Supplier Quality Management System Audit …

1 Supplier Quality Management System Audit Checklist (ISO 9000:2000, TS 16949:2002). Supplier : _____. Plant/Location: _____ Date: _____. Audit Team: _____. _____. _____. _____. Scope of Audit : _____. Number of s: _____ Corrective Action Due: _____. Potential suppliers may be requested to conduct a self-assessment of their Quality System to determine eligibility. The Nova Sourcing Team shall determine eligibility after analysis of the self-assessment. Results of the Checklist shall be documented and communicated to the Supplier by the Nova Sourcing Team. NOTE: Sections in red are questions relevant to TS 16949. APPENDIX A. 09/15/08 Rev. 1 John Farmer, ISO 9001:2000 and/or Q# Audit Question Evidence ISO/TS 16949 Clause Text 4 Quality Management System General requirements The organization shall establish, document, Has Supplier established, documented, implement and maintain a Quality implemented and maintained a QMS.

2 Management System and continually and continually improved its improve its effectiveness in accordance effectiveness in accordance with ISO. with the requirements of this International 9001:2000? (Questions in section Standard. are verified throughout the Audit ). The organization shall a) identify the Where has Supplier identified the processes needed for the Quality processes needed for the QMS and their Management System and their application application throughout Supplier ? (See throughout the organization (see ), ). The organization shall b) determine the Where has Supplier determined the sequence and interaction of these sequence and interaction of QMS. processes, processes?

3 (See ). The organization shall c) determine criteria What are the criteria and methods and methods needed to ensure that both Supplier uses to ensure that the the operation and control of these operation and control of QMS processes processes are effective, are effective? The organization shall d) ensure the Has Supplier provided resources and availability of resources and information information needed to support the necessary to support the operation and operation and monitoring of QMS. monitoring of these processes, processes? (See section 6). The organization shall e) monitor, measure How does Supplier monitor, measure and analyze these processes, and and analyze QMS processes?

4 (See section 8). The organization shall f) implement actions How has Supplier implemented actions necessary to achieve planned results and necessary to achieve planned results continual improvement of these processes. and continual improvement of processes needed for the QMS? These processes shall be managed by the Are processes needed for the QMS. organization in accordance with the managed by Supplier in accordance with requirements of this International Standard. the requirements of ISO 9001:2000? Where an organization chooses to When Supplier out sources any process outsource any process that affects product that affects product conformity with conformity with requirements, the requirements, how is control ensured organization shall ensure control over such over such processes?

5 (See ). processes. Control of such outsourced processes shall Where is the control of outsourced be identified within the Quality Management processes that affect product conformity System . with requirements identified within the QMS? (See ). 10/15/08 Rev. 1 Page 2 of 45 John Farmer, ISO 9001:2000 and/or Q# Audit Question Evidence ISO/TS 16949 Clause Text NOTE Processes needed for the Quality Management System referred to above should include processes for Management activities, provision of resources, product realization and measurement. General requirements Supplemental Ensuring control over outsourced Does Supplier have adequate control processes shall not absolve the over outsourced processes to ensure organization of the responsibility of conformity to all customer requirements?

6 Conformity to all customer requirements. (See ). NOTE See also and Documentation requirements General The Quality Management System Does Supplier have documented documentation shall include statements of a Quality policy and Quality a) documented statements of a Quality objectives? (See , ). policy and Quality objectives, Does Supplier have a Quality manual? b) a Quality manual, (See ). c) documented procedures required by this International Standard, Does Supplier have the documented d) documents needed by the organization procedures required by ISO 9001:2000? to ensure the effective planning, (See , , , , , ). operation and control of its processes, Are adequate documents in place to and ensure the effective planning, operation e) records required by this International and control of Supplier 's processes?

7 Standard (see ). Does documentation include the records required by ISO 9001:2000? NOTE 1 Where the term documented procedure appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. NOTE 2 The extent of the Quality Management System documentation can differ from one organization to another due to a) the size of organization and type of activities, b) the complexity of processes and their interactions, and c) the competence of personnel. NOTE 3 The documentation can be in any form or type of medium. Quality manual The organization shall establish and Where in the Quality manual is the scope maintain a Quality manual that includes of the QMS identified, including details a) the scope of the Quality Management of and justification for exclusions?

8 System , including details of and justification for any exclusions (see ), Where does the Quality manual contain b) the documented procedures or reference the documented established for the Quality Management procedures established for the QMS? System , or reference to them, and c) a description of the interaction between Where does the Quality manual include a the processes of the Quality description of the interaction between Management System . the processes of the QMS? 10/15/08 Rev. 1 Page 3 of 45 John Farmer, ISO 9001:2000 and/or Q# Audit Question Evidence ISO/TS 16949 Clause Text Control of documents Documents required by the Quality How are the documents required by the Management System shall be controlled.

9 QMS controlled? Records are a special type of document and shall be controlled according to the (Documents should be reviewed throughout requirements given in the Audit ). A documented procedure shall be Can you show a documented procedure established to define the controls needed that defines the controls needed for each of a) to approve documents for adequacy the following? prior to issue, a) approve documents for adequacy prior b) to review and update as necessary and to issue? re-approve documents? b) review and update as necessary and c) to ensure that changes and the current re-approve documents? revision status of documents are c) ensure that changes and the current identified?

10 Revision status of documents are d) to ensure that relevant versions of identified? applicable documents are available at d) ensure that relevant versions of points of use? applicable documents are available at e) to ensure that documents remain points of use? legible and readily identifiable? e) ensure that documents remain legible f) to ensure that documents of external and readily identifiable? origin are identified and their f) ensure that documents of external distribution controlled? origin are identified and their g) to prevent the unintended use of distribution controlled? obsolete documents, and to apply g) prevent the unintended use of obsolete suitable identification to them if they are documents, and to apply suitable retained for any purpose.