- Supplier audits must be part of the supplier management approach (Section 220.127.116.11.1)
- Supplier audits must be a part of an organization’s supplier development process –
- 18.104.22.168 Supplier Development. The organization shall determine the priority, type, extent, and timing of required supplier development actions for its active suppliers. Determination inputs shall include but are not limited to the following (22.214.171.124 b) - second-party audit findings (see Section 126.96.36.199.1);
- Supplier selection shall be based on ”An evaluation of the supplier’s quality management system” (188.8.131.52) – audit is not explicitly required, but could meet this requirement.
- Supplier auditors must be training and qualified to very specific requirements (7.2.4) (Essentially the same as internal auditors with the additional requirement of understanding the applicable manufacturing processes to be audited)
- These qualifications must be maintained, including changes to any of the core tools