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

[samsung]

Re: What should be changed in the ISO 9001:2014 Standard?

Why should the Standard be written in a way that ONLY applies to commercial organisations and ONLY deals with external customers? I disagree.

I'm sure this sounds simply logical, fine and dandy when your experience is only the former, but there are many different possible permutations out there! One of the strengths and things I like about the Standard is its flexibility.

There are many instances that confirm that the standard itself leans largely towards the External Customers and that's what most organizations feel. Some of the questions that I raised in an earlier post are repeated here:

"The input to management review shall include information on (b) customer feedback",
Which category of customers ? If the answer is 'both', do organizations collect & review the feedback from the 'Internal' customers along the line it does for 'externals'? If not, is it acceptable ?

Clause 7.2 'Customer related processes - again which customer ? Is it necessary to maintain records of the results of the review (of internal customer requirements) and actions arising from the review ?

Clause 7.5.4 Customer property - Is it applicable to the internal customers as well ? Intellectual property and personal data of the employees (that include many of the internal customers as well) is a common feature and every organization has to have them.

Clause 8.2 and so forth.

I have also attached the APG ISO Guidelines on Customer Feedback (highlighted portions may please be referred to) wherein I didn't find any clue to get myself convinced that the standard ever had the intention of addressing the Internal Customers when it refers the term CUSTOMER.

 

[Peter Fraser]

Re: What should be changed in the ISO 9001:2014 Standard?

I have also attached the APG ISO Guidelines on Customer Feedback (highlighted portions may please be referred to) wherein I didn't find any clue to get myself convinced that the standard ever had the intention of addressing the Internal Customers when it refers the term CUSTOMER.

From the Guidelines:... "It is important to remember that the organization may have more than one category of customer - see the definition of “customer” in ISO 9000 clause 3.3.5 ['customer = organization or person that receives a product EXAMPLE Consumer, client, end-user, retailer, beneficiary and purchaser']
For example, a manufacturer may sell to wholesalers, who then sell to retailers, who in turn sell to the general public. In this case the organization may need to address all three types of customer and they may all have different perceptions. The organization could be satisfying one group and upsetting another."

i) "may need"? Surely "shall", if they are all classed as Customers in this example.

ii) If this is how the standard intends the term to be used, it needs to expand on the example - if an Organisation sells to a wholesaler which sells to a retailer which sells to an organisation which includes the product with what it sells to another organisation which sells to a member of the public who gives the product to a friend who may then use it in any way they see fit, and which the Organisation may not even have imagined (as an example, something as simple as a paperclip, which could be used in a handout for a set of training course notes - and we all know what you can do with a paperclip)...: every single point in the chain is a "customer" whose expectations and feedback needs to be considered. There must come a point when an Organisation ceases to be "liable" for how their product is used down the supply chain.

Surely the needs and expectations of the wholesaler will include the "needs and expectations" of their immediate customer, and so on down the line, so only the first "customer" in the chain needs to be considered by the Organisation? And this must apply to Health and Safety as well as to Quality.

It is difficult enough to decide who is the (immediate) Customer of a school or university, or a hospital, I would have thought.

 

[Helmut Jilling]

Re: What should be changed in the ISO 9001:2014 Standard?

Based on my discussions this weekend, a clarification of whether the process approach is a definite requirement or is merely encouraged should be added. There is much discussion and disagreement about this in ISO land. ISO 9004 contains much good info on this topic, maybe some of it could be brought into 9001.

 

[Stijloor]

Re: What should be changed in the ISO 9001:2014 Standard?

Based on my discussions this weekend, a clarification of whether the process approach is a definite requirement or is merely encouraged should be added. There is much discussion and disagreement about this in ISO land. ISO 9004 contains much good info on this topic, maybe some of it could be brought into 9001.

I agree! And I stick to my comments in an earlier post.

Stijloor.

 

[samsung]

Re: What should be changed in the ISO 9001:2014 Standard?

One of the strengths and things I like about the Standard is its flexibility.

I too but only as long as the 'flexibility' is confined to 'freedom of application' not the 'freedom of interpretation'.

 

[samsung]

Re: What should be changed in the ISO 9001:2014 Standard?

Here's one more ambiguous definition that needs to be 'clarified' or 'rectified' in the next version:

If one goes by the notes on 'product' as 'clarified' in the latest version (ISO 9001:2008)

NOTE 1 In this International Standard, the term “product” only applies to
a) product intended for, or required by, a customer,
b) any intended output resulting from the product realization processes.,

then the definition of 'product' as given in ISO 9000:2005* has no meaning as it states:

product (3.4.2) is defined as “result of a process (3.4.1)”;

It means whatever that results from a process is a 'product' whether or not it was intended for or required by a customer. Effluents, emissions, hazardous wastes etc. are afterall the results of their respective processes and are, imo, neither intended by the customers nor by the producers.

