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  • Questions about ISO 13485 implementation

    1) Is it a requirement for the medical device outsourcing company to have implemented ISO 13485 before my company implements GMP?

    According to the MDR 2017/745, any entity that is involved in the life cycle of medical devices (manufacturer, outsourced production company, distributor, importer, authorized representative), needs to have a quality management system. ISO 13485:2016 is a standard that is specific for Manufacturers of medical devices (Medical devices — Quality management systems — Requirements for regulatory purposes).

    Besides that, on the web pages of the European Commission are stated which standards are applicable for all types of medical devices: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en 

    On that list, which has around 300 standards, only ISO 13485:2015 is the standard for the quality management system.

    From this point of view, ISO 13485 is more important than GMP and GDP.

    2) If the outsourcing company (who owns the product label or brand name) fails in being ISO 13485 compliant, should my company then implement ISO 13485 instead of GMP?

    The company that owns a product label or brand name can not fail in being ISO 13485 compliant because it won't be in compliance with MDR requirements. Yes, from the medical device point of view, ISO 13485 is more suitable. 

    3) In doing my research for my company, I noticed that GMP and GDPMD have certain similar mandatory document requirements – e.g. the Quality Manual, SOP on Document Control, SOP on Pest Control, SOPs on Internal Audit and Management Review. Instead of having duplicate documents, could such documents be adapted to accommodate both GMP and GDPMD? For instance, drafting one Quality Manual that caters for both GMP and GDPMD?

    You do not need to duplicate documents, you can adapt them to accommodate both GMP and GDP.

    4) Should the scope of the GMP include the other products (not technically defined as medical devices) manufactured and distributed by my company, or could it be limited to the medical products only?

    GMP can be applicable to different kinds of products, therefore, it does not need to be limited to medical device products only.

    If you need more information regarding ISO 13485, please see the following articles:

    You can even see how our ISO 13485:2016 Documentation toolkit looks like on the following link: https://advisera.com/13485academy/iso-13485-documentation-toolkit/

  • AS9100 - defining Top Management

    The use of “top management” in AS9100 carries over from the ISO 9001 standard; as such the definition comes from ISO 9000. Top Management is the person or group who direct the organization at the highest level within the scope of the QMS. So, if the QMS scope is the one building you are located in, but you have a parent company in another country, then top management refers to the senior managers at the facility detailed in the scope.

    You can learn more about meeting the QMS leadership requirements in this applicable 9001Academy article: How to comply with new leadership requirements in ISO 9001:2015, https://advisera.com/9001academy/knowledgebase/how-to-comply-with-new-leadership-requirements-in-iso-90012015/

  • Single person company becoming ISO 9001?

    First, note this is typical corporate culture, apply one size to fit all rules.
    Second, there is no basic or entry-level ISO, but ISO 9001:2015 is very flexible. Organizations can design a very light quality management system. For a single person company, you can minimize documentation to almost only what is mandatory.

    You can find more information in the following links:

  • Change request procedure

    In ISO 13485:2016, in requirement 4.1.4, there is no request to have a documented procedure for change control. In this requirement is stated that changes need to be made, evaluated for their impact on the quality management system and medical device, and controlled. In our documentation toolkit, in procedure 21_Procedure_for_Management_Review_Premium_EN, in section 3.2.1 Review inputs is stated that one of the inputs is Changes that affect the quality system. The section about changes is also stated in form 21.2_Appendix_2_Management_Review_Minutes_Premium_EN.

    In our procedure 14_Warehousing_Procedure_Premium_EN is stated that the purpose of this procedure is to describe the process of warehousing and planning warehousing resources. The warehousing process includes, but is not limited to: storage of raw materials, products, clients’ property, nonconforming products, and hazardous waste. This procedure excludes: Storage, transport, and handling of medical products; and Temporary storage in case of incidents and emergency situations. In section 4.1 is stated that both FEFO and FIFO can be used. It is up to you to decide which approach is most suitable for you.

    There is no direct requirement in the ISO 13485:2016 in section 7.5.11 to have documented Goods in and Goods out procedure.

  • Can single process (stamping) be certified to IATF 16949 standard?

    If your production process is just "stamping" and you are selling the pressed part to your automotive customer without any further action, you can apply for IATF certification. Your scope would be "Manufacturing of stamped parts" if product design excluded.

    If you have welding and assembly processes in your automotive product other than the stamping process, then the welding and assembly processes must also be audited under IATF certification. 

    If you have welding and assembly processes within the scope of ISO 9001 and "stamping" is only within the scope of automotive; Even if your scope is ‘’ manufacturing of stamped parts’’ because production processes cannot be separated according to IATF rules and they are all in the same factory; welding and assembly processes must also be audited.

    In the case of this situation I have mentioned, 3 different actions can be taken in accordance with IATF rules:

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