ISO 9001 has been published to the new ISO 9001:2015 version. The main objective of the new version of ISO 9001 is to provide confidence in the organization’s ability to consistently provide customers with conforming goods and services and to enhance customer satisfaction.
New ISO 9001:2015 standard characterize a technical revision compared to 2008 edition. It also adopts revised clause sequence, quality management principles and addition of new concepts.
Some concepts introduced in new standard are:
- Integration of Risk Management
- Resource Management
- Systematic problem solving and learning
- Voice of the customer
- Knowledge management
- Measures (examples are performance, satisfaction and ROI.)
ISO 9001:2015 – Quality Management Principles
Following Seven Management System Principles have been used in ISO 9001:2015 standard
- Customer Focus
- Engagement of People
- Process Approach
- Evidence based Decision Making
- Relationship Management
ISO 9001:2015 – Major Changes
- “High Level Structure” is used in text writing (i.e. clause sequence, common text and terminology)
- New clause sequence is adopted in new version which is consistent with “Annex SL”, highlighted in main body of the text (clause 1 to 10).
- No specific reference and text for possible exclusions of requirements
- No specific requirement and text for‘documented procedures’ and ‘records’. Both have been replaced throughout by the text ‘documented information’.
- Role of“Management Representative” Now the activities of Management Representative should be performed by one of group of Senior Management.
- No mention of a “Quality Manual”. Specific word “Quality Manual” is no-were mentioned in the Draft Standard.
- Quality policy / objectives compatible with strategic direction
- Integration of QMS requirements into business processes
- Change of term ‘product’ to ‘product and services’. New term include all output categories i.e. hardware, services, software and processed materials
- Organization needs to determine the knowledge necessary for the operation of the QMS and its processes and to achieve conformity of process
- “Risk-based thinking” introduced in all clauses
- Organization needs to determine the risks to conformity of goods and services and to customer satisfaction and opportunities in place of preventive action
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Source: Information collected from ISO Website