ISO 9001:2015 is more compatible with other managent systems, such as ISO 14001, making it more effective and efficient to integrate management systems
There are changes to the structure
- The adoption of the high level structure as set out in Annex SL of ISO Directives Part 1
- An explicit requirement for risk-based thinking to support and improve the understanding and application of the process approach
- Fewer prescriptive requirements
- More flexibility regarding documentation
- Improved applicability for services
- A requirement to define the boundaries of the QMS
- Increased emphasis on organisational context
- Increased leadership requirements
- Greater emphasis on achieving desired process results to improve customer satisfaction
High level changes to all management system standards - The most significant changes in the 2015 standard are in Clauses 4, 5 and 6, i.e. Context of the organisation, Leadership and Planning, but there are many others throughout the standard.
Context of the Organisation
This is a new concept and relates to the external factors and conditions that could affect an organisation and its ability to provide products and services to customer requirements. Examples could include governance, regulation, sector, stakeholders and shareholders to name but a few.
There are enhanced requirements for top management to demonstrate leadership and commitment directly with the QMS.
Is a new term introduced to the high level structure, with a requirement to address risks and opportunities and to carefully plan changes within the management system.
This new section builds upon the 2008 requirements for competence and awareness (now extended to include persons under the organisations control, not just employees) and communication.
This section has similar requirements to the existing standard, but with a new emphasis on evaluation in addition to the monitoring, measuring and analysing requirements.
Sector specific changes
ISO 9001 is the base standard for sector specific standards including AS 9100 (aerospace), ISO 13485 (medical devices) and TL 9000 (telecommunications).
These are likely to be revised in the near future, although each industry oversight body (e.g. IATF and IAQG) will determine the change process.
How can we help
- Conduct a gap analysis on exisiting system
- Prepare a Project Plan
- Review your exisitng documentation
- Conduct internal audits