ISO 9001:2015

ISO 9001:2015

Posted by Victor Nicolas on Jan 29, 2019 10:47 am

Is it normal that the content of Quality Manual is just a copy paste of ISO 9001:2015 requirements? Our consultant provided us a QM but after reviewing it, most of the contents are just copy paste from ISO requirements.
Thank you in advance for your advice.

Re: ISO 9001:2015

Posted by Edward Myers on Jan 30, 2019 7:28 am

Not to sound too harsh but you need a better consultant. If all you are using is a copy and paste of the ISO standard with the organization changed to company XYZ why even have one? Its not required anymore (this was common in many small businesses with 2008)? While mine tracks with the ISO standard, it also contains other items that are required to be documented and don't have a natural fit anywhere. Also, it contains some processes that are so simple and common place that the QMS manual contains the 2-3 paragraphs of the procedure. In other places, it may cover the essence of the standard but then directs the employees to the right procedure, where to find forms, or store a record. I've used this method for 3 companies I have worked at and made similar recommendations to others I have consulted with. Hope this helps.

Re: ISO 9001:2015

Posted by Lisnnette Rhea on Jan 30, 2019 9:00 am

Interesting question! Unfortunately, the answer is yes. But, within these clauses there has to be a certain degree of personalization with the uniqueness of your company. Not personalizing these can lead to a misinterpretation of management commitment. It is great you caught it! Add the personalization or ensure the teams are all engaged with capturing how they are committing themselves and their team to meeting these requirements.

Re: ISO 9001:2015

Posted by Victor Nicolas on Jan 30, 2019 9:26 am

Thank you very much for your response. We are currently preparing for ISO 9001:2015 and IATF 16949: 2016 certification. And my biggest concern is that our consultant is insisting to integrate our procedures and Quality Manual in one document.

Re: ISO 9001:2015

Posted by Glen Pullin on Jan 30, 2019 9:56 am

It has been normal to copy & paste the standard and create a Quality Manual, which does not add value to the QMS.  The latest version of ISO 9001:2015 does not require a Quality Manual, and provides the organization options in meeting requirements.  One option that may work better for your organization is to create a business plan that includes what the business/organization feels necessary and several requirements in the ISO 9001:2015 standard.  The requirements in ISO 9001:2015 that I recommend be included in the business plan are = Mission/Vision, Quality Policy, Scope, Strategic Direction, High Level Process Map plus list of process owners.  Could also include your Quality Objectives here and show the connection to external & internal issues, needs & expectations of interested parties, and risks & opportunities.  So the ISO Standard and your Business Plan become you level 1 documentation without copy & paste the standard and rephrase "we do --"  You still have level 2 & 3 documentation to give more detail of the QMS.

Re: ISO 9001:2015

Posted by Sherri Gallagher on Jan 30, 2019 12:54 pm

Hi Victor,
That is very "old school" and something that was done for previous revisions of ISO 9001, it does not make it wrong. The 2015 revision does not require a quality manual. That being said, the company should have a way to communicate the scope of the organization including exclusions and not applicable sections of the standard, the quality policy, the context of the organization (what are the internal and external issues and interested parties) and the processes and how the QMS relates to these processes. If there is a documentation system such as procedures/videos, risk matrix, training and/or job descriptions the quality manual is a helpful place to identify them, however there is no requirement for this to be the place all of this is done. If a auditor asks, "What is your scope?" and you show a video  or a plaque on the wall that should be acceptable as long as that video or plaque covers all the points required by the standard for a scope.

Re: ISO 9001:2015

Posted by Paulo Costa De Oliveira on Jan 30, 2019 2:09 pm

This is a usually a good start document for companies that don't have a QM at all. But once created you should personalize it to make it fit with your organizations' practices. An auditor might frown upon it, as it might not show enough commitment from management to quality (just a copy paste culture). On your second question, keeping the procedures separate from the QM will probably make it easier for updating them in the future. In practicality terms, if you actually want to make these procedures and QM useful, people will tend to avoid "one giant quality document" and be more likely to understand and follow the smaller individual procedures.

