Standards Needed In House - Determining what standards are applicable


Dear all,

I hope this post finds you doing well. I have been tasked with purchasing the newest version of the standards we have in house. When looking to the ones we have, I am not able to determine why we purchased some of the standards in the first place or where they are used. Is anyone able to explain 1. How to determine if a standard is applicable to your facility, 2. General guidelines on choosing the right standards. We are a medical device contract manufacturer of electromechanical device which incorporate lasers. We are ISO 13485 certified.

Any feedback would be greatly appreciated,

Thank you and kind regards,

Bender BioMed



Thank you for the reply. I was able to figure out the answer for ISO standards. However, I am still unsure on IEC standards. If we send a device to Intertek for IEC 61010-2-051 testing, are we required to have a copy of this standard in house? I understand the standard may be useful for the design team, but just want to understand if there is a statutory requirement to own the standard.



To answer your question will require a little digging on your part but a good start would be:

- Quality Management Standard (ISO 9001, ISO 13485, AS9100) for your quality system certification.
- Customer contract specified standards related to product to be manufactured.
- Specification to which your company procures materials against. I.e. ASTM, SAE etc.

You are not required, by most Standards, to maintain current revisions of specifications or standards until there is a need for the current revision. Start first by building a database of in-house specifications and standards; listing them by ID number, title, in-house revision and current revision which will become your master list. Publish the list internally to all users so they understand what is available and order current revisions when needed.
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