The purchasing requirements have not changed very much. Organizations will need
to continue following their purchase order process (7.4.2 Purchasing Information),
Supplier Development (18.104.22.168 Supplier Quality Management System Development) process,
and Receiving Inspection process (7.4.3 Verification of Purchased Product). What
has changed is the scope of supplier development and the new deadline imposed for
supplier development. A note on the bottom of 7.4.1 Purchasing process carefully
defines purchased products as including "all products and services that affect customer
requirements." Organizations will be required to carefully study their supplier
lists and add in all suppliers that affect customer needs and expectations. (Note
"requirement" is defined in ISO 9001:2008 as a "need or expectation".)
A series of three notes in the bottom of 22.214.171.124 Supplier Quality Management System
development requires that suppliers of products and services that affect customer
requirements comply with ISO 9001:2008 by Dec. 15, 2003. This, of course, is the
first step of the ultimate goal of driving the manufacturing supply base to ISO/TS
16949, Second Edition.
This requirement is causing concern among QS-9000-registered organizations. Many
QS-9000-registered organizations do not feel that they have the clout to impose
standards on their supply base. Omnex has seen the effects of standards on supply
bases since Q-101 and Targets for Excellence. Organizations are encouraged to move
forward as follows:
- Determine your product and service supply base (i.e. add to your key supplier lists).
- Determine the criteria and deadlines for supplier development requirements, including
ISO 9001:2008, by Dec. 15, 2001 and TS-16949, Second Edition subsequently.
- Announce the requirements and criteria to your supply base.
- Have evidence that you are trying to comply with the intent of the standard.
Typically organizations mention all the exceptions as reasons why they cannot implement
supplier development - ie. suppliers who are unwilling, small or strategic. Omnex's
suggestion is to formulate your strategies around 95% of your supply base and not
the exceptions. Both your customer and auditor will understand the odd exceptions.
This article covers three of the seven significant challenges facing QS-9000 registered
organizations transitioning to ISO/TS 16949, second edition. There is a lot of work
ahead for companies with only approximately two years remaining. Organizations need
to make their plans to transition to ISO/TS 16949, Second Edition today.
How much work your organization has depends on the quality of your QS-9000 registration.
The remaining four requirements and more on the case study will be covered in greater
detail in the next article.
Case Study of an International Tier One Supplier
A registrar that was not on the IAOB list audited this organization. At the end
of the registrar's contract for QS-9000, this company decided to change registrars
to one of the registrars included on the IAOB list.
The organization had thought that it could very easily transition to both ISO 9001:2008
and ISO TS 16949. In fact, they had already been working for over five years on
meeting excellence standards.
The assumption audit included a transition from ISO 9001:1994 and QS-9000:1994 to
ISO 9001:2008 and ISO/TS 16949:1999. The audit was a wake up call. The company ended
up with several majors - including one that required them to align with a "site"
since they were technically a "remote location". This company has a design center,
sales, purchasing and some senior management located in the US.
Some of the nonconformance resulted from the lack of preparation of the auditors.
In fact, they had not completed a document review prior to the onsite audit. The
other non-conformances were there because the organization was not prepared for
both ISO 9001:2008 and TS-16949:1999.
This company has a few special circumstances. Ten to fifteen product lines are located
in the US. Several of the Business Units that the product line reports to are located
in Europe. What then is the definition of "top management"?
After the poor showing on the audit, this organization contacted Omnex. We collectively
decided that it did not make sense for them to pursue ISO 9001:2008 and ISO/TS 16949:1999,
but that they should instead pursue ISO 9001:2008 and ISO/TS 16949:2009, which had
just become available in final draft form.
The implementation is in its infancy. The scope of the implementation is the first
challenge. Then the requirements of the ISO ISO/TS 16949:2009 and ISO 9001:2008,
especially management review, linkage of processes, and purchasing, are other significant
issues. This case study will be expanded in the future issues of Informed Outlook.