- its business environment, changes in that environment, or risks associated with that environment,
- its varying needs/particular objectives
- the products it provides/processes it employs
- its size and organisational structure.
This International Standard can be used by internal and external parties, including certification bodies, to assess the organisations ability to meet customer, statutory and regulatory requirements applicable to the product, and the organisation’s own requirements.
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.
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