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ISO 9001:2008 4.2 Documentation Requirements

Important note: Documentation may be in any form or medium suitable for the needs of the organization.

Reading back through the guidance offered in previous pages on ISO 9001:2008 section 4.1 will give a you reasonable idea of the type of documented evidence the standard implies. Whilst, within the requirements of the standard it actually defines only six mandatory procedures, clearly most organisations will require much more than this to meet their day to day activities and contractual, statutory and regulatory requirements. Understandably ISO 9001:2008 as a standard for quality management systems is seeking to improve the way organisations manage their processes in order to show continual improvement. Documentation will need to support the fact the quality management system is effective and efficient in meeting the products and / or services the organization provides. Access to documentation within an organisation should ensure communication both internally and externally is managed this to guarantee the product or service is not affected, something that can become increasingly more difficult as the size of an organization grows.

To provide guidance of how to achieve control of documentation ISO 9001:2008 clause 4.2 is subdivided into four requirements:

4.2.1 General
4.2.2 Quality manual
4.2.3 Control of documents
4.2.4 Control of records

ISO 9001:2008 4.2.1 General

The Quality Management System includes:

documented quality policy and objectives;
quality manual;
documented procedures as required by ISO 9001:2008;
documents required to ensure the effective planning, operation and control of the processes;
records relative to the Quality Management System;
quality system requirements imposed by regulatory authorities.

Again, this can be in a variety of mediums and not simply the traditional paper based systems.

Examples being an organization intranet or designated controlled workstations. Employees, customer and or selected regulatory authorities can be given access to the quality management system documentation upon request.

The standard also makes it clear that the extent of the quality management system documentation can differ from one organization to another, taking into account;

the size of organization and type of activities, the complexity of processes and their interactions, and the competence (training, experience, skills and knowledge) of personnel.

The UK Training Agency (1988) defines 'Occupational competence' as:

... the ability to perform the activities within an occupation or function to the standards expected in employment. (This includes)... the ability to transfer skills and knowledge to new situations... organisation and planning of work, innovation and coping with non-routine activities... (and the)

personal effectiveness... to deal with co-workers, managers and customers. It stems from an understanding (that) to perform effectively in a work role an individual has to combine... performance of various technical and task components, overarching management of the various technical and task components to achieve the overall work function, management of the variance and unpredictability in the work role and the wider environment, (and) integration of the work role within the context of the wider organisation, economic, market and social environment.

The opposite of competence is incompetence, which can be defined by the lack of physical or intellectual ability or qualifications. Clearly the quality management system will suffer if the organization pursues a competence based system without due consideration of the levels and depth of competency required. Another common problem with organizations is they tend to promote 'to an individuals level of incompetence', taking them one step further than their optimum role... This is both unhealthy for the business and the individual concerned.

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