Regulations for HKAS Accreditation

Transcription

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2 Regulations for HKAS Accreditation

3 Published by Innovation and Technology Commission The Government of the Hong Kong Special Administrative Region 36/F., Immigration Tower, 7 Gloucester Road, Wan Chai, Hong Kong. The Government of the Hong Kong Special Administrative Region 2003 ISBN First Edition : March 2003

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5 INTRODUCTION The Hong Kong Accreditation Service (HKAS) was set up in 1998 by the Government of the Hong Kong Special Administrative Region to provide accreditation service to the public. It was formed through 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 principal aims and objectives of HKAS are:- * to upgrade the standard of conformity assessment services provided by laboratories, certification bodies and inspection bodies; * to identify and officially recognise competent conformity assessment bodies in Hong Kong; and to promote the acceptance of conformity assessment data from accredited conformity assessment bodies, both locally and internationally. The operating cost of HKAS is funded by the Government and is partly recovered by charging fees for services provided by HKAS. HKAS Executive is responsible for administering HKAS, including the accreditation schemes undertaken by HKAS. At present, there are three schemes: the Hong Kong Laboratory Accreditation Scheme (HOKLAS) for laboratories, the Hong Kong Certification Body Accreditation Scheme (HKCAS) for certification bodies and the Hong Kong Inspection Body Accreditation Scheme (HKIAS) for inspection bodies. Participation in the three schemes is voluntary. Organisations which are applying to be accredited or have been accredited under any of the three schemes are required to demonstrate that:- * they are competent in the performance of specific activities for which they are applying for accreditation or have been accredited; * they have implemented an effective quality system which is in compliance with the accreditation criteria as required under the relevant scheme; and * they are in compliance with all the regulations in this booklet (HKAS 002) for activities they have been accredited or for which they are applying for accreditation. These regulations are the governing rules for the administration of the three schemes and contain the obligations of any organisation which has been accredited by HKAS. This booklet has 11 Chapters. The general regulations applicable to all the three schemes are given in Chapters 1 to 8 while the regulations specific to HOKLAS, HKCAS and HKIAS are in Chapters 9, 10 and 11 respectively. The regulations in this booklet will be amended from time to time and organisations accredited by HKAS or have applied for HKAS accreditation will be notified of the changes. All other interested parties are advised to ensure through contact with HKAS Executive that they hold the current edition.

6 1. DEFINITIONS AND ABBREVIATIONS For the purpose of the regulations detailed in this booklet, the following definitions and abbreviations shall apply:- "accreditation" "accreditation body" "accredited certification body" "accreditation criteria" "accredited inspection body" "accredited laboratory" "accredited organisation' 1 'applicant organisation" ''approved inspector" "approved signatory" I4 area of activity" a formal recognition given by an authoritative body that a body or person is competent to carry out specific tasks a body that conducts and administers an accreditation system and grants accreditation (17.2 of ISO/EEC Guide 2 : 1996) a certification body some or all activities of which have been accredited by HKAS and which continues to comply with HKCAS accreditation criteria accreditation regulations, technical and managerial requirements and other accreditation conditions set by HKAS an inspection body some or all activities of which have been accredited by HKAS and which continues to comply with HKIAS accreditation criteria a laboratory some or all activities of which have been accredited by HKAS and which continues to comply with HOKLAS accreditation criteria an accredited certification body, accredited inspection body or accredited laboratory an organisation which has submitted an application for accreditation to the HKAS Executive an individual who is an employee of an accredited inspection body and has been authorised by the inspection body to perform specific inspections for it and to whom HKAS Executive has given formal approval as a competent person for performing such inspections an individual who is an employee of or under contract to an accredited laboratory/inspection body and has been authorised by the accredited laboratory/inspection body to sign reports or certificates issued by the laboratory/inspection body for specific activities and to whom HKAS Executive has given approval for signing endorsed reports or certificates for such activities a name used by HKAS Executive to represent a branch of certification for which HKAS provides accreditation under HKCAS

7 assessor "authorised representative' 1 "Executive Administrator" "HKAS" "HKAS Executive" "HKCAS" "HKIAS" "HOKLAS" "HKSAR" "ICAC" "inspection field" "notification letter" "proficiency testing" a technical expert who has the qualifications and experience necessary for examining, evaluating and judging the effectiveness and quality of an activity of a laboratory, certification body or inspection body, has undergone appropriate training for conducting assessments and has been formally appointed by the HKAS Executive the person who has been employed by an accredited organisation or applicant organisation and is formally nominated by such organisation to represent it to deal with any matter relating to an application for accreditation or an accreditation under a HKAS accreditation scheme (see Chapter 5) the staff member of HKAS Executive who is responsible for the administration of HKAS Hong Kong Accreditation Service the decision making body of HKAS with the executive authority to implement and run HKAS on behalf of the Government. Members include the Commissioner for Innovation and Technology (as the Head), the Assistant Commissioner for Innovation and Technology (Quality Services), the Executive Administrator and professional staff officers. The Head of HKAS Executive is also the Head of HKAS Hong Kong Certification Body Accreditation Scheme Hong Kong Inspection Body Accreditation Scheme Hong Kong Laboratory Accreditation Scheme Hong Kong Special Administrative Region Independent Commission Against Corruption of the Government of the HKSAR a name used by HKAS to represent a branch of inspection for which HKAS provides accreditation under HKIAS letter issued by the Head of HKAS Executive to an applicant or accredited organisation notifying it the terms of accreditation under a HKAS accreditation scheme a method of determining the performance of an organisation by means of comparing the results it obtained for a specific activity from a sample, an instrument or another item with the results for the same activity obtained by other organisations from the same or similar sample, instrument or item. Proficiency testing may be used to determine the performance 6

8 of laboratories and inspection bodies "scope of accreditation" "surveillance" "suspension"* "termination" * "terms of accreditation" "test category" "voluntary suspension" * the activities for which an organisation has been accredited byhkas action taken by HKAS over and above the scheduled reassessments to check an accredited organisation in order to ensure that it continues to comply with the accreditation criteria accreditation held in abeyance by HKAS withdrawal of accreditation by HKAS conditions under which accreditation is granted, for example, the scope of accreditation, reassessment schedule, list of approved signatories, list of approved inspectors, and other special conditions appropriate for a particular accreditation as specified by HKAS a name used by HKAS to represent a branch of testing, calibration or other laboratory activity for which HKAS provides accreditation under HOKLAS suspension requested in writing by an accredited organisation "voluntary termination requested in writing by an accredited termination" * organisation For any other terms not listed above, the relevant definitions in ISO/IEC Guide 2 and the International Vocabulary of Basic and General Terms in Metrology apply. In this document, the term "test" includes "examination" performed by medical laboratories. * This term applies to all or part of the activities under the scope of accreditation of an accredited organisation. No endorsed reports or certificates may be issued by an accredited organisation for the activities which are in the state of suspension, termination, voluntary suspension or voluntary termination.

9 2. AUTHORITY AND ADMINISTRATION OF HKAS 2.1 HKAS Executive is the authority to grant, maintain, supervise, renew, suspend or terminate any accreditation under HOKLAS, HKCAS and HKIAS on behalf ofhkas. 2.2 HKAS Executive is advised by the Accreditation Advisory Board (AAB) (See Chapter 3). 2.3 HKAS Executive will keep confidential all information provided by an organisation in relation to preliminary enquiries or to an application for accreditation and all information obtained in connection with an assessment of an organisation, such that only personnel who require the information for the assessment will have access to such information. Such personnel will include HKAS Executive, assessors involved in the assessment and members of AAB (except where a conflict of interest arises). However, an organisation shall note that it may be necessary to pass the HKAS's files, including any information in relation to it to persons responsible for evaluating the performance of HKAS under a mutual recognition arrangement/agreement which HKAS has concluded or intended to conclude with other accreditation bodies. HKAS will notify those persons the confidential nature of the information. Where the law requires any information to be disclosed to a third party, HKAS will, where possible and permitted by the law, inform the organisation concerned. Furthermore, HKAS will comply with the provisions under the Personal Data (Privacy) Ordinance (Cap. 486) and the rales under the Code on Access to Information of the Government. Subject to the above, HKAS Executive may make copies of any document submitted by an applicant organisation or an accredited organisation. 2.4 HKAS may publish information as HKAS Executive sees necessary, in order to inform applicant organisations and accredited organisations of accreditation criteria and requirements for applying accreditation. 2.5 HKAS Executive may perform an on-site reassessment of an accredited organisation at any time earlier than the scheduled reassessment or conduct an on-site surveillance visit to it without giving prior notice to the organisation. 2.6 HKAS Executive shall have the right to withdraw accreditation or reduce the scope of accreditation of an accredited organisation. Official notification of such withdrawal or reduction will be given in writing by HKAS Executive to the authorised representative. Clause 6.14 in this booklet is applicable to the exercise of rights and powers by HKAS Executive under this clause. 2.7 HKAS Executive shall set fees and charges for any service provided by HKAS. An applicant organisation or an accredited organisation can obtain a list of such fees and charges from HKAS Executive. 2.8 HKAS Executive may investigate any complaint made to the HKAS Executive by a third party against an accredited organisation concerning activities included

10 in its scope of accreditation. The organisation shall provide information to HKAS Executive upon request and shall co-operate with HKAS for the purpose of investigating the complaint. 2.9 HKAS Executive may publish information relating to any suspension and termination of accreditation granted by HKAS in any HKAS publications and in the website of HKAS.

