Difference Between ISO 9001:2015 and ISO 9001:2008?

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.

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