ISO 9001:2015: archived draft and transition outlook

Archived pre-2015 draft commentary. Forecasts, proposed terminology and 2015–2018 milestones are retained as historical context, not current conformity guidance.

At the time this article was written, several anticipated structural changes could already be identified, as outlined below.

I. The proposed ISO 9001:2015 development schedule

Proposed development schedule: Publication was then expected during the fourth quarter of 2015.

1. December 2012: approve the draft for consultation.
2. April 2013: submit to the committee for comments and voting.
3. April 2014: Draft International Standard for ballot.
4. November 2014: prepare the final draft International Standard.
5. January 2015: final International Standard stage for voting.
6. September 2015: planned publication of ISO 9001:2015.

This schedule records proposals made before publication of ISO 9001:2015.

Document ISO/TC 176/SC 2/N 1147 indicated an anticipated three-year transition period, ending in the second half of 2018, for full implementation of the revised quality management standard.

The advice at that time was to prepare the resources and activities needed for the transition.

II. Structure of the ISO 9001:2015 draft

The structure of ISO 9001:2015 was expected to undergo several changesto align with other management system standards. The draft structure was described as follows:

1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organisation: understanding the organisation, the needs and expectations of interested parties, the scope of the QMS and the QMS itself.
5. Leadership: top management and commitment.
6. Planning
7. Support: resources, competence, communication and documented information.
8. Operation
9. Performance evaluation: monitoring, measurement, analysis and evaluation, internal audit and management review.
10. Improvement: nonconformity, corrective action and improvement activities.

Changes discussed at the draft stage

A new emphasis was risk-based thinking in managing quality within the organisation.

The interested-parties approach extended attention beyond customers to other relevant groups and aligned with management system standards then in use, including ISO 14001:2004 and OHSAS 18001:2007.

Organisations would need to identify issues and relevant requirements that influence QMS planning, consider risks associated with relevant interested parties, and determine appropriate actions within the system.

The revised edition was expected to strengthen the process approachthroughout the QMS. The earlier ISO 9001:2008 edition already used the process approach; the revision developed its application further.

At the draft stage, whether exclusions would remain possible was still under discussion. Consult the published standard for the final requirements.

III. Terminology changes discussed in the draft

Substantial terminology changes were anticipated. Draft document: http://www.globalcomplianceseminar.com/documents/standards/ISO-9001-2015-draft.pdf

Some commonly used terms were also expected to change. The proposals discussed included:

• Replacing “product” with “goods and services” to emphasise applicability beyond manufacturing. This was proposed draft terminology, not a quotation of the final standard.
• Using “improvement” more broadly than “continual improvement” to align with other management system standards.
• Using “documented information” to cover the concepts previously described as documents and records.
• Clarifying outsourcing as an arrangement under which an external organisation performs part of an organisation's function or process.

A management system is itself intended to support prevention, so a separate preventive-action clause was not expected. Requirements for nonconformity and corrective action would remain.

In planning quality objectives, organisations would need measurable objectives and to determine the actions, resources, responsibilities, timing and evaluation needed to achieve them.

Another topic discussed was the management representative. The draft-stage commentary anticipated a more integrated role, with a stronger understanding of operational risks, customer requirements, change and quality management principles. This commentary should not be read as a requirement in the final published standard to appoint a particular management representative.

Historical note

During the revision process, organisations were encouraged to prepare resources for the coming transition. Further clarification was expected in the final draft during 2015.