ISO 13485 Document Control Procedure Bundle

The Document Control Procedure Bundle includes six (6) ISO 13485:2016 quality system procedures relating to the creation, maintenance, distribution, format and retention of all controlled documents within an organization.

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Document Control Procedure Bundle Content

The Document Control Procedure Bundle includes the following procedures:

Engineering Change Notice Procedure -The Engineering Change Notice (ECN) Procedure defines the process to create, modify, or obsolete controlled documents within the company in accordance with GMP and ISO 13485:2016 requirements.

Document Control Procedure -The Document Control Procedure governs all aspects of documentation management needed to address GMP and ISO 13485:2016 requirements for controlled documents.

Record Retention Procedure - The Record Retention Procedure outlines records requirements for each department, archive records requirements, off-site storage, record retention periods for each type of document and the retention schedule for each specific record.

Specification Format Procedure -The Specification Format Procedure ensures that consistent formats are used throughout the company for numbering schemes, header, footer, body text, title blocks, drawing dimensions, and change history.

Medical Device File / Device Master Record Procedure -The Device Master Record / Technical Documentation Summary Procedure defines the creation and content of a Device Master Record / Technical Documentation for the manufacture of a finished medical device per ISO 13485:2016 clause 4.2.3 (medical device file), incorporated by reference in 21 CFR Part 820 and MDR EU 2017/745