Hong Kong Laboratory Accreditation Scheme




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Hong Kong Laboratory Accreditation Scheme



HOKLAS 007

Assessment/Reassessment Questionnaire for Non-medical Laboratories



For initial applications for accreditation and applications for extension of scope of accreditation, this questionnaire should be completed and returned to HKAS Executive together with the application form HOKLAS 005 and all relevant documents as listed in the checklist on page 2. HKAS Executive will only process an initial application for accreditation or an application for extension of scope of accreditation when completed forms HOKLAS 005, HOKLAS 007 and application fee are submitted.


For reassessments, the completion of this questionnaire is also required. The completed questionnaire and relevant documents should be provided to HKAS Executive one month before the scheduled reassessment date.
Fees payable for assessments are calculated in accordance with:
HOKLAS 006 Schedule of Accreditation Fees for Laboratories within the Hong Kong Special Administrative Region, or
HOKLAS 013 Schedule of Accreditation Fees for Laboratories outside of the Hong Kong Special Administrative Region.
You should study carefully the latest version of the following documents before completing this questionnaire:
HKAS 002 Regulations for HKAS Accreditation
HKAS Supplementary Criteria No. 6 Code of Conduct
HOKLAS Supplementary Criteria No. 33 Accreditation Regulations Specific for HOKLAS – Laboratory
HOKLAS 003 Technical Criteria for Laboratory Accreditation


HONG KONG ACCREDITATION SERVICE

36/F., Immigration Tower, 7 Gloucester Road, Wanchai, Hong Kong.

Tel : 2829 4840 Fax : 2824 1302 E-mail : hkas@itc.gov.hk

Notes: 1. The personal data provided by you will be retained and used by HKAS for accreditation purpose only. The personal data may be disclosed to members of the assessment team.

2. You have the rights to obtain a printed copy of your personal data held by HKAS and request correction of the personal data. Please contact HKAS at the above address for access to and correction of your personal data.


Attachment Checklist

(Please tick the box or boxes below as appropriate)
This Questionnaire is for :

 Initial Assessment  Extension of Scope  Reassessment


List of Attachments (for initial assessment and extension of scope only)



Application fee in the form of a cheque payable to The Government of the Hong Kong Special Administrative Region.
Note : Application fee will be charged only for initial application and application for extension of accreditation. No application fee is required for reassessment. In addition to application fee, assessment fee will be charged. The Applicant will be informed of the exact amount when the on-site assessment has been arranged.




Documents authenticating that the applicant laboratory is a legal entity or part of a legal entity




Quality manual




Operation procedure manual




Latest audit schedule




Summary of the findings of the latest management review





Test/calibration procedure manual(s), test/calibration standard(s) and normative reference, where applicable
Method verification/validation report, where applicable




Measurement uncertainty estimation




CV’s and copies of qualification documents for new nominees for signatory/operator approval




Laboratory floor plan




Laboratory organisation charts, with key positions clearly identified




Sample test/calibration records (please refer to “Records” section on page 9 of this questionnaire for details)




Sample test/calibration reports (please refer to “Reporting the Results” section on page 17 of this questionnaire for details)




Relevant proficiency test (PT) reports and one-year PT participation plan (please refer to “Proficiency Testing Activities” section on page 16 of this questionnaire for details)




Code of conduct




Other documents (please specify)





     




Note : For reassessment, the required documents are listed in the AF07 form accompanying the letter to the laboratory which will normally be issued two months prior to the due date for the reassessment.


SCOPE OF ACCREDITATION



For application for accreditation and application for extension of scope of accreditation, the tests and calibrations proposed for accreditation shall be detailed in the “Scope of Accreditation Sought” table on page 4 and page 5.

For reassessment, the “Scope of Accreditation to be Reassessed” should have been sent to the laboratory together with the letter informing it of the forthcoming reassessment. The laboratory should check the scope carefully and minor changes should be annotated on it. The reviewed scope should then be signed for confirmation and returned to HKAS Executive together with this completed questionnaire. If major additions to the scope of accreditation are requested, the laboratory should consult HKAS Executive on whether an application for extension of scope of accreditation should be submitted.



Scope of Accreditation Sought (for application for accreditation or extension of scope of accreditation only)
Please specify as precisely as possible below the scope of accreditation sought. Specifications quoted in the fourth column should be of national or international standards or those published by reputable technical organisations or in relevant scientific texts or journals. In the absence of such standard specifications, documented and validated in-house methods may be quoted and the laboratory shall provide a copy of these documented methods to the HKAS Executive together with this completed questionnaire.

HOKLAS


test category

Items, materials

or products tested/calibrated

Specific tests, properties measured

or ranges of measurement

Standard methods, specifications,

or technique used (where appropriate)


     

     

     

     

Photocopy this sheet if required.

Notes : 1. Please state the identification numbers of the laboratory internal technical procedures for the tests/calibrations listed in columns 3 and 4 on page 4.

2. Please state the approximate frequency of performing the tests/calibrations in number per year

3. Please state the approximate experience of the laboratory in performing the test/calibration, in total number of tests/calibrations performed per year

4. Please state the identification numbers of the sample test/calibration records provided (see the “Records” section on page 9).

5. Please state the identification numbers of the sample test/calibration reports provided (see the “Reporting the Results” section on page 17).



Calibration and measurement capability (CMC) or limits of reporting

(where appropriate)

Test/Calibration

procedure1

Frequency of performing2



Experience3


Sample


test/calibration record4

Sample


test/calibration report/certificate5

     

     

     

     

     

     

Photocopy this sheet if required.

Note: All tests within the same test category listed in the above table will be processed together. When all the listed tests within the same category have met relevant accreditation criteria, a notification letter granting accreditation for them will be issued.

General Information

Organisation name

(See Note 1)



     







Laboratory name

(See Note 2)



     







General description of the organisation and the laboratory including their major activities and history

     







Laboratory physical address

     




Telephone




Fax




E-mail




     




     




     







Correspondence address


     




 Hong Kong




 Kowloon




 N.T.




Telephone




Fax




E-mail




     




     




     

Questionnaire completed by




Name

     







Position

     




Telephone



Fax




E-mail




     




     




     

Authorised representative




Name

     







Position

     







Address

(if different from the correspondence address)



     




 Hong Kong




 Kowloon




 N.T.




Telephone



Fax




E-mail




     




     




     




Signature




Date



     




     

Note 1 – Organisation is the legal identity of the owner of the laboratory. It may be a government department, instrumentality, company, person operating a laboratory or other legal entity.

Note 2 – The name used by the organisation to identify the laboratory.

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