Support (clause 7)

Auditor :

Documents selected for the audit : ISO 9001 (clause 7) and PN111 (clauses 4 / 5 / 6)

Have all Non-conformances from the previous audit been actioned and closed?

Are all documents available for the audit?

Where applicable are all personnel trained in the process?

7.1.1) Does the organisation determine and provide the resources needed to establish, implement, maintain and continually improve the QMS?

7.1.2) Does the organisation determine and provide the persons necessary for the effective implementation of the QMS and for the operation and control of it's processes?

7.1.3) Does the organisation determine, provide and maintain the infrastructure necessary for the operation of it's processes and to achieve conformity of products and services?

7.1.4) Does the organisation determine, provide and maintain the environment necessary for the operation of it's processes and to achieve conformity of products and services?

7.1.5.1) Does the organisation determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements?

7.1.5.2) When measurement equipment calibration and traceability are required, does the organisation ensure that : a - Equipment is calibrated and traceable to international or national measurement standards? b - Records of calibration are maintained? c - Equipment is identified in order to determine their status? d - Equipment is safeguarded from adjustment, damaged and deterioration that could invalidate measurement results? e - The validity of previous measurement results have been adversely affected when the equipment is found to be unfit for it's intended purpose and appropriate action is taken?

7.1.6) Does the organisation determine the information necessary for the operation of its processes and to achieve conformity of products and services and ensure that the information is maintained and made available as necessary?

7.2) Does the organisation determine the necessary competence of persons that have an affect on the performance and effectiveness of the QMS? Are details of competence evaluated for effectiveness and documentation retained?

7.3) Does the organisation ensure that personnel are aware of the Quality Policy, relevant Quality Objectives, their contribution to the effectiveness of the QMS and the implications of not conforming with the requirements of the QMS?

7.4) Does the organisation determine what to communicate, when to communicate, who to communicate with, how to communicate and who communicates?

7.5.1) Does the organisations QMS include documented information that is necessary for the effectiveness of the QMS?

7.5.2) When creating and updating documented information, does the organisation ensure appropriate identification and description? Is the documentation reviewed and approved for suitability?

7.5.3.1) Does the organisation ensure that documented information required by the QMS is available and suitable for use where and when it is needed and is adequately protected against loss of integrity and improper use?

7.5.3.2) Does the control of documented information address the following : a - Distribution / access / retrieval / use. b - Storage and preservation (including legibility). c - Control of changes. d - Retention and disposition. e - Documentation of external origin is identified and controlled.

PN111 - 6) Does the organisation hold and update a register of "Critical Components"?

PN111-6) Does the organisation maintain a master list that details all QMS documents?

Have the OFI / OBS details been added to the Audit Tracker (DW065)?

Have the Non-conformance details been added to the Audit Tracker (DW065)?