Requirements in ISO 9001:2000 for Planning

Some of you have asked about the expanded requirements for planning defined in the new ISO 9001:2000 standard. The key clauses related to planning are:

  • 5.4 for quality objectives and the quality management system
  • 7.1 for product realization
  • 8.1 for monitoring, measurement, analysis, and improvement

Resource planning is addressed at the system-level in clause 5.4 (through its reference to clause 4.1) and covered at the product-level in clause 7.1.

5.4 Planning

Clause 5.4.1 covers the planning necessary to establish measurable quality objectives that are consistent with the quality policy. This planning must ensure the objectives include those needed to meet product requirements and are established at the relevant functions and levels within the organization.

Guidance from ISO 9004 suggests that management consider current product and process performance, as well as, relevant findings from management reviews, in establishing the objectives. This planning should also cover how the objectives will be communicated to ensure their understanding and achievement.

Clause 5.4.2 addresses the system-level planning necessary to meet the overall requirements expressed in clause 4.1. Therefore, planning must be carried out to establish, document, implement, and maintain the quality management system.

The system planning must include:

  • Identifying the processes needed for the system
  • Determining the process sequence and interaction
  • Applying the processes throughout the organization
  • Determining the criteria and methods for effective operation and control of these processes
  • Ensuring resources and information are available to support operation and monitoring of processes
  • Monitoring, measuring, and analyzing these processes
  • Implementing actions to achieve the planned results
  • Continually improving these processes
  • Managing the processes in accordance with the Standard
  • Identifying and controlling any outsourced processes

Since this planning is for the system, the processes involved are those for management activities, provision of resources, product realization, and measurement. Clause 5.4.2 also reminds us that the system integrity must be maintained when changes are being planned and implemented.

ISO 9004 summarizes this planning by suggesting it focus on defining the processes needed to effectively and efficiently meet the quality objectives and requirements in a manner consistent with the strategies of the organization.

7.1 Planning of Product Realization

Clause 7.1 requires the organization to plan and develop its processes for product realization. This planning must be consistent with other process requirements defined for the system in clause 4.1 and, therefore, compatible with the planning covered in clause 5.4.

The product realization planning must determine:

  • Quality objectives and product requirements
  • Needed processes, documents, and resources
  • Required verification, validation, monitoring, inspection, and test activities
  • Criteria for product acceptance
  • Records needed as evidence that realization processes and the resulting product meet requirements

The planning output can be placed in any form suitable for the organization. A clarifying NOTE informs us that a document specifying the quality management system processes (including the product realization processes) and the resources for a specific product, project, or contract can be referred to as a Quality Plan. Another NOTE suggests we consider applying the Design and Development requirements of clause 7.3 to the development of the product realization processes.

According to ISO 9004, the product realization plan, or operating plan, should consider topics such as the desired outputs, process steps, activities, flows, control measures, training needs, equipment, methods, information, resources, and support processes.

8.1 General

Clause 8.1 requires an organization to plan and implement the monitoring, measurement, analysis, and improvement processes necessary to:

  • Demonstrate conformity of the product
  • Ensure conformity of the quality management system
  • Continually improve the effectiveness of the system

This planning must also determine the applicable methods (including statistical techniques) and the extent of their use.

According to clause 8.1.1 of ISO 9004, this planning should cover the processes for recording, collecting, analyzing, summarizing, and communicating the relevant data needed to monitor and improve organizational performance. It goes on to say the measurement criteria and objectives should be identified. Clause 8.1.2 provides a list of issues to be considered when planning for measurement, analysis, and improvement.

Planning Evidence

Since system-level planning also includes planning for product realization and measurement processes, an organization could devise a checklist to address most, if not all, of these related planning requirements. The checklist itself would be evidence of system planning. The completed checklist, along with actions, would be evidence of product realization and measurement planning.

Since ISO 9001 states the planning output can be in any form suitable for the organization, the evidence could also be in planning documents, such as a quality plan, or even meeting minutes. The key is to recognize the related planning activities and determine if multiple requirements can be addressed in a single, comprehensive approach.