Call: Click: ASRworldwide.com. Reviewing Scope and Non Applicable Sections of ISO 13485:2016 June 2018

Transcription

1 Call: Click: ASRworldwide.com Reviewing Scope and Non Applicable Sections of ISO 13485:2016 June 2018

2 Importance of Properly Documented Scope Scope called out in Section 1 of ISO 13485:2016 shall be documented in the quality manual in accordance with 4.2.2a. Some of these non-applicable (exclusions) sections apply to the original equipment manufacturer (OE) as well as the supply chain. Examples of non-applicable sections called out by manufacturers at all levels could be Sterile Medical Devices, and 7.5.7; Installation Activities, 7.5.3; Service Activities, 7.5.4; and Particular Requirements for Implantable Medical Devices,

3 Sections Not to Be Declared as Non-applicable at Any Level Following sections important for all manufacturing levels and should not be declared as non-applicable: Advisory notices Medical device files Reporting to regulatory authorities , 5.6.2c Very few original equipment manufactures will list the above sections as non-applicable.

4 Requirements - How Suppliers Should Address Advisory notices - generally issued to the OE, and if appropriate, the OE will involve the supplier. At supplier level this could be handled as non-conforming material or customer complaint (8.2.2) and records of the investigation documented in one of these two areas. Supplier might never see the actual advisory notice, but the customer must provide documentation regarding the requested investigation. Standard requires a documented procedure to address customer complaints. Medical device and component suppliers cannot exclude advisory notices! Expect ISO auditors to review documents to ensure the supplier is addressing receipt of advisory notices from the OE is the ideal section for documentation of an advisory notice. An example of a supplier s documentation might read - if an Advisory Notice is received from the customer, it will be handled in accordance with requirements of the customer complaint procedure. Medical device suppliers could use their corrective action procedure to address advisory notices. Medical device files - all organizations (OE,1,2,or 3) have some form of records maintained for each product(s), or product family in a separate file that meets requirements of This file may have a different name. Example component documentation file. Suppliers should not exclude medical device files. They should adjust the name of the files to meet the client s record requirements. Since lower tier suppliers do not build a complete device, they must maintain appropriate documents in the event of any type of investigation by a higher tier supplier or perhaps the FDA.

5 More - Suppliers Addressing Requirements Reporting to regulatory agencies begins with if applicable, and 5.6.2c is a line item in management review. If there is no regulatory action to report, management review minutes should show the word none. Medical device component suppliers must address 5.6.2c as part of the management review. There are other portions of ISO 13485:2016 addressing regulatory issues and could be addressed by stating as an organization, we do not receive regulatory requirements. However, if our customer has a regulatory issue, it will become a customer-specific requirement and transmitted from the customer to our organization.

6 Only Situation Where Previous Discussion May Not Apply Sterilizing and/or packaging products in a clean room environment. If the medical device is built in a clean room and then sterilized, and the manufacturer of record has subcontracted one or both of these processes, it is possible these locations could be subject to an FDA audit. As a result, suppliers need to be in compliance with all sterilization and clean room regulatory issues, advisory notices, and adverse event notifications.