Toughest ISO 9001:2000 Requirements (5.4.2)

In the December, 2003 newsletter, I identified twelve ISO 9001:2000 clauses as the toughest requirements to understand and meet with conforming practices. Clauses 4.1, 5.1, and 5.4.1 were addressed in previous newsletters.

This article covers clause 5.4.2, Quality Management System Planning. The next article in this newsletter deals with clause 6.2.2, Competence, Awareness, and Training.

4.1  General Requirements (and 0.2 Process Approach) – article in December, 2002.
   5.1  Management Commitment – article in January, 2003
5.4.1  Quality Objectives – article in January, 2003
5.4.2  Quality Management System Planning (vs. 7.1) 
6.2.2  Competence, Awareness, and Training 
6.3  Infrastructure
7.3.1  Design and Development Planning
7.5.2  Validation of Processes for Production and Service Provision
8.2.1  Customer Satisfaction
8.4  Analysis of Data
8.5.1  Continual Improvement
8.5.3  Preventive Action

Clause 5.4.2, Quality Management System Planning, states:


Top management shall ensure that:
a) the planning of the quality management system is carried out in order to meet the requirements of given in 4.1, as well as, the quality objectives, and


b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.


Most of the planning to meet the requirements of 4.1, General Requirements, is completed at the early stages of developing and implementing a quality management system. For example, processes must be identified for the system, along with their sequence and interaction.

In addition, the criteria and methods for operating and controlling these processes must be determined. The resources and information needed to operate and monitor the processes must also be planned. Organizations must then decide how to monitor, measure, and analyze their processes, as well as, be ready to implement the actions necessary to achieve planned results and continually improve the processes. Even outsourced processes are included in the planning.

The need for additional planning after the system is operational may surface during management reviews. Remember, management reviews are to ensure the continued suitability, adequacy, and effectiveness of the system. The reviews also determine if any changes are needed or opportunities for improvement exist.

A key part of system planning is setting quality objectives (see the January 2003 newsletter). Since quality objectives should change over time, this type of system planning will be ongoing. As we plan for changes, 5.4.2.b requires the integrity of the system to be maintained. In other words, make sure the system continues to be effective during and after the changes.

Clause 7.1, Planning of Product Realization

Some organizations confuse the “system-wide” planning of 5.4.2 with the “product-specific” planning of 7.1. Planning the product realization processes means planning the processes that manufacture a specific product or deliver a unique service.

If your product manufacturing or service delivery is routine and highly repetitive, the necessary planning may be carried out by merely establishing your quality manual and related documents. If not, you may need separate planning for each new order, contract, or project. The output of this planning process can be a quality plan, project plan, or a process planning checklist for new or changed products.

For more information, see the article “Requirements in ISO 9001:2000 for Planning” in the January 2001 newsletter.