Are you ready to transition to ISO 9001:2015?

ISO 9001:2015 is here, are you ready? The ISO 9001:2015 standard was just released on September 15, 2015. The ISO 9001:2015 standard is the replacement for the ISO 9001:2008 Standard for business. ISO standards are reviewed for suitability and effectiveness every 5-7 years and the last update was in 2008, as expected the new version offers substantial differences from the previous version of the standard. The new certification will be based on Annex SL that brings a common structure to all management systems (QMS, EMS, ISMS) in order to ensure uniformity, align varying management system standards, apply a universal language across all standards (sections, texts, terms, and definitions), improve the communication with senior management,make it easier for organizations to incorporate their quality management system and increase the importance given to risk and risk management.

Transition Period

Organizations will have up to three years to complete the transition. ISO 9001:2008 certificates will expire in Sept. of 2018.  ISA will require all clients to complete the transition four months prior to the September 2018 deadline. Thus, all transition audits must be completed by May 1, 2018.

ISO 9001:2015 has a New Focus

The focus on quality management should not only be seen as a means to ISO 9001 certification, but a key to long-term success. This can be done by promoting Quality through all avenues and encouraging management to prioritize risk and opportunities and to look beyond compliance to a set of long-term requirements and best practices. There have been several “Major Changes” to the standard including a Greater Focus on Management Leadership. The “context of the organization” (internal & external contexts) must now be determined. Also, the “needs and expectations of interested parties” (i.e. customers and other stakeholders) now receives much closer scrutiny than before. Under the “Section 4.4 – Quality Management System”, the 4.4.2 Process Approach has been explicitly included as a requirement and is no longer implied. Risk Management is also explicit and replaces preventative action in sections 4, 5, 6, 8, 9, 10.

Annex SL replaces Guide 83

Annex SL is a new quality management system format which assists in the streamlining and creation of new management system standards. It further eases the process for businesses who wish to implement more than one standard in their organization.

Annex SL is a replacement for the ISO Guide 83. Guide 83 provided a foundational structure along with a standardized text for many management systems. Guide 83 was starting to address certiain complaints that many had when integrating current management systems standards such as ISO 9001, ISO 14001 and ISO 27001. These standards do have common elements, however, they are organized differently. The differences in the aformentioned standards made it difficult for organizations to implement multiple standards at once, thus providing the necessity for a different QMS Format.

“Annex SL” also creates a “template”, thereby further addressing many issues upon which management systems standards are to be built in the future.

First and formost Annex SL is written as a guide to those individuals and organization who write standards.

The core of Annex SL consists of:

  • 8 clauses and 4 appendices covering a “high level structure” (thus sharing high level concepts amongst differing standards)
  • Shared terms/definitions, shared clauses, titles and text.
  • Various “high level structures” covered by Annex SL include sections such as support, operations, leadership and planning.

Are you ready to upgrade to the new ISO 9001:2015 standard?

If you are ready to upgrade, please call ISA Registrar at (951) 736-0035, we are here to assist you with matters relating to upgrading and auditing of your current Quality Management System.