11 3. ACCREDITATION ADVISORY BOARD 3.1 The Accreditation Advisory Board (AAB) is an advisory committee which serves to advise HKAS on matters relating to accreditation. Its Chairman and members are appointed by the Secretary for Commerce, Industry and Technology under the delegated authority from the Chief Executive by notice in the Gazette, normally for a term of two years. The Chief Executive reserves the right to terminate the membership of any member of AAB at any time. 3.2 The Head of HKAS Executive or his/her representative shall act as the ex-officio Vice Chairman of AAB. 3.3 The terms of reference of AAB shall be:- (a) to provide advice to the Head of HKAS Executive on general policy matters relating to accreditation. Such policy matters include:- (i) the modus operandi, management and future development of HKAS; (ii) accreditation criteria, including technical and non-technical requirements and conditions, which an applicant organisation or an accredited organisation shall meet; (iii) charges and fees for the services provided by HKAS; (iv) remuneration for assessors and technical experts; (v) relationships with other accreditation bodies; (vi) promotion of HKAS; and (vii) procedure for handling disputes, complaints and appeals made to HKAS. (b) (c) to review (see Chapter 7), if requested by an accredited organisation, decisions made by HKAS Executive or by AAB; to review and appraise assessment reports and to make recommendations to the Head of HICAS Executive on the following:- (i) (ii) whether accreditation should be granted to an organisation; the scope of accreditation of an organisation; (iii) the terms of accreditation; (iv) whether accreditation regarding any activity of an organisation shall be deferred until the organisation attains the requisite standard; (v) requirements which an individual organisation shall meet in order to 10

12 comply with the HKAS accreditation criteria; and (vi) intervals at which an accredited organisation shall be reassessed. (d) to establish working parties to undertake specific tasks. Where a working party is established for the purpose of examining technical problems in relation to an activity for accreditation, the member of AAB who is most experienced in such an activity will become the chairman of the working party. The findings and recommendations of the working parties shall be reported to AAB. (e) (f) to propose proficiency testing programmes for laboratories and inspection bodies and to review the results of such programmes. to advise HKAS Executive on the establishment and maintenance of a panel of assessors and technical experts for each of the accreditation schemes administered by HKAS., including the following:- (i) (ii) to advise HKAS Executive on the qualification and experience criteria for the selection of assessors and technical experts; and to recommend to the Head of HKAS Executive any training and instructional needs for assessors and technical experts. (g) (h) to identify and evaluate acceptable sources of calibration to meet the needs of any HKAS accreditation scheme and to review periodically these sources of calibration; and to advise HKAS Executive on any other technical or non-technical matters in connection with accreditation in the furtherance of good practice. 3.4 Members of AAB shall include:- (a) (b) (c) (d) representatives from private and public bodies having interests in the promotion of accreditation for laboratories, inspection bodies, certification bodies and other relevant organisations as HKAS Executive sees fit; technical specialists in disciplines relating to HKAS accreditation; major users of HKAS accredited activities in Hong Kong; and representatives from organisations which perform activities which may be accredited under a HKAS accreditation scheme. 3.5 The Executive Administrator, whilst not as a member of AAB, shall attend all meetings of AAB and he/she or his/her appointed deputy from HKAS Executive shall participate in all evaluation meetings of an assessment. 3.6 The meetings of AAB shall be convened by the Chairman. Attendance of at least one-third of its members shall constitute a quorum. 11

13 3.7 AAB may delegate its responsibility to individual members for the purpose of evaluating reports on assessments of individual organisations. AAB is not required to re-consider those reports unless the Chairman considers otherwise. Reports concerning the initial assessment of an applicant organisation and major extensions of scope of the accreditation of an accredited organisation shall in most cases be submitted to the Chairman of AAB and the chairman of the relevant working party, where appropriate, for review. 3.8 If a member of AAB has a pecuniary or otherwise conflict of interest on any matter in relation to a discussion or decision at any of the AAB meetings, he/she shall declare his/her interest to the Chairman before the discussion is to begin or the decision is to be made. The Chairman shall decide, in each case, the extent to which that member may participate in the discussion and decision of the matter. 3.9 If any member of AAB has any connection with an organisation which is being assessed or if there is a conflict of interest on the part of a member of AAB with the organisation which is being assessed, he/she shall abstain from giving any opinion or view on that assessment and withdraw from making any decision on that assessment The Head of HKAS Executive may from time to time establish other special advisory committees separate from AAB and define their terms of reference. 12

14 4. ACCREDITATION PROCEDURES 4.1 An organisation seeking accreditation under any of the three accreditation schemes shall follow the relevant accreditation procedure (See Chapter 9 for HOKLAS, Chapter 10 for HKCAS and Chapter 11 for HKIAS). The organisation shall provide HKAS with all information as required by HKIAS Executive for preparing the assessment of the organisation and shall pay the specified application fees. The organisation shall further cooperate with HKAS Executive and its assessment teams and provide them with full support during an on-site assessment and in any other situation such as to provide all necessary information for assessment of the organisation's competence and its compliance with the accreditation criteria. The organisation shall permit HKAS Executive to make copies of any documents submitted by it for the purpose of assessing its application in accordance with 2.3 of HKAS 002. Furthermore, upon the request of HKAS Executive, the organisation shall provide HKAS Executive with a copy of the documentary standard for which it seeks HKAS accreditation for use during the assessment. All documents provided by the organisation shall be legitimate for use by HKAS Executive in relation to the accreditation under the Copyright Ordinance (Cap. 528). 4.2 An applicant organisation shall use its name and address on an application form. If such organisation is a company incorporated in Hong Kong, the name and address on the application form shall be the name and registered address as recorded in the Company Registry of the HKSAR. If such organisation is a sole-proprietor, the name and address of the organisation shall be those marked on its business registration certificate issued under the Business Registration Ordinance (Cap. 310). 4.3 An applicant organisation shall authorise a person to be its authorised representative. All official communications between HKAS and an applicant organisation or accredited organisation shall be made between HKAS Executive and the authorised representative,, or in his absence, the chief executive or other responsible persons nominated by the organisation. 4.4 If accreditation of an activity of an organisation cannot be completed within one year after the date of the application, HKAS Executive will examine the progress for accreditation. If the delay is not caused by HKAS, HKAS Executive may require the organisation to pay the application fee again. 4.5 On receipt of an application for accreditation under any one of the three schemes from an organisation, a member of HKAS Executive will conduct an advisory or pre-assessment visit to the organisation, with assessors and/or technical experts if necessary, to advise it on accreditation requirements. 4.6 On receipt of sufficient information from the applicant organisation, HKAS Executive will arrange an assessment and set a mutually convenient time with the organisation for an on-site assessment visit. 13

