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

S

Sorin

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

The problem with that idea is that ISO 9001 was originally intended to be a one-size-fits-all standard, but it had barely hit the ground before it started having babies. Automotive, aerospace, telecommunications, medical devices and god knows who else decided that the standard in its raw form wasn't prescriptive enough for their "special" needs. Not only that, but the automotive industry in particular, in its disparate forms, decided that even QS 9000/TS16949 wasn't enough, and burdened it with customer-specific requirements. The whole idea behind AIAG was to normalize the requirements of the (then) Big Three so as to relieve suppliers of the burden of keeping track of each customer's requirements. Ha.
You are right o/c....BUT....AS and TS incorporate ISO 100%. It would be easier (IMO) to merge the generic parts from every standard (AS, TS, ISO) and just have supplemental standards (see Nadcap supplemental checklists) for AS/TS.

As it is now, there are still "generic" requirements common to AS/TS but not incorporated in ISO.

BUT (again) some money would be lost in the process by the registrars...the audits for supplemental standards would be considerably shorter. Not even considering the reduction in staff committee.
 
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S

Sorin

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

Can you give an example?
For a "specific" example it will take too much time (rare commodity for me now) - as there is too much cross checking to do.

But, you can take purchase process or design validation or special processes and you will see that in the essence it's more or less the same thing with different wordings (IMO again and I could be wrong).
 

Sidney Vianna

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

(IMO again and I could be wrong).
I believe your proposal misses the point. To add Automotive/Aerospace management system requirements to a standard that is supposed to be a basic, "universal" model does not make any sense whatsoever. Why would a mining operation or a bakery be expected to do certain things that are designed to minimize risks in the Automotive/Aerospace supply chain?
ISO 9001, by design, has to reflect a very basic set of requirements, so it can be deployed irrespective of industry sector, size of organization, type of product involved.
 
S

Sorin

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

I believe your proposal misses the point. To add Automotive/Aerospace management system requirements to a standard that is supposed to be a basic, "universal" model does not make any sense whatsoever. Why would a mining operation or a bakery be expected to do certain things that are designed to minimize risks in the Automotive/Aerospace supply chain?
ISO 9001, by design, has to reflect a very basic set of requirements, so it can be deployed irrespective of industry sector, size of organization, type of product involved.
Now we getting somewhere...let's see...which of the following requirements CANNOT be set as basic quality requirements/principles and why?


1.
Suppliers
The organization shall:
a. maintain a register of approved suppliers that includes the scope of the approval;
b. periodically review supplier performance; records of these reviews shall be used as a basis for establishing the level of controls to be implemented;
c. define the necessary actions to take when dealing with suppliers that do not meet requirements;
d. ensure where required that both the organization and all suppliers use customer-approved special process sources;
e. ensure that the function having responsibility for approving supplier quality systems has the authority to disapprove the use of sources.


2.
Purchasing
d. the name or other positive identification, and applicable issues of specifications, drawings, process requirements, inspection instructions and other relevant technical data,
e. requirements for design, test, examination, inspection and related instructions for acceptance by the organization,
f. requirements for test specimens (e.g., production method, number, storage conditions) for design approval, inspection, investigation or auditing,
g. requirements relative to
- supplier notification to organization of nonconforming product and
- arrangements for organization approval of supplier nonconforming material,
h. requirements for the supplier to notify the organization of changes in product and/or process definition and, where required, obtain organization approval,
i. right of access by the organization, their customer, and regulatory authorities to all facilities involved in the order and to all applicable records, and
j. requirements for the supplier to flow down to sub-tier suppliers the applicable requirements in the purchasing documents, including key characteristics where required.

3.
Traceability
According to the level of traceability required by contract, regulatory, or other established requirement, the organization’s system shall provide for:
a. identification to be maintained throughout the product life;
b. all the products manufactured from the same batch of raw material or from the same manufacturing batch to be traced, as well as the destination (delivery, scrap) of all products of the same batch;
c. for an assembly, the identity of its components and those of the next higher assembly to be traced;
d. for a given product, a sequential record of its production (manufacture, assembly, inspection) to be retrieved.

Note: I was applying most of these in 1996 (and they were not required).

As for the bakery comment . The idea is to have a general standard and everyone will use it as applicable and not to take exceptions in consideration and construct the standard to accommodate them.
 

Sidney Vianna

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

Because many of these requirements would just add unnecessary and costly controls to many organizations, without any significant gain.

That is why ISO 9001 is the common denominator amongst AS9100, TS 16949, TL-9000, etc.; the baseline requirements apply to everyone. Industry specific requirements become augmentations in dedicated standards.
 
J

JaneB

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

Sorin,
Sidney's right on the money, as so often.

The kinds of things you're wanting to insist on are too detailed and too prescriptive - these would define how you think everyone oughta do it A small example: an 'approved register' - WHY? it's important to manage suppliers, yes, but NOT to maintain an 'approved register!!!

OK, purchasing IS highly important in many QMSs... but in others, believe it or not, it ain't. And in those organisations stuff like this could tie them up in tedious knots for zilch gain!
And so on.
 
S

Sorin

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

Well, you (generally speaking) know very well that ISO, as any standard, can have exclusions, and as much as it pains me to say it it seems that most ppl did not learn much from ISO edition 1987 which was a general standard intended for evryone.

We live with the idea that ISO shall be a general standard that can be applied by everyone instead of working with a detailed standard that can be applicable as suitable by every company.

With disregard to the level of complexity of a QMS standard, it still can be applicable as determined and suited to the needs of a company, as it is seen by the top management.

But maybe I am too pushy....
 
J

JaneB

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

maybe I am too pushy....
I don't think overly prescriptive is the same thing as pushy :tg: You may have found the 1987 model a 'good standard' but it was utterly focussed on manufacturing. I don't discount the importance of same (I like excellent cars and refrigerators that work etc etc as much as the next person) BUT services matter too.

And I would see any Standard that tried to push on with seeing the world strictly through the eyes of one set of implementations (albeit with a brief 'oh, you can exclude things if you wish') as a backward step.
 
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