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

The diagram below records the proposed development schedule discussed in the original article. Publication was then expected during the fourth quarter of 2015.

Based on document ISO/TC 176/SC 2/N 1147, the article anticipated a 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 discussed in the article was risk-based thinking in managing quality within the organisation.

The article discussed interested parties, extending attention beyond customers to other relevant groups. It also related this approach to the management system standards then referenced, 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, the article reported uncertainty about exclusionsand speculated about whether they would remain possible. This was a draft-stage view, not a statement of the final published requirements.

III. Terminology changes discussed in the draft

The article anticipated substantial changes to terminologyand referred readers to the 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.

Forpreventive action, the article explained that 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

The original article was written during the revision process and encouraged organisations to prepare resources for the coming transition. It described developments then in progress and anticipated further clarification in the final draft during 2015. The forecasts are retained here as historical context.