15 4.7 HKAS Executive will appoint an assessment team to assess the organisation. Members of the team will be selected to provide adequate expertise to cover the activities to be assessed. The team may include assessors for quality system operation and technical operation, technical experts and member(s) of the HKAS Executive. A member of HKAS Executive,, if included in the team, will in most cases, be appointed as the team leader and may perform the role as an assessor for assessing the quality system operation of the organisation. A technical expert, if included in an assessment team, will provide technical advice to the team leader and will work closely with an assessor of the team. The HKAS Executive may also include observer(s) in an assessment team. An observer shall be allowed to observe the activities of the assessment team but his/her opinion will not be taken into consideration by the assessment team nor the HKAS Executive. The team leader will determine the responsibility of each team member. 4.8 An applicant organisation may object on reasonable grounds to the appointment of any assessor, technical expert and observer made by HKAS Executive to an assessment team. 4.9 HKAS Executive will set fees for the services provided by assessors and technical experts for assessing an applicant organisation or an accredited organisation. The organisation concerned shall pay the assessment fees and reimburse HKAS Executive of travel expenses incurred in providing services to it HKAS Executive will brief the assessment team in advance on relevant background information of the organisation, its activities to be assessed, the names and backgrounds of its senior staff and the qualification and experience of its proposed approved signatories (if relevant) The assessment team shall assess whether the organisation is competent to perform the activities for which it seeks accreditation. The accreditation criteria set by HKAS will be the criteria for assessing the competence of the organisation Every assessor in an assessment team shall record his/her findings in writing and shall discuss the findings with the team leader who shall thereafter prepare an assessment report summarising the findings. The team leader shall provide a copy of the report to the organisation at the end of the assessment visit and submit the report to the HKAS Executive HKAS Executive may submit the findings of the assessment to AAB for review. HKAS Executive will take into consideration any comments of AAB in the determination of the assessment results and inform the organisation of such results in writing The organisations may be required to complete any remedial measures as HKAS Executive sees necessary. The organisation shall complete the remedial measures and shall inform HKAS Executive in writing of such completion 14

16 within 6 months of the assessment. HKAS Executive will decide whether or not to grant accreditation for the relevant activities to the organisation HKAS will grant accreditation for an activity to an organisation only when: (a) (b) (c) (d) (e) the organisation has applied for HKAS accreditation for such activity, accreditation for such activity is within the scope of accreditation service provided by HKAS, the organisation is found to be competent in performing such activity as assessed by HKAS based on the technical criteria and supplementary criteria set out in 5.1, compliance of the organisation with Chapter 4 and the relevant specific regulations set out in Chapters 9 to 11 is confirmed, and upon granting of the accreditation, the organisation agrees to comply with Chapters 4 to 8, relevant specific regulations set out in Chapter 9 to 11 and any other conditions as specified by HKAS Executive If accreditation for an activity is granted to an organisation, the head of HKAS Executive will send a notification letter to the organisation to inform it of the terms of accreditation HKAS Executive will further issue a certificate of accreditation of the accreditation scheme under which the accreditation is granted to the organisation if any of its activities has been accredited under such scheme The certificate of accreditation shall include details of the accreditation granted, such as the name of the accreditation scheme under which the accreditation is granted, the activities to which the accreditation is related and the conditions under which the certificate is issued. The certificate of accreditation shall also bear a registration number and the date on which it is issued The certificate of accreditation shall remain the property of HKAS and shall be returned to HKAS Executive forthwith upon termination of accreditation The accreditation granted is valid only for the activities described in the accredited organisation's scope of accreditation. The HKAS Executive may amend such scope of accreditation from time to time. For avoidance of doubt, granting of accreditation to an organisation for an activity is recognition of the organisation's competence in performing that particular activity but is not a guarantee of the performance of the organisation nor does it equate to product certification HKAS Executive will maintain and publish in a suitable form as it sees fit in respect of each of the three accreditation schemes a directory of accredited organisations. Each of the directories will contain details of every accreditation granted under the relevant scheme. The details may include the name and address of the accredited organisation, the name of its authorised representative, the name and contacting details of the person responsible for answering 15

17 enquiries and the current scope of accreditation at the time of publication. If any other information in relation to an accredited organisation is to be included in the directory, HKAS Executive will obtain prior consent from it. (See also clauses 9.3.2,103.2 and ) 4.22 The directories will be made available to the accredited organisations and other parties HKAS Executive considers appropriate If an accredited organisation has more than one name, upon its request and at the discretion of HKAS Executive, HKAS may grant accreditation for an activity included in its scope of accreditation to it under its other names. The organisation shall pay application fees and annual subscription fee for the use of each additional name The accreditation obtained by an accredited organisation may be renewed subject to payment of the annual subscription fee and reassessments and surveillance of the relevant activities. HKAS Executive may reaffirm, suspend or terminate the accreditation on the basis of the findings of the reassessment or surveillance The activity/activities listed in the scope of accreditation of an accredited organisation will be reassessed regularly in accordance with the schedule specified in the relevant specific regulations in this booklet. HKAS Executive may vary the reassessment schedule as it sees fit When an organisation is due for a reassessment, HKAS Executive will issue a reminder letter to it and ask it to provide the information necessary for the reassessment within a specified period of time. HKAS Executive may suspend the accreditation of an organisation which fails to provide the information within the specified period. The procedure for arranging a reassessment is the same as for an assessment and as set out in 4.6 to The procedure for carrying out a reassessment is similar to that of an initial assessment except that in most cases, the findings will not be submitted to AAB for review unless its members so request. The organisation being reassessed will be required to carry out any remedial measures as HKAS Executive sees necessary. The organisation shall complete such remedial measures and inform HKAS Executive in writing within the period of time specified in the assessment report. When the remedial measures have been completed to the satisfaction of HKAS Executive, HKAS Executive will issue a notification letter to the organisation to reaffirm the relevant accreditation. Any changes to the terms of accreditation as HKAS Executive sees fit will also be identified in the notification letter A surveillance visit may be paid to an accredited organisation:- (a) (b) (c) when there are changes in the organisation's circumstances which may affect its continued compliance with HKAS accreditation criteria; when such a visit is, in the opinion of HKAS Executive, necessary to monitor the performance of the accredited organisation; or, in accordance with the routine surveillance visit schedule specified in the relevant specific regulations. 16

18 A surveillance visit shall be conducted by an assessment team as described in clause 4.7 above. The assessment team will usually select part of the accredited activities for examination. Such a visit may be made without giving prior notification to the organisation concerned An accredited organisation may seek to extend its scope of accreditation under the same accreditation scheme. To do so, the organisation shall complete an application form and an assessment questionnaire. It shall provide HKAS with information as required by HKAS Executive for arranging an assessment. It shall further pay the relevant application fee. If an organisation which has been accredited under an accreditation scheme seeks accreditation of its other activities under another accreditation scheme, it shall make an initial application for such accreditation The procedure for processing an application for an extension of scope of accreditation is similar to that for an initial application for accreditation except that no advisory visit/pre-assessment visit will be paid to the applicant organisation. However, only the report of assessments for extension to cover major new classes of activity, i.e., new test categories for HOKLAS, new certification systems for HKCAS, or new inspection fields for HKIAS will be referred to AAB for review. Where the activities covered in the application are very similar to activities for which the applicant organisation has already been accredited by HKAS, HKAS Executive may, at its discretion, assess the application without conducting an on-site assessment visit. 17

19 5. THE OBLIGATIONS OF AN ACCREDITED ORGANISATION 5.1 An accredited organisation shall at all times:- (a) (b) (c) (d) (e) comply with the accreditation criteria, including accreditation regulations specified in this booklet, technical and non-technical requirements and other conditions as specified by HKAS Executive under its terms of accreditation. The accreditation criteria of each accreditation scheme are listed in the relevant regulations (see Chapter 9 for HOKLAS, Chapter 10 for HKCAS and Chapter 11 for HKIAS). HKAS Executive may amend the accreditation criteria from time to time and the accredited organisation shall within the time specified by HKAS Executive comply with the amended accreditation criteria; represent honestly and truthfully to any person concerned that it is only accredited for activities stated in its scope of accreditation; pay the fees and charges as determined by HKAS Executive; endeavour to ensure that the accreditation granted by HKAS is not used in a misleading manner; and be a legal entity. 5.2 An accredited organisation which performs an accredited activity for any of its clients shall maintain for such activity a quality standard which is in compliance with the accreditation criteria as set by HKAS. The same standard shall be maintained at all times, no matter whether or not the HKAS accreditation mark will be used in the report or certificate covering the result of such activity. 5.3 A statement indicating which activities are not accredited shall accompany any statement made in relation to an organisation's accreditation status in situation where non-accredited activities are also mentioned. 5.4 Upon termination of accreditation for all activities of an organisation as specified in a certificate of accreditation, the organisation shall return such certificate of accreditation to HKAS Executive forthwith. 5.5 An accredited organisation shall cooperate with HKAS Executive and its assessment teams and provide them with full support during an on-site assessment and in any other situation such as to provide all necessary information for assessment of the organisation's competence and its compliance with the accreditation criteria. Upon the request of HKAS Executive, such organisation shall provide HKAS Executive with a copy of the documentary standard for which it seeks HKAS accreditation for use during the assessment. 5.6 An accredited organisation shall not use its accreditation status in such a manner that will bring HKAS or any of its accreditation schemes into disrepute, and shall not make any statement regarding its accreditation status that HKAS Executive may reasonably consider it to be misleading. 18

