing of results from receipt of sample to the issued test (or calibration) / inspection report and vice versa. The application of these concepts will vary from one organisation to another and will depend upon the extent to which the record system is computerised.

The assessment team should be particularly careful to assess whether the record system is sufficient to meet the real needs and circumstances of the organisation. An over-elaborate system is unjustified and should not be demanded.

9.2 Technical Requirements 9.2.1 Personnel

The soundness of management and the competence of staff together represent the most critical factors in the credibility of any organisation. Without sound management and competent staff, no organisation can be regarded as reliable, irrespective of the extent of quality of other facilities it might have.

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The assessment team shall therefore assess the management structure and authority / responsibility relationships within the organisation and probe the organisation manager's understanding of and attitudes to the principles of good management.

Basic information including the names, professional qualifications, titles, duties and technical experience of senior officers of the organisation and Approved Signatories are normally provided in the briefing documents. The assessment team shall establish whether these officers have the depth of knowledge of the testing (and/or calibration) / inspection operations appropriate to their levels of responsibility and are aware of HKAS criteria for accreditation and issue of endorsed test (or calibration) / inspection documents.

HKAS Approved Signatories are officers of the organisation approved by HKAS to sign test (or calibration) / inspection reports bearing the HOKLAS / HKIAS mark. They shall be supervisory and management personnel responsible for the activity, spend sufficient time in the organisation, have sufficient knowledge for making critical evaluation of the results and fully aware of the accreditation regulations and technical criteria. Nominees for signatory approval should be interviewed to determine their suitability. The HOKLAS / HKIAS policies on Approved Signatories and endorsed test (or calibration) / inspection documents are detailed in HOKLAS 003 / HOKLAS 015 / HKIAS 003.

For certain inspection fields, HKIAS may implement a system of approved inspectors. Only the inspection results obtained by approved inspectors may be included in HKIAS endorsed inspection reports. Approval is granted for specific inspections. To obtain approval, an inspector must be nominated by the inspection body, meet the requirements for academic qualification and experience, be competent to perform the inspection, understand the need for integrity and impartiality and have acceptable communication skill. The detailed requirements are given in HKIAS 003 and relevant HKIAS Supplementary Criteria. To assess nominees for approved inspectors, assessors may have to interview the nominees and/or witness inspections performed by the nominees.

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Approved signatories and approved inspectors are not personal qualification. They are granted as part of the accreditation for the organisation. When an approved signatory or an approved inspector leaves the organisation, the approval given to him / her shall be withdrawn.

The testing (and/or calibration) / inspection personnel shall have adequate knowledge of the test (and/or calibration) / inspection procedures used and be skillful in their performance. For smaller organisation, this may be evaluated by questioning the staff concerned and observing their performance of the tests (and/or calibrations) / inspections. For larger organisations, it may not be possible to interview all testing (and/or calibration) / inspection staff and more attention to investigation of arrangements for staff training and supervision should therefore be given. At least some of the testing (and/or calibration) / inspection personnel should be assessed carefully by observation and questioning.

In the course of the visit, the assessment team shall also determine whether:

(a) the total number of staff and the ratio of senior to junior staff are

adequate in relation to the range and volume of work being undertaken; (b) the work of the testing (and/or calibration) / inspection staff are

adequately supervised; (c) satisfactory provisions exist for the control and supervision of

organisation operations during absence of the designated manager or section supervisors;

(d) proper procedures are used for training new staff and for training existing staff in new or rarely used techniques;

(e) opportunities are provided for the organisation’s professional and other staff to maintain contact with developments in relevant testing (and/or calibration) / inspection techniques.

9.2.2 Accommodation and Environmental Conditions

The relative importance of the environment provided for testing (and/or calibration) / inspection depends upon the nature and requirements of the testing (and/or calibration) / inspection undertaken. The environmental conditions shall meet the requirements stated in the test (or calibration) / inspection methods.

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If there are none stated, then the testing (or calibration) / inspection environment should be such that it does not inhibit proper performance of the tests (and/or calibrations) / inspections, or detract from the reliability of the results obtained.

For laboratory assessments, the assessment team should determine whether:

(a) any of the organisation's tests (and/or calibrations) require

environmental control pertaining to temperature, relative humidity, illumination level, air flow, air quality etc. and if so, whether these conditions are controlled and monitored effectively;

(b) all sensitive equipment is suitably situated and isolated from any environmental conditions (e.g. vibration, dust, corrosive fumes, direct sunlight, voltage fluctuations) likely to affect performance;

(c) all ancillary services (e.g. gas, electricity, water, waste disposal, fume extraction) are available and suitably located;

(d) an appropriate standard of tidiness, housekeeping and cleaning is being maintained;

(e) appropriate provision is made for sample preparation and storage, clerical operations and storage of documentation; and

(f) all incompatible activities are effectively separated.

