What should be changed in the ISO 9001:2015 Standard?

[Antonio Vieira]

Thats quite a list, though I am not seeing any in bold.
2,5,6,7,10,12,14,17 and 20 look like great topics to consider!

I'm sorry!

According to the article, bold are:
1. Financial resources of the organization
6. Inclusion of risk-based thinking approach
7. Life cycle management
10. Process results and effectiveness
12. Process innovation
14. Process management

 

[supermac]

In case no one has ever mentioned this before, the drafters of ISO 9001 (and all ISO standards) have to keep in mind translation concerns. For example the discussion on management - top, senior, executive - has translation issues that may not be immediately apparent to native English speakers.

As an aside, I deliberately used issues and concerns to highlight this. Most of us were taught in elementary school that we shouldn't use the same term repeatedly; sophisticated English uses slightly different terms. So we generate confusion unconsciously. Admittedly this ins't the best example, but I'm sure you get the picture.

 

[tampk]

Re: Split top management: At the beginning and at the end.

Hi Sidney,

It seems to me that all of that is covered in ISO 9001 under section 5.6.2. and 3.
Here they are for discussion purposes:

5.6.2 Review input
The input to management review shall include information on:

a) results of audits,
b) customer feedback,
c) process performance and product conformity,
d) status of preventive and corrective actions,
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system, and
g) recommendations for improvement​

5.6.3 Review output
The output from the management review shall include any decisions and actions related to:

a) improvement of the effectiveness of the quality management system and its processes,
b) improvement of product related to customer requirements
c) resource needs​

.
​

I think that one of the problems that organizations have is that they have one annual "Management Review", and they don't understand or acknowledge that "Management Review" is conducted at multiple levels, on numerous occasions, all over the organization. This myopic view precludes the likelihood the the PDCA cycle is perpetuated and implemented throughout the organization as a process methodology.

I still contend that it's there...but, I would concede that perhaps it does merit repeating.

Patricia

I concur with Patricia's outlook .. the systems that I have designed for my clients have always contained management system reviews at various strata/ levels. One can get guidance from the USAF systems management manuals as how they address system reviews periodically and at various levels. Al these reviews should be driven through an established control system of sequentially generated action items/ work items.

Secondly, all organizations should have a " XX Company Management System Manual' (which may be used as a marketing document but essentially lets everyone within the org understand their own system, direction and objectives .. it also clears confusion as to different interpretations within the org), but this Manual should not be called as "Quality Manual" or "Environmental System Manual". The scope of the Manual should address all these issues and describe what all aspects the manual covers and various standard compliance matrices placed at the end of the Manual as appendices (or separately kept as annexed docs) especially to handle the audit requirements.

As far as the processses are concerned, the core and supporting processes and their inter linkages can only be best described through graphical representations especially their directional flows and "handshakes'. Since I am an Avionics Engineer too, I have designed the systems which could best be explained through logical troubleshooting charts. These can be padded up with short descriptions to who, the when and where .. though I even include these as well in my processes.

 

[tampk]

After much thought, I believe that the TC 176 must try a significant new way to promote ISO 9001 in the future. The endless discussion if ISO 9001 is a quality management system standard or a business management system standard led me to the conclusion that ISO 9001 must be sold as a standard that contains requirements for the Quality (please note the capital Q) component of Business Processes.

For example, product realization is NOT a quality process. Products will be manufactured/produced and services will be delivered IRRESPECTIVE of the organization having a formalized quality system or not. Thus, product realization is a business process, just like purchasing, sales, marketing, management, etc. ISO 9001 contains quality management requirements that need to be embedded in the business processes. Only when organizations understand that, they will realize that quality needs to be managed as part of the business and not as a side issue.

Some processes, e.g., corrective action, internal audits, etc... are NOT business processes "per se", but are part of the quality system.

So, in my view point, and in preparation for the 5[sup]th[/sup] Edition of ISO 9001, expected sometime in 2015, the TC 176 has to learn from the lessons learned and start plugging the future ISO 9001 as it fits the business processes of the organizations. The management of the organization FOR quality and not the management of quality.

The process approach should not be the management of quality related processes any longer, but the management of business processes. ISO 9001 provides a component of requirements for the business processes. ISO 14001 provides another set of requirements.

No more (quality) process approach, but business process approach. Focusing on business processes will make the integration of management system standards even easier.

I normally use the example of using various coloured glasses to cover aspects in the organization .. wear the glass of quality and look through the main process/ core process and sub-processes/ supporting processes (all based on PDCA cycle) .. look for quality aspects like product conformity etc ..then replace your quality glass with another one say the environmental glass and again go through the business/ non-business management system .. and cover all the environmental aspects .. and so on. Essentially a managemnt system covers the PDCA cycle with various colours/ shades included therein.

 

[tampk]

"The process approach should not be the management of quality related processes any longer, but the management of business processes. ISO 9001 provides a component of requirements for the business processes".

Do you think upper management is ready for that statement?

We need to give a separate ISO number to MSS HSL document (prepared to urge orgs to develop their business processes on the basis of PDCA cycle and process based approach .. they can generate their single Mangement System Manual as an empty glass to be filled in with various types of drinks like QMS, EMS etc .. as such standards covering a specific aspect will be required anyhow and shouls continue to remain in field.

Secondly, the current ISO 9000, 9001 and 9004 should be combined while clearly highlighting as to which are mandatory requirements supported with notes as guidelines. This way people would understand the philosophy of quality before it gets implemented and practiced in true spirit, otherwise I know that hardly even auditors donot read guidelines.

 

[supermac]

I'm not saying it's right or wrong (a separate topic perhaps) but the size of the standard directly affects the cost of the standard. So, if ISO 9000, ISO 9001 and ISO 9004 are combined that will make probably put it beyond the reach of a lot of SMEs. They will become even more reliant on expensive consultants and I don't believe that's a good path to go down.

 

[Peter Fraser]

I'm not saying it's right or wrong (a separate topic perhaps) but the size of the standard directly affects the cost of the standard.

OK, then I will - I'll say it is wrong! It should be the same as pricing software - the cost should reflect the value to the customer.

Now that might be a separate topic perhaps...

 

[encee98]

I am working in an organization that provides services...I think it may be helpful to use the term "control of nonconforming events/products". For example, if the organization brought in the wrong expert (a mortal sin) then it is easier to look at the incident as a nonconforming event.

 

[John Broomfield]

I am working in an organization that provides services...I think it may be helpful to use the term "control of nonconforming events/products". For example, if the organization brought in the wrong expert (a mortal sin) then it is easier to look at the incident as a nonconforming event.

encee,

Trouble is this would substantially increase the record keeping. Imagine everyone having to record the nature of every nonconforming event. We'd do nothing else!

Better for service providers to determine if the nonconforming event was part of the product experienced by the customer and then act per clause 8.3 as currently written.

If the nonconforming event is part of the process, not experienced by the customer, then correct the service process per 8.2.3.

John

 

[grizwald]

I feel that there should be a section regarding internal customers. identifying your department's customers and their requirements with the intent to meet those requirements. The standard talks about some aspects of that relationship but it should go farther.