20 5.7 An accredited organisation shall maintain complete integrity and impartiality in all circumstances. The authorised representative shall report any impropriety or unlawful act of the organisation or any iniquitous management and/or staff to HKAS Executive. He/she shall further report immediately any corrupt practice to the ICAC (or similar authority or the police when outside the jurisdiction of the HKSAR). 5.8 If an accredited organisation appoints a new authorised representative, it shall notify HKAS Executive of such change within one calendar month. 5.9 The authorised representative or in his absence, other responsible person of an accredited organisation shall inform HKAS Executive in writing immediately of any changes or intended changes in the organisation's circumstances that may affect its compliance with relevant accreditation criteria. The following list, which is not exhaustive, gives examples of such changes:- (a) (b) (c) (d) (e) (f) (g) (h) change in ownership or name of the accredited organisation including the change in legal, commercial or organisational status, e.g., mergers, company dissolutions, bankruptcies, compulsory or voluntary liquidation or any other matters concerning the Official Receiver; change in its organisational structure and managerial staff; change of the approved signatories; change in the organisational policies, where relevant; change in its registered address or any place where the accredited activities are to be carried out; change in working procedures and resources including personnel, equipment, facilities, working environment, where significant; change in the nature of the work performed by an accredited organisation; and, any other matters that may affect the organisation's capability, or its scope of accreditation or its compliance with the accreditation criteria An accredited organisation shall pay due regard to the confidentiality of its client's information and shall make internal rules and guidelines in order to ensure protection of its client's information. Confidential information about a particular client shall not be disclosed to a third party without the consent of the client, except where the law requires such information to be so disclosed. However, an applicant organisation or an accredited organisation shall allow HKAS Executive to examine all its records which are relevant to the scope of accreditation in order to assess its competence and compliance with the relevant accreditation criteria. An applicant organisation and an accredited organisation shall obtain consent from their clients for the disclosure of any relevant information to HKAS. 19

21 5.11 An accredited organisation or an applicant organisation shall not make any unofficial contact with assessors, technical experts and/or AAB members on any matter relating to or in connection with the assessment of any activity for the purpose of granting or maintaining accreditation. All communications concerning its assessment shall only be made between the organisation's authorised representative or his/her representative and HKAS Executive An accredited organisation shall have a clear policy in writing concerning the provision or receipt of commissions by its staff. The policy document shall contain a statement notifying its staff the law under Section 9 of the Prevention of Bribery Ordinance (Cap 201). The accredited organisation shall further ensure that the policy is made known to all its staff members An accredited organisation shall have a policy and procedure in writing for handling and resolving complaints, disputes and appeals made to it by its clients or other parties. Records of all such complaints, disputes and appeals and actions taken shall be kept by the accredited organisation for a minimum of 3 years and shall be made available to HKAS Executive for inspection upon request Where a complaint, dispute or appeal made to an accredited organisation by its clients or other parties raises any doubt on its compliance with its policies or procedures, the accredited organisation shall ensure that relevant areas of its accredited activities are promptly audited If a complaint, dispute or appeal made to an accredited organisation by its clients or other parties relating to any of its accredited activities is not satisfactorily resolved within 60 days from the date of receipt, the accredited organisation shall notify HKAS Executive in writing of this matter Any concerned party may lodge complaints with HKAS on any accredited activities carried out by an accredited organisation. 20

22 6. SUSPENSION AND TERMINATION 6.1 An accredited organisation may voluntarily suspend or terminate its accreditation. HKAS Executive may also suspend or terminate an accredited organisation's accreditation. 6.2 The accreditation in suspension or in voluntary suspension shall only be reinstated by written notification from HKAS Executive. 6.3 An accredited organisation may, by serving a written notice signed by its authorised representative to HKAS Executive, voluntarily suspend its accreditation for any or all of its accredited activities. Such accredited organisation shall specify the effective date of the voluntary suspension in the written notice. 6.4 The accreditation in voluntary suspension may be reinstated by HKAS Executive on written request of the authorised representative. HKAS Executive may refuse to reinstate the accreditation if there has been a change in the circumstances of the organisation which affects its compliance with the terms of accreditation or performance of its accredited activities. HKAS Executive may conduct a reassessment or a surveillance visit to determine whether the voluntarily suspended accreditation should be reinstated. 6.5 If in the opinion of HKAS Executive, an accredited organisation has failed to comply with or is incapable of complying with the accreditation criteria, HKAS Executive may, at its discretion, suspend such organisation's accreditation. 6.6 HKAS Executive may suspend the accreditation for part or all of the accredited activities of an organisation as defined in its scope of accreditation. 6.7 The suspension imposed by HKAS Executive shall commence on the date of the written notice issued by HKAS Executive. The notice shall detail the grounds of such suspension. 6.8 The suspension may be imposed by HKAS Executive when an accredited organisation:- (a) fails to abide by any of the obligations set out in Chapter 5; (b) (c) (d) fails at any time to comply with any of the terms of accreditation; is found to be incompetent in carrying out any accredited activities or to be incapable of complying with any of the relevant accreditation criteria; or, is, in the opinion of HKAS Executive, involved in any impropriety, corrupt practice or other activities which is prejudicial to the good reputation of HKAS. 21

23 6.9 Within four weeks from the date of the notice of suspension (whether or not the suspension is voluntary), the authorised representative shall provide HKAS Executive a programme setting out the actions to be taken by the accredited organisation in order to rectify the situation. The maximum period allowed for such rectification is one year from the date of the notice of suspension An organisation which is in a state of suspension (whether or not the suspension is voluntary) and, if in the opinion of HKAS Executive, has failed to take adequate measures to rectify the situation, may have its accreditation terminated by HKAS Executive. Such termination may be made in respect of all or any part of the accredited activities of the organisation. The organisation will be notified in writing of the effective date of such termination by HKAS Executive An accredited organisation may voluntarily terminate its accreditation for all or any part of its accredited activities by serving upon HKAS Executive a written notice signed by its authorised representative. Such accredited organisation shall specify the effective date of the voluntary termination in the written notice An organisation with its accreditation in suspension (whether or not the suspension is voluntary) shall not issue any report or certificate which bears the HKAS accreditation mark for any activities for which accreditation has been suspended, and shall not make any representation to any parties suggesting or implying that the accreditation of such activities is still valid and effective. The organisation shall continue to pay the annual subscription fee An organisation with its accreditation terminated (whether or not the teraiination is voluntary) shall not issue any report and certificate that bears the HKAS accreditation mark for any activities for which accreditation has been terminated, and shall not make any representation to any parties suggesting or implying that the accreditation of such activities is still valid and effective HKAS, the HKAS Executive, any member of AAB and any person acting on behalf of HKAS shall not be liable for any loss or damage suffered by an accredited organisation or an applicant organisation arising from whatever cause (including but not limited to any act or statement made) in connection with the termination or suspension of the accreditation, or in relation to the refusal to reinstate or to grant the accreditation, unless such organisation can prove that HKAS Executive, any member of AAB or any person acting on behalf of HKAS has not acted in his/her bona fides whilst determining such termination or suspension of accreditation or refusal to reinstate or to grant accreditation. 22