In some laboratories, the specific hazards of the testing (and/or calibration) work may require examination of aspects of accommodation arrangements which might otherwise be classed as staff amenities, for example, provision and location of hand washing, toilet and eating facilities in microbiological laboratories. Team members should be alert to such interactions between the hazards and requirements of testing (and/or calibration) and the utilisation of the organisation by the testing (and/or calibration) staff.

Assessment team members are encouraged to note any facilities or practices within the organisation that are considered to be unsafe, discuss them with the organisation staff and give comments in the assessment report. Any areas of the organisation posing a potential health hazard or considered unsafe should not be entered. Unsafe environment or practices would reflect poorly on the management of the organisation. Failure to note unsafe conditions and make recommendations for corrective action would also reflect poorly on the professionalism of the assessment team.

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However, it should be noted that, for non-medical laboratories, safety is outside the scope of laboratory assessment. Inspections are mostly performed on-site and in many cases the site accommodation and environmental conditions are outside the control of the inspection body. Nevertheless, the inspection body shall check and record in the inspection report the accommodation and environmental conditions for conformity with the specified inspection requirements, if any. In case where these requirements are not met, the inspection body shall consult the client to obtain instruction on whether the inspection should be continued or terminated. As regards inspection safety, the assessment team should check if there are documented instructions given by the inspection body to inspectors for conducting inspection safely. These instructions should highlight the potential danger, precautions and protective measures for different types of inspection site as well as the actions needed when an inspection site is identified to be unsafe for performing inspections. In certain cases, the inspection body may have to provide training to inspectors on safety aspects. If in doubt, the assessment team should seek expert advice. Hong Kong legislation covering safe working environments is given in the Factories & Industrial Undertakings Ordinance, Cap. 59, and monitoring is carried out by the Labour Department, Factories Inspectorate Division. A list of references on safety at work is available at the HKAS website.

9.2.3 Test (or Calibration) / Inspection Methods

The origin of an organisation’s test (and/or calibration) / inspection methods will largely depend upon the nature of the testing (and/or calibration) / inspection work which the organisation undertakes. In some areas of testing (and/or calibration) / inspection, the use of nationally or internationally recognised test (or calibration) / inspection methods is mandatory. In other cases, an organisation may have to adopt test (and/or calibration) / inspection methods specified by its clients or develop its' own procedures. In the latter case, the steps taken by the organisation to validate the test (and/or calibration) / inspection methods shall be examined.

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Proper documentation of the organisation's test (and/or calibration) / inspection methods and strict adherence to these test (or calibration) / inspection methods are important. Stand-alone documents are not necessary if a recognised standard or method is used, providing that standard or method is clear, unambiguous and does not require choices between alternatives. If there is any doubt, then stand-alone procedures should be demanded. In all cases, there shall be effective procedures to ensure that the test (and/or calibration) / inspection methods being used are kept up-to-date. For HOKLAS, the uncertainty of measurement should be reasonably estimated. Rigorous, metrologically and statistically valid calculation may not be necessary. Nature of the test (or calibration) methods and practices within the testing (or calibration) discipline should be taken into consideration.

Ready availability of the test (and/or calibration) / inspection method documents to testing (and/or calibration) / inspection personnel is often a critical factor in ensuring adherence to correct testing (and/or calibration) / inspection procedures. The assessment team shall establish whether the testing (and/or calibration) / inspection personnel have ready access to the documented test (and/or calibration) / inspection methods and are encouraged to refer to them frequently. Although inspection methods are, in many cases, stipulated by the clients, the inspection body should study the methods carefully and resolve any ambiguity and inadequacy. It is also useful to agree with the clients on the procedure to deal with any departure from the inspection requirements.

9.2.4 Equipment

The assessment team shall ensure that the organisation holds all items of equipment necessary for the performance of the tests (and/or calibrations) / inspections for which it is accredited or is seeking accreditation. The organisation shall maintain a list of the significant items of equipment available in the organisation, and this should be inspected during the course of the visit.

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In examination of equipment, the assessment team shall take into account: (a) compliance of the equipment with the detailed requirements of any

relevant standard test (or calibration) / inspection methods; (b) the environment in which the equipment is sited; (c) the condition of the equipment and the manner in which it appears to be

maintained.

