ISO DOCUMENTATION DESIGN AND DEVELOPMENT SERVICE

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Kelmac Group can assist you with many of the headaches and much of the stress associated with ISO Documentation Design and Development covering a broad range of Management Systems including ISO 9001, ISO 14001, OHSAS 18001, ISO 22000 and much much more.

Example (ISO 9001 Documentation) - For organizations that are in the process of implementing a QMS, and wish to meet the requirements of ISO 9001:2008, the following comments may be useful:

Identifying the processes necessary for the effective implementation of the quality management system

Understanding the interactions between these processes.

Documenting the processes to the extent necessary to assure their effective operation and control. (It may be appropriate to document the processes using process maps. It is emphasized, however, that documented process maps are not a requirement of ISO 9001:2008.)

These processes include the management, resource, product realization and measurement processes that are relevant to the effective operation of the QMS.

Analysis of the processes should be the driving force for defining the amount of documentation needed for the quality management system, taking into account the requirements of ISO 9001:2008. It should not be the documentation that drives the processes.

For Example - Documentation Requirements for ISO 9001:2008

ISO 9001:2008 clause 4.1 General requirements requires an organization to "establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard"
Clause 4.2.1 General explains that the quality management system documentation shall include:

documented statements of a quality policy and quality objectives;

a quality manual

documented procedures required by this International Standard

documents needed by the organization to ensure the effective planning, operation and control of its processes, and

records required by this International Standard;

The notes after Clause 4.2 make it clear that where the standard specifically requires a "documented procedure", the procedure has to be established, documented, implemented and maintained. It also emphasizes that the extent of the QMS documentation may differ from one organization to another due to:

the size of organization and type of activities;

the complexity of processes and their interactions, and

the competence of personnel.

All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4.

 

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