(SECOND EDITION) Accreditation of Inspection Bodies · the Application of ISO/IEC 17020” which is...

HKIAS 003 (SECOND EDITION) Criteria for

Accreditation of Inspection Bodies

Abridged Version

(Requirements and notes of ISO/IEC 17020

are not included in this document. This

document should be read in conjunction

with ISO/IEC 17020 : 1998)

Published by Industry Department, The Government of the Hong Kong Special Administrative Region

36/F., Immigration Tower,

7 Gloucester Road, Wan Chai, Hong Kong

@ Copyright The Government of the Hong Kong Special Administrative Region 1999

First Edition : December 1999 Second Edition : January 2005

Table of Contents

Page

Introduction....................................................................................................................... 1

1. General.............................................................................................................................. 2

2. Definitions ........................................................................................................................ 3

3. Administrative requirement .............................................................................................. 4

4. Independence, impartiality and integrity .......................................................................... 4

5. Confidentiality .................................................................................................................. 5

6. Organisation and management.......................................................................................... 5

7. Quality system .................................................................................................................. 5

8. Personnel........................................................................................................................... 6

9. Facilities and equipment ................................................................................................... 7

10. Inspection methods and procedures................................................................................ 10

11. Handling inspection samples and items.......................................................................... 11

12. Records ........................................................................................................................... 12

13. Inspection reports and inspection certificates................................................................. 14

14. Subcontracting ................................................................................................................ 16

15. Complaints and appeals .................................................................................................. 16

16. Cooperation..................................................................................................................... 17

Annex A - Independence criteria for Type A inspection body ................................................ 18

Annex B - Independence criteria for Type B inspection body................................................. 19

Annex C - Independence criteria for Type C inspection body................................................. 20

Annex D - Information to be included or referenced in the Quality Manual........................... 21

Annex E - Procedures for HKIAS Accreditation ..................................................................... 22

Annex F - Inspection Fields ..................................................................................................... 27

1

INTRODUCTION

The Hong Kong Accreditation Service (HKAS) was set up in 1998 by the expansion of the Hong Kong Laboratory Accreditation Scheme (HOKLAS). HKAS now offers accreditation for laboratories, certification bodies and inspection bodies. It may offer other accreditation services in the future when the need arises.

The accreditation of inspection bodies will be granted under the name of the Hong

Kong Inspection Body Accreditation Scheme (HKIAS). The HKAS Executive is the authority for administering the accreditation of inspection bodies under the name of HKIAS as well as the accreditation of laboratories under the Hong Kong Laboratory Accreditation Scheme (HOKLAS) and the accreditation of certification bodies under the name of Hong Kong Certification Body Accreditation Scheme (HKCAS). The principal aims and objectives of the Hong Kong Inspection Body Accreditation Scheme (HKIAS) are to recognise competent inspection bodies in Hong Kong and to create a fair competitive environment where performance is assessed in accordance with international standards. This booklet (HKIAS 003) details the technical criteria for HKIAS accreditation of inspection bodies. It is subject to regular review and all interested parties are advised to ensure through contact with the HKAS Executive that they hold the current edition. Inspection body accreditation is a formal recognition that an inspection body is competent to carry out specific inspections or specific types of inspection activity. Inspection bodies intending to obtain or maintain accreditation under HKIAS are required to demonstrate:

• technical competence in the specific inspections for which they are accredited or seeking accreditation;

• compliance with the regulations (HKAS 002) which govern the administration of HKIAS and the obligations of HKIAS accredited inspection bodies.

• implementation of an effective quality system in compliance with the technical and management criteria detailed in this booklet HKIAS 003, ‘Criteria for Accreditation of Inspection Bodies’.

• compliance with the IAF/ILAC A4 “Guidance on the Application of ISO/IEC 17020”, a document available for downloading free of charge from the IAF website of www.iaf.nu and the ILAC website of www.ilac.org.

The procedures for seeking accreditation, the processing of applications, and the assessment mechanism are detailed in Annex E of this booklet. HKIAS accreditations are classified under Inspection Fields and the currently available fields are listed in Annex F.

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1. GENERAL 1.1 This document specifies general criteria for the accreditation of impartial bodies

performing inspection irrespective of the sector involved. It also specifies independence criteria.

