ISO 9001 Training

Understanding ISO 9001:2008
Requirements for Quality Management Systems

4.2.1 Documentation Requirements - General

ISO 9001 Training - Key Explanation Points and Tips:

Let’s begin with some definitions. A document is information that is written or recorded on some medium such as paper or computer. A document may specify requirements (e.g. a drawing or technical specification); provide direction (e.g. quality plan or checklist); or show results or evidence of activities performed (e.g. training or testing records).

A procedure is a specific way to perform an activity or process (methods or practice used by an organization) and it may or may not be written. If it is written, it is called a documented procedure. The same reasoning applies to work instructions which may or not be documented.

Clause 4.2.1d requires you to have documents needed to ensure the effective planning, operation and control for QMS processes. Each organization must determine what documentation is needed to achieve this based upon the factors listed below.

This standard is not heavy on documented (written) procedures as was the case with previous standards priot to the year 2000. Clause 4.2.1 specifies all the different types of documentation needed for your QMS. The need to have additional documentation beyond those specified in this standard may depend upon - 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; stability of the organization workforce.

You must have documented statements of your quality policy and objectives. These will be discussed later in clause 5. Other mandatory documentation include your Quality Manual; procedures for control of documents; control of records; control of Nonconformities; internal audit; corrective action and preventive action. You have hte flexibility to combine some of these procedures, e.g. document and record control; or corrective and preventive action. This might make sense for a small company. You are also allowed to have more than one procedure for these activities, e.g. a separate procedure for QMS documents and engineering documents. This might make sense for a larger company.

Documented records are specifically called for or implied throughout the standard. These will be covered as we go through each clause. Examples include records for - training , competency, contract review, design and development, inspection and test, purchasing , noncormity, corrective action, etc.