24 7. DISPUTES, COMPLAINTS AND APPEALS 7.1 An accredited organisation or an applicant organisation may lodge a complaint or a dispute against any decision made or action taken by HKAS Executive or AAB. A written submission setting out the grounds of such complaint and dispute shall be made to HKAS Executive within four weeks after such decision or action has been made or taken. 7.2 HKAS Executive shall investigate and examine such complaints and disputes. HKAS Executive shall notify the organisation concerned the outcome of such investigation and examination. 7.3 The organisation may lodge an appeal to HKAS Executive if it considers the outcome of the investigation and examination as specified in clause 7.2 above is not unacceptable to it. 7.4 An accredited or applicant organisation may also lodge an appeal against any decision of HKAS Executive or AAB to HKAS Executive directly without going through the complaints and disputes procedure (See clauses 7.1 to 7.2 above) in the first place. 7.5 An appeal shall be lodged by making a written submission to HKAS Executive providing the grounds of the appeal within four weeks from the date of notification of a decision. 7.6 The organisation lodging an appeal may indicate whether it wishes the matter to be referred first to AAB for review or whether it wishes the appeal to be referred directly to the Secretary for Commerce, Industry and Technology. 7.7 Upon a request from an organisation for a review by AAB, the Chairman of AAB shall convene a working party, chaired by a AAB member who has no prior involvement in the matter in question, to investigate the case. 7.8 The chairman of the working party shall further appoint at least two persons who need not be members of AAB. 7.9 The working party shall examine matters set out in the submission and may interview individuals involved in the case AAB shall make a decision on the review on the basis of the findings of the working party. The Chairman of AAB shall inform the organisation the result of the review in writing If the organisation is aggrieved of the AAB's decision on the review, it may request that the appeal be referred to the Secretary for Commerce, Industry and Technology Upon an request for an appeal, and subject to the agreement of payment of expenses as provided in clause 7.15 below, the Secretary for Commerce, Industry and Technology shall convene an appeals board comprising experts 23

25 such as auditors, assessors, specialists, professional scientists, engineers, technologists and inspectors to investigate the matters set out in the written submission. The appeals board may interview any person involved in the matters, such as staff members of HKAS Executive, assessors and technical experts of HKAS, the organisation's staff or members of the public The appeals board may also seek assistance and expert advice from overseas accreditation bodies The Secretary for Commerce, Industry and Technology shall make a decision on the basis of advice from the appeals board and such decision will be final and conclusive Expenses arising from convening of the appeals board may be levied against the party who, in the view of the appeals board, has brought a frivolous and vexatious claim in the appeal HKAS, HKAS Executive, any member of AAB, the Secretary for Commerce, Industry and Technology and any person acting on behalf of HKAS or the Secretary for Commerce, Industry and Technology shall not be liable for any loss or damage suffered by an accredited organisation or an applicant organisation arising from whatever cause (including but not limited to any act or statement made) in connection with a complaint, dispute or appeal lodged with HKAS Executive, unless such organisation can prove that HKAS Executive, any member of AAB, the Secretary for Commerce, Industry and Technology or any person acting on behalf of HKAS or the Secretary for Commerce, Industry and Technology has not acted in his/her bona fides whilst determining a decision in connection with such a complaint, dispute or appeal. 24

26 8. USE OF HKAS ACCREDITATION MARKS AND CLAIMS OF ACCREDITATION STATUS 8.1 An accredited organisation may use the relevant HKAS accreditation mark as described in HKAS Supplementary Criteria No.l and claim its accreditation status provided that the following conditions are complied with:- (a) (b) (c) all advertising and promotional materials (including letterheads) in which the accreditation status of an organisation is referred to shall be submitted to HKAS Executive for approval before use; HKAS Supplementary Criteria No.l and requirements relevant to the accreditation scheme concerned as described in the relevant specific regulations, are complied with at all times; and any statement made by the organisation in connection with its accreditation status shall not, in the opinion of HKAS Executive, give a false or misleading impression to any third party of its accreditation status. Where possible, HKAS may provide guidance on the use of HKAS accreditation marks when accreditation is granted. 8.2 An accredited organisation shall ensure that its clients, on receiving any report or certificate which bears a HKAS accreditation mark are aware that the subject of the activity (e.g., the sample, instrument, product, design or system tested, calibrated, certified or inspected) as referred to in such report or certificate is in no way approved nor disapproved by HKAS or HKAS Executive. 8.3 Upon termination of the accreditation of any activities carried out by an organisation, whether or not voluntarily made, all reference to the accreditation status of such organisation in any report, certificate, letterhead, brochure and advertising material shall be removed immediately. 25

27 SPECIFIC REGULATIONS FOR HOKLAS 9.1 Accreditation Procedures An assessment team may require a laboratory to demonstrate a test, a calibration or other laboratory activities as part of an assessment, or to participate in proficiency testing in order to evaluate the laboratory's standard and competence. The specific laboratory activities to be demonstrated will be selected from those covered in the proposed scope of accreditation at the discretion of the assessment team HKAS Executive shall conduct a reassessment on the accredited activities of a laboratory:- (a) (b) (c) (d) twelve months after the date of the notification letter in which HKAS Executive has granted the accreditation to the laboratory; every two years after the due date of the first reassessment; at such other times as may be specified in the terms of accreditation; and upon notification by the authorised representative, or in his absence, other responsible person of an accredited laboratory, of any change in the structure and circumstances of the laboratory since the last assessment or reassessment and in the opinion of HKAS Executive, such change may affect the laboratory's competence or compliance with the accreditation criteria. HKAS Executive may, at its discretion, vary the reassessment schedule HKAS Executive shall conduct a surveillance visit to an accredited laboratory if no reassessment nor surveillance visit to the laboratory has been conducted for the past twelve months. HKAS Executive may, at its discretion, vary the surveillance visit schedule Upon granting of accreditation for a test category to a laboratory, HKAS Executive shall issue to it a certificate of HOKLAS accreditation for such test category. 9.2 Accredited Laboratory Obligations HOKLAS Accreditation Criteria An accredited laboratory shall at all times comply with the following HOKLAS accreditation criteria:- HKAS Regulations for HKAS Accreditation (i.e. regulations in this booklet) HOKLAS Technical Criteria for Laboratory Accreditation or its equivalent as specified and published by the HKAS Executive 26

28 Relevant HOKLAS Supplementary Criteria Relevant HKAS Supplementary Criteria A list of HOKLAS and HKAS Supplementary Criteria and copies of such documents can be obtained from the office of HKAS Executive. These documents have also been uploaded to the website of HKAS An accredited laboratory shall not use its accreditation status in a way that may be interpreted by any person that any product, material or any other subject of an activity for which HOKLAS accreditation has been granted has been approved or disapproved by HKAS or HKAS Executive. It shall further endeavour to ensure that no person will use any certificate or report issued by it for such activity in a misleading manner A laboratory accredited under HOKLAS shall afford its clients or their representatives reasonable cooperation to monitor the laboratory's performance (in so far as to their respective contracts are concerned). This cooperation shall include:- (a) (b) to perform any reasonable check tests or calibrations or checks for other laboratory activities, including to prepare, pack and dispatch the test pieces, samples and other items for such check activities, which serve to verify its capability or standard of service as requested by the client; and to allow each of its clients or their representatives reasonable access to the laboratory in order to observe any test, calibration or other laboratory activity performed by it for the client. However, the laboratory shall ensure that the confidentiality of its other clients will be protected and their information will not be divulged to any third party (subject to clause 5.10) If an accredited laboratory intends to subcontract any part of its activities to which HOKLAS accreditation has been granted, it shall ensure that the activities of the laboratory to which the activities will be subcontracted have been accredited by HKAS or an accreditation body recognised by HKAS under a mutual recognition arrangement/agreement. A list of such accreditation bodies is obtainable from the HKAS Executive. The accredited laboratory shall notify its client concerned in writing of its intention to subcontract the activities and the extent of such subcontract. It shall obtain agreement from the client regarding such arrangement and shall further keep records of such agreement. In the report or certificate, the accredited laboratory shall specify the name of such subcontractor and identify the activities performed and the results obtained by such subcontractor An accredited laboratory shall take part in proficiency testing programmes which are relevant to its scope of accreditation organised or specified by HKAS Executive unless it can demonstrate to HKAS Executive that it has already participated in alternative programmes which are acceptable to HKAS Executive. The performance of an applicant or an accredited laboratory in any proficiency testing activity relevant to its scope of accreditation shall be acceptable to the HKAS Executive. 27

