ISO/Draft International Standard (DIS) 9001:2014 and what is expected in ISO 9001:2015

The Draft International Standard (DIS) ISO 9001:2014 Quality Management System (QMS) is a precursor of the revised ISO 9001:2015 (scheduled for release in late 2015) and gives great visibility on what the final ISO 9001:2015 Standard will include.  What does the new ISO 9001 mean for organisations? Changes include:

Organisational Context. This requires organisations to determine the internal and external key stakeholders/interested parties, context, issues, and requirements that can impact on the planning and development of the Quality Management System (QMS). This is intended to provide the right focus, approach and balance to the different elements of the Quality Management System (QMS) structure and design of the Quality Management System (QMS).

Leadership. The requirements relating to the leadership role that senior management play in creating, supporting and maintaining an effective Quality Management System (QMS) have been enhanced. Senior management will need to demonstrate their involvement in and engagement with the Quality Management System (QMS) including accountability for the effectiveness of the Quality Management System (QMS).

Process-Based Approach. The Draft International Standard (DIS) ISO 9001:2014 contains many references across several clauses to organisations placing a greater emphasis on applying a process-based approach to their management system.
Risk-Based Approach. The Draft International Standard (DIS) ISO 9001:2014 requires a risk-based approach to planning, systems, processes and the extent of controls and performance/outcome monitoring. The requirements under a risk-based approach affect quality planning and now incorporate much of what was previously referred to as “Preventive Action”. Now organisations will need to determine the risks that need to be addressed to give assurance that their Quality Management System (QMS) can consistently achieve its intended results/outcomes and quality objectives.  Many organisations already have risk-based planning in many services and functions (eg, safety), but this may not previously have been connected to the Quality Management System (QMS). This greater focus on risk will mean that organisations will need to demonstrate how quality risk is managed. The extent of quality risk management needed in organisations will be influenced by the nature and risk of goods and services provided by the organisation.
Knowledge. Organisations will now need to consider and identify what knowledge is needed to achieve consistent standards and conformity of products and services along with how it will develop, maintain and retain such knowledge.

Control of Externally Sourced Products and Services. The requirements apply to both externally sourced goods and services that can potentially impact on the quality of an organisations end product or services. This has always been a requirement but now organisations will need to apply a risk-based approach and determine the type and extent of controls required over external suppliers and providers.

Moving from ISO 9001:2008 to ISO 9001:2015. Senior management in organisations should start the transition planning now, including setting and communicating a transition date with their consultants and certifying organisation. Also, we recommend that you make sure that senior management and internal auditors understand the differences that ISO 9001:2015 will bring to your Quality Management System (QMS). We suggest that you liaise with your consultants to conduct a gap analysis and training in ISO/DIS 9001:2014.