Toughest ISO 9001:2000 Requirements

As I teach, consult, and audit, I find that some organizations have a difficult time understanding a few of the new ISO 9001:2000 requirements. They either don’t know how to interpret a requirement, or they don’t know the practices to implement for a conforming system. The toughest new ISO 9001:2000 requirements seem to be:

   4.1 General Requirements (and 0.2 Process Approach)
   5.1 Management Commitment
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning (vs. 7.1 Planning of Product Realization
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

I’ll cover 4.1 General Requirements (and clause 0.2, Process Approach) in this article. I will address the other requirements in later newsletters.

0.2 Process Approach
Some people are in such a hurry to implement their quality system, they skip over the introductory ISO 9001:2000 clauses and focus just on the requirement clauses.

Without reading clause 0.2, Process Approach, organizations are overlooking an important concept that is at the heart of the new standard. ISO 9001:2000, through its structure and requirements, promotes the adoption of a process approach.

To function effectively, an organization has to identify and manage numerous linked activities. When an activity uses resources to transform inputs into outputs, this activity can be considered a “process”.

The output of one process often forms the direct input to another process. Identifying the system of related processes, along with their interaction and management, can be viewed as the “process approach”.

The standard doesn’t force a system on your organization. Adopting the process approach merely helps your organization describe its system, understand the interacting processes, and control the linked activities.

A process model diagram is included at clause 0.2 to highlight the main processes of the standard. It can be used as a starting place to develop a model of your own system.

The process model points out the importance of customers by showing they submit requirements into the system, accept products, and share feedback on their level of satisfaction with how well their requirements were met.

Customer requirements are used in product planning, which is part of the Product Realization process. In addition, this process covers transforming requirements into a design, purchasing the needed resources, producing the product under controlled conditions, and using calibrated equipment.

Data on customer satisfaction flows into the Measurement, Analysis, and Improvement process. This information, along with other measurements and evaluations, provides vital feedback on the performance of the system.

Management must act on this feedback to provide or adjust resources to maintain and improve the system. Therefore, the performance data flows into the process box for Management Responsibility. Management must demonstrate their commitment, focus on meeting requirements, ensure the adequacy of the quality policy and objectives, and review the system at planned intervals to ensure its effectiveness.

Management decisions and actions flow into the Resource Management box. Resources are needed to assure product quality and include items such as workspace, equipment, materials, and people.

The iterative nature of the model, along with its data analysis activities, may identify system improvements as shown by the Continual Improvement box. If justified, the necessary steps should be taken to put these recommendations into practice.

4.1 General Requirements

The process approach has been explained, but how does ISO 9001 promote its adoption? Look closely at clause 4.1, General Requirements. Processes must be identified for your 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 these processes must also be available. Your organization must then monitor, measure, and analyze the processes, as well as, implement the actions necessary to achieve planned results and continually improve the processes. Even outsourced processes are included.

Clause 4.2.2, also promotes adoption of the process approach by requiring the quality manual to describe the process interaction of the system. And, throughout the standard, references are made to process requirements.

An organization can satisfy the process interaction requirement of the quality manual by including flow charts, process maps, cross-reference tables, and/or written text.

An advantage of looking at your system as a linked set of activities is the ongoing control it provides over the linkage and interaction of individual processes. Although the process approach might seem an abstract concept, it will become common sense when you begin to look at how your organization actually operates.