1.2 This document is intended for the use of inspection bodies seeking and maintaining

HKIAS accreditation. 1.3 Where necessary, HKIAS will provide interpretation documents for applying this set

of criteria to particular sectors and to in-service inspection. 1.4 This criteria document is based on the ISO/IEC 17020: 1998 - ‘General Criteria for

the operation of various types of bodies performing inspection’ published by ISO for use by inspection bodies and does not cover testing laboratories, certification bodies or the suppliers’ declaration of conformity, the criteria for which are contained in other ISO/IEC Standards.

The requirements of ISO/IEC 17020 are reproduced as the main text and additional

HKIAS policies are printed as ….

1.I.1 HKIAS Policy for Subclause 1.4 Applicant and accredited inspection bodies shall also comply with the IAF/ILAC A4 “Guidance on the Application of ISO/IEC 17020” which is available for downloading free of charge from the IAF website of www.iaf.nu and the ILAC website of www.ilac.org. Since the Guidance may be revised from time to time, its latest version shall apply unless announced otherwise by the HKAS Executive. The inspection body should operate, when relevant, in accordance with ISO/IEC 17025 when performing laboratory tests in support of inspection.

This document sets out the basic quality system requirements which all HKIAS

accredited inspection bodies must meet. More detailed requirements specific to certain aspects are issued as individual HKIAS Supplementary Criteria.

A list of such Supplementary Criteria may be obtained from the HKAS Executive.

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2. DEFINITIONS For the purpose of this document the following definitions apply. 2.1 Inspection

(The main text of this clause is the text of the same clause of ISO/IEC 17020 : 1998)

2.I.1 HKIAS Policy for Subclause 2.1 Inspection (ISO/IEC 17020) and product certification (ISO/IEC Guide 65) can be similar. It must be appreciated that one body may carry out and seek accreditation for more than one function of conformity assessment. This document is laying down requirements for and therefore defining inspection. It should be quite evident that a body carrying out product certification in accordance with ISO/IEC Guide 65 should be assessed against that standard. It is for the applicant body itself to request accreditation to a specific standard.

2.2 Inspection Body (The main text of this clause is the text of the same clause of

ISO/IEC 17020 : 1998)

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3. ADMINISTRATIVE REQUIREMENT


3.I.1 HKIAS Policy for Subclause 3.3 Comments on Scope (i) HKIAS presents the scope of activity for which accreditation of inspection bodies is granted

in a formal statement called the scope of accreditation that accompanies the notification letter granting accreditation. An Accreditation Certificate is also issued to the inspection body upon granting accreditation. The scope of accreditation is produced by HKIAS in consultation with the assessor(s) involved in the assessment of the inspection body. It is based on assessment findings and information provided by the inspection body in connection with the application for accreditation. The scope of accreditation will indicate the type of body as defined in Subclause 4.2.

(ii) The scope of accreditation will be defined in sufficiently precise terms such that the client or

user may establish accurately and unambiguously the general inspection field, the type and range of inspection and the methods and procedures or requirements against which the inspection will be performed. The inspection methods that are defined in the scope may be those laid down in national or regional regulations, standard specifications or specific or general requirements. In case of specific or general requirements the inspection body may have to develop its own documented in-house inspection methods or procedures (see Subclause 10.3) and these will be referenced in the scope of accreditation. They may be specific or generic.

Comment on work order (iii) In many inspection areas (e.g. in-service inspection based on national regulations)

individual contracts are not signed with the clients. In these cases the work order is contained in some underlying documentation, e.g. regulations issued by regulatory authorities.

4. INDEPENDENCE, IMPARTIALITY AND INTEGRITY


4.1 General 4.2 Independence 4.2.1 Type A Inspection Body 4.2.2 Type B Inspection Body

4.2.3 Type C Inspection Body

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5. CONFIDENTIALITY


6. ORGANISATION AND MANAGEMENT


7. QUALITY SYSTEM


7.I.1 HKIAS Policy for Subclause 7.2 and 7.3 The quality system of an inspection body need not be complex and its format will depend on factors affecting its operation, including its size, number of staff members, its organisation structure, the range, volume and complexity of the inspections it performs, and whether it has any branch offices. The quality manual describing the inspection body’s quality system should be developed as a working document for use by managers and staff -- not as a checklist for presentation to inspection body assessors. It should be written in a language and a form which is readily understandable by its target users. For large and complex inspection bodies, the quality manual and its related documents may be arranged in a hierarchical format. The top-level manual states the objectives and policies and the lower level manuals provide details of implementing those objectives and policies in specific areas. The quality manual shall be available for examination as a part of the accreditation process. If the inspection activity is already incorporated in a quality manual covering an organisation's total range of operations, it may be necessary to extract the relevant information and expand on it to establish a manual specifically relating to the inspection functions.

