ISO 9001:2015 is more compatible with other management systems, such as ISO 14001, making it more effective and efficient to integrate management systems.
There are changes to the:
- structure - which follows the ten section structure defined in Annex SL.
- key concepts
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.
High level changes to all management system standards - The most significant changes expected in the 2015 standard are in Clauses 4, 5 and 6, i.e. Context of the organization, Leadership and Planning, but there are many others throughout the standard.
Context of the Organization
This is a new concept and relates to the external factors and conditions that could affect an organization and it’s ability to provide products and services to customer requirements. Examples could include governance, regulation, sector, stakeholders and shareholders to name but a few.
Tip: The context will influence the type and complexity of management system needed.
There are enhanced requirements for top management to demonstrate leadership and commitment directly with the QMS.
Tip: Top management is expected to be “hands on” and to ensure that the quality policy and quality objectives are consistent with the overall strategy and context. This is new territory for ISO 9001 audits (NOT NECESSARILY), and more audit time is expected to be devoted to discussions with the organizations leaders.
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.
Tip: Risks and opportunities, for example, could relate to the use of electronic systems within the management system. Introducing such systems would require change and transition arrangements, which should be planned within the management system.
This new section builds upon the 2008 requirements for competence and awareness (now extended to include persons under the organization’s control, not just employees) and communication.
Tip: With the increasing use of outsourced providers, this requirement reminds organizations that this resource must be managed effectively just as internal providers are managed.
This section has similar requirements to the existing standard, but with a new emphasis on evaluation in addition to the monitoring, measuring and analyzing requirements.
Tip: Evaluation is the interpretation of results and analysis. Processes may be well defined and effective, but do they yield optimum results? This may be a new challenge for internal audits.
ISO 9001:2015 is expected to be much less rigid than previous versions, and to incorporate more business management terminology and concepts. Documentation requirements are much less prescriptive and left more to the organization to judge its own needs.
The standard is written for the benefit of organizations, not auditors. There are likely to be more challenges to auditors to understand and recognise the extent and type of evidence that would be acceptable to confirm compliance to the 2015 requirements.
ISO 9001:2015 auditors will be engaging in dialogue with business leaders, seeking understanding and explanations from them about policy, strategy and quality objectives, and ensuring these are compatible.
The audit experience from the client perspective is could be very different. Systems should be updated to benefit the user, not the author!
HOW WE CAN HELP YOU
You will need to prepare for change and adapt your quality management system to meet the new requirements and transition timelines. With NQA as your partner we will help you to understand the changes, interpret the new concepts and act on the implications. The following offer additional information on the ISO 9001:2015 standard:
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