For inspection performed on site, it may not be practical for inspectors to bring their own equipment and they may have to use the equipment available on-site. The assessment team should check if the inspectors have adequately verified the suitability of the equipment for use and whether verification records are maintained. To ensure proper verification of equipment, the inspection body is required to provide appropriate training to the inspectors. In certain cases, inspectors may have to bring suitable reference standards for verification of the on-site equipment. However, checking of the calibration certification of the on-site equipment may sometimes be the only practical means of verification. If it is impractical to verify the equipment or if the equipment is found unsuitable, advice from the client as to the continuation of the inspection should be sought. Any observed non-conformities relating to the equipment shall be noted in the inspection report.

9.2.5 Measurement Traceability

HKAS requires testing (and/or calibration) / inspection equipment to be calibrated or verified with traceability, wherever practicable, to the International System of Units (SI). Should this be impossible, traceability to either certified reference materials, agreed methods or consensus standards has to be demonstrated. Equipment having no effect on the accuracy or validity of the tests (or calibrations) / inspections need not be calibrated or verified. The requirements for calibration or verification of individual items of equipment for HOKLAS are detailed in HOKLAS Supplementary Criteria No. 2.

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The organisation shall have a calibration surveillance system to ensure that equipment requiring periodic calibration or verification is calibrated or verified at appropriate time. The assessment team shall determine if the organisation has an effective system extending from primary standards of measurement through to working equipment. The calibration status of all testing (and/or calibration) / inspection equipment shall be fully documented and copies of the calibration documents shall be readily available.

For laboratories seeking HOKLAS accreditation for testing or calibration activities, the assigned assessment team members shall determine the appropriate least uncertainty of measurement to be quoted in the laboratory's Scope of Accreditation (See Section 2 of HOKLAS 003 and Clause 5.6.2 of HOKLAS 015).

Where an organisation calibrates its own equipment, documented calibration procedures shall be provided, the competence of the staff in performing such calibration assessed and the measurement uncertainty estimated.

Specific details of acceptability of chemical reference materials and commercial standard solutions used for the calibration of equipment are found in HOKLAS Supplementary Criteria No. 1.

9.2.6 Sampling

The assessment team shall ensure that the organisation performing sampling holds necessary equipment for the sampling process. The organisation shall have a sampling plan and a sampling procedure that are in compliance with the requirements of test standard or international practices. For in-house sampling procedures, the basis of the suitability of the documented procedures for the intended purposes shall be assessed. Specific sampling requirements for asbestos, environmental samples, construction materials and air testing under HOKLAS are detailed in the corresponding HOKLAS Supplementary Criteria No. 5, 10, 11 and 12 respectively.

Sub-sampling / sample preparation within the organisation shall also be documented. The assessment team shall determine the suitability of the procedures in obtaining a representative test portion for test (or calibration) / inspection.

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For inspection, it is often necessary to perform on-site sampling. The assessment team should witness the performance of such sampling and determine whether the sampling has been carried out in accordance with the established procedure, whether the inspector is competent in performing the sampling and whether agreement has been made with the client on the sampling plan. Assessment on the procedure for locating and verifying the items or lots to be inspected, identification of the selected samples and protection of sample integrity should also be made.

9.2.7 Handling of Test (or Calibration) / Inspection Items

Samples shall be registered upon their arrival at the organisation and uniquely labelled such that there is no confusion in their identification whilst they are in the organisation. They shall be stored safely and securely before, during and after testing (or calibration) / inspection until disposal. The organisation shall have procedures to cover all these aspects. The actual practice must be examined to see that it meets the accreditation requirements. Preparation of samples for test (or calibration) / inspection is an integral part of the testing (or calibration) / inspection process in many tests (or calibrations) / inspections and shall be examined in the same depth as the testing (or calibration) / inspection operations.

If the sample preparation procedures are a possible source of cross-contamination of testing (or calibration) / inspection work, the assessment team should satisfy itself that the sample preparation area or processes are effectively isolated from the testing (or calibration) / inspection processes.

For product inspection, clients will often provide reference samples to the inspection body as standards for comparison with the lots to be inspected. The system adopted by the inspection body to identify such reference samples and to ensure the provision of correct reference samples to inspectors for specific inspections should be assessed. Whether storage condition is suitable for protection of sample integrity should also be checked.