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8. PERSONNEL


8.I.1 HKIAS Policy for Subclause 8.1 The appraisal of personnel is a major part of each inspection body assessment as the standard of performance depends largely on the skills of the inspection body's personnel. Three categories of personnel will be assessed. They are :- (a) Inspectors (b) Supervisory personnel (c) Management personnel The requirements for inspectors are covered in Subclause 8.2. The requirements for supervisory personnel and management personnel are given below. The need for supervisory and management personnel and requirements for their qualifications and experience will be carefully examined during the assessment of each inspection body. Factors which will be considered include : (a) the size of the inspection body and the number of inspections carried out, and the

inspections included in the proposed scope of accreditation. (b) the technical complexity of the inspection and professional judgement involved; (c) the frequency at which specific inspections are conducted by the inspection body,

particularly those inspections that are judged to be highly experience dependent; (d) the contact that the management personnel maintain with the development of methodology

and adoption of new methodology within the inspection body. The more remote the management personnel are from the technical inspection operation, the more important would be the supervisory personnel in providing the necessary technical supervision.

Supervisory personnel must have suitable qualifications or training and have sufficient authority, skills and experience to train and supervise their subordinates properly. They must demonstrate appropriate understanding of the field of inspection in which they exercise supervision. They should also have the necessary knowledge and experience to evaluate the professional judgement made by their subordinates. In assessing qualifications, the balance between relevant academic qualifications and practical inspection experience will be examined in the light of the range of inspections performed by the inspection body, its complexity and the precision required. Management personnel need not fully understand every field of inspection they manage but must have adequate inspection experience. They must have suitable qualifications or training, and have sufficient experience and ability to direct the operations of the inspection body, and to accept responsibility for the implementation of the quality system. For an inspection body seeking accreditation for a wide range of complex inspections, management personnel would be expected to hold qualifications which would permit membership of an appropriate professional body. For an inspection body engaged in a limited range of relatively simple inspections, the management personnel, while holding lesser qualifications, must be able to demonstrate their competence by having relevant experience. HKIAS endorsed inspection reports and certificates must be signed by HKIAS approved signatories and the requirements for these signatories are detailed in 13.I.2.

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8.I.2 HKIAS Policy for Subclause 8.2 HKIAS may implement a system of approved inspectors for certain Inspection Fields. Approved inspectors are appraised to be competent by HKAS for carrying out specific inspections or specific types of inspections and the inspection results obtained by them may be reported in HKIAS endorsed inspection reports and certificates. Inspectors to be approved must satisfy the requirements of Subclause 8.2 and are to be nominated by the applicant or accredited inspection bodies. In particular, approved inspectors should be proficient in performing the inspection and using the corresponding inspection equipment, understand the factors affecting the inspection results and possess the required knowledge to make professional judgements based on the examination results. They are also expected to be familiar with Section 9 of the Prevention of Bribery Ordinance (or equivalent ordinance when outside of Hong Kong) and maintain a high level of integrity and professionalism when performing inspections. The approval will be forthwith withdrawn upon any confirmed impropriety, unlawful act or corrupt practice of an approved inspector. As approval is granted in the context of the inspections being performed by a particular inspection body, it is not to be considered as personal qualifications. Details of the approved inspector system and specific requirements applicable to each type of inspection, including the qualification and experience requirements for approved inspectors and the approval procedures are detailed in the HKIAS Supplementary Criteria for the relevant fields of inspection. Colour vision defects and other sensory defects may prevent some people from performing some inspections satisfactorily (such as inspections involving colours). It is the responsibility of the inspection body's management to ensure in such cases that colour vision problems or other sensory defects will not affect validity of inspection results.