Re: ISO 9001:2015

Posted by Victor Nicolas on Jan 30, 2019 2:55 pm

Thank you Edward Myers for your response, I will suggest to our management to make changes on our QM.

Re: ISO 9001:2015

Posted by Victor Nicolas on Jan 30, 2019 2:58 pm

Lisnnette Rhea:
Interesting question! Unfortunately, the answer is yes. But, within these clauses there has to be a certain degree of personalization with the uniqueness of your company. Not personalizing these can lead to a misinterpretation of management commitment. It is great you caught it! Add the personalization or ensure the teams are all engaged with capturing how they are committing themselves and their team to meeting these requirements.


Thank you Lisnnette Rhea, we will revise the QM that fits to our organization and activities.

Re: ISO 9001:2015

Posted by Victor Nicolas on Jan 30, 2019 3:06 pm

Sherri Gallagher:
Hi Victor,
That is very "old school" and something that was done for previous revisions of ISO 9001, it does not make it wrong. The 2015 revision does not require a quality manual. That being said, the company should have a way to communicate the scope of the organization including exclusions and not applicable sections of the standard, the quality policy, the context of the organization (what are the internal and external issues and interested parties) and the processes and how the QMS relates to these processes. If there is a documentation system such as procedures/videos, risk matrix, training and/or job descriptions the quality manual is a helpful place to identify them, however there is no requirement for this to be the place all of this is done. If a auditor asks, "What is your scope?" and you show a video  or a plaque on the wall that should be acceptable as long as that video or plaque covers all the points required by the standard for a scope.

Hi Sherri Gallagher,
 Thank you for your response, we are working on both ISO and IATF certification, and as per our consultant, QM is required by IATF. The scope stated on our QM is very generic and I am encouraging my superiors to make necessary changes that suits to our company activities.

Re: ISO 9001:2015

Posted by Victor Nicolas on Jan 30, 2019 3:12 pm

Paulo Costa De Oliveira:
This is a usually a good start document for companies that don't have a QM at all. But once created you should personalize it to make it fit with your organizations' practices. An auditor might frown upon it, as it might not show enough commitment from management to quality (just a copy paste culture). On your second question, keeping the procedures separate from the QM will probably make it easier for updating them in the future. In practicality terms, if you actually want to make these procedures and QM useful, people will tend to avoid "one giant quality document" and be more likely to understand and follow the smaller individual procedures.

Thank you for your response Paulo Costa De Oliveira.  Our consultant insinuating that the revision of QM will not be complicated but I am encouraging my superior to have procedures and QM in separate documents.

Re: ISO 9001:2015

Posted by Girish Trehan on Jan 30, 2019 8:23 pm

Hello Victor,

This is the norm.

You can augment the Quality Manual if you want as a team your Vision, Mission, Quality Policy, Process Flows and so on....

Thanks.


Best Regards, 
Girish Trehan

ISO 9001:2015 Lead Auditor

ASQ Education Chair Section 0402

 

Re: ISO 9001:2015

Posted by Debra Hay Hampton on Jan 30, 2019 8:27 pm

To see a one page quality manual, go to www.CE-Q.com.
There isn't a requirement in the standards for a manual.  Have one if it adds value to your system.
You can have a risk/opportunity table with controls for any chance of not meeting interested parties requirements if you want to truly eliminate the quality manual.

Re: ISO 9001:2015

Posted by Amanda Foster on Feb 4, 2019 6:59 am

I agree with those who say that it has been common practice, but that it adds nothing. We opted to retain our QM with the 2015 upgrade and to align it with the standard at that time. Prior to that our QM was arranged in a different order, and our auditors HATED it. We do not keep all our procedures inside the QM, instead we prefer to keep it high level and refer out to other procedures. This way we can easily update a procedure without updating the entire manual. Hope that helps.
Amanda Foster, ASQ CQA

Re: ISO 9001:2015

Posted by Jerry Rice on Feb 4, 2019 6:17 pm

Victor,

The Quality Manual that regurgitates the standard with [Your Company Here] in place of “the organization” has been a relatively standard practice for almost as long as ISO 9001 has been around. Your question is a good one. Why bother if all you are doing is copying the standard? It becomes an insanely boring document that nobody reads. Not even auditors read them. Once an auditor understands that you basically copied the standard they stop reading....at least I do. They may use your document to guide them through procedure numbers and such but that is a terribly inefficient way to index quality system documents.

