MDSAP Audit Approach (MDSAP AU P0002) C1-T8: Control documents and records of internal and external origin, and keep records and an obsolete copy of documents for at least the device lifetime (minimum two years) or the longer jurisdiction periods

What does C1-T8 require?

Procedures must control QMS documents (including regulator-required documentation) and records, internal and external, so current versions are identified and available, and must retain records, and one or more superseded copies of each controlled document, for no less than the device's lifetime and never under two years from product release. Australia: QMS documents and records for a device, sponsor-requested support for specially imposed sponsor duties (TG Act s 41FN and Regs 5.7 to 5.13) and records of the conformity assessment procedure applied must be kept for at least five years; where the sponsor shares the QMS, records for Class III, implantable Class IIb and Class 4 IVDs on distribution and complaints are kept up to ten years (Reg 5.10). Brazil: change records must show the change, affected documents, approver signature, approval date and effective date; a master list of approved documents must be kept; electronic records must be backed up. Japan: retention of 15 years for specially designated maintenance-controlled devices and 5 years for others (or shelf life plus one year if longer), and 5 years for training records. Clauses: ISO 13485:2016 4.1.4, 4.2.1, 4.2.4, 4.2.5; RDC 665/2022 Arts 28 to 37; MO169 Arts 5-4, 6, 8, 9; 21 CFR 820.35.