9. FACILITIES AND EQUIPMENT


9.I.1 HKIAS Policy for Subclause 9.2 There should be documented instructions to control the use and operation of equipment to ensure that they are used by authorised operators only.

9.I.2 HKIAS Policy for Subclause 9.5 (i) A staff member of the inspection body should be assigned the responsibility to ensure that

the maintenance and necessary calibrations are conducted according to schedule.

(ii) Inspection equipment should be maintained according to an established programme. Maintenance requirements depend on the type, material, construction and frequency of use. Items of equipment consisting of moving parts may require more frequent maintenance.

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9.I.3 HKIAS Policy for Subclause 9.7 and 9.8 (a) HKIAS accepts as evidence of traceability to national and international standard of

measurements those calibrations performed by:

(i) The Government of the HKSAR Standards and Calibration Laboratory; (ii) Nominated primary standards institutions as listed in the HOKLAS Supplementary

Criteria No. 2. (iii) Laboratories accredited by HOKLAS for the specific calibration services provided that

the calibration results are documented in HOKLAS endorsed calibration reports/ certificates.

(iv) Calibration laboratories accredited by MRA partners of HOKLAS for the relevant

calibration, provided that the calibration results are documented in endorsed calibration reports/certificates of the respective accreditation body.

(v) Other specified calibration laboratories within and outside Hong Kong designated by

the HKAS Executive from time to time.

(b) Some items of equipment may be calibrated internally provided the inspection body has the necessary reference standards and materials and the calibration procedures do not demand specialist techniques which are outside the capabilities and experience of its staff. The acceptability of internal calibrations will be evaluated during assessments.

(c) Where the inspection body conducts in-house calibrations, the competence of the

calibration staff, reference standards, calibration procedures including uncertainty estimation and adequacy of calibration records will be assessed.

9.I.4 HKIAS Policy on Subclause 9.10 (a) Many items of equipment, and particularly for chemical analyses, are calibrated by

comparative techniques using reference materials. The employment of reference materials to ensure demonstrated traceability to the relevant basic quantities is an essential condition for the accuracy of results.

The metrological quality of the calibration performed depends on: - the uncertainty of the reference used; - the appropriateness of the reference under the practical conditions of use, also

taking into account the analytical method used and the tested samples.

ISO Guide 32 gives guidelines on calibration in analytical chemistry and use of certified reference materials. Inspection bodies should follow these guidelines for equipment calibration. When using certified reference materials (CRMs) for assessment of a measurement process, the guidelines given in ISO Guide 33 should be followed.

Reference material (RM) : Material or substance, one or more of whose property values

are sufficiently homogeneous and well established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials.

Continued ….

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NOTE : A reference material may be in the form of a pure or mixed gas, liquid or solid.

Examples are water for the calibration of viscometers, sapphire as a heat capacity calibrant in calorimetry, and solutions used for calibration in chemical analysis.

Certified reference material (CRM) : Reference material, accompanied by a certificate,

one or more of whose property values are certified by a procedure which establishes its traceability to an accurate realisation of the unit in which the property values are expressed, and for which each certified value is accompanied by an uncertainty at a stated level of confidence.

NOTES :

1. A reference material certificate is defined as the document accompanying a certified reference material stating one or more property values and their uncertainties, and confirming that the necessary procedures have been carried out to ensure their validity and traceability.

2. CRMs are generally prepared in batches for which the property values are

determined within stated uncertainty limits by measurements on samples representative of the whole batch.

3. The certified properties of reference materials are sometimes conveniently and

reliably realised when the material is incorporated into a specially fabricated device, e.g. a substance of known triple-point into a triple-point cell; a glass of known optical density into a transmission filter; spheres of uniform particle size mounted on a microscope slide. Such devices may also be considered as CRMs.

4. All CRMs lie within the definition of measurement standards or etalons given in the

International vocabulary of basic and general terms in metrology (VIM).

5. Some RMs and CRMs have properties which, because they cannot be correlated with an established chemical structure or for other reasons, cannot be determined by exactly defined physical and chemical measurement methods. Such materials include certain biological materials such as vaccines to which an international unit has been assigned by the World Health Organisation.

