ISO Compliance doesn’t require the use of software. It does require you to manage your documents and processes which can be accomplished in a paper based environment.
Paper Based Compliance
Document management – Documents must be stored in a secure location. Access must be restricted by a role, title or name. Documents must not be deleted and they must be versioned.
Process Management – There are steps to manufacturing widgets. These steps must be identified and followed. Signatures are required to show that a step has been completed.
Companies taking this approach will generally have a ‘program manager’ oversee all of these activities.
Compliance with PLM Software
Just like in a paper based system, you must manage documents. PLM software provides you with a secure vault. It provides for access controls – check in, check out based on your role, title or name. The vault manages versions automatically.
Just like in a paper based system, PLM software provides Process Management [workflow]. The software will route tasks, documents to the next person in the process. When you have completed your task, the software will record an electronic signature.
PLM software provides an audit trail – needed for ISO compliance.
It is not necessary to have PLM software [or something similar] but it will make your life easier and will eliminate the need for a ‘program manager’…
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