If you are only looking for ISO 9001:2015 certification then it is true you don’t need a manual. However, depending on your industry, you may still need a manual for other ISO 9000 based industry specific standards.

We are taking a different approach. What if your Quality Manual told a compelling story about your quality journey? What if your quality manual was NEVER printed? What if it was designed to be navigated through taps and swipes? Could you imagine handing a tablet to an auditor when they walk in the door with the Quality Manual loaded on it that would allow them to intuitively navigate policies, documents and records as they audited?

There is no requirement that a Quality Manual shall be boring. Why can’t it tell an interesting story? Why can’t it even have some humor? Why can’t it be something people want to read? Could it be used to make advocates out of interested parties? Something to think about.

Jerry
 

Re: ISO 9001:2015

Posted by Amanda Foster on Feb 5, 2019 7:26 am

Jerry Rice‍ very interesting ideas indeed!

There is no requirement that a Quality Manual shall be boring. Why can’t it tell an interesting story? Why can’t it even have some humor? Why can’t it be something people want to read? Could it be used to make advocates out of interested parties?

Amanda Foster, ASQ CQA

Re: ISO 9001:2015

Posted by Victor Nicolas on Feb 6, 2019 2:50 pm

Amanda Foster:
I agree with those who say that it has been common practice, but that it adds nothing. We opted to retain our QM with the 2015 upgrade and to align it with the standard at that time. Prior to that our QM was arranged in a different order, and our auditors HATED it. We do not keep all our procedures inside the QM, instead we prefer to keep it high level and refer out to other procedures. This way we can easily update a procedure without updating the entire manual. Hope that helps.

Amanda Foster
Thank you very much for the information, We are working on creating a new QM without our procedure in it, although our consultant is still insisting to include all procedures on our QM.

Re: ISO 9001:2015

Posted by Victor Nicolas on Feb 6, 2019 3:12 pm

Jerry Rice:
Victor,

The Quality Manual that regurgitates the standard with [Your Company Here] in place of “the organization” has been a relatively standard practice for almost as long as ISO 9001 has been around. Your question is a good one. Why bother if all you are doing is copying the standard? It becomes an insanely boring document that nobody reads. Not even auditors read them. Once an auditor understands that you basically copied the standard they stop reading....at least I do. They may use your document to guide them through procedure numbers and such but that is a terribly inefficient way to index quality system documents.

If you are only looking for ISO 9001:2015 certification then it is true you don’t need a manual. However, depending on your industry, you may still need a manual for other ISO 9000 based industry specific standards.

We are taking a different approach. What if your Quality Manual told a compelling story about your quality journey? What if your quality manual was NEVER printed? What if it was designed to be navigated through taps and swipes? Could you imagine handing a tablet to an auditor when they walk in the door with the Quality Manual loaded on it that would allow them to intuitively navigate policies, documents and records as they audited?

There is no requirement that a Quality Manual shall be boring. Why can’t it tell an interesting story? Why can’t it even have some humor? Why can’t it be something people want to read? Could it be used to make advocates out of interested parties? Something to think about.

Jerry
 

Jerry Rice
Good Day

Thank you very much for your response, We are preparing for both ISO 9001:2015 and IATF 16949:2016 certification. Our company is an automotive assembly and supply parts  and one of our customers required us to be IATF certified. The contents of the QM manual provided to us by our consultant are mostly copy and paste or rephrased from ISO requirements. Another issue is that our consultant is insisting to integrate all of our procedures in our QM which is complicated and would required constant revision even with a  simple change on a procedure.  We are working on a new QM that does not include our procedures..

