It needed to change to become more compatible with service organisations and non-manufacturing users. And with the ever-complex environments organisations now operate in, there is a clearer understanding that ‘one size does not ﬁt all’.
There are four key concepts that organisations should be aware of when implementing the ISO 9001:2015 requirements:
- Organisational context
ISO 9001 now expects a stronger emphasis on an organisation’s context. This means organisations must now determine what the relevant external and internal issues are and then demonstrate these are relevant or aligned with the organisation’s strategic direction.
A greater emphasis is on leadership in ISO 9001:2015 now requires top management to be directly responsible and therefore, accountable for their management system. Top management can no longer delegate the responsibility to a management systems representative.
- Process approach
As with the 2008 standard, there is a focus on a process-based approach, but ISO 9001:2015 has strengthened this focus and it has become more explicit. Although the structure has changed the Plan-Do-Check-Act (PDCA) cycle is still very much at the heart of the management system standard.
- Risk-based thinking
The concept of preventive action has now been addressed throughout the standard by risk identiﬁcation and mitigation and there has been an increased emphasis on seeking opportunities for improvement.
This article provides some practical guidance and advice for those who are responsible for implementing a quality management system to ISO 9001:2015 requirements.
Read Next: ISO 9001 Requirements - Context of Organisation