Difference Between ISO 9001:2015 and ISO 9001:2008
The main difference between ISO 9001:2015 and ISO 9001:2008 revision of ISO 9001 is adoption of risk-based thinking and requirement to determine context of the organization.
Beside that, the new version of the standard excludes requirements for preventive actions, quality manual, management representative and so on. It also has a new structure (10 clauses instead of 8) and different approach to documents and records.
ISO 9001:2015 standard is on the basis of the new high level structure (HLS) that brings to us the framework which is universal to all standards of management systems which keeps consistency of all standards.
- The key changes of the standard are:
- Risk management more focused
- Leadership more emphasized
- Awareness and effective communication
- Objectives to be measurement and changed
ISO 9001: 2008 | ISO 9001: 2015 |
| Products | Products and Services |
| Exclusions | It’s not being used (See Chapter A.5 for clarification of implementation and exclusions ) |
| Management Representative | It’s not being used (Assigned similar responsibilities and authorities, but there is no requirement for a single representative of the Top Management) |
| Documentation, Quality Manual, Documented Procedures, Records | Documented information |
| Working environment | Environment for the operation of processes |
| Monitoring and measurement equipment | Monitoring and measurement resources |
| Purchased product | Products and Services provided by the external provider |
| Purchaser | External provider |
ISO 9001:2008:
- Scope
- Normative reference
- Terms and definitions
- Quality management system
- Management responsibility
- Resource management
- Product realization
- Measurement, analysis and improvement
ISO 9001:2015:
- Scope
- Normative reference
- Terms and definitions
- Context of the organisation
- Leadership
- Planning
- Support
- Operation
- Performance evaluation
- Improvement
The first three clauses in ISO 9001:2015 are largely the same as those in ISO 9001:2008, but there are considerable differences between ISO 9001:2008 and ISO 9001:2015 from the fourth clause onward. The last seven clauses are now arranged according to the PDCA cycle (Plan, Do, Check, Act).
There is more emphasis in ISO 9001:2015 on measuring and properly assessing the input and output of processes. According to ISO 9001:2015, you must closely monitor which articles, information and specifications are involved in the production process. You must also clearly check whether good articles come out of the production process.
RISK-BASED THINKING IS AT THE CORE OF ISO 9001:2015
Risk-based thinking has a very important place in ISO 9001:2015. You are now strongly encouraged as an organisation to use risk analysis in order to decide for yourself which challenges you see in the management of your business processes.
Formal risk analysis, familiar to many organisations via FMEA or HACCP techniques, is now standard for everyone. To emphasis their dominance, the concept of ’risk’ occurs forty-eight times in ISO 9001:2015, compared with only three times in ISO 9001:2008.
The addition of risk-based thinking has made the ‘preventive measures’ of ISO 9001:2008 redundant. These preventive measures no longer appear in ISO 9001:2015.
