ISO 9001 is currently undergoing its’ first major revision in nearly 15 years. It’s an exciting time in the Quality world.
According to the draft design specification, the revised ISO 9001:2015 standard should (among other things):
- Provide a stable core set of requirements for the next 10 years or more
- Remain generic, and relevant to all sizes and types of organization operating in any sector
- Maintain the current focus on effective process management to produce desired outcomes
- Take account of changes in quality management systems practices and technology since the last major revision in 2000
- Reflect changes in the increasingly complex, demanding and dynamic environments in which organizations operate
- Apply Annex SL of the ISO Directives to enhance compatibility and alignment with other ISO management system standards
- Facilitate effective organizational implementation and effective conformity assessment by first, second and third parties
- Use simplified language and writing styles to aid understanding and consistent interpretations of its requirements
The revised Standard has significantly upgraded the clause structure as follows:
- Clause 1 – Scope
- Clause 2 – Normative references
- Clause 3 – Terms and definitions
- Clause 4 – Context of the organization
- Clause 5 – Leadership
- Clause 6 – Planning
- Clause 7 – Support
- Clause 8 – Operation
- Clause 9 – Performance evaluation
- Clause 10 – Improvement
Per Nigel H. Croft – Chair – ISO/TC 176/SC 2, Quality systems
Significant Changes in ISO 9001 Revision 2015 Committee Draft
1. The term “product” has been replaced by “goods and services”.
2. Two new clauses related to the context of the organization:
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties.
3. The requirement to use the process approach has been more explicit by adding a new clause.
4.4.2 Process approach
4. The standard does not include a specific clause for “Preventive Actions”.
5. The terms “document” and “records” have been replaced with the term “documented information”.
6. Control of external provision of goods and services address all forms of external provisions.
7. The term “continual improvement” has been replaced with “improvement”.
That is quite significant.
More to come in our next BLOG…