After three years of revision work, the ISO 9001:2015, the most popular management system standard with over 1.1 million certificates globally issued, has published now. Similar to ISO 14001:2015 which was published mid-September, it has been also restructured based on High Level Structure (HLS) to be aligned with other management systems.
The new version is adapted with 21st century circumstances with more focus on performance and process approach and less requirements for documentation and compliance.
The process approach which is introduced as a “requirement” now will challenge both organisations and auditors how to restructure the existing functional approach to a process-based mindset throughout the whole organisation in design, implementation and auditing.
Need to understand the context of the organisation and the needs and expectations of interested parties helps the organisations to establish and implement a quality management system which is tailor-made to add value to the organisation and its interested parties rather than a bunch of document to tick the boxes and satisfy the auditors.
The risk-based thinking is a real masterpiece in the 2015 version. It will help the organisations to consider both adverse and beneficial impacts of its processes, products and services internally and externally.
Change management is also a breakthrough in this version which reduce the risk of unplanned changes which can potentially cause even more issues. Any changes are supposed to be reviewed and analysed in advance considering the risks and impacts to internal and external interested parties.
Regarding the changes in the new version such as “Design & Development” and “Measuring equipment” clauses, it is more understandable and adaptable for service sector.
Please fill out the Questionnaire or contact us if you need our hands to assist you in the journey of transition to the new version of the standard. We will help you assess the gaps between your existing system and the requirements of the new version and also assist you in filling the gaps and getting ready for ISO 9001 certification.