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.