29 9.2.6 An applicant laboratory shall take part in at least one appropriate proficiency testing activity, where available, before accreditation will be granted. After accreditation has been granted, the laboratory shall take part in at least one appropriate proficiency testing activity, when available, which is related to each major sub-area of major disciplines of the accredited activities as specified in its scope of accreditation, every four years. The assessment team shall determine the appropriateness of any proficiency testing activities and may, at its discretion, require the laboratory to participate in other forms of proficiency testing activity so as to evaluate its competence in performing specific tests, calibrations or other laboratory activities. Where an applicant or an accredited laboratory is unable to participate in any appropriate proficiency testing activity because such activity is not available, it shall demonstrate to the satisfaction of the assessment team that it has taken all reasonable steps to identify such activity. In this clause, proficiency testing activity includes any international, regional and national interlaboratory comparisons as well as measurement audits and check samples acceptable to HKAS Where the performance of an applicant laboratory or an accredited laboratory in a proficiency testing activity is unsatisfactory, the laboratory shall investigate the cause and take effective remedial actions An applicant laboratory shall nominate persons to HKAS Executive for approval as approved signatories for signing HOKLAS endorsed reports and certificates for every test, calibration or other laboratory activity for which it seeks accreditation. Accreditation for such activity will not be granted unless HKAS Executive is satisfied that at least one nominee meets the requirements for approved signatories as laid down in the accreditation criteria. An accredited laboratory shall maintain at least one approved signatory for each accredited activity. Additional persons may be nominated by an accredited laboratory to HKAS Executive for approval as approved signatories at any time An accredited laboratory shall inform HKAS Executive of any change in the availability and duties of any of its HOKLAS approved signatories. HKAS shall withdraw the approval concerning such approved signatory who no longer meets the requirements for approved signatories as laid down in the accreditation criteria. HKAS Executive may suspend the accreditation of a laboratory for a test, calibration or other laboratory activity if it does not have any approved signatory for such activity and has failed to obtain approval from HKAS Executive for a new signatory within three months from the date when it ceased to have any approved signatory for such activity. 93 Suspension and Termination The authorised representative of a laboratory, which has its accreditation suspended or terminated (voluntarily or by HKAS Executive) shall within 14 days from the effective date of such suspension or termination, identify the clients to whom the laboratory has issued results for tests, calibrations or other laboratory activities which are found to be unreliable because of the deficiencies which have been brought to light and inform them that the results are unreliable HKAS Executive may report a suspension or termination for a major part of the activities as specified in the scope of accreditation of an accredited laboratory in 28

30 the next issue of the HOKLAS Directory and the website of HKAS. 9.4 Use of HKAS Accreditation Marks and Claims of Accreditation Status An accredited laboratory may display the HOKLAS accreditation mark in a report or certificate issued by it for reporting the result of an activity accredited under HOKLAS. Such a document is referred to hereafter as a HOKLAS endorsed report or certificate. A HOKLAS endorsed report or certificate shall contain the HOKLAS accreditation mark and other details as described in clause below An accredited laboratory shall include in a HOKLAS endorsed report or certificate the following:- (a) (b) the HOKLAS accreditation mark (which includes the laboratory's registration number) at the top right hand corner of the front page; on the same page the following statement (except as specified in (d) below) > "Hong Kong Accreditation Service (HKAS) has accredited this laboratory under the Hong Kong Laboratory Accreditation Scheme (HOKLAS) for specific laboratory activities as listed in the HOKLAS directory of accredited laboratories. The results shown in this report (or certificate, where appropriate) were determined by this laboratory in accordance with its terms of accreditation." and; (c) for reports and certificates showing the results of calibrations which have been accredited under the "calibration services" test category, the following statement shall be appended to the above statement. "Such terms of accreditation stipulate that the results shall be traceable to the International System of Units (S.I.) or recognised measurement standards." (d) for reports and certificates showing the results of examinations and their clinical interpretations which have been accredited under the "medical testing" test category, the following statements shall be used instead of the statement in (b) above: "Hong Kong Accreditation Service (HKAS) has accredited this laboratory under the Hong Kong Laboratory Accreditation Scheme (HOKLAS) for specific examinations and clinical interpretations of examination results as listed in the HOKLAS directory of accredited laboratories. The results and their clinical interpretation shown in this report (or certificate, where appropriate) were determined by this laboratory in accordance with its terms of accreditation." The term "HOKLAS" and the HOKLAS accreditation mark shall not be used in any report or certificate of laboratory activities except in a HOKLAS endorsed report or certificate The form, size, colour and usage of the HOKLAS accreditation mark shall be in accordance with the HKAS Supplementary Criteria No.l A HOKLAS endorsed report or certificate shall be signed by a HOKLAS 29

31 approved signatory of the issuing laboratory. Such signature can be made in hand-written form or in the form of an electronic signature acceptable under the Electronic Transactions Ordinance (Cap. 553). The full name of the approved signatory shall be typed on such endorsed report or certificate A HOKLAS endorsed report or certificate may contain signatures of others provided that the laboratory's HOKLAS approved signatory has signed the report or certificate A HOKLAS endorsed report or certificate shall only contain the results of the tests, calibrations or other laboratory activities for which the laboratory is holding valid HOKLAS accreditation The results of any activity which has not been accredited (whether obtained by the laboratory or its subcontractor) can only be included in a HOKLAS endorsed report or certificate if HKAS Executive has explicitly approved such inclusion in writing. The HOKLAS endorsed report and certificate which contains the said results shall clearly state therein that the activities are not covered by the laboratory's HOKLAS accreditation An accredited laboratory shall keep at least one exact copy of the HOKLAS endorsed report or certificate issued by it for record. It shall also keep such copies, all original observations and records in relation to any accredited activity performed by it for a period of not less than three years or for a period specified by HKAS Executive Every HOKLAS endorsed report or certificate shall comply with all relevant accreditation criteria as specified by HKAS Executive from time to time A HOKLAS endorsed report or certificate shall bear either:- (a) (b) a statement indicating that such report or certificate shall not be reproduced except in full, or a statement indicating the conditions under which such report or certificate may be reproduced either in full or in part. Any extract or abstract of a HOKLAS endorsed report or certificate shall not contain the HOKLAS accreditation mark nor other details as specified in clause above unless the Authorised Representative of the accredited laboratory which issues the report or certificate has approved in writing of such inclusion in the extract or abstract. The Authorised Representative, if granting approval under this clause, shall ensure that such extract or abstract will not be used for any purpose which HKAS Executive may consider it as having misleading effect An accredited laboratory may issue a HOKLAS endorsed report or certificate which extends the results of a test, a calibration or another laboratory activity on a sample or samples to the properties or qualities of the inspected lot, batch or consignment from which the sample(s) was drawn provided that- 30

32 (a) (b) the accredited laboratory's scope of accreditation covers the sampling involved; and the sample or samples concerned were taken by staff of the accredited laboratory using the accredited sampling procedure A HOKLAS endorsed report or certificate may include statements in amplification of results reported therein provided that:- (a) (b) (c) where a sample, batch or consignment is tested, calibrated or examined to specification requirements such statements shall be limited to information as to whether or not the sample, batch or consignment conforms with the specification requirements and the manner or degree in which it departs from such specification requirements; where a sample is not tested, calibrated or examined to specification requirements such statements shall be limited to explanation of the results as is necessary for interpretation of their meaning; and where an instrument or measuring device is calibrated such statements shall be limited to> (i) (ii) the uncertainty to be associated with its use, or the information referred to in (a) or (b) above as appropriate Opinions or interpretations for which a laboratory is not accredited for providing can only be included in a HOKLAS endorsed report or certificate if HKAS Executive has given its approval for such inclusion in writing. An endorsed report or certificate containing such opinions or interpretations shall in all cases clearly state that the laboratory is not accredited for providing such opinions or interpretations. 9.5 Forms Application for any HOKLAS service from HKAS shall be made in appropriate forms. These forms are obtainable from the office of HKAS Executive and have been uploaded to the HKAS website. 9.6 Sample HOKLAS endorsed report and letterhead bearing the HOKLAS accreditation mark An example of a HOKLAS endorsed test report is provided on page 32. An example of a letterhead bearing the HOKLAS accreditation mark is provided on page 33. They are provided for reference only. An accredited laboratory shall submit its letterhead and formats for HOKLAS endorsed report and certificate to HKAS Executive for approval before use. 31

