HKAS

Full details of the processes involved in achieving HKAS accreditation are given in Chapter 4 of HKAS 002 - Regulations for HKAS Accreditation. A brief summary of the main features is given below:

Accreditation processes

For assessment visits outside HKSAR, please refer to Guideline to organisation "Travelling, accommodation and meals for assessments visits outside Hong Kong SAR"


Step 1 - Initial Contact

(i) An organisation interested in seeking accreditation contacts the HKAS Executive.
(ii) Download the appropriate documentation from the HKAS website :
 
HKAS
-
HKAS 002 Regulations for HKAS Accreditation
-
List of HKAS Supplementary Criteria
 
 
HOKLAS
-
HOKLAS Supplementary Criteria 33 Accreditation Regulations Specific for HOKLAS - Laboratory
 
-
HOKLAS 005 Application for Laboratory Accreditation (including Proficiency Testing Providers) / Extension of Scope of Accreditation
-
HOKLAS 006 / HOKLAS 013 Schedule of Accreditation Fees for Laboratories within / outside the Hong Kong Special Administrative Region
-
Relevant HOKLAS Supplementary Criteria and Information Notes
 
For non-medical laboratories :
-
HOKLAS 003 Technical Criteria for Laboratory Accreditation
-
HOKLAS 007 Assessment / Reassessment Questionnaire for Non-medical Laboratories
-
HOKLAS 007 Checklist Checklist on conformity with HOKLAS requirements (Non-medical Laboratories)
 
For medical laboratories :
-
HOKLAS 015 Technical Criteria for Laboratory Accreditation (Medical Laboratories)
-
HOKLAS 016 Assessment/ Reassessment Questionnaire (Medical Laboratories)
-
HOKLAS 016 Checklist Checklist on comformity with HOKLAS requirements (Medical Laboratories)
 
For proficiency testing providers:
 
-
HOKLAS Supplementary Criteria 34 Accreditation Regulations Specific for HOKLAS ¡V Proficiency Testing Provider
-
HOKLAS 017 Technical Criteria for Accrediting Proficiency Testing Providers
-
HOKLAS 018 Assessment / Reassessment Questionnaire for Proficiency testing Provider
-
HOKLAS 018 Checklist Checklist on comformity with HOKLAS requirements for Proficiency Testing Provider
 
HKCAS
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HKCAS 005 Application for Certification Body Accreditation / Extension of Scope of Accreditation
-
HKCAS 006 Schedule of Accreditation Fees for Certification Bodies in Hong Kong
-
Relevant HKCAS Supplementary Criteria
 
For quality and environmental management system certification:
-
HKCAS 007 Assessment / Reassessment Questionnaire (For quality and environmental management system certification only)
-
HKCAS 007 Checklist Checklist on conformity with HKCAS requirements (ISO/IEC 17021)
 
For Product Certification:
-
HKCAS 013 Assessment / Reassessment Questionnaire for Product Certification
-
HKCAS 013 Checklist Checklist on conformity with HKCAS requirements (ISO/IEC Guide 65)
HKIAS
-
HKIAS 003 Criteria for Accreditation of Inspection Bodies
-
HKIAS 005 Application for Inspection Body Accreditation / Extension of Scope of Inspection Body Accreditation
-
HKIAS 006 Schedule of Accreditation Fees for Inspection Bodies within the Hong Kong Special Administrative Region
-
HKIAS 007 Assessment / Reassessment Questionnaire
-
HKIAS 007 Checklist Checklist on conformity with HKIAS requirements
-
Relevant HKIAS Supplementary Criteria
   
(iii) The organisation lodges the application by providing the following to the HKAS Executive -
HOKLAS (a)
A completed Application Form for Laboratory Accreditation (HOKLAS 005)
(b)
A completed Application Questionnaire (HOKLAS 007 for non-medical laboratory or HOKLAS 016 for medical laboratory)
(c)
The documents specified in the Application Questionnaire
(d)
Appropriate application fees as stated in HOKLAS 006 /013
   
HKCAS (a)
A completed Application Form for Certification Body Accreditation (HKCAS 005)
(b)
A completed Application Questionnaire (HKCAS 007)
(c)
The documents specified in the Application Questionnaire
(d)
Appropriate application fees as stated in HKCAS 006
   
HKIAS (a) A completed Application Form for Inspection Body Accreditation (HKIAS 005)
(b) A completed Application Questionnaire (HKIAS 007)
(c) The documents specified in the Application Questionnaire
(d) Appropriate application fees as stated in HKIAS 006


Step 2 - Preliminary Advice to Laboratory

(i) Following examination of the documentation submitted by the organisation, the HKAS Executive arranges an advisory / pre-assessmemt visit to:
(a)
Answer any questions relating to technical criteria and regulations.
(b)
Advise on any obvious improvements to existing practice as necessary.
(c)
Advise on probable calibration requirements for the tests for which accreditation is being sought.
(d)
Comment on the acceptability of the organisation's quality manual.