Where inspection bodies are undertaking calibrations of equipment through the use of

certified reference materials or reference materials, the onus will be on the inspection bodies to demonstrate to the HKAS Executive :

(i) that sufficient reference materials are held by the inspection body to calibrate the

relevant items of equipment over their intended measurement ranges;

(ii) that full records are kept of the identity and source of each certified reference material and/or reference material;

(iii) in cases where certified reference materials are used, that these materials are

supplied by a recognised national institution. Full documentation of the certified values of these materials and the mode of validation of the certified values must be held;

(iv) in cases where it is necessary to use commercially prepared chemical standards as

reference materials, that the claimed values of each batch of these chemicals are verified before use and records of verification are held; and

(v) that, where necessary, all precautions have been taken to match the matrices of the

reference materials to those encountered in the test samples or that the inspection body has determined and accounted for the effects of any non-matching of matrices.

Continued ….

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Inspection bodies are asked to advise the HKAS Executive of any doubts about the

assigned values of reference materials and inspection bodies are encouraged to refer all such doubts, together with supporting technical details, to the producers of the materials concerned.

10. INSPECTION METHODS AND PROCEDURES


10.I.1 HKIAS Policy for Subclause 10.3 (i) Appropriateness of non-standard methods or procedures implies that these methods or

procedures have been shown to be effective and that their validation procedure is fully documented.

(ii) Inspection bodies may update and modify generic methods and procedures (see HKIAS

policy (ii) to Subclause 3.3) or implement new ones, to allow for technological progress or to satisfy the changing needs of customers, provided that such changes are controlled, that they will not imply any significant deviation from the defined scope and that they are made after proper notification to the HKAS Executive.

10.I.2 HKIAS Policy for Subclause 10.8 The adjective ‘safely’ refers to the safety of personnel and to the protection of surrounding environment.

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11. HANDLING INSPECTION SAMPLES AND ITEMS


11.I.1 HKIAS Policy for maintenance of client information confidentiality during storage and disposal of inspection items

The system employed for storage and disposal of inspection items and information obtained during the inspection process should comply with the confidentiality requirements stated in Clause 5. The inspection body should ensure that the same requirements are observed by its subcontractors and other individuals and organisations working for it.

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12. RECORDS


12.I.1 HKIAS Policy for Subclause 12.1, 12.2 and 12.3 The specific features of inspection body records and their verification which are required of accredited inspection bodies are: (a) Each inspection body must maintain a record system designed to suit its particular

requirements. It need not be an elaborate system but it must include all raw inspection data and provide a traceable link between the item inspected and the report which is eventually issued based on the inspection result obtain from that item. This applies equally to computer and manual record systems.

(b) The system must allow for ready retrieval of original inspection data pertinent to any issued

inspection report or certificate, particularly :

(i) details of the clients and the work order, including records of contract negotiation and telephone conversation;

(ii) full description of each product design, product, service, process or plant inspected; (iii) the unique identifications of the inspected items; (iv) identification of inspection method and the sampling method; (v) identification of inspection equipment and where relevant, the specification of the

equipment; (vi) original inspection and/or test observations, checklists and calculations; (vii) identification of the person performing the inspection and sampling; (viii) identification of where and when the inspection and sampling was performed; (ix) environmental conditions during the inspection and sampling, where relevant; (x) the results of any laboratory tests on the samples; (xi) the supporting rationale for any professional judgement; (xii) identification of the person checking the calculations and data transfer; (xiii) a copy of the issued inspection report or certificate. (This copy must be a complete

and exact copy of the report issued by the inspection body.)

(c) All manual calculations and data transfers shall be subject to appropriate checks.

(d) Where inspection results are derived by electronic data processing techniques, the requirements stated in Subclause 9.13 must be complied with.

(e) All records and inspection reports shall be protected from loss, damage or misuse and

retained in confidence to the client for an appropriate period. (For HKIAS endorsed reports and certificates, the relevant requirements are stated in HKAS 002, Chapter 11.)

Continued ….

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(f) Original inspection observations should be entered at the time of inspection or sampling into

bound notebooks, or onto properly designed proforma worksheets. Where data processing systems are used, records of raw inspection data must be retained unless such data are (electrically) fed directly into the processing system.

