Is there a need to reference Documented Procedures - 4.2.2 b)

I

ISO tired

Is there a need to reference any documented procedures besides the required ones in the QA Manual. Required procedures: 4.2.3,4.2.4,8.2.2,8.3,8.5.2 and 8.5.3.
 

Sidney Vianna

Post Responsibly
Leader
Admin
Re: 4.2.2 b)

Is there a need to reference any documented procedures besides the required ones in the QA Manual. Required procedures: 4.2.3,4.2.4,8.2.2,8.3,8.5.2 and 8.5.3.
The (ISO 13485) standard is very clear. You need to reference the documented procedures that were established as necessary. By the way, the 13485 standard requires many more documented procedures than the ones you listed, as a minimum.
 

AndyN

Moved On
Is there a need to reference any documented procedures besides the required ones in the QA Manual. Required procedures: 4.2.3,4.2.4,8.2.2,8.3,8.5.2 and 8.5.3.

If you wish to describe your 'system' and those procedures (required by the standard or by your management) are part of that system, then why wouldn't you want to reference them in the manual? Isn't one purpose of having a manual to help employees etc find their way around the way to do things?;)
 

somashekar

Leader
Admin
Is there a need to reference any documented procedures besides the required ones in the QA Manual. Required procedures: 4.2.3,4.2.4,8.2.2,8.3,8.5.2 and 8.5.3.
When you are into ISO 13485 you respect a lot many regulatory like the MDD, IVD, MDR, The FDA GMP ..etc etc, Now depending upon your alignment, you make a table in the Quality Manual which captures your documented procedures against the ISo 13485 requirements and similarly the sections of the other regulatory. You will be here giving a overall references to all your applicable documented procedures.
 
Top Bottom