Does API Q1 Require Suppliers To Be ISO 9001:2008 Certified?

Fayyaz Ahmed Asks The Following About APIQ1 :
What will be viable corrective action to take if it is observed during an audit that one of their suppliers of calibration services does not have valid ISO 9001:2008 certification? Should a corrective action report (CAR) be issued because the supplier possess an invalid ISO 9001:2000 QMS certification and is not being evaluated?
ATCS REPLY: 
Hi Fayyaz, ISO 9001, clause 7.4.1, requires the organization to establish criteria for the selection, evaluation and re-evaluation of suppliers. ISO 9001:2008 does not prescribe the use of any specific methods. Therefore, it may or may not include insuring that a supplier has a documented quality management system such as ISO 9001:2008 or a currently certified QMS.

API Q1, supplemental requirement, 7.4.1.2, sub clause d, lists verifying that a supplier’s quality management system conforms with an international standard/technical specification such as ISO 9001, ISO TS29001/API Q1, ISO 17025 or others, as one (1) of four (4) potential methods for selection, evaluation and re-evaluation of suppliers. Another potential method of selection could be grandfathering, provided that criteria is established for grandfathering suppliers.

Consider this, an organization may select to keep a supplier with an expired ISO 9001:2000 certification on their approved supplier list based upon that supplier’s past performance, inspection of delivered items or inspection of product at the supplier’s facility. Any or all of these methods are acceptable and within the requirements of ISO 9001:2008 and ISO TS29001/API Q1. Provided that the organization has records of their supplier selection, evaluation and re-evaluation, no corrective action would be warranted. I hope this helps.

Best regards,
Bill Aston, Managing Director
Aston Technical Consulting Services
Kingwood, TX 77339
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