(g) Sheets of plain paper should not be used, not only because they are easily lost or discarded,

but also because they engender a less disciplined approach to the recording of information required by an inspection.

(h) Mistakes in recorded data should never be erased or deleted; they should be altered by

crossing out the error and entering the correct information alongside. Any alterations to the inspection records should be clearly initialled or signed by the person making the correction.

(i) Errors in calculations and incorrect transfer of data from workbooks to inspection reports are

major causes of incorrect inspection reports. Calculations and data transfers must be checked and signed or initialled, preferably by a second person. It is desirable to design workbooks and worksheets so that there is a place for the signature of the checking officer.

(j) The period for retention of original inspection data, other inspection body records and test

reports and documents has been set by the HKAS Executive to be a minimum of three years unless otherwise required by law.

For inspections which are impracticable to repeat for evaluating the correctness of inspection results, it is particularly important that the record system is capable of retaining sufficient objective evidence on how the inspection was performed. Photographs or videotapes may be necessary to record how the inspection was performed and how the samples were obtained. Where an inspection body has branch offices at different locations, the inspection records should be retrievable from both the branch office responsible for the inspections and at the main office. The inspection records may be kept at the main office, the branch office or any suitable location.

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13. INSPECTION REPORTS AND INSPECTION CERTIFICATES


13.I.1 HKIAS Policy for Subclause 13.1 (i) Under its HKIAS accreditation the inspection body may issue HKIAS endorsed inspection

reports or certificates for inspection activities described in generic terms in the scope of accreditation (see HKIAS policy (i) for Subclause 3.3), provided that such reports or certificates are issued for an accredited type of inspection using an accredited technical procedure and that they are covered in the accredited Inspection Field.

(ii) Inspection body may issue inspection reports and certificates in electronic formats provided

that they satisfy the requirements of this documents, including those relating to quality of reported results and protection of client information confidentiality.

13.I.2 HKIAS Policy on Approved Signatories for HKIAS Endorsed

Inspection Reports and Certificates HKIAS endorsed inspection reports and certificates must be signed by an approved signatory. An approved signatory is a supervisory or management officer nominated by the inspection body and subsequently assessed and approved by the HKAS Executive to sign such reports. A person nominated for approved signatory status must be competent to make critical evaluation of the inspection results and professional judgements and spend sufficient time in the inspection body to enable him to make this evaluation, occupy a position in his organisation's staff structure which makes him responsible for the adequacy of the inspection results and be fully aware of the requirements detailed in this document and in HKAS 002. Approval may be limited to specific inspections, or may be granted for all inspections for which the inspection body is accredited. As approval is granted in the context of the inspections being performed by a particular inspection body, it is not to be considered as personal qualifications. Signatory approval may be granted to management personnel, provided that they have maintained sufficient contact with inspection techniques to retain a faculty for critical evaluation of the inspection results and professional judgements. The following attributes are taken into account when assessing the suitability of a staff member nominated for approval as a signatory : (a) qualifications and experience; (b) position in the staff structure; (c) knowledge required of an inspector as detailed in Subclause 8.2; (d) knowledge of the inspection procedures and the equipment used; (e) knowledge of the procedure for recording, reporting and checking inspection results; (f) familiarity with the quality system of the inspection body;

Continued ….

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(g) awareness of the regulations and criteria of HKIAS, and particularly those referring to

inspection reports and certificates; (h) awareness of the need to maintain complete integrity and impartiality in all operations and

Section 9 of the Prevention of Bribery ordinance (or similar regulations when outside of Hong Kong).

13.I.3 HKIAS Policy on the amendment of inspection reports or inspection certificates

Amendment to reports or certificates shall be issued in the form of a document bearing an unique identification and include a statement having the meaning of ‘This report supersedes report number xxx issued on date yy’ or ‘This document supplements report number xxx issued on date yy.’

13.I.4 HKIAS Policy on HKIAS Endorsed Inspection Reports and

Certificates Inspections bodies should note the following requirements are applicable to HKIAS endorsed inspection reports and certificates: (a) HKIAS endorsed inspection reports and certificates are governed by the regulations

specified in Chapter 11 of HKAS 002. (b) It is the responsibility of the HKIAS approved signatory to ensure that all relevant

information, including calculations and transfers of data, have been checked before signing an inspection report or certificate.