One can't ignore this definition because the standard further directs:

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 9000:2005, Quality management systems — Fundamentals and vocabulary

Let's hope such issues will be duly addressed in the forthcoming versions.

* third edition 2005-09-15

 

[Sidney Vianna]

Re: What should be changed in the ISO 9001:2014 Standard?

I too but only as long as the 'flexibility' is confined to 'freedom of application' not the 'freedom of interpretation'.

Both are necessary. For ISO 9001 to be potentially applied to the bakery in the corner of the street and NASA, proper interpretations will have to be made to the requirements. There is no possible way to develop an "universal" management system standard without interpretation.

Here's one more ambiguous definition that needs to be 'clarified' or 'rectified' in the next version:

If one goes by the notes on 'product' as 'clarified' in the latest version (ISO 9001:2008)

then the definition of 'product' as given in ISO 9000:2005* has no meaning as it states:

.....B><]

Once again, I disagree. The definition of product is broad and includes both the intended product and byproducts. Then ISO 9001 CLARIFIES that, IN THE CONTEXT of the ISO 9001 STANDARD, only the intended products are covered. Since ISO 9001 does not deal with the management of byproducts (which is the scope of ISO 14001), the clarification is spot on, in my opinion.

 

[samsung]

Re: What should be changed in the ISO 9001:2014 Standard?

Both are necessary. For ISO 9001 to be potentially applied to the bakery in the corner of the street and NASA, proper interpretations will have to be made to the requirements. There is no possible way to develop an "universal" management system standard without interpretation.
Once again, I disagree. The definition of product is broad and includes both the intended product and byproducts. Then ISO 9001 CLARIFIES that, IN THE CONTEXT of the ISO 9001 STANDARD, only the intended products are covered. Since ISO 9001 does not deal with the management of byproducts (which is the scope of ISO 14001), the clarification is spot on, in my opinion.

Since ISO 14001 doesn't make any reference to ISO 9000:2005 for Normative References, can you please explain to which standard, the definition of 'Product' (9000:2005) applies to & retained for.

Even if I agree to what said above, it's still confusing when 9001 states

The following referenced documents are indispensable for the application of this document.
ISO 9000:2005, Quality management systems — Fundamentals and vocabulary

Since the 'product' holds a pivotal position in any BMS, the standard, while 'clarifying' could have added something like ".....and IN THE CONTEXT of the ISO 9001 STANDARD, the definition given in 9000:2005 shall be ignored" leaving no room for confusion.

Thanks for starting such a nice thread.

 

[samsung]

Re: What should be changed in the ISO 9001:2014 Standard?

More instances of ISO 9001 being an 'External Customer oriented' standard especially in the context of its reference to the term 'CUSTOMER' else it does recognize the 'Internal Customers' as 'people in the organization' or 'process owners' or 'employees' (what they actually are).

9004:2000
0.1 General
The purpose of an organization is
— to identify and meet the needs and expectations of its customers and other interested parties (people in the organization, suppliers, owners, society),

5.1.2 Issues to be considered
identifying process owners and giving them full responsibility and authority,

5.2 Needs and expectations of interested parties
5.2.1 General
Every organization has interested parties, each party having needs and expectations. Interested parties of organizations include
— customers and end-users,
— people in the organization,
— owners/investors (such as shareholders, individuals or groups, including the public sector, that have a specific
interest in the organization),
— suppliers and partners, and
— society in terms of the community and the public affected by the organization or its products.

5.2.2 Needs and expectations
The success of the organization depends on understanding and satisfying the current and future needs and expectations of present and potential customers and end-users,

To satisfy customer and end-user needs and expectations, the management of an organization should
— understand the needs and expectations of its customers, including those of potential customers,
— determine key product characteristics for its customers and end-users,

Examples of customer and end-user needs and expectations, as related to the organization's products, include
— conformity,
— dependability,
— availability,
— delivery,
— post-realization activities,
— price and life-cycle costs,
— product safety,
— product liability, and
— environmental impact.

- The organization should identify its people's needs and expectations for recognition, work satisfaction, and personal development. Such attention helps to ensure that the involvement and motivation of people are as strong as possible.

- Activities for communicating include, for example .......employee surveys and suggestion schemes.

There can be many more and all such instances are sufficient to demonstrate that the CUSTOMERS (as referenced in ISO 9001) are the people or organizations who buy and/or make use of the products. And also, it doesn't intend to address the employees / people of the organization as 'Internal Customers'.

 

[Helmut Jilling]

Re: What should be changed in the ISO 9001:2014 Standard?

......CUSTOMERS (as referenced in ISO 9001) are the people or organizations who buy and/or make use of the products. And also, it doesn't intend to address the employees / people of the organization as 'Internal Customers'.

Actually, the concept of internal customers is mentioned in a number of ISO documents and writings. Many internal processes have contact only with internal customers, not with with the external, ultimate customer.