The main changes in the new version of ISO 9001:2015 are:

i)                The adoption of the HLS as set out in Annex SL of ISO Directives Part 1.

ii)              An explicit requirement for risk-based thinking to support and improve the understanding and application of the process approach.

iii)            Fewer prescribed requirements.

iv)             Less emphasis on documents.

v)               Improved applicability for services.

vi)             A requirement to define the boundaries of the QMS.

vii)           Increased emphasis on organizational context.

viii)         Increased leadership requirements.

ix)             Greater emphasis on achieving desired outcomes to improve customer satisfaction.

Relevant interested parties who may benefit from guidance documents:

·       Organizations certified and/or using ISO 9001:2008.

·       Accreditation Bodies (ABs).

·       Certification Bodies (CBs).

·       Training bodies and consultants.

TRANSITION: The International Accreditation Forum (IAF) and the ISO Committee on Conformity Assessment (CASCO) have agreed to a three year transition period from the publication date of ISO 9001:2015.

Validity of certifications to ISO 9001:2008: ISO 9001:2008 certifications will not be valid after three years from publication of ISO 9001:2015. The expiry date of certifications to ISO 9001:2008 issued during the transition period needs to correspond to the end of the three year transition period.

Organizations using ISO 9001:2008 are recommended to take the following actions:

i)                Identify organizational gaps which need to be addressed to meet new requirements.

ii)              Develop an implementation plan.

iii)            Provide appropriate training and awareness for all parties that have an impact on the effectiveness of the organisation.

iv)             Update the existing quality management system (QMS) to meet the revised requirements and provide verification of effectiveness.

v)               Where applicable, liaise with their Certification Body for transition arrangements.