Production Process Control Procedure (SYS-012)

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The purpose of this procedure is to define the overall production process controls, while the product-specific controls are documented in the technical documentation for each product or product family.

This procedure covers production process controls that have been implemented. It does not include outsourced contract manufacturing. Contract manufacturing is controlled in accordance with the Supplier Quality Management Procedure (SYS-011). The procedure includes all six of the production process controls specified in Section 7.5.1a-f of ISO 13485:2016. The procedure also includes requirements for traceability (covered in more detail within SYS-032, Identification & Traceability).

This is one of the documents meeting the applicable regulatory requirements for Production Processes Controls as defined in Quality System Manual (POL-001). The procedure does not include all of the details for a specific manufacturing process. Instead, the individual manufacturing process requirements are intended to be included in a Device Master Record (DMR) and/or Technical File (TF). Ideally, these two documents would be satisfied by an index that meets both requirements (e.g., FRM-040, TF/DMR Index Template included with SYS-025, Technical Documentation). There is also a section in the procedure to list each of your DMR indices to provide a quick reference list for internal and external auditors.

This document is updated for ISO 13485:2016 and the new European Regulations. We also added a simple, one-page template for a Device History Record (DHR) release checklist. The following is a list of documents included:

  • SYS-012 A, Production Process Control Procedure
  • FRM-047 A, DHR Release Checklist

Production Process Controls Procedure Production Process Control Procedure (SYS 012)
Production Process Control Procedure (SYS-012)

The purpose of this procedure is to define the overall production and process controls, while the product-specific controls are documented in the technical documentation for each product or product family. If you would like to make other payment arrangements, please contact us @ rob@13485cert.com or +1.802.281.4381.

Price: $299.00

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