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14. SUBCONTRACTING


14.I.1 HKIAS Policy for Subclause 14.1 Assigning inspection work to branch offices within the organisation structure of the main office and operating under the same quality system is not considered as subcontracting. However, these branch offices may have to be covered during the assessment if they are to be included in the accreditation sought. The inspection body will also be required to demonstrate that it can exercise effective supervision over the inspections performed by these branch offices.

14.I.2 HKIAS Policy for Subclause 14.2 (a) When an inspection body subcontracts inspection activities, it should select a subcontractor

inspection body which meets the same independence criteria as itself. (see Subclause 4.2) (b) One example of competence needed for the demonstration of the capability of a

sub-contractor is the technical competence needed to assess whether a particular testing facility of the sub-contractor fulfils the requirements of ISO/IEC 17025 which is the relevant standard for testing.

(c) The HKAS regulations governing the reporting of results obtained by subcontractors are

stipulated in clause 11.4 of HKAS 002. 15. COMPLAINTS AND APPEALS


15.I.1 HKIAS Policy for Complaints and Appeals In addition to the requirements in the preceding paragraphs, inspection bodies should note that when a complaint or appeal involving a HKIAS accredited inspection is not satisfactorily resolved within 60 days from the date of receipt, they are required to notify HKAS Executive in writing of the complaint or appeal.

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16. COOPERATION


16.I.1 HKIAS Policy for Cooperation Cooperation may take many different forms, including discussion groups, seminars, exchange of staff, comparison of inspection results obtained from the same samples, etc. Inspection bodies are recommended to plan their cooperation activities to cover its entire range of activities. Participation in local, regional or international inspection body organisation is encouraged.

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ANNEX A (normative)

Independence criteria for Type A inspection body


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ANNEX B (normative)

Independence criteria for Type B inspection body


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ANNEX C (normative)

Independence criteria for Type C inspection body


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ANNEX D (informative)

Information to be included or referenced in the Quality Manual


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ANNEX E PROCEDURES FOR HKIAS ACCREDITATION

A brief summary of the main features is given below. Further details of the processes

involved in achieving HKIAS accreditation are available from the HKAS Executive. STEP 1 - INITIAL CONTACT

(i) An inspection body interested in seeking accreditation contacts the HKAS

Executive in writing.

(ii) Appropriate documentation is provided to the inspection body, including :

HKAS 002 Regulations for HKAS Accreditation

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 the Hong Kong Special Administrative Region

HKIAS 007 Assessment/Reassessment Questionnaire

Relevant HKAS, HOKLAS and HKIAS Supplementary Criteria and Information Notes

(iii) The inspection body lodges the application by providing the following to the HKAS Executive

(a) A completed Application Form for Inspection Body Accreditation (HKIAS 005)

(b) A completed Assessment/Reassessment Questionnaire (HKIAS 007)

(c) The documents specified in the Assessment/Reassessment Questionnaire

(d) Appropriate application fees as stated in HKIAS 006

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STEP 2 - PRELIMINARY ADVICE TO INSPECTION BODY

Following examination of the documentation submitted by the inspection body, the HKAS Executive arranges an advisory visit to :

(a) Answer any questions relating to general criteria and regulations.

(b) Advise on any obvious improvements to existing practice necessary.

(c) Advise on probable requirements for the specific inspections and types of inspection for which accreditation is being sought.

(d) Comment on the acceptability of the inspection body’s quality manual.

STEP 3 - PREPARATION FOR ASSESSMENT

(i) The inspection body submits the final copies of its quality manual and inspection procedures.

(ii) The HKAS Executive seeks any further information required from the inspection body.

(iii) The HKAS Executive selects suitable expert assessors to undertake on-site assessment of the inspection body.

(iv) Arrangements are made with the inspection body for a mutually convenient date or dates for an on-site assessment of the inspection body.

Note : Applicant inspection bodies have the rights to object on reasonable grounds, such as conflict of interest, to the assessors nominated for the assessment of the inspection body.

