Life Sciences ISO 9001:2015 Revision
ISO 9001:2015 encourages increased external focus on quality management as part of its risk-based approach – work with SGS to transition to the new edition.
ISO 9001:2015 positions the new version of the standard as an integral part of an organization’s efforts towards sustainable development and promotes it as a tool for improving overall performance.
It encourages more internal and external stakeholder focus as part of the adoption of a risk-based approach to quality management and emphasizes the importance of adopting a Quality Management System (QMS) as a strategic decision for an organization.
We offer a suite of solutions to help you make the transition from the current ISO 9001:2008 certification to meet the requirements of ISO 9001:2015.
ISO 9001:2015 – the main changes
In addition to renaming and repositioning some QMS activities, other significant new requirements have been introduced.
Consideration of an organization’s context must now be an element of the QMS design and implementation process.
Risks and opportunities
A vital part of the planning and implementation of a QMS is a new requirement to identify the risks and opportunities that can potentially impact the operation and performance of the QMS, as well as the corresponding ‘proportionate’ actions to address them.
Top-level management is now required to demonstrate a greater direct involvement in the organization’s QMS, with a focus on ‘leadership’ rather than just management of the QMS.
The terms ‘documented procedure’ and ‘record’ used in ISO 9001:2008 have both been replaced throughout the ISO 9001:2015 by the term ‘documented information’. This is defined as information that is required to be controlled and maintained by an organization. It is up to each organization to determine the level and type of documentation necessary to control its own QMS.
Other QMS requirements
There are also other changes to QMS requirements, including:
- Proposed specific requirements for organizations in relation to the execution of a process approach when planning, implementing and developing a QMS
- Identification of the competence necessary for personnel doing work that affects its quality performance
- Identification and maintenance of the knowledge needed to ensure that an organization can achieve conformity of products and services
- A risk-based approach to ascertain the type and extent of controls suitable to all types of external provider
Structure and terminology
ISO 9001:2015 adopts the clause structure specified in Annex SL, which is now the required framework for all new and revised ISO Standards. The stated intention behind this is to ensure that the final version of ISO 9001 is aligned with other management systems standards.
By utilizing the Annex SL structure, it is intended to present QMS requirements in a more consistent, rational manner and not simply offer a template for the elements of an organization’s QMS.
It is important to note that for those organizations that already have an ISO 9001 compliant QMS, there will be no requirement to change their existing QMS procedure and document structure, or the terminology they use, to mirror that specified in ISO 9001:2015.
ISO 9001:2008 transition
Organizations that are already certified to ISO 9001:2008 will have three years from formal publication of ISO 9001:2015 to transfer to the new version of this standard. Based on the current publication schedule, this transition period would end in September 2018.
How can SGS help?
We provide training courses to help you understand the requirements of ISO 9001:2015 and risk-based thinking. We are the first professional learning and development organization to offer one-day courses as an IRCA Approved CPD.
Our experts can carry out a gap analysis against the requirements of ISO 9001:2015 to make the transition smooth and transparent. This exercise will provide your organization with structured assistance to highlight the extent to which existing systems and controls cover the requirements of ISO 9001:2015, or to identify an implementation action plan, where needed.
We will offer audit and certification against the requirements of ISO 9001:2015.
Contact your local SGS office today and start the ISO 9001 transition process.