APMP Quality System Questionnaire: QS1  (Version 04 April 2003)

Quality System details to cover CMCs already in the BIPM Database..

If the NMI is following more than one pathway, separate questionnaires should be submitted for each pathway.

If convenient, separate questionnaires may be submitted for each technical area.

NMI submitting QS details:

Contact Person (for further information) Name:

Email:

Phone:                                                            Fax:

 

1.

What are the CMCs supported by this application?

 

2.

The "APMP Guidelines For Accepting A Quality System" (available on the APMP website) recognises 3 pathways that could be followed to demonstrate compliance:

(a)        Third party accreditation, or

(b)         Certification to ISO 9001 and attestation by technical peers, or

(c)         Attestation by a team consisting of quality system experts and technical peers, organised through APLAC or a recognised accreditation body.

Which pathway are you following?

 

3.

Which standard(s) does your quality system conform to?

 

4.

Are there any CMCs in this application not covered by your quality system? If so, please identify them.  (If response is lengthy, attach it as a separate document).

 

4.1

Give a time frame when you expect to have the CMCs identified in 4 covered by the quality system.

5.

For NMIs following pathway (a):

 

5.1

Name address and fax number of the Accreditation body.

 

 

5.2

Are there any CMCs in this application not covered by the accreditation? If so, please identify them.  (If response is lengthy, attach it as a separate document).

 

 

5.3

Give a time frame when you expect to have the CMCs identified in 5.2 covered by the accreditation.

 

5.4

Please send copies (electronic copies preferred) of:

·         Accreditation certificate(s).

·          Scope of accreditation.

·          Names and affiliations of technical assessors.

Alternatively, give website addresses where this information is available.

 

6.

For NMIs following pathway (b):

 

6.1

Name address and fax number of the certification (ISO 9001) body.

 

 

6.2

Are there any areas relevant to the CMCs in this application not covered by the certification? If so, please identify them. (If response is lengthy, please attach as a separate document).

 

 

6.3

Give a time frame when you expect the areas identified in 6.2 to be covered by this certification.

 

 

6.4

List the names and affiliations of the technical peers.

 

 

6.5

Are there any areas relevant to the CMCs in this application that have not been peer reviewed? If so, please identify them. (If response is lengthy, please attach as a separate document).

 

 

6.6

Specify a time frame when you expect the areas identified in 6.5 to be peer reviewed.

 

 

6.7

Please send copies (electronic copies preferred) of:

·         Quality (ISO 9001) certificate(s) with details of areas covered by the certification.

·         The Review Report* or a Summary Report by the Technical Peers

·          Final attestation by the reviewers, or at least the leader of the review team, stating that all the non-conformances have been satisfactorily addressed.

Alternatively, give website addresses where this information is available.

 

* A Summary Report as in "APMP Guidelines For Accepting A Quality System" is preferred. However, if such a Summary Report is not available, please send the Review Report.

 

 

 

 

7.

For NMIs following pathway (c):

 

7.1

List the names and affiliations of the technical peers.

 

 

7.2

Specify the names and affiliations, qualification and experience of the QS experts.

 

 

7.3

Are there any areas relevant to the CMCs in this application that have not been peer reviewed?  If so, please identify them. (If response is lengthy, please attach as a separate document).

 

 

7.4

Give a time frame when you expect the areas identified in 7.3 to be peer reviewed.

 

 

7.5

Please send copies (electronic copies preferred) of:

·        The Review Report* or a Summary Report by the Technical Peers.

·         Final attestation by the reviewers, or at least the leader of the review team, stating that all the non-conformances have been satisfactorily addressed.

Alternatively, give website addresses where this information is available.

 

* A Summary Report as in "APMP Guidelines For Accepting A Quality System" is preferred. However, if such a Summary Report is not available, please send the Review Report.