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35 10 SPECIFIC REGULATIONS FOR HKCAS 10.1 Accreditation Procedures An assessment team may, at its discretion, carry out an observation on a certification body while it is performing certification audits for which it is accredited or seeking accreditation. The certification body shall seek consent from and shall explain to its clients concerning the presence of the assessment team in such certification audits. The certification body shall further assure its client that the presence of the assessment team during the certification audits will not affect the outcome of the audits HKAS Executive shall conduct a reassessment on the accredited activities of a certification body every three years after the accreditation has been granted HKAS Executive shall also conduct a surveillance visit to an accredited certification body routinely every six months. HKAS Executive has discretion to vary the period for reassessment and surveillance visit as it sees fit Upon granting of the accreditation to a certification body for a certification system, HKAS Executive shall issue to it a certificate of HKCAS accreditation for such certification system Accredited Certification Body Obligations HKCAS Accreditation Criteria An accredited certification body shall at all times comply with the following:- HKAS Regulations for HKAS Accreditation (i.e. regulations in this booklet) Relevant HKCAS Supplementary Criteria Relevant HKAS Supplementary Criteria A certification body accredited for certification of quality systems shall also comply at all times with the following: ISO/EEC Guide 62:1996(E) - General Requirements for Bodies Operating Assessment and Certification of Quality Systems, and The latest edition of the following IAF (International Accreditation Forum, website: documents: IAF Guidance on the Application of Guide 62:1996 IAF Guidance on the Application of ISO 9001:2000, where applicable A certification body accredited for certification of environmental management systems shall also comply at all times with the following: ISO/IEC Guide 66: General Requirements for Bodies Operating Assessment and Certification / Registration of Environmental Management Systems, and 34

36 The latest edition of the following IAF (International Accreditation Forum, website : document: IAF Guidance on the Application of ISO/IEC Guide 66 A certification body accredited for certification of products shall also comply at all times with the following: ISO/IEC Guide 65:1996(E) - General Requirements for Bodies Operating Product Certification Systems, and The latest edition of the following IAF (International Accreditation Forum, website: documents: IAF Guidance on the Application of Guide 65. A list of HKCAS and HKAS Supplementary Criteria and copies of such documents are obtainable from the office of HKAS Executive. Such documents have also been uploaded to the website of HKAS. When the accreditation service of HKCAS is extended to other certification systems, HKAS Executive will publish the necessary accreditation criteria for the new service For a certification body accredited for quality or environmental management system certification, it shall not use its accreditation status in a way that may be interpreted by any person that any product, process, system or person certified by such certification body has been approved by HKAS or HKAS Executive. It shall further endeavour to ensure that the organisations certified by it will implement the certified system at all time The requirements and conditions for the use of accreditation marks on products certified under an accredited product certification scheme are specified in the relevant HKCAS Supplementary Criteria If an accredited certification body intends to subcontract any part of its activities for which it is accredited, it shall ensure that the certification body, to which the activities will be subcontracted, is a certification body accredited for performing the activities by HKAS or an accreditation body which has concluded a mutual recognition arrangement/agreement with HKAS. A list of such accreditation bodies is obtainable from the HKAS Executive. The certification body shall notify the client in writing of its intention to subcontract the activities, the extent of such subcontract and the name of the subcontractor. The certification body shall further ensure that its client agrees to such arrangement and shall keep all records of such subcontracted activities Suspended or Terminated Accreditation The authorised representative of a certification body which has its accreditation suspended or terminated (voluntarily or by HKAS Executive) shall within 14 days from the effective date of such suspension or termination, inform each of its clients of activities for which the accreditation has been suspended or terminated in writing of such suspension or termination HKAS Executive may report the details of such suspension or termination in the 35

37 next issue of the HKCAS Directory and the website of HKAS Use of HKAS Accreditation Marks, Claims of Accreditation Status and use of Certification Marks Every certification body accredited under HKCAS shall be awarded with a distinctive HKCAS accreditation mark An organisation which is certified by a certification body accredited by HKAS may also use the HKCAS accreditation mark of such certification body (subject to regulations set out in this booklet) to demonstrate to the public that it has been certified by a competent and impartial certification body accredited by HKAS A HKAS accredited certification body may use its HKCAS accreditation mark on its certificates, stationery, documents, publications and its advertisements, subject to the regulations set out in this booklet and any other relevant requirements as specified from time to time by HKAS The form, size, colour and usage of the HKCAS accreditation mark shall be in accordance with the HKAS Supplementary Criteria No.l An accredited certification body shall use different certification marks for different certification systems. Furthermore, the certification marks shall be sufficiently different in their shapes and designs in order to enable easy differentiation between them and from any other marks used by the certification body itself An accredited certification body shall not use the HKCAS accreditation mark on any document unless such document relates in whole or in part to an accredited activity of the certification body. However, the accredited certification body is allowed to print the accreditation mark on its pre-printed letterhead paper Where an organisation is certified by a HKCAS accredited certification body, such certified organisation may use the HKCAS accreditation mark of the accredited certification body in conjunction with the certification mark of the certification body. Any use of the accreditation mark is subject to the regulations set out in this booklet, HKAS Supplementary Criteria No.l and any other relevant HKCAS requirements as specified from time to time by HKAS An accredited certification body shall ensure that organisations certified for management system will NOT use the certification mark on a product or a test certificate, or in any way that may be interpreted by any person as suggesting product certification An accredited certification body shall not use the HKCAS accreditation mark on any stationery, documents, publications and advertisements unless those stationery, documents, publications and advertisements are related in whole or in part to the accredited certification body's scope of accreditation. An accredited certification body shall ensure that the HKCAS accreditation mark will not be used by any organisation certified by it on any stationery, documents, publications and advertisements unless those stationery, documents, publications and advertisements are related in whole or in part to the accredited certification 36

38 body's scope of accreditation and to the certification scope of the organisation An accredited certification body shall ensure that any organisation certified by it will only use the HKCAS accreditation mark together with the certification mark in such a manner as set down in HKAS Supplementary Criteria No. 1 and any other relevant HKCAS Supplementary Criteria An accredited certification body shall not use the HKCAS accreditation mark in any way that may be interpreted by any person as suggesting that HKAS Executive has certified or approved the activities of any organisation certified by it, or in any way which may have a misleading effect. It shall also take reasonable steps to ensure that any organisation certified by it will not use the HKCAS accreditation mark in such a way If the accreditation in relation to any activity under the scope of accreditation of a certification body is terminated, the certification body shall immediately cease to use and to distribute any certificate, stationery, document, publication and advertisement which bears the accreditation mark, save for those which relate in whole or in part to activities, the accreditation of which is not terminated If the accreditation of an accredited certification body for a certification system is terminated, the certification body shall take all steps to ensure that its certified organisations will cease to use the HKCAS accreditation mark, save for those which relate in whole or in part to certification systems, the accreditation of which is not terminated Forms Application for any HKCAS service from HKAS shall be made in appropriate forms. These forms are obtainable from the office of HKAS Executive and have been uploaded to the HKAS website. 37

39 11 SPECIFIC REGULATIONS FOR HKIAS 11.1 Accreditation Procedures An assessment team may, at its discretion, carry out an observation on an inspection body while it is performing inspections for which it is accredited or seeking accreditation. The inspection body shall seek consent from and explain to its clients concerning the presence of the assessment team during such inspections. The inspection body shall further assure its clients that the presence of the assessment team will not affect the results of the inspections HKAS Executive shall conduct a reassessment to an accredited inspection body:- (a) (b) (c) (d) two years after the date of the notification letter in which HKAS Executive has granted the accreditation to the inspection body; every two years after the due date of the first reassessment; at such other times as may be stated in the terms of accreditation; and upon notification by the authorised representative, or in his absence, other responsible person of an accredited inspection body, of any change in the structure and circumstances of the inspection body since the last assessment or reassessment and in the opinion of HKAS Executive, such change will affect the inspection body's performance and its compliance with the accreditation criteria. HKAS Executive may, at its discretion, vary the reassessment schedule HKAS Executive will conduct a surveillance visit to an accredited inspection body routinely every six months after the granting of accreditation. For certain inspection fields, HKAS Executive may specify a different frequency of surveillance visit and the applicable frequency will be stated in the HKIAS Supplementary Criteria for that field. Furthermore, HKAS may vary the frequency of surveillance visit to any individual accredited inspection body as it sees fit Upon granting the accreditation for an inspection field to an inspection body, HKAS Executive shall issue to it a certificate of HKIAS accreditation for such inspection field Accredited Inspection Body Obligations HKIAS Accreditation Criteria An accredited inspection body shall at all times comply with the following:- HKAS Regulations for HKAS Accreditation (i.e. regulations in this booklet) HKIAS Criteria for Accreditation of Inspection Bodies 38

