Result Of My Critique

My critique of author John Seddon's "Case Against ISO 9000" in the last News & Views was concluded with an opinion that it is possible to make ISO 9000 right; that ISO 9000 isWhere CMII Takes It Another Step

Establishing a reliable methodology for assuring that the requirements are achieved consistently is only part of the first step. Maintaining those methods is also a challenge because the requirements are always changing.

The ability to accommodate change is the first building block within the CMII model. This includes assurance that the requirements remain clear, concise and valid as changes are being made.

Provisions For Change In ISO 9001

Within the 20 elements of ISO 9001, the subject of change is addressed in two places. It is addressed in Paragraph 9 of Section 4 (Design Control). It is also addressed in Paragraph 3 of Section 5 (Document and Data Control).

Section 4 states that "changes and modifications shall be identified, documented, reviewed and approved by authorized personnel before their implementation." Section 5 states that "changes shall be reviewed and approved by the same functions that performed the original review and approval." It also states that "where, practical, the nature of the change shall be identified in the document."

ISO 9001 Is The What, Not The How

Each of the 20 elements of ISO 9001, including Sections 4 and 5, represent requirements. They are the what, not the how-to.

At ICM, we endorse the requirements that are stated in ISO 9001. They are simply that; requirements. CMII is the how-to. It is the how-to that is the weak link in most organizations today.

CMII fixes the how-to. It makes ISO 9000 right. not the full answer in itself, but that it is a first step; that CMII is a major step beyond ISO 9000 and that CMII would "put it right." Some of our readers have raised the obvious question; "how does CMII make it right?"

Focus of ISO 9000

I believe that the intent of ISO 9000 is to establish a full scope of the requirements that an organization needs to satisfy in order to be successful. It is up to the individual organization to develop procedures which are capable of achieving those requirements and which can do so efficiently.

Requirements Versus Procedures

There are few, if any, requirements within ISO 9001 that anyone would challenge. How to achieve those requirements is a different story. That is the issue.

There is very little argument that some kind of a guide or template is needed in order for several different individuals to achieve the same requirement in an orderly and consistent manner.

To use a "procedure" as such a guide or template, however, is where the differing opinions become exposed. Those who have never seen effective procedures are likely to challenge their use. Conversely, those who have will defend their use.

How to write effective procedures; that is one of the ways in which CMII makes ISO 9000 right.