Validation of Processes does not seem to apply - Scientific Research Company

K

kgott

We are an environmental scientific research company, we carry out research, analyse the data (sometimes we contract it out) and write a report for the client.

Section 7.5.2 of ISO 9001 re Validation of processes for production and service provision states;

‘The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.

Validation shall demonstrate the ability of these processes to achieve planned results.

I cannot see how this clause applies to us which means that we should be able to say that this clause is not part of our quality system but 9001 states that exemptions to Section 7 product realisation; cannot be claimed. Presumably this is because the ISO considers that all part of Section 7 are applicable to every business no matter what they do, in which case it must apply to us.

It appears to me; that should it apply, then we comply this requirement when we send a draft report to the client for comment prior to formal issue and/or; when we do not get any negative feedback from ‘interested parties’ about the preperation of the report after the final report is issued to the client.

Please recommend how I should proceed with this.

Thank you

 
H

harry

Trusted Information Resource
kgott said:
...................... but 9001 states that exemptions to Section 7 product realisation; cannot be claimed. Presumably this is because the ISO considers that all part of Section 7 are applicable to every business no matter what they do, in which case it must apply to us. ................
Click to expand...

1. I think you've got it all wrong. On the contrary, all clauses including sub-clauses in section 7 can be exempted provided you are able to justify it.

2. I am sure there are established methods of research and data gathering in your business as well as some templates or way of presenting the reports. These need to be validated (somebody with expertise go through it and say it is relevant and good enough for the intended purpose) to be good enough at least at the beginning and from time to time.

3. Most organization do not exclude this because they don't know when will be the next time that some parts of their service need to be validated. They do not need to do anything if no such activities take place. However, it will be strongly challenged if they claim exclusion.
 
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