Library / Analysis

Control of Document Changes. Three findings.

Analysed today against ISO 13485:2016 · reached from the Library and the document

Executive summary

The procedure covers approval before issue and keeps changes identifiable. It does not say how obsolete versions are withdrawn, and periodic review is mentioned without a frequency.

Findings

MajorNo control of obsolete documentsISO 13485 4.2.4 gAdd a section that withdraws superseded versions from use and marks retained copies as obsolete.Open

MinorPeriodic review has no frequencyISO 13485 4.2.4 bState that each document is reviewed at least every 24 months, and by whom.Open

ObservationChange log location not namedISO 13485 4.2.5Name where the change log is kept.Open

Three things we liked

Clear owner for every change
Version identifiers on every page
Emergency changes still get reviewed

Clause coverage

Clause	Requirement	Coverage
4.2.4 a	Review and approve before issue	Met
4.2.4 b	Review, update and re-approve	Partly
4.2.4 e	Documents remain legible and identifiable	Met
4.2.4 g	Prevent use of obsolete documents	Not met