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Getting ISO 13485

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Guest user Created:   Dec 17, 2019 Last commented:   Dec 23, 2019

Getting ISO 13485

So to make a long story short, we are basically promised more work if we have ISO 13485 on our belt. In reading the standard I find that it really doesn’t apply to us. We do not do any sterilization, assembly, servicing, design, installation, particular requirements of implantable devices, CFR regulations, special labeling and traceability for medical devices. We do have a Clean Room where we mold medical products that has compliant procedures, risk assessments and so forth.

XYZ is a small rubber molding manufacturer (33 people) certified to ISO9001:2015 with the exclusion of Design. We manufacture for the Government, Aerospace, Military, Commercial and Medical fields. We manufacture small o-rings and core seals to medical manufacturer that typically ships in bulk with no major requirements such as CFA, FDA, labeling, etc.

So my question, is it a norm for a manufacturer to be ISO 9001 certified with an emphasis on ISO 13485? Getting ISO 13485 with so many exclusions or at least half of the standard doesn’t seem right.

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Dec 23, 2019

If I have understand it correctly, you are supplier of critical parts to other medical device companies. Therefore, there is no strict regulation that you need to be certified according to the ISO 13485:2016, and from quality management system perspective norm for a manufacturer can be ISO 9001.

Can you explain what you meant by „with an emphasis on ISO 13485“?

However, I would like to point out the following. According to the ISO 13485:2016 in requirement 4.1 is stated that when the organization chooses to outsource any process that affects product conformity to requirements, it shall monitor and ensure control over such processes. Then, in requirement 4.1.6 is stated that organization that subcontracts the activity remains responsible for it.  

With MDR, from May 2020, the notified bodies will take more attention to critical suppliers and there is a possibility that notified bodies will audit certain critical suppliers, according to their risk assessment.  Therefore, you must be prepared that there is a chance that the notified bodie will audit your manufacturing process as part of the medical device manufacturer's audit.

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Dec 17, 2019

Dec 23, 2019