Design and Development Clause ISO 9001:2015 Exclusion for Medical Services

#1
Hi! I am having a difficult time deciding if this clause is applicable to our organization. It was an exclusion in the 2008 standard but we are now transitioning to the 2015 standard.

We are providing diagnostic medical services to clients. One set of exams (for pre-employment purposes) we perform is currently mandated by the government while other sets or packages are custom-made for our clients' other requirements such as annual physical examination (which the government do not have any prescribed set of exams); therefore we prepare sets of examinations based on the requirements we receive.

Is this clause still not applicable to our services since we offer service that we do not design and we are just following the prescribed set by the government? OR this clause is applicable because we get to design 'HOW' we provide those services?

Thank you in advance for you help!
 
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John Broomfield

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#2
Hi! I am having a difficult time deciding if this clause is applicable to our organization. It was an exclusion in the 2008 standard but we are now transitioning to the 2015 standard.

We are providing diagnostic medical services to clients. One set of exams (for pre-employment purposes) we perform is currently mandated by the government while other sets or packages are custom-made for our clients' other requirements such as annual physical examination (which the government do not have any prescribed set of exams); therefore we prepare sets of examinations based on the requirements we receive.

Is this clause still not applicable to our services since we offer service that we do not design and we are just following the prescribed set by the government? OR this clause is applicable because we get to design 'HOW' we provide those services?

Thank you in advance for you help!
Phil,

Both products and services are the result of design processes. Changes to services and products may also be planned, controlled, verified, validated and delivered by these design processes.

But the documented parts of your management system may not have made your service design visible for conscious use, monitoring, audit and improvement. Your risk assessments and your registrar may have supported your decision to exclude services design from the scope of your certification.

This does not necessarily mean that your organization is ignoring service design.

Take another look at the frequency and impact of service failures and you may see the cost benefits of blueprinting the design of your organization's services.

This site may help:

Service Blueprints - Communicating the Design of Services | Interaction Design Foundation

Then update the documented parts of your management system accordingly.

You may also be able to convince the boss to widen the scope of your certification to include service design thereby further differentiating your company from its competitors.

Best wishes,

John
 

dsanabria

Quite Involved in Discussions
#3
Hi! I am having a difficult time deciding if this clause is applicable to our organization. It was an exclusion in the 2008 standard but we are now transitioning to the 2015 standard.

We are providing diagnostic medical services to clients. One set of exams (for pre-employment purposes) we perform is currently mandated by the government while other sets or packages are custom-made for our clients' other requirements such as annual physical examination (which the government do not have any prescribed set of exams); therefore we prepare sets of examinations based on the requirements we receive.

Is this clause still not applicable to our services since we offer service that we do not design and we are just following the prescribed set by the government? OR this clause is applicable because we get to design 'HOW' we provide those services?

Thank you in advance for you help!
If your services are prescribed and design by another entity - then, they are not applicable and in your justification explain that you are following the established guidance of another entity.
 

EthanLoh

Involved In Discussions
#4
The requirements of clause 7.3 Design and development are identical in 2008 and 2015 version.

If your company exclude this clause during the 2008 version, it should be the same approach for 2015 version.

Just out of curiosity, what is the scope of your QMS? :)
 
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