We are having to audit a critical supplier as they are being bought out by another company. Because we are in the process of our MDR application, I didn't know if we had to audit against the MDR. Our checklist right now is tailored to ISO 13485:2016 and the FDA.
Your question is fairly general so without being very specific, here's an overview for a generalized checklist for MDR. You would have to tailor this checklist to your specific needs and requirements. When combined with the FDA process, it's a little bit different with purchasing controls and receiving acceptance activities, closeout meeting, etc.
Audit Program and Plan
- Develop an audit program that identifies the number and sequence of activities required to demonstrate complete coverage of the manufacturer's quality management system (MDR, ANNEX VII (a)(1), MDCG 2022-17 Paragraph 6)
- Define the objectives, criteria, and scope of each audit in the audit program (MDR, ANNEX VII (a)(1), MDCG 2022-17 Paragraph 6)
- Plan and periodically carry out appropriate surveillance audits and assessments (MDR, ANNEX VII (10))
Supplier Identification and Assessment
- Identify relevant suppliers and/or subcontractors of the manufacturer (MDR, ANNEX VII (a)(2))
- Consider the need to specifically audit any of those suppliers or subcontractors (MDR, ANNEX VII (a)(2))
- Gather information relating to the name and location of the manufacturer's critical suppliers of products and services (IMDRF Guidance, IMDRF/MDSAP WG/N3FINAL:2016 (Edition 2), 9.1.1)
- Include a list of critical suppliers, their legal name, full address, product or service provided, and any changes to those suppliers identified as critical suppliers since the previous audit (IMDRF Guidance, IMDRF/MDSAP WG/N24FINAL:2015, (I))
On-site Audits
- Conduct audits on the premises of the manufacturer and, if appropriate, of the manufacturer's suppliers and/or subcontractors (MDR, ANNEX VII (b)(14), MDCG 2022-17 Paragraph 3, Paragraph 5)
- Perform unannounced on-site audits (MDR, (52))
Testing and Verification
- Carry out or request certain tests to verify the proper functioning of the quality management system (MDR, ANNEX VII (10))
- Conduct physical or laboratory tests on devices to ensure continuous compliance by manufacturers after receipt of the original certification (MDR, (52))
Audit Reporting
- Notify the manufacturer of the outcome of the assessment and the resultant decision (MDR, ANNEX VII (10))
- Enter the assessment outcome and decision into the electronic system referred to in Article 57 (MDR, ANNEX VII (10))
- Provide information to the recognizing Regulatory Authority(s) about the audits and decision on conformity to quality management system requirements (IMDRF Guidance, IMDRF/MDSAP WG/N3FINAL:2016 (Edition 2), 8.6.3)
