Establish & maintain procedures for the medical device familyĮvery file must include established procedures, or reference to production procedures and all related manufacturing processes, for instance packaging, inventory maintenance, safe handling, and shipment protocols of packed finished products.
#Iso 13485 clauses code#
The description contains out of incorporated issues related to labelling, such as device code, name, classification status, bar code and CE requirement. It should have the approved and documented IFUs, for example instructions for use. The file of all medical device families should include a general description of the medical device, along with its designed application or subject of its use.
#Iso 13485 clauses manual#
The reference can be a Quality System Manual that is established on ISO 13485 and related compliance and regulatory requirements. This means that the medical device file should either have the certificate of conformity, or it should mention any document that shows that all processes in the design, production, packing, storage, and handling suffice the requirements of ISO 13485, relevant regulatory and legal requirements.
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With the incorporation of Clause 4.2.3 on the subject of medical device files in ISO 13485:2016, the standard has offered improved value for organisations opting the implementation of standard. However, it was a regulatory obligation in many countries, such as Medical Devices Directive 93/42/EEC in Europe, and FDA 21 CFR Section 820 in the United States.
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Medical device files were not required in the earlier edition of the international standard, i.e. This is to prevent any shortcomings or non-conformities during production or distribution of a medical device. Hereby, ISO TC 210 incorporates the need of a medical device file. Therefore, helping organisations to imitate the processes repeatedly when it is required.
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Hence, it is important that these organisations standardise their design and development processes, production processes, medical products record, inspection protocols and enhanced industrial controls for each product family. Medical device manufacturers and others in supply chain have to manage numerous medical devices.
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With this change in the standard Quality Management System, it becomes vigilant and it is required to help organisations to meet the regulatory requirements as well, since similar requirements have been stated by regulatory bodies. ISO Technical Committee (TC 210) mandates the requirements of medical device files in the latest version of ISO 13485:2016 in order to make a consistent work flow for manufacturers and suppliers in the medical devices industry. Waqas Imam, Industrial Engineer, Certified Lead Auditor, Blog Writer and Ambassador of the Medical Devices Community