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9.2.8 Assuring the Quality of Test (or Calibration) / Inspection Results

A well-structured and on-going quality control programme for monitoring the validity of test (or calibration) / inspection results is an essential element in the overall quality assurance system within the organisation. The programme will depend upon the nature of the testing (or calibration) / inspection work. For HOKLAS, one or more of the following generalised approaches will normally be applicable:

(a) use of standard reference materials and/or internal quality control (b) replicate tests (or calibrations) using the same or different methods (c) recirculation of samples (d) participation in interlaboratory comparisons and proficiency testing

programmes.

The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to the reviewing of the results. The assessment team shall evaluate the effectiveness of the organisation's quality control system and the techniques used in reviewing of the results. Aspects for review of results obtaining from proficiency testing (or calibration) / inspection programme are covered in Section 7.2.3 of this document. For certain types of inspection, repeat of inspection by the same inspector, another inspector or another inspection body and use of samples of known characteristics for checking the competence of inspectors are possible means of quality assurance. In many cases where these are not practical, the following indirect methods to assure quality of inspection may be useful: (a) more frequent appraisal of staff performance (b) comparison of results obtained by different inspectors for similar

products (c) comparison of results obtained at different time on the same equipment (d) examination of defective samples by another inspector (e) inclusion of further details of inspections in records to allow a more

meaningful review (f) analysis of clients’ feedback

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The acceptability of the overall quality assurance plan should be assessed on the basis of the inspection skill required, the application of the inspection results, the consequence of erroneous inspection results, the requirements of the inspection clients, the practicality of other quality assurance measures and other pertinent factors.

9.2.9 Reporting Results

The form and content of test (or calibration) / inspection reports will depend upon the nature of the tests (or calibration) / inspections being reported, the needs of the recipient, any specific reporting requirements laid down in a standard test (or calibration) / inspection method or by specifying authorities and the requirements of HKAS.

The assessment team should take into account the number of test (or calibration) / inspection reports being issued in relation to the number and availability of people authorised to sign them. The number of test (or calibration) / inspection reports expected to be signed by any one officer of the organisation should not exceed that person's capacity to review and check them adequately before issue.

Specific details of regulations required to be met by the organisation issuing test (or calibration) / inspection reports bearing the HOKLAS / HKIAS endorsement are found in HKAS 002 and HKAS Supplementary Criteria No. 1.

For inspections, certain information may be omitted from an inspection report or certificate or presented in a simplified format upon the request of the clients. The report may also make reference to another documents for more detailed results. However, the assessment team should ensure that the information included in the report or certificate is adequate for the understanding and interpretation of the inspection results and the abridgement or omission will not result in any misunderstanding.

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APPENDIX 1 LIST OF PUBLISHED DOCUMENTS HKAS HKAS 002 Regulations for HKAS Accreditation

HKAS 008 Guide for HKAS Lead Assessors, Assessors and Technical Experts

HOKLAS HOKLAS 003 Technical Criteria for Laboratory Accreditation

HOKLAS 005 Application for Laboratory Accreditation / Extension of Scope of Laboratory Accreditation

HOKLAS 006 Schedule of Accreditation Fees for Laboratories within Hong Kong

Special Administrative Region

HOKLAS 007 Assessment / Reassessment Questionnaire

HOKLAS 009 Directory of Accredited Laboratories (published annually)

HOKLAS 011 Change of Authorised Representative

HOKLAS 012 Application for Additional Copy of a Certificate of Accreditation

HOKLAS 013 Schedule of Accreditation Fees for Laboratories outside the Hong Kong Special Administrative Region

HOKLAS 015 Technical Criteria for Laboratory Accreditation (Medical Laboratories) HOKLAS 016 Assessment / Reassessment Questionnaire – Medical Laboratories

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HKIAS HKIAS 003 Criteria for Accreditation of Inspection Bodies

HKIAS 005 Application for Inspection Body Accreditation / Extension of Scope of Inspection Body Accreditation

HKIAS 006 Schedule of Accreditation Fees for Inspection Bodies within Hong

Kong Special Administrative Region

HKIAS 007 Assessment / Reassessment Questionnaire

HKIAS 011 Change of Authorised Representative

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APPENDIX 2 LIST OF SUPPLEMENTARY CRITERIA . HKAS Supplementary Criteria No.1 Use of HKAS Accreditation marks and claims of

accreditation status Supplementary Criteria No.2 Non-conformities and their grading HOKLAS Supplementary Criteria No.1 Acceptability of Chemical Reference Materials and

Commercial Standard Solutions Used for the Calibration of Equipment

Supplementary Criteria No.2 All Test Categories - Equipment Calibration

Requirements

Supplementary Criteria No. 5 “Environmental Testing" Test Category - Asbestos Sampling and Testing

