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Slide  121
Quality Management System Implementation
‘Areas’ go here.
Area responsibilities come from Organization Charts.
Each area has certain QS-9000 - ISO 9001 elements it is responsible for complying with. Each should be listed and the departmental managers should know their responsible elements.

We can track each area’s compliance with a matrix like this one. Verification and validation are by the use of internal audits.

One element every area will have to comply with is Element 4.16 ‘Quality Records’. Does each area manager know what quality records they have and are responsible for?

It is very important that this responsibility chart be presented during staff meetings weekly to ensure that there is progress!
An Example Area ‘Element Responsibility’ Chart
Note that this example responsibility chart is from an  ISO 9001:1994 implementation. In the package you purchased you will find the file “Responsibility_Matrix.xls”. It is already set up with the ISO 9001:2000 elements. See the Process matrix sheet within the file.

The bottom line is this may serve to give you some ideas on how to track the project from a high level. Unless we’re talking a company of 10 to 15 people, I really recommend tracking matrices. Even then it’s a good idea.

Note that a master matrix can be effectively used to define what managers are responsible for understanding what elements. For example, every functional department is responsible for understanding and complying with document control procedures (4.1, 4.2). But only ‘management’ is responsible for Management Review (5.6).

So - you can use this matrix to track implementation (compliance) and you can use it to define which departments are responsible for compliance with each element of ISO 9001. The next slide shows this in detail.