Step 3 - Preparation for Assessment

(i) The organisation submits the final copies of its quality manual and test procedures.
(ii) The HKAS Executive seeks any further information required from the organisation.
(iii) The HKAS Executive selects suitable expert assessors to undertake on site assessment of the organisation.
(iv) Arrangements are made with the organisation for a mutually convenient date or dates for an on-site assessment of the organisation.
NOTE :Applicant organisations may object on reasonable grounds to the assessors nominated for the assessment of their organisations.


Step 4 - Assessment of Organisation

(i) An on-site assessment is undertaken at the organisation.
NOTES :
(a) All key organisation personnel shall be available for interview during the on-site assessment.
(b) The organisation may be asked to undertake typical tests as part of the assessment process.
   
(ii) On completion of the on-site assessment, the organisation's management is provided with an assessment report by the assessment team which includes:
(a) the assessment team's recommendation for granting of accreditation for all or part of the list of tests sought by the applicant laboratory;
(b) list of any action which may be necessary before accreditation for all or any of the tests that can be further considered;
(c) details of follow-up action.


Step 5 - Advice of Assessment Outcome

(i) For reassessments and assessments for extension of accreditation within a test category/certification system/inspection field for which the organisation is already accredited, the assessment report will be reviewed by the HKAS Executive. Any amendment to the assessment report will be issued to the organisation within 10 working days of the assessment.
(ii) For initial assessments for a test category/certification system/inspection field or a major test area, the assessment will be reviewed by the HKAS Executive as well as AAB. The reviewed assessment results will be issued to the organisation in the form of an outcome letter.
(iii) In most cases specific matters requiring attention before accreditation can be further considered, and these are listed in the assessment report and in the outcome letter.


Step 6 - Remedial Actions (if required)

(i)
On receipt of formal advice from an applicant organisation that all required actions have been taken, HKAS Executive will take 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 HKAS Executive and where necessary with an assessor, but in some cases, a further on-site assessment may be needed.
(ii)
Assuming the remedial actions are found acceptable, a recommendation for accreditation will normally follow. A formal notification letter and a certificate of accreditation will be issued.
(iii)
If an organisation is unsuccessful in achieving accreditation, it has the right to appeal (See Disputes, Complaints and Appeals Mechanism in HKAS 002).


Step 7 - After Accreditation

(i) After accreditation has been granted, accredited laboratory are reassessed the following year and thereafter at intervals not exceeding two years. Surveillance visits will also be conducted. The purpose is to ensure that the standards required for continued accreditation are being maintained. Accredited certification bodies are reassessed on the accredited activities every three years. For inspection bodies, reassessment are conducted two years after the granting of accreditation and thereafter at every two year intervals. Surveillance visit to accredited certification bodies and inspection bodies are conducted routinely at every six months intervals.
(ii)

Organisations may seek to have their scope of accreditation extended or reduced or they may seek changes to their approved signatories. Such changes may require on-site assessment.

(iii) Organisations are required from time to time to participate in proficiency testing programmes organised or specified by HKAS (where appropriate).
(iv) Organisations are required under HKAS regulations to advise the HKAS Executive immediately in writing of any changes in the organisation's circumstances which may affect its continued coformity with HKAS requirements.
   
This includes notification of such changes as:
(a)

change in ownership or name of the accredited organisation including the change in legal, commercial or organisational status, e.g. mergers, company dissolution, bankruptcies, compulsory or voluntary liquidation or any other matters concerning the Official Receiver;

(b) change in its organisational structure and managerial staff;
(c) change of the approved signatories;
(d) change in the organisational policies, where relevant;
(e) change in its registered address or any place where the accredited activities are to be carried out;
(f) change in working procedures and resources including personnel, equipment, facilities, working environment, where significant;
(g) change in the nature of the work performed by an accredited organisation; and,
(h) any other matters that may affect the organisation's capability, or its scope of accreditation or its conformity with the accreditation criteria.
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