Standards Needed In House - Determining what standards are applicable

#1
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
 
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#2
Hi. Can you please further clarify what do you mean by standards? Are you referring to

- standards as in quality management standards
- standards as in reference equipment used to calibrate your measuring instrumentations?
 
#3
Hello,

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.

Bender
 
B

BoardGuy

#4
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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