40 Relevant HKIAS Supplementary Criteria Relevant HKAS Supplementary Criteria A list of HKIAS and HKAS Supplementary Criteria and copies of such documents are obtainable from the office of HKAS Executive. These documents have also been uploaded to the website of HKAS An accredited inspection body shall not use its accreditation status in a way that may be interpreted by any person that any product, design, system or any other subject of inspection has been approved or disapproved by HKAS or HKAS Executive. It shall further endeavour to ensure that no person shall use any inspection certificate or report issued by it in a misleading manner If an accredited inspection body intends to subcontract any part of its activities to which HKIAS accreditation has been granted, it shall ensure that the organisation to which the activities will be subcontracted is accredited for performing the activities by HKAS or an accreditation body which has concluded a mutual recognition arrangement/agreement with HKAS. A list of such accreditation bodies is obtainable from the office of HKAS Executive. The inspection body shall notify the client concerned in writing of its intention to subcontract the activities and the extent of such subcontract. The inspection body shall further ensure that the client agrees to such arrangement and shall keep records showing the agreement of the client to such arrangement. Where the activities concerned of the subcontractor is not accredited by HKAS or an accreditation body which has concluded a mutual recognition arrangement/agreement with HKAS, the inspection body shall include a statement describing such fact in the inspection report or certificate An accredited inspection body is required to participate in proficiency testing programmes relevant to its scope of accreditation organised or specified by HKAS Executive unless it can demonstrate that it has already participated in alternative programmes which are acceptable to HKAS Executive. The performance of an accredited inspection body in any proficiency testing activities relevant to its scope of accreditation shall be acceptable to HKAS Executive An applicant inspection body shall nominate persons to HKAS Executive for approval as approved signatories for signing HKIAS endorsed reports and certificates for every inspection activity for which it seeks accreditation. Accreditation for such activity will not be granted unless HKAS Executive is satisfied that at least one nominee meets the requirements for approved signatories as laid down in the accreditation criteria. An accredited inspection body shall maintain at least one approved signatory for each accredited inspection activity. Additional persons may be nominated by an accredited inspection body to HKAS Executive for approval as approved signatories at any time An accredited inspection body shall inform HKAS Executive of any change in the availability and duties of any of its HKIAS approved signatories. HKAS Executive shall withdraw the approval concerning such approved signatory who no longer meets the requirements for approved signatories as laid down in the accreditation criteria. HKAS Executive may suspend the accreditation of an 39

41 inspection body for an inspection activity if it does not have any approved signatory for such activity and has failed to obtain HKAS Executive approval for a new signatory within three months from the date when it ceased to have any approved signatory for such activity Suspension and Termination The authorised representative of an inspection body which has its accreditation suspended or terminated (voluntarily or by HKAS Executive) shall within 14 days from the effective date of such suspension or termination, identify the clients to whom the inspection body has issued inspection results which are found to be unreliable because of the deficiencies which have been brought to light and inform them that the results are unreliable HKAS Executive may report a suspension or termination for a major part of the activities as specified in the scope of accreditation of an accredited inspection body in the next issue of the HKIAS Directory and the website of HKAS Use of HKAS Accreditation Marks and Claims of Accreditation Status An accredited inspection body may display the HKIAS accreditation mark in a report or certificate issued by it for reporting the results of an inspection accredited under HKIAS. Such a document is referred hereafter as a HKIAS endorsed inspection report or certificate. A HKIAS endorsed report or certificate shall contain the HKIAS accreditation mark and other details as described in clause below An accredited inspection body shall include in a HKIAS endorsed report or certificate the following:- (a) (b) the HKIAS accreditation mark (which include the inspection body's registration number) at the top right hand comer of the front page, and on the same page, the following statement:- "Hong Kong Accreditation Service (HKAS) has accredited this inspection body under the Hong Kong Inspection Body Accreditation Scheme (HKIAS) for specific inspection activities as listed in the HKIAS directory of accredited inspection bodies. The results shown in this report (or certificate, where appropriate) were determined by this inspection body in accordance with its terms of accreditation." The term "HKIAS" and the HKIAS accreditation mark shall not be used on any inspection report or certificate except in a HKIAS endorsed inspection report or certificate The form, size, colour and usage of the HKIAS accreditation mark shall be in accordance with the HKAS Supplementary Criteria No A HKIAS endorsed report or certificate shall be signed by a HKIAS approved signatory of the issuing inspection body. Such signature can be made in handwritten form or in the form of an electronic signature acceptable under the 40

42 Electronic Transaction Ordinance (Cap. 553). The foil name of the approved signatory shall be typed on such endorsed report or certificate A HKIAS endorsed inspection report or certificate may contain signatures of others provided that the inspection body's HKIAS approved signatory has signed the report or certificate Except as permitted in clause , HKIAS endorsed inspection reports and certificates shall only contain results of accredited activities, i.e., within the inspection body's scope of accreditation. For inspections for which HKAS has implemented an approved inspector system, a HKIAS endorsed report or certificate issued by an accredited inspection body shall only contain results of inspections performed by an approved inspector of the accredited inspection body The result of the following activities shall only be included in a HKIAS endorsed report or certificate if HKAS Executive has explicitly approved such inclusion in writing:- (a) (b) (c) results of any activity for which the inspection body is not holding valid HKIAS accreditation; results of any activity performed by a subcontractor which is not accredited by HKAS nor an accreditation body recognised by HKAS through a mutual recognition agreement; or results of any activity which is not performed by an approved inspector if HKAS has implemented an approved inspector system for the activity concerned. The accredited inspection body which includes the result of any of the above activities in any endorsed inspection report or certificate shall in all cases state clearly on the endorsed inspection report or certificate that such activity is not accredited If a HKIAS endorsed inspection report or certificate contains any result which is supplied by a subcontractor, the accredited inspection body which issues such report or certificate shall identify in such a report or certificate any of the activities which is performed by the subcontractor An accredited inspection body shall keep at least one exact copy of every HKIAS endorsed inspection report or certificate issued by it for record. It shall also keep such copies, all original observations and records in relation to any accredited inspection performed by it for a period of not less than three years or for a period as specified by HKAS Executive Every HKIAS endorsed inspection report or certificate shall comply with the accreditation criteria as specified by HKAS Executive from time to time A HKIAS endorsed inspection report and certificate shall bear either:- 41

43 (a) (b) a statement indicating that such report or certificate shall not be reproduced except in full, or a statement indicating the conditions under which such report or certificate may be reproduced either in full or in part. Any extract or abstract of a HKIAS endorsed inspection report or certificate shall not contain the HKIAS accreditation mark nor other details as specified in clause above unless the authorised representative of the accredited inspection body which issues the report or certificate has approved in writing of such inclusion in the extract or abstract. The authorised representative, if granting approval under this clause, shall ensure that such extract or abstract will not be used for any purpose which HKAS Executive may consider it as having misleading effect An accredited inspection body may issue a HKIAS endorsed report or certificate which extend the results of an inspection on a sample or samples to the properties or qualities of the inspected lot, batch or consignment from which the samples were drawn provided that:- (a) (b) the accredited inspection body's scope of accreditation includes the sampling involved; and where applicable, the sample(s) concerned were taken by an approved inspector of the accredited inspection body by using an accredited sampling plan and procedure A HKIAS endorsed inspection report or certificate may include statements in amplification of results reported therein provided that:- (a) (b) (c) the inspection body is accredited for giving such a statement, if a statement on the conformity of an inspected sample or the lot, batch or consignment from which the sample was drawn with specified general requirements is made, the accredited inspection body shall include sufficient information required for the understanding and interpretation of such statement in such report or certificate; and any additional statement interpreting the results shall be limited to explaining whether or not the subject of inspection conforms with and the manner or degree it departs from the specification stated on such report or certificate If any opinion which is not supported by objective evidence or any statement in amplification of the inspection results other than those allowed in clause above is to be included in a HKIAS endorsed inspection report or certificate, the accredited inspection body shall include a statement in such report or certificate which states clearly that the inspection body is not accredited for providing such opinion or statement. 42

44 11.5 Forms Application for any HKIAS service from HKAS shall be made in appropriate forms. These forms are obtainable from the office of HKAS Executive and have been uploaded to the HKAS website Sample HKIAS endorsed reports and letterhead bearing the HKIAS accreditation mark An example of a HKIAS endorsed report is provided on page 44. An example of a letterhead bearing an HKIAS accreditation mark is provided on page 45. They are provided for reference only. An accredited inspection body shall submit its letterhead and formats of HKJAS endorsed report and certificate to HKAS Executive for approval before use. 43

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