ISO 13485 Document Control Procedure Bundle
$399.00
$399.00
per item
The Document Control Procedure Bundle includes six (6) ISO 13485 quality system procedures relating to the creation, maintenance, distribution, format and retention of all controlled documents within an organization. All procedures are ISO 13485:2016 and FDA QSR compliant.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- Includes Related Forms
- MS Word Format
- Instant Download Digital Content
SKU:
DC-BNDL
ISO 13485 Document Control Procedure BundleThe Document Control Procedure Bundle includes six (6) ISO 13485 quality system procedures relating to the creation, maintenance, distribution, format and retention of all controlled documents within an organization. All procedures are ISO 13485:2016 and FDA QSR compliant.
Document Control Procedure Bundle ContentThe 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.
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 21 CFR Part 820.181 and MDR EU 2017/745
Document Control Procedure Bundle ComplianceAll of the procedures contained within the Document Control Procedure Bundle are ISO 13485:2016 and FDA QSR compliant.
For more information about our Document Control Procedure Bundle contact us at [email protected]
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Document Control Bundle Contents
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