ISO 9001 Training

Understanding ISO 9001:2008
Requirements for Quality Management Systems

4.1 QMS General Requirements

ISO 9001 Training - Key Explanation Points and Tips:

The primary focus of clause 4.1 requirements is to manage and control all your QMS processes including product realization processes. The note under clause 4.1 requires that your QMS must also include processes for management activities, provision of resources, product realization, and measurement as part of QMS.

Clause 4.1 requires the ‘Process Approach’ to be used in defining your QMS. Review section 0.2 Process Approach of this document for a good understanding of clause 4.1 requirements and how they may be applied.

Documentation of QMS processes and the need for and detail of specific process documentation is determined by - ISO 9001; customer; regulatory and your own organizational requirements. Other factors to consider may include - complexity of products and processes; effect on quality; risk of customer dissatisfaction; economic risk; effectiveness and efficiency; competence of personnel. Clause 4.2.1d requires you to have documents needed to ensure the effective planning, operation and control for QMS processes.

Based on these factors, you must determine what processes need to be documented and how you will document it.  Not all processes need to be documented; however your quality manual must include a description of the interaction between your QMS processes.

A number of different methods can be used to document processes, such as graphical representations, written instructions, checklists, flow charts, visual media, or electronic methods, etc. Process flowcharts or block diagrams can show how policies, objectives, influential factors, job functions, activities, material, equipment, resources, information, people and decision making interact and/or interrelate in a logical order.

Procedures may be an acceptable way to document processes provided they describe inputs and outputs, appropriate responsibilities, controls and resources needed to satisfy customer requirements.

Regardless of whether or not you document all of your processes, you must provide evidence of effective implementation of all your QMS processes. Such evidence does not necessarily need to be documented.

Clause 4.1c requires you to determine criteria for effective process operation and control. You could determine criteria to control inputs, outputs and resources used.

For example - raw materials as an input to production would have acceptance criteria that it must meet before it can be used; finished product as an output of the production process must meet acceptance criteria before it can be shipped to the customer; the equipment used to transform raw materials into finished product may have set-up and capability criteria or parameters that it must meet in order to produce conforming product. These prevention based criteria (controls) must be established for each QMS process. Note that such controls may also come from the customer, regulatory or industry bodies.

Equally important are the specific methods (clause 4.1c) required for effective operation and control of each process. These may include job travelers; work instructions; in process inspection sheet; specifications and drawings; SPC charts; set up checklist; machine manuals; etc. Note these control methods may apply to any or all of inputs, outputs or conversion activities.