The latest version of Quality Management Standard, ISO 9001, was published in September 2015. With over 1,100,000 certificates issued in the world, ISO 9001 has helped organisations to demonstrate consistency in providing good quality product and services. ISO 9001 has helped organisations also as a tool to streamline the processes and make them more effective and efficient. ISO 9001 enhances organisation’s ability to meet customers’ needs and expectations and provides a framework for sustained growth success.
The 2015 version of ISO 9001 features some important changes and aligns ISO 9001 with needs of modern managements system. The previous editions of ISO 9001 were more prescriptive, with more requirements for developing documents and maintain records, however ISO 9001:2015 is less prescriptive and more focused on performance and effectiveness. In ISO 9001:2015, the process approach has been now combined with new introduced concept of risk-based thinking.
Most of the organisations now implement more than one management standard, such as ISO 9001, ISO 14001, AS/NZS 4801 (OHSAS 18001), HACCP, ISO 22000, ISO 13485, ISO 27001 or other management system standards. The new ISO 9001:2015 uses a common framework named Annex SLA which facilitates integration with other management system. The new structure of ISO 9001:2015 based on Annex SLA is the most noticeable change of standard however it is now easier for organisations to integrate multiple management systems.
Risk based thinking is another change introduced in new standard, ISO 9001:2015. There are certainly some risks in all levels, functions and systems of any organisation. ISO 9001:2015 has introduced Risk-based thinking to ensure that risks in organisation are identified, assessed and controlled throughout the process of quality management system.
ISO 9001 in previous versions had a separate requirement for preventive action which is replaced now by risk-based thinking. Risk based thinking is more explicit and proactive rather than implicit and reactive. Preventive action requirement is now removed as preventive action is embedded in risk based thinking requirement.
The changes introduced in ISO 9001:2015 bring some challenges for organisations to develop/upgrade their management system however these changes may also bring some great opportunity for making management system more effective and efficient. The new edition of the ISO 9001 brings also some new benefits to organisations such as:
- More emphasis on leadership accountability and engagement
- identifying risks and opportunities in a structured manner increases the probability of reaching objectives and reduces the probability of negative results
- More simplified language and a common structure for integration
- Easy to understand and implement in service providers and knowledge based companies
Plan to upgrade your Quality management system by following below steps:
Step 1 – Familiarise yourself and other staff with ISO 9001:2015 and new requirements by reading the standard and participating in a seminar or training. There are some changes and new concepts however many requirements remain the same.
Step 2 – Identify your QMS gaps which need to be developed or upgraded to meet the new requirements and sort them based on the priority.
Step 3 – Make an action plan and identify responsibilities and timeframe.
Step 4 – Enhance awareness of project team and other staff by short training or inductions before implementing the actions.
Step 5 – Update existing QMS and documentation to meet the revised requirements.
Step 6 – Implement the actions
Step 7– Be prepared for transition audit and certification based on ISO 9001:2015.
How GCC can help you
Global Compliance Certification (GCC) will assist you in:
- Conducting gap assessment as a standalone audit or integrated with other management system audits
- Training your team through our public or in-house training courses