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.
Supplied as nine editable Microsoft Word documents in a digital download.
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.
External Standards Procedure — Establishes how external standards and other controlled reference documents are identified, maintained and made available to personnel who need them.
Medical Device File / Device Master Record Procedure — The Device Master Record and Technical Documentation Procedure organizes manufacturing documentation under ISO 13485:2016 clause 4.2.3 (medical device file), which is incorporated into FDA QMSR through ISO 13485. EU MDR 2017/745 has separate technical-documentation requirements, including Annex II
Engineering changes and controlled-document issuance
Document formatting and external-standard control
Record retention and supporting forms
For completing and correcting individual quality records, see the separately sold Good Documentation Practices Procedure. It is not among the six documents in this bundle.
Individual documents in this bundle
Bundle value: The 6 included procedures total $434 when purchased individually at current prices. This bundle is $399, saving $35 (8%). Related forms are included as described above.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Medical Device Document Control: From Approval to Record Retention for workflow guidance, a checklist and common mistakes.
