ISO 9001:2000, Clause 7.1 and Quality Plans

The words “plan”, “planned”, and “planning” are used more than 30 times in the requirement clauses of the ISO 9001:2000 standard. A plan is simply a method you develop before doing something so you are more likely to have a successful result.

The term “quality plan” is only used once in the standard, in a Note associated with clause 7.1, Planning of Product Realization. The Note refers to a quality plan as a document specifying the processes of the quality management system, as well as, the resources to be applied for a specific product, project, or contract.

According to ISO 10005:2005, quality plans provide a means of relating specific requirements of the process, product, project, or contract to work methods and practices that support product realization. The benefits of establishing a quality plan include:

1. Increased confidence that requirements will be met
2. Greater assurance that processes are in control
3. Motivation it can give to those involved
4. Insight into opportunities for improvement

Development of a Quality Plan

Your organization should identify the need for a quality plan. For example, a quality plan may be needed for legal or customer reasons, to organize and manage activities, optimize the use of resources, to monitor or assess compliance, or minimize the risk of not meeting requirements.

However, in some cases, an organization with a well established system may be able to meet its needs for quality planning without developing separate quality plans.

After deciding to create a quality plan, it is time to identify its inputs. For example, what are the requirements for the plan, the needs of the people that will use it, the resource requirements, and any risk assessments.

You must determine what is to be covered by the quality plan and what will be addressed by other documents. The scope of the plan will depend on the extent the plan will be supported by a documented quality management system, as well as, the processes and quality characteristics that are unique to the product, project, or contract being addressed.

You will need to name someone as the author of the document and responsible for its preparation. Of course, multiple people may be involved in contributing to its content. 

Content of a Quality Plan

The quality plan should indicate how the required activities will be carried out, either by including that information, or referring to other documents, for example, documented procedure, project plan, work instruction, checklist, or computer application.

A quality plan may include the topics listed below or refer to their coverage in other documents:

  • Scope, purpose, and expected outcome
  • Inputs and reference documents
  • Quality objectives and customer satisfaction issues
  • Management responsibilities for activities
  • Document and record controls
  • Resources for successful execution
  • Infrastructure and work environment
  • Requirements to be met for product, project, or contract
  • Customer communication and records
  • Plan for design and development
  • Purchasing requirements, methods, and controls
  • Production and service inputs, activities, and outputs
  • Methods for identification and traceability
  • Customer property identification and control
  • Product preservation and delivery
  • Nonconformity control and limits on rework and repair
  • Monitoring and measurement to obtain evidence of conformity
  • Audits to monitor conformity and effectiveness

The quality plan may be in presented in one of several different structures. For example, it could be a simple text description, a table, a document matrix, a process map, or a work flow. ISO 10005:2005, Guidelines for Quality Plans, includes examples of quality plans in its Annex A.

ISO 10005:2005 can be ordered at this ASQ Web Page.