ISO 13485:2016 Pt 3 – Purchasing and Production
EU, ISO 13485, Non-Conforming, Outsourcing, Process Validation, Purchasing, Quality Management System, Supplier
This is the third device tip in a series on the changes in EN ISO 13485:2016. This device tip focuses on changes to the purchasing and production processes.
If your Quality Management System is currently certified as compliant with ISO 13485:2003 (and/or EN/ISO 13485:2012), certification in the EU expired in February 2019. After February 2019, only certification to the latest edition published in 2016 will be valid in the EU. Any design changes made from now on and any new development projects should conform to ISO 13485:2016.
In order to be prepared (and here’s the tip):
Identify and incorporate the updates needed to your purchasing and production processes to ensure continued certification in the EU to EN ISO 13485:2016. Begin using the updated processes as soon as possible to generate objective evidence of conformance to the 2016 standard to prepare for your next certification audit.
There are significant changes to requirements in both the purchasing and the production processes that need to be considered. This list is not comprehensive, but it includes either new sections of the standard orupdates to the existing requirements. You should review the following areas in the 2016 standard to ensure that your Quality Management System is compliant:
- Outsourcing
- Supplier selection
- Purchasing
- Process validation
- Non-conforming product
More Info
There are significant changes found in the 2016 update to EN ISO13485 that need to be incorporated into your purchasing and production processes in order to maintain certification in the EU. Just a few are listed here:
- Outsourcing – there is a new requirement in the standard outlining the requirements for outsourcing of processes that affect product conformity to requirements. Outsourced processes must be monitored and controlled and the controls must be documented in a written quality agreement.
- Supplier selection – the requirements for evaluation and selection of suppliers are detailed and a plan for monitoring and re-evaluation of suppliers is required.
- Purchasing – a significant new requirement is that purchasing information shall include a written agreement that suppliers provide notification of changes in the purchased product prior to implementation.
- Process validation – inclusion of statistical techniques with a rationale for sample size is a new requirement for process validation procedures.
- Non-conforming product – the requirements are separated into new sections for actions required in response to non-conformances detected prior to and after delivery. Notifications shall be made to any responsible external parties.