ISO 9001:2015 – 8.1 Operational planning and control

Planning Quality with a Quality Plan

I promote the use of the quality plan because I find it to be the most effective method for planning quality. Quality planning requires a type of blueprint or guideline for the organization that states how quality requirements are to be achieved, the quality plan, its methodical approach or structure that describes and specifies all the requirements needed to be followed, met, maintained, and documented while realizing the product and consists of all necessary information that would assist the participants to manufacture a product that meets its requirements. I highly recommend the maintenance of such documentation. The quality plan integrates all relevant demands for activities, resources, and information concerning the realization of a product and makes them available to any interested party. In other words, when one carries out all that is mentioned on this plan, the product is bound to meet its requirements. The goals of the quality plan include the following:

  • Identifying all the specifications and characteristics of a product including quality requirements. These must match with the expectations of the customers.
  • Identifying all the required processes and their activities needed for product realization.
  • Describing the necessary or expected inputs and outputs of each activity and so defining the relations between the various processes.
  • Defining the required resources and conditions needed to support these activities.
  • Defining the controls that will ensure intended outcomes—validation and verification.
  • Defining the criteria for acceptance (or rejection) of outputs of activities (processes or products).

Reference to the Quality Objectives

Establishing and maintaining a quality planning means implementing the QMS and its objectives while realizing products or services. Quality planning is to promote quality objectives by describing the activities, resources, controls, and documented information that shall support the achievement of relevant quality objectives. We already know that processes are to be planned and controlled in accordance with the organization’s strategy. The quality plan provides you with a practical approach to meet these objectives and implement the strategy by defining the exact tools and measures needed to achieve them, that is, by performing these activities, the quality objectives of the organization shall be reached. For example, let us assume that the organization decided that one of its quality objectives is to reduce the number of customer complaints. After a review of last year’s complaints, it was discovered that most of these complaints are related to the packaging activities and the packaging of the product. The conclusion is that further controls related to those activities must be planned and implemented in order to achieve this specific quality objective—reduce the number of such complaints. The quality plan is where you act to implement these controls.

Identifying Product Characteristics

The quality planning shall identify all of the product characteristics with respect to customer expectations or specifications:

  • When necessary the planning shall indicate all the components, sub- or semiproducts, bill of materials, parts, and materials of the product.
  • The plan will identify different characteristics of a product such as geometrical, material, or functional requirements.
  • It is necessary to specify the tests that must be performed in order to ensure the adherence to the specifications of the product.
  • A description of the material and function tests that are required and were determined either during the design and development phase or by the customer.
  • Identification of all monitoring and measuring devices that are necessary for measuring products and process outputs.
    A test for sampling products from a process.
  • Requirements for purchase and external providers will be specified.
  • A reference sample of the product may be used during the planning.
  • If applicable, the management and routing of materials will be described.

When it is not applicable to include all this information, reference to the documents where this information exists will be included in the plan.

This webpage contains only a fragment of the chapter 8 – Operation from the book: ISO 9001: 2015 – A Complete Guide to Quality Management Systems published by:

Why choose the book ISO 9001: 2015?
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