Hospital Product/Service Realization and Monitoring/Measurement (ISO 9001)

I

ImJoe007 - 2013

#1
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.
 
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Stijloor

Staff member
Super Moderator
#2
Welcome to The Cove Forums. :bigwave: :bigwave:

Top Management must ensure that quality objectives are established.

From ISO 9001:2008:

5.4.1 Quality objectives

Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.
Emphasis mine.

So, what functions (processes) are "relevant" within your organization?

Relevant processes could be processes that affect the customers and stakeholders in the organization...

Unless there's agreement within your organization what "relevant" means, you will likely have to fight an uphill battle.

Other Cove Members will chime in soon...

Glad you're here. :agree:
 

Colin

Quite Involved in Discussions
#3
To add to Stijloor's post, I think this is also a matter of timing. I think it would be good to have metrics for all processes where doing so would add value to the organisation but to try and do so all at once would be quite onerous.

I normally look at the major/most important processes (i.e. those which have the greatest impact on the customer) first and set objectives around them.

As the system matures you can always add other objectives and maybe change or drop previous ones as they become less important.
 

somashekar

Staff member
Super Moderator
#4
I see two things here...
>> Monitoring and measurement of the product and process = Compliance
>> Establishing quality objectives = Continual improvement
and both mean different things to do.
The first is required for all of your QMS processes and product requirements to check its effective performance
The second is to be established at relevant areas / functions for betterment from the present situation, that will go directly in meeting your set quality policy.
 
Last edited:

Raffy

Quite Involved in Discussions
#5
Hi... Welcome to the Cove!.. :bigwave:
Currently the company I worked with is a Hospital and the quality indicator was patterned to one of the regulatory requirements in which the hospital seek also for accreditation. All of the objectives were defined for each process, that's why we have a big number of quality indicators per department. And the auditor did make a comment but we just have it reference to one of the book of our accrediting body. :notme:

Yes, there should be a monitoring process in service realization. With regard to an outsourced process, there should be a contract (Memo of Agreement) plus the Service Level Agreement per supplier.

Hope this helps.
Warm regards,
Raffy :cool:
 
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