ANSWER FROM THE CENTER'S EXPERTS:
The audit, performed by PRI, is more complex than typical quality management system audits. What you need to know about the auditing process:
- Critical process audits are conducted using collaboratively created, industry-managed performance standards and manufacturer specifications which lead to an accreditation granted by the industry
- In-process job audits are conducted by industry-approved and trained auditors, who have extensive experience and knowledge of their process specialty
- Verification of compliance to an appropriate general quality management system (such as ISO 9001 or ISO 13485) is a pre-requisite for current PRI programs