Fundamentals and vocabulary
The ISO Navigator™ database hyperlinks the ISO 9000 principles and the ISO 9001 requirements; and explains them in plain English with practical guidance.
ISO 9000:2005 – fundamentals and vocabulary
ISO 9000:2005 only introduces clarifications to the existing requirements of ISO 9001:2008 and some changes intended to improve consistency with ISO 14001:2004. There are no new requirements.
ISO 9000:2005 Quality management systems – Fundamentals and vocabulary makes no changes to the basic principles of quality management stated in ISO 9000:2005.
For example: both ISO 9000:2005 and ISO 9001:2008 define a procedure as a specified way to carry out a task which does not necessarily have to be documented and that generating documentation should not be an end in itself.
ISO 9001:2008 - What's New?
ISO 9001:2008 is essentially a tidying-up exercise to ensure consistency within ISO Standards. 15 definitions and explanatory notes have been added or expanded to align ISO 9000 with more recent ISO Standards:
ISO 9001:2008 adds “business environment” to the list of factors that influence the design and implementation of a quality management system. The other changes to this text are minor revisions to the other factors, as well as, the use of a bulleted list.
The design and implementation of an organization's quality management system is influenced by - its business environment, changes in that environment, or risks associated with that environment, - its varying needs, - its particular objectives, - the products it provides provided, - the processes it employs employed, and - its the size and organizational structure of the organization.
Later in section 0.1, ISO 9001:2008 changes "regulatory" to "statutory and regulatory” and clarifies that the customer, statutory, and regulatory requirements are those applicable to the product. This International Standard can be used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, statutory, and regulatory requirements applicable to the product, and the organization's own requirements.
What Do I Need To Do?
This is a relatively minor revision. It will probably have little, or no real impact on your quality system.
If your documentation refers to any ISO 9000:2005 or ISO 9001:2008 terminology you should revise as necessary on ensure consistency with the new 2008 terminology.
ISO 9000:2005 Basic QMS Terminology
- The product - the thing that your company provides to the customer
- The organization - your company
- The customer - the people you supply product to
- The supplier - the people who supply you something that contributes to your product
- Top management - the company directors, executive management
- Shall - means "you must" - you will be audited to ensure you comply with the "shalls"
- Effectiveness - means that the QMS works and achieves its objectives.
- Efficient - means that the QMS uses minimum resources
- Quality - there are many incomprehensible, official definitions. Think of quality as "we keep our promises".