Supplementary Criteria No. 6 “Environmental Testing” Test Category – Water/

Sediment / Waste Testing

Supplementary Criteria No. 7 Quality Audits and Quality System Review

Supplementary Criteria No. 8 “Environmental Testing”, “Food”, “Miscellaneous” and “Toys and Children’s Products” - Microbiological Testing

Supplementary Criteria No. 9 "Toys and Children's Products" Test Category -

Mechanical and Physical Testing Supplementary Criteria No. 10 "Environmental Testing" Test Category - Accreditation

of Site Testing/Sampling (Water, Waste Water and Sediment)

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HOKLAS (cont’d) Supplementary Criteria No. 11 "Construction Materials" Test Category - Accreditation

of Site Testing/Sampling (Steel, Concrete and its Constituent Materials)

Supplementary Criteria No. 12 “Environmental Testing” Test Category -

Testing/Sampling of Toxic Organic Compounds in Ambient Air

Supplementary Criteria No. 13 “Calibration Services” Test Category - HOKLAS

Policy on Evaluation of Calibration Uncertainties and Reporting of Calibration Results

Supplementary Criteria No. 14 “Electrical and Electronic Products” Test Category -

Accreditation of Product Safety Tests

Supplementary Criteria No. 15 “Construction Materials” Test Category - Accreditation of Non-destructive Tests for Welding of Steel and Metal

Supplementary Criteria No. 16 "Construction Materials" Test Category - Accreditation

of Foundation Tests

Supplementary Criteria No. 17 "Construction Materials" Test Category - Accreditation of Building Components and Related Tests

Supplementary Criteria No. 18 "Construction Materials" Test Category - Accreditation

of Soil and Rock Testing Supplementary Criteria No. 20 "Chemical Testing”, “Construction Materials", “Food”

and “Toys and Children’s Products” – Chemical Testing

Supplementary Criteria No. 21 “Food” – Detection and Quantification of Genetically

Modified Organisms (GMO) in Food by Polymerase Chain Reaction (PCR)

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HOKLAS (cont’d) Supplementary Criteria No. 22 “Textiles and Garments” Test Category Supplementary Criteria No. 23 “Medical Testing” Test Category – Hospital Autopsy Supplementary Criteria No. 24 “Medical Testing” Test Category – Cytopathology Supplementary Criteria No. 25 “Medical Testing” Test Category – Histopathology Supplementary Criteria No. 26 “Medical Testing” Test Category – Chemical Pathology Supplementary Criteria No. 27 “Medical Testing” Test Category – Clinical

Microbiology and Infection Supplementary Criteria No. 28 “Medical Testing” Test Category – Haematology Supplementary Criteria No. 29 “Medical Testing” Test Category – Immunology Supplementary Criteria No. 30 “Medical Testing” Test Category – Molecular

Pathology HKIAS Supplementary Criteria Supplementary Criteria No. 1 Consumer Product Inspection Supplementary Criteria No. 2 Construction Product Inspection – General Products

Supplementary Criteria No. 3 Construction Product Inspection – Welding Inspection

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APPENDIX 3 LIST OF INFORMATION NOTES Information Notes No. 1 "Toys and Children's Products" Test Category -

Determination of Play Value of a Toy

Information Notes No. 2 Safety in the Laboratory - List of References

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APPENDIX 4 LIST OF FORMS USED IN ASSESSMENT 1. AF 01 HOKLAS Observation Form 2. AF 02 HOKLAS Signatory Assessment Form 3. AF 03 HOKLAS Assessment Report 4. AF 04 HOKLAS Detail Report Form (Medical laboratories) 5. AF 05 HOKLAS Signatory Assessment Form (Medical laboratories) 6. AF 06 HOKLAS Assessment Report (Medical Laboratories) 7. IF 01 HKIAS Detail Report Form 8. IF 02 HKIAS Signatory Assessment Form 9. IF03 HKIAS Summary Report Form 10. IF04 HKIAS Inspection Assessment Form 11. IF05 HKIAS Approved Inspector Assessment Form 12. WD-9.4 HOKLAS / HKIAS Assessor Evaluation Form 13. WD-9.4A HOKLAS / HKIAS Lead Assessor Evaluation Form 14. WD-9.26 HOKLAS / HKIAS Technical Expert Evaluation Form 15. WD-9.11 HOKLAS Pre-assessment Meeting Record 16. WD-9.21 Checklist for Mandatory Requirement(s)

Note : All AF and IF forms can be downloaded from HKAS website at

www.info.gov.hk/itc/hkas. Others forms are available at HKAS Office