STEP 4 - ASSESSMENT OF INSPECTION BODY

(i) An on-site assessment is undertaken at the inspection body facility.Where an inspection body seek to include its branch offices in the accreditation, these branch offices may have to be assessed.Witnessing of the inspection body in performing typical on-siteinspections is also part of the assessment process.

Note : All key inspection body personnel must be available for interview on the nominated assessment dates.

(ii) On completion of the on-site assessment, the inspection body management is provided with an assessment report by the assessment team which

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‧ recommends accreditation for the specific inspections and types of inspection sought by the applicant inspection body;

‧ lists any corrective actions which are necessary before accreditation for all or any inspections can be further considered;

‧ details follow-up action.

STEP 5 - ADVICE OF ASSESSMENT OUTCOME

For reassessments and assessments for extension of accreditation within

an Inspection Field for which the inspection body is already accredited, the assessment report will be reviewed by the HKAS Executive. Any amendment to the assessment report will be issued to the inspection body within 10 working days of the assessment. For intial assessments for an Inspection Field, the assessment will be reviewed by the HKAS Executive as well as AAB. The reviewed assessment results will be issued to the inspection body in the form of an Outcome Letter. When there are specific matters requiring attention before accreditation can be considered further, these are listed in the assessment report and in the Outcome Letter.

STEP 6 - CORRECTIVE ACTIONS (if required)

(i) On receipt of written advice from an applicant inspection body that all corrective actions have been taken, the HKAS Executive will take the follow-up action. If the matters are of a minor nature, corrective actions may be confirmed through submission of supporting documentation or through a brief visit by a member of the HKAS Executive and where necessary with an assessor, but in some cases, a further on-site assessment may be needed.

(ii) Assuming the corrective actions are found acceptable, a recommendation for accreditation will normally follow. A formal notification letter, which includes the scope of accreditation and Certificate of Accreditation will be issued.

(iii) If an inspection body is unsuccessful in achieving accreditation, it has the right to appeal (See Chapter 7 of HKAS 002).

STEP 7 - AFTER ACCREDITATION

(i) After accreditation has been granted, inspection bodies are reassessed every two years. Surveillance visits will also be conducted at least once every six months. The purpose is to ensure

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that the standards required for continued accreditation are being maintained.

(ii) Inspection bodies may seek to have their Scope of Accreditation extended or reduced or they may seek changes to their lists of HKIAS approved signatories and lists of approved inspectors. Such changes may require on-site assessment.

(iii) Inspection bodies are required under HKIAS regulations to advise the HKAS Executive immediately in writing of any changes in the inspection body’s circumstances which may affect its continued compliance with HKIAS requirements.

This includes notification of :

(a) Changes in the ownership, name, or any legal, commercial or organisation status of the inspection body;

(b) Changes in the organisation and management staff, e.g. key manager staff;

(c) Changes in policies or procedures; where appropriate;

(d) Changes in the premises, and address of the inspection body;

(e) Changes in personnel, equipment, facilities, working environment or other resources where significant.

(f) Such other matters that may affect the inspection body’s capability, or scope of accreditation or compliance with HKIAS criteria and conditions of accreditation.

CONFIDENTIALITY All information provided by an inspection body in relation to preliminary enquiries, or to an application for accreditation and all information obtained in connection with an assessment of an inspection body is considered by the HKAS Executive to be confidential. Such information is received and studied by only a small number of the HKAS Executive staff, by the expert assessors involved in the assessment and by members of AAB (except where a member may have a conflict of interest). All such persons are made aware of the HKAS policy onconfidentiality of such information.

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ANNEX F INSPECTION FIELDS HKIAS accreditation is currently available in the Inspection Fields detailed below. Additional Inspection Fields may be added as the system develops and requests from the inspection bodies for including additional inspections may be considered by the HKAS Executive.

1. Consumer products: The products include mass produced goods such as

textiles, garments, food and food containers, footwear, toys and children’s products, sundry items, giftware, medical and health products, household appliances, furniture and electrical and electronic products. The inspections may be pre-production inspections, during production inspections, pre-shipment inspections, part of a factory evaluation or for other purposes.

2. Construction products: The products include building, highway and

waterworks products. Welding inspection is also included. The inspections may be pre-production inspections, during production inspections, pre-shipment inspections, part of a factory evaluation or for other purposes.

3. Indoor air quality inspection

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