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
contact@lne-america.com 1-301-495-0477 lne-america.com Speaker Florianne Torset - Bonfillou Director of Regulatory, Education and Quality – Lead Auditor at LNE/G-MED North America, Inc . 6/6/2017 Do not distribute or reproduce without permission 2
contact@lne-america.com 1-301-495-0477 lne-america.com 6/6/2017 Do not distribute or reproduce without permission 3
contact@lne-america.com 1-301-495-0477 lne-america.com General modifications • 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 6/6/2017 Do not distribute or reproduce without permission 4
contact@lne-america.com 1-301-495-0477 lne-america.com 6/6/2017 Do not distribute or reproduce without permission 5
contact@lne-america.com 1-301-495-0477 lne-america.com Supplier • According to ISO 9000:2015 , a Supplier is “ an organization that provides a product or a service” . • ISO 13485:2016 specifies that a product is the “ result of 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: 6/6/2017 Do not distribute or reproduce without permission 6
contact@lne-america.com 1-301-495-0477 lne-america.com 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 6/6/2017 Do not distribute or reproduce without permission 7
contact@lne-america.com 1-301-495-0477 lne-america.com Definitions from NBOG BPG 2010-1 • Supplier: …Organization or person that provides a product, a service, or information, and which is outside 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 6/6/2017 Do not distribute or reproduce without permission 8
contact@lne-america.com 1-301-495-0477 lne-america.com 6/6/2017 Do not distribute or reproduce without permission 9
contact@lne-america.com 1-301-495-0477 lne-america.com When the organization chooses to outsource any process that affects product conformity to requirements, it shall monitor and ensure control over such processes. 6/6/2017 Do not distribute or reproduce without permission 10
contact@lne-america.com 1-301-495-0477 lne-america.com 6/6/2017 Do not distribute or reproduce without permission 11
contact@lne-america.com 1-301-495-0477 lne-america.com 6/6/2017 Do not distribute or reproduce without permission 12
contact@lne-america.com 1-301-495-0477 lne-america.com 6/6/2017 Do not distribute or reproduce without permission 13
contact@lne-america.com 1-301-495-0477 lne-america.com • • • • 6/6/2017 Do not distribute or reproduce without permission 14
contact@lne-america.com 1-301-495-0477 lne-america.com • • • 6/6/2017 Do not distribute or reproduce without permission 15
contact@lne-america.com 1-301-495-0477 lne-america.com 6/6/2017 Do not distribute or reproduce without permission 16
contact@lne-america.com 1-301-495-0477 lne-america.com 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. 6/6/2017 Do not distribute or reproduce without permission 17
contact@lne-america.com 1-301-495-0477 lne-america.com 6/6/2017 Do not distribute or reproduce without permission 18
contact@lne-america.com 1-301-495-0477 lne-america.com 6/6/2017 Do not distribute or reproduce without permission 19
contact@lne-america.com 1-301-495-0477 lne-america.com 6/6/2017 Do not distribute or reproduce without permission 20
contact@lne-america.com 1-301-495-0477 lne-america.com 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. 6/6/2017 Do not distribute or reproduce without permission 21
contact@lne-america.com 1-301-495-0477 lne-america.com 6/6/2017 Do not distribute or reproduce without permission 22
contact@lne-america.com 1-301-495-0477 lne-america.com 6/6/2017 Do not distribute or reproduce without permission 23
contact@lne-america.com 1-301-495-0477 lne-america.com LNE/G-MED North America, Inc Thank you! Any questions? Email us: contact@lne-america.com 6/6/2017 Do not distribute or reproduce without permission 24
Recommend
More recommend
