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ImJoe007 - 2013
Our organization (a hospital) is working toward ISO 9001:2008 compliance and having an ongoing debate about whether or not all products/services (regardless of whether or not they are contracted) need to have at least 1 quality indicator reported somewhere within the QMS.
I'm the Quality Director and my advice has been to weigh-in to say that ISO 9001:2008 seems to imply (if not explicitly require) that there is a monitoring and measurement requirement (for all services/products); I'm looking to sections 7.1a,c/7.5.1 and 8.2 (8.2.3/8.2.4) / 8.4.
A consultant recommended that each of our contracts should include some type of wording requiring vendors providing services to give us quality data regarding their product/service (prioritized according to the impact the service/product has on the customer/patient).
Our Compliance officer (who is in charge of contracts) has decided not include this language in contracts (citing the amount of work required to do so). Our Top Management views quality through the lens of compliance vs. continual improvement - but that's another problem all-together... Compliance and Top Management do not believe there is a requirement in ISO that all services need to have quality indicators.
Even if we don't include quality indicators as part of the contract process, am I on the right track in believing that "everyone" needs to be part of the QMS? Does ISO require that all of our service / product providers have a quality objective/requirement defined and that we need to monitor/measure it?
I am new to the Forum and very much appreciate and value the opportunity to post. I look forward to contributing as much as I can along the way...
Thanks for any advice/assistance you can provide.
I'm the Quality Director and my advice has been to weigh-in to say that ISO 9001:2008 seems to imply (if not explicitly require) that there is a monitoring and measurement requirement (for all services/products); I'm looking to sections 7.1a,c/7.5.1 and 8.2 (8.2.3/8.2.4) / 8.4.
A consultant recommended that each of our contracts should include some type of wording requiring vendors providing services to give us quality data regarding their product/service (prioritized according to the impact the service/product has on the customer/patient).
Our Compliance officer (who is in charge of contracts) has decided not include this language in contracts (citing the amount of work required to do so). Our Top Management views quality through the lens of compliance vs. continual improvement - but that's another problem all-together... Compliance and Top Management do not believe there is a requirement in ISO that all services need to have quality indicators.
Even if we don't include quality indicators as part of the contract process, am I on the right track in believing that "everyone" needs to be part of the QMS? Does ISO require that all of our service / product providers have a quality objective/requirement defined and that we need to monitor/measure it?
I am new to the Forum and very much appreciate and value the opportunity to post. I look forward to contributing as much as I can along the way...
Thanks for any advice/assistance you can provide.