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21 cfr part 206 - labeling of drug pills, 21 cfr part 820 - med. device mfger. qsr requirements, 3.4.1 (iso 9000), 7.5 - production and service provisions, iso 13485 - medical device qms, iso 9001 - quality management systems, service company or industry, service provisions
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Old 3rd July 2003, 04:55 PM
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Question ISO 9001 Clause 7.5 Production and Service Provision - What does 'Service' apply to?

What would you say that the service part of 7.5, "Production and Service Provision" applies to?

Service after the sale?

Thanks!

Mike W

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Old 3rd July 2003, 06:53 PM
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7.5.1

Mike,

I think it means that you will have in place reasonable controls for all of your production/service activities. These are the heart of the operation. They want you to control how you provide the service. All of it is probably in place but you need to tell them how you provide the service. Do you have specifications, Work Instructions, Equipment etc. I basically wrote this off by referring to other parts of the QM and the procdures that we have in place for manufacturing and delivery etc. There are a lot of areas in the standard that seem to duplicate themselves and I think this is one of them. How come they did not include trained staff in this area?? They seemed to cover everything else.

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Old 4th July 2003, 02:58 AM
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Hi Mike,

I agree with Greg. Let's assume your product is services rather than physical products (Transport for instance)... 7.5 still requires you to do so under controlled conditions.

ISO 9000:2000, 3.4.1 defines product as the result of a process, one or a combination of the following:

services
software
hardware
processed materials.

/Claes

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Old 7th July 2003, 09:03 AM
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What if you MANUFACTURE and don't service anything?
(Except when the customer calls up and demands that you get to their plant and sort NC products).

-------------
Do you just exclude this sections when writing up the Quality Manual?

(No I really haven't gotten started on our manual yet. - Mental block).

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Old 7th July 2003, 09:19 AM
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We also just MANUFACTURE however we do provide Technical Service on the application of the product. I was told this is SERVICE. This service is provided off site by Corporate labs that are not within the scope of the registration. I identified the Labs as a contractor in the QM and placed them on our suppliers list. Does this make sense?
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Old 2nd June 2005, 11:12 AM
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Hi,

Was interested to view this thread I'm also interested in the explanation.Does it refer to service as in maintenance of the product that you supply ref maintenance contracts or service ref. supply of product. We are a manufacturing company supplying pressed components. I'm doing internal audit ref 7.5.1.7 Help appreciated.

Shallowmike
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Old 2nd June 2005, 11:56 AM
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We manufacture a product that, while certified that it is the grade and product we say it is (and also, hopefully, the grade and product that was ordered). How ever we do not service it should it require additional work once delivered. Nor do we actually deliver the product - we hire other people (who are on our Approved Vendor List) to do that for us.

Should a Customer wish to have additional work done on the product, it is at their discretion (while we may pay for the work).

So far, we have excluded the Service aspect from that Clause and our Registrar has not had a problem with this.

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Old 2nd June 2005, 01:21 PM
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Here's the exclusion statement from our manual:

7.5.1.5 - Control of Service Operations: Thread-Craft does not offer post-delivery services; however, our highly experienced staff of customer service representatives can offer expertise, on-site if required, once the product is in use. Instructions, verbal or written, for installation, operation and routine maintenance of Thread-Craft products can be provided upon request.

We don't go to the customer's shop and ensure that our ballscrew is being properly lubricated, but we can tell our customer - if they need to be told - that they should ensure proper lubrication and they should frequently inspect the wipers, blah, blah, blah. If a customer is having a problem with our ballscrew, we can send a technician out to check out the problem and see if we can help them out. If it is determined that our ballscrew is the problem, it is returned under warranty - which is controlling nonconforming product - not servicing.

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