Re: ISO 9001:2015

Posted by Jerry Rice on Feb 6, 2019 8:03 pm

Victor,

I think you are doing the right thing separating the procedures from the quality manual policies. It's still a shame that typical quality manual has to be so boring. 

Jerry

Re: ISO 9001:2015

Posted by Ralph Reid on Feb 7, 2019 6:11 am

The QM should describe your approach to addressing the requirements, not just parrot the Standard which does not add any value. The point is “how” do you meet the requirements in all the documentation.

Re: ISO 9001:2015

Posted by Kaiwen Cheng on Feb 7, 2019 10:27 am

Victor, I agreed with Edward’s comment from 9/28/18 regarding your consultant.

The purpose of a quality manual is to document how our organization would conduct business.  Regardless ISO, IATF, Marine, or other certifications, their purposes are to ensure the processes (procedures, forms, etc.) contains the best practices in their industries.  Quality manual shall be used by the whole organization and satisfying the auditor should never be the primary focus.  Design quality manual for the business, not for the auditor, please.

Back in my corporate days, we have not printed the whole manual probably since 2004.  The quality manual existed in electronic form and perform as the gateway to the detail processes and procedures.  The processes and procedures are maintained by the process owner, but the format is controlled by the quality management crew.  The two key objectives that we try to drive are 1. Making QM as the one stop shop for employee to understand the norm about how their work to be performed (and what would be used for the internal audit).  2.  To impose change management to stabilize the processes.

Actually, many IATF updates were in place in our QM years ago, and our QM didn’t look like the standard(s) other than some bullet points.  There are lots of additional details and thoughts that I can share, just reach out to me.  Good luck!       

Re: ISO 9001:2015

Posted by David Levy on Feb 8, 2019 11:02 am

I've not yet read any of the responses to your question so some of what I say may be repetitive and some may be contradictory.
First of all, ISO 9001:2015 does not require a Quality Manual at all.
Therefore creating a document that is a regurgitation of the standard is a waste of either paper or zeros (0) and ones (1) (digital / binary characters).
If you must have a Quality Manual to satisfy your organizations' needs, not your consultants insistence, then make it a useful document.
I have been using a 3 page document as a Quality Manual since the 2000 version of the ISO 9001 standard.
Pages 1 & 2 contain language to explain what we do pertaining to those parts of the standard that do not fit into our Interactions process map.
Each section of the document references the applicable section of the standard and where applicable also references associated internal procedures.
If you consultant is telling you that you must have a Quality Manual that repeats the standard then take corrective action by terminating the relationship and find a modern quality expert.
If you need my assistance, I will find time in my busy schedule

David Levy
ASQ Fellow
Principal, Levy Quality Consulting, LLC

Re: ISO 9001:2015

Posted by Victor Nicolas on Feb 8, 2019 1:50 pm

David Levy:
I've not yet read any of the responses to your question so some of what I say may be repetitive and some may be contradictory.
First of all, ISO 9001:2015 does not require a Quality Manual at all.
Therefore creating a document that is a regurgitation of the standard is a waste of either paper or zeros (0) and ones (1) (digital / binary characters).
If you must have a Quality Manual to satisfy your organizations' needs, not your consultants insistence, then make it a useful document.
I have been using a 3 page document as a Quality Manual since the 2000 version of the ISO 9001 standard.
Pages 1 & 2 contain language to explain what we do pertaining to those parts of the standard that do not fit into our Interactions process map.
Each section of the document references the applicable section of the standard and where applicable also references associated internal procedures.
If you consultant is telling you that you must have a Quality Manual that repeats the standard then take corrective action by terminating the relationship and find a modern quality expert.
If you need my assistance, I will find time in my busy schedule

David Levy
ASQ Fellow
Principal, Levy Quality Consulting, LLC

David Levy,
Good Day
We are preparing for ISO 9001:2015 and IATF 16949:2016 certification, the IATF requires the Quality Manual as per our consultant. When my manager decided to cut the ties with our current consultant, I will contact you.
Thank you very much