We are in the process of implementing ISO 9001:2015 in our organisation. However, there are certain issues I need help with, for my understanding.. They are as follows :
1. There are certain parameters that need to be set / verified before the start of Production, to ensure process ensures meeting product specifications.. If the same is not available (as documented information) for a new job being run, and the machines are allowed to run, would it be a violation of Clauses 7.5.1 OR 8.5.1 ??
2. Certain accessories used in producing the product have become obsolete. Which clause of ISO will I be violating if I do not mark the same accordingly therefore allowing a chance for wrong / obsolete fixture being used for current job?
3. Is it a requirement that MSDS for chemicals (eg. Soldering Flux etc) being used be displayed near area of work? Can I keep it in a file near the place of work for reference if and when reqd??
I will be grateful if u could help...
Answers:
1. Yes, that would be a violation of clauses 7.5.1 and 8.5.1. For more information, see: ISO 9001:2015 clause 8.5 Product realization – Practical examples for compliance https://advisera.com/9001academy/blog/2015/11/03/iso-90012015-clause-8-5-product-realization-practical-examples-for-compliance/
2. I'm not sure if I understand correctly, you are talking about using wrong equipment in the production process. In that case it would be violation of the clause 8.1.c) determining resources needed for achieving compliance with requirements for product and service.
3. The standard does not define how to act with MSDSs, however it can be considered as a part of clause 7.5.3.1 that require documented information to be available and suitable for use where and when it is needed. This requirement allow you to keep the MSDS in a way that is the most suitable for you. On the other hand, MSDS are part of occupational health and safety regulations and they can be more strict than ISO 9001, if the legislation doesn't prevent you from keeping them the way you prefer, the standard does not have any additional requirements towards them.
Thanks for the reply Strahinja.. That helped..
coming to pt 2 ; No it is not using wrong equipment.. But a fixture that is now obsolete but has not been identified properly & hence stands chance of being used by mistake. So which ISO clause is applicable ??
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Oct 04, 2016