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LNE/G-MED North America, Inc Control of Critical Suppliers for - - PowerPoint PPT Presentation
LNE/G-MED North America, Inc Control of Critical Suppliers for - - PowerPoint PPT Presentation
contact@lne-america.com 1-301-495-0477 lne-america.com LNE/G-MED North America, Inc Control of Critical Suppliers for Medical Devices: ISO 13485:2016 perspectives 6/6/2017 Do not distribute or reproduce without permission 1
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- Broader application scope
- Possible exclusion of sections 6, 7 or 8
- Increased focus on the risk based approach
- Increased link to the applicable regulatory
requirements
General modifications
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Supplier
- According to ISO 9000:2015, a Supplier is “an
- rganization that provides a product or a service”.
- ISO 13485:2016 specifies that a product is the “result
- f a process” and that it includes “services, software,
hardware and processed material”. If we translate it to the Medical Device industry, Suppliers include, for example:
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Supplier
If we translate it to the Medical Device industry, Suppliers include, for example: – Raw material suppliers – Sub-assembly suppliers – Design/Manufacturing Subcontractors – Consultants – Any other service providers
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Definitions from NBOG BPG 2010-1
- Supplier: …Organization or person that provides a
product, a service, or information, and which is
- utside of the QMS of the manufacturer
- Critical supplier: …a supplier delivering materials,
components, or services that may influence the safety and performance of the device Supplier = Subcontractor
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When the organization chooses to outsource any process that affects product conformity to requirements, it shall monitor and ensure control over such processes.
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The organization shall document procedures (see 4.2.4) to ensure that purchased product conforms to specified purchasing information. The organization shall establish criteria for the evaluation and selection of
- suppliers. The criteria shall be:
The organization shall plan the monitoring and re-evaluation of suppliers. Supplier performance in meeting requirements for the purchased product shall be monitored. The results of the monitoring shall provide an input into the supplier re-evaluation process. Non-fulfilment of purchasing requirements shall be addressed with the supplier proportionate to the risk associated with the purchased product and compliance with applicable regulatory requirements.
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Conclusion
The ultimate goals of these changes made in the control of suppliers within the ISO 13485:2016 are:
- to increase the harmonization with existing Quality
System Regulatory requirements and ensure consistency between the different texts.
- to increase organizations’ suppliers control in order
to meet standards and regulatory requirements.
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