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58 areas of compliance required by ISO 13485

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Guest user Created:   Feb 09, 2021 Last commented:   Feb 09, 2021

58 areas of compliance required by ISO 13485

In order for an organisation to be able to demonstrate compliance within the requirements of ISO 13485 and maintain approval from a certifying body ( 3rd party audit ) there are 58 areas that company must demonstrate adherence to. This need was highlighted from a white paper you sent me. Would you be able to send me details of the 58 areas of compliance required by ISO13485:2016?

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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 Feb 09, 2021

This means that in the standard ISO 13485:2016 on 58 places is put that manufacturer needs to be in compliance with applicable regulatory requirements. Regulatory requirements are any other standard, law, rule, regulation that is applicable for certain medical devices or manufacturers of medical devices. These requirements can be international or national. The point is that manufacturers of medical devices understand that it is not only ISO 13485 that is applicable to them, that there are a number of other rules by which they must be complied with. 

For example, in point 4.1 General each manufacturer of medical devices must be in compliance with requirements from this standard, but also with any other applicable regulatory requirements. This means that any technical standard must be taken into account when designing and manufacturing a medical device, but also any national law, rule, or ordinance must be considered. 

If manufacturers have any outsourced process, this also must be organized by the requirements of ISO 13485 but also any other applicable regulatory requirements. If there are some national laws and rules how contracts between two companies must look like, then it also must be taken into account. 

Considering the retention period of obsolete documents, the standard stipulates that mandatory storage is a minimum of two years. However, if there is a national rule on how long a particular type of documentation must be kept, then the manufacturer must comply with that as well. 

I hope that these examples approached what it means to be in compliance with regulatory requirements. Throughout the standard, this term extends and is found at almost every point. A detailed list of this is essentially the whole standard.

For more details on this topic, please see the following articles:

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Feb 09, 2021

Feb 09, 2021