Understanding ISO 9001:2015 - 10.3 Continual Improvement

[Joe Smith]

Having my other thread about design dealt with promptly, I thought I'd give this one a go.

10.3 says "The organization shall continually improve the suitability, adequacy and effectiveness of the quality management system."

Now, the 'effectiveness' part is the same as in the 2008 standard. But, how do you continually improve the suitability and adequacy of the QMS? Surely such improvements will only occur - or be necessary - if the needs, processes, capabilities or strategic direction of the organization change?

 

[mgcm1]

Re: ISO9001:2015 - 10.3 Continual improvement

I think its covering that any successful organisation gathers appropriate data regarding its performance and so can continually refine its processes over time, to deliver the desired suitability, adequacy and effectiveness.

 

[howste]

Let's start with a couple of definitions from ISO 9000:2015:

continual improvement
Recurring activity to enhance performance

Note 1 to entry: The process of establishing objectives and finding opportunities for improvement is a continual process through the use of audit findings and audit conclusions, analysis of data, management reviews or other means and generally leads to corrective action or preventive action.

performance
measurable result

Note 1 to entry: Performance can relate either to quantitative or qualitative findings.
Note 2 to entry: Performance can relate to the management of activities, processes, products, services, systems or organizations.

The recurring activities then are establishing objectives, conducting audits, collecting and analyzing data, holding management reviews, and other activities to identify improvement opportunities, which lead to corrective and preventive actions. If these actions lead to improved performance as demonstrated by measurable results with process and system metrics, then you could say that the system is more effective than it was before.

If the system is more effective, then could you not also say that the changes we made to the system have made it more suitable than it was before? And could you also say that it's more adequate than it was before?

I work and receive a salary that is suitable and adequate for my needs. But last year I earned less money and at the time it was suitable and adequate for my needs. I think that's improvement!

 

[Sidney Vianna]

Differently from the stock market, customer expectations only go one way: up. If an organization fails to improve it's delivery to minimize the gap between customer (ever evolving) wants and the actual product, you are not managing your quality risks appropriately.

Customer (always changing) expectations is the driving force behind the QMS improvement bit. An organization that is deaf to voice of the customer and stagnates it's business processes, including, obviously, the ones that affect customer satisfaction and product regulatory compliance is destined to lose market share into oblivion.

 

[somashekar]

Having my other thread about design dealt with promptly, I thought I'd give this one a go.

10.3 says "The organization shall continually improve the suitability, adequacy and effectiveness of the quality management system."

Now, the 'effectiveness' part is the same as in the 2008 standard. But, how do you continually improve the suitability and adequacy of the QMS? Surely such improvements will only occur - or be necessary - if the needs, processes, capabilities or strategic direction of the organization change?

The same as was done towards the ISO 9001:2008 clause 5.4.2 b)

 

[Joe Smith]

Hmm. Thanks for the various replies, but the general sense I'm getting is that suitability, adequacy and effectiveness are the same thing, which they're surely not.

Let me try another tack. A system can be effective or ineffective, but the effectiveness can be improved by improving performance, as mgcm1, howste and Sidney say (e.g. shortening delivery times.) But suitability and adequacy seem to me to be binary states. Something can be suitable or unsuitable. Something can be adequate or inadequate. How do you continually improve either of those?

I'm particularly focussed on this at the moment because, under clause 10.3, our BSI Readiness Review for the transition to 2015 says this: "there are additional requirements specifically related to continually improving the 'suitability' and 'adequacy' of the QMS and not just the 'effectiveness'. Please provide information on the process for determining the suitability and adequacy to address this clause."

Right now, I don't know how to deal with this specific requirement, and it's giving me a headache. Or am I just over-thinking it?

 

[Sidney Vianna]

I'm getting is that suitability, adequacy and effectiveness are the same thing, which they're surely not.

You are correct; according to the ISO TC 176 document that provides guidance on the meaning of terms used in the ISO 9000 family of documents, adequacy means sufficiency to satisfy a requirement, suitable means appropriate (for a particular purpose), while effectiveness, defined in ISO 9000:2015, means extent to which planned activities are realized and planned results are achieved.

Who could imagine quality professionals involved with ISO 9001 would have to improve their command of the language so much?

The day an auditor issues a nonconformity for a QMS that is improving it's effectiveness, but failing to improve it's adequacy and suitability, is the day we should revolt....

 

[Bev D]

the language is a bit ambiguous and you are over thinking it.
Sidney is correct. as long as you are regularly assessing new requirements, shifting market needs, new contracts weaknesses in the system, etc. and improving your system you should be fine.

 

[Joe Smith]

The day an auditor issues a nonconformity for a QMS that is improving it's effectiveness, but failing to improve it's adequacy and suitability, is the day we should revolt....

Thank you Sidney. On this and the rest of the Readiness Review, I can feel a revolt coming on.....

 

[somashekar]

Hmm. Thanks for the various replies, but the general sense I'm getting is that suitability, adequacy and effectiveness are the same thing, which they're surely not.

Let me try another tack. A system can be effective or ineffective, but the effectiveness can be improved by improving performance, as mgcm1, howste and Sidney say (e.g. shortening delivery times.) But suitability and adequacy seem to me to be binary states. Something can be suitable or unsuitable. Something can be adequate or inadequate. How do you continually improve either of those?

I'm particularly focussed on this at the moment because, under clause 10.3, our BSI Readiness Review for the transition to 2015 says this: "there are additional requirements specifically related to continually improving the 'suitability' and 'adequacy' of the QMS and not just the 'effectiveness'. Please provide information on the process for determining the suitability and adequacy to address this clause."

Right now, I don't know how to deal with this specific requirement, and it's giving me a headache. Or am I just over-thinking it?

You have to come back to the organization context and the interested parties needs and expectations. There is no just one way for determining suitability and adequacy. Your determination of outsourced process and controls could be just one. The determining of resources could be another.....
You cannot read this through to the auditor. You must talk this through to the auditor convincingly. Bring your leadership to board here, or be that leader... Good luck.