Process Approach & Continual Improvement Clauses and Evidence of its Effective Use

[qmsboy]

Hi There,

What are all the sub clauses of ISO 9001 are of particular relevance/importance in relation to the process approach and continual improvement and according to these sub-clauses what evidence could demonstrate that an organisation is using these principles in an effective manner?

Thanks

 

[somashekar]

Re: Process approach&Continual improvement clauses and evidence of it's effective us

Hi There,

What are all the sub clauses of ISO 9001 are of particular relevance/importance in relation to the process approach and continual improvement and according to these sub-clauses what evidence could demonstrate that an organisation is using these principles in an effective manner?

Thanks

The standard is based on this philosophy and accepts your process approach as you define relevant to your organization. The standard asks you to detail it in the manual which comes under your documentation requirements of your established QMS.
When all your processes plan, do, check and act to meet the desired outcome of the organization, your wheel of ongoing quality management moves with time and when you begin to further act taking customer requirements and internal measurement and analysis to improve from where you started, you continually improve.
The clause 0.1 and 0.2 of the ISO9001 says it in such simple words
For specifics see clause 8.4 and 8.5

 

[qmsboy]

Re: Process approach&Continual improvement clauses and evidence of it's effective us

The standard is based on this philosophy and accepts your process approach as you define relevant to your organization. The standard asks you to detail it in the manual which comes under your documentation requirements of your established QMS.
When all your processes plan, do, check and act to meet the desired outcome of the organization, your wheel of ongoing quality management moves with time and when you begin to further act taking customer requirements and internal measurement and analysis to improve from where you started, you continually improve.
The clause 0.1 and 0.2 of the ISO9001 says it in such simple words
For specifics see clause 8.4 and 8.5

Then what are these clauses in ISO 9001:2008 4.1(f),4.2.3(b),5.1, 5.3(b), 6.1(a),8.1(c),8.5.1 ? Moreover,I am looking for precise answer as I am not confident in ISO 9001 interpretation.

Thanks

 

[somashekar]

Re: Process approach&Continual improvement clauses and evidence of it's effective us

4.1 f) implement actions necessary to achieve planned results and continual improvement of these processes.

Tells you to consider it in your QMS general requirements.

4.2.3 b) to review and update as necessary and re-approve documents

Tells you to keep your QMS documents updated and approved as necessary

5.3 b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,

Asks you to state this commitment in your quality policy so that all actions have directions towards continual improvement.

6.1 a) to implement and maintain the quality management system and continually improve its effectiveness

Tells you to determine and provide such resources including human resources capable of implementing, maintaining and continually improving your QMS

8.1 c) to continually improve the effectiveness of the quality management system.

Your measurement, analysis and next steps must be also directed towards continual improvement of your QMS. It gives a general framework to plan your measurement analysis and improvement processes.

8.5.1 Continual improvement
The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.

Provides a framework for improvement continually through well applied CA and PA processes.

As you do the specifics keeping in line with the general directions as these said above your QMS is step by step moving forward with the intention of planned continual improvement.

 

[Big Jim]

Re: Process approach&Continual improvement clauses and evidence of it's effective us

Then what are these clauses in ISO 9001:2008 4.1(f),4.2.3(b),5.1, 5.3(b), 6.1(a),8.1(c),8.5.1 ? Moreover,I am looking for precise answer as I am not confident in ISO 9001 interpretation.

Thanks

I'm not sure about how good of a list you have there.

For continual improvement there is a good list in 8.5.1.

For the process approach, all of 4.1, not just f. 4.1 is where the "shalls" start and they start with the process approach. Most everything in 4.1 (if not everything) is repeated later. The one with the most teeth is probably 8.2.3.

I would go further and say that EVERYTHING from 4.1 to 8.5.3 is about continual improvement.

 

[qusys]

Re: Process Approach & Continual Improvement Clauses and Evidence of its Effective Us

Hi There,

What are all the sub clauses of ISO 9001 are of particular relevance/importance in relation to the process approach and continual improvement and according to these sub-clauses what evidence could demonstrate that an organisation is using these principles in an effective manner?

Thanks

Suggestion could be to have a process in place , even though it is not a requirement of ISO 9001 but for ISO TS.
However it could be helpful as well for ISO 9001.
It is important to note that continual improvement applies to your QMS processes through a combinationon of the item cited in 8.5.1 ( quality policy, quality objectivies...). From a general point of view, it is a sort of "raising the bar" continually ( step by step) by the organization.

 

[qmsboy]

Re: Process Approach & Continual Improvement Clauses and Evidence of its Effective Us

Hi all,

What about the following?is this matches with my query?Could you complete the list by filling missed information and adding missing clauses?

4.1(f)- what is the evidence?I don't know

5.4.1 - quality objectives - reduction in repair/rework,reduction in energy consumption,reduction in defect etc are evidence.

5.6 - management review - audit data, customer feed back, process performance etc as evidence.

7.1 - planning of product realisation - what is the evidence?I don't know

8.2.1 - Customer satisfaction - customer satisfaction survey data as evidence.

8.2.3 - monitoring&measurement process - data collected from monitoring and measurement like defect data,scrap data,customer satisfaction data etc. as evidence.

8.2.4 - monitoring and measurement of product - Inspection data,contamination check etc as evidence.

8.4 - data analysis - data from measuring and monitoring,internal audit,purchase data as evidence

8.5.2 - CA (Is this part of process approach?I don't know)

8.5.3 - PA (Is this part of process approach?I don't know)

 

[kgott]

Re: Process Approach & Continual Improvement Clauses and Evidence of its Effective Us

Suggestion could be to have a process in place , even though it is not a requirement of ISO 9001 but for ISO TS.
However it could be helpful as well for ISO 9001.
It is important to note that continual improvement applies to your QMS processes through a combinationon of the item cited in 8.5.1 ( quality policy, quality objectivies...). From a general point of view, it is a sort of "raising the bar" continually ( step by step) by the organization.

One thing I've wondered is, is it possible, or would it be likely, to get an NC from a certification authority for not demonstrating an act of, or having sufficient evidence of committment to continuous improvement?

thanks - k

 

[ssz102]

Re: Process Approach & Continual Improvement Clauses and Evidence of its Effective Us

4.1，the evidence have: quality management system(quality manual, procedure and WI etc), record related was established by your company according to ISO standard

7.1 the quality objectives and requirements of product, record and documents and operation or inspection instruction with production process needed

8.5 CA&PA, the results of compare between prior to and after improvement and corrective action report

 

[qusys]

Re: Process Approach & Continual Improvement Clauses and Evidence of its Effective Us

One thing I've wondered is, is it possible, or would it be likely, to get an NC from a certification authority for not demonstrating an act of, or having sufficient evidence of committment to continuous improvement?

thanks - k

Yes, it is possible.
However I think that if an organization does not have it , it will finish by itself.
I think that each organization works for projects, aimed at improving also the QMS processes.
If you measure results with goal and objective and demonstrated that you are adopting spet by step continual imrovement, it is ok.
This is a clear action of top mgmt to sponsor it and plan recommendation for improvement.
If there is no committment to continuous improvement, the question is very serious.