QMT Features: June 2015
Focus on ISO 9001:2015
Dr David Scrimshire* gets to grips with the changes to the ISO 9001:2015

When ISO 9001:2015 is released this September, organisations will have three years to implement the changes required to their Quality Management Systems (QMS). This sounds like a long time, but it’s never too early to plan for a change of this magnitude. Leaving it to the last minute would be a very risky strategy indeed.

As with all management system standards (MSS), ISO 9001 is reviewed periodically to ensure that the standard continues to meet the needs and demands of interested parties. What’s particularly different about the current review is that the new standard will adopt the new HL (high level) structure laid down in Annex SL of the ISO/IEC Directives, Part 1 – Consolidated ISO Supplement – Procedures document.

Previous MSS differed in structure, terminology and requirements, and this has led to confusion and difficulties in the way they’re implemented. Annex SL (previously known as ISO Guide 83) overcomes these difficulties by imposing a generic management system structure with a common high level structure, identical core text and common terminology and core definitions for use in all MSS.

Individual MSS will add further “discipline-specific” requirements as required, provided that these additions do not affect harmonisation or contradict or undermine the intent of the high level structure. A major consequence will be the development of integrated management systems which will address multiple disciplines (e.g. quality, environmental, etc.).

This article focuses on the next revision of ISO 9001 to help organisations fully to exploit the opportunities offered by the adoption of a visual, process-based approach. The following commentary is based on the recently published ISO 9001:2014 Draft International Standard and addresses the key changes only.

Summary of key ISO 9001 changes

The new ISO 9001:2015 standard will make risk-based thinking more explicit and incorporates it in requirements at all stages of the QMS. Clauses 4.1 and 4.2 are new, relating to the context of the organisation, which require organisations to determine the issues and requirements that can affect the planning and development of the management system.

As anticipated, the MSS requirements make the adoption of a process approach an explicit requirement (clause 4.2.2) across all disciplines.

In order to remove the existing bias towards organisations dealing with physical commodities the MSS has adopted the term products and services (i.e. products and services intended for, or required by, a customer).
It is important to emphasize that organisations are not required to follow an identical clause-by-clause sequence when defining their quality management system, and they are encouraged to use the process approach when describing and documenting their unique systems. This should decrease the emphasis on documentation and re-focus on delivering value to the organisation and their customers. Be careful though – there are still more than 30 mandatory requirements for maintaining and retaining documented information which can refer to traditional ‘documents’ and ‘quality records’.

There is no “exclusions clause” as such, but the “scope requirement” (Clause 4.3) must clearly state when a requirement cannot be applied, and justification for this.
The recent revision of the Quality Management Principles (QMPs) has led to a change in ISO 9001:2015 of one of the principles from “continual improvement” to just “improvement”.

Preventive action as a requirement has been replaced with “risk-based thinking” as outlined above, and the need to understand risk in the context of the management system. The rationale behind this is because one of the key purposes of a formal management system is to act as a preventive tool, therefore ‘preventive action’ is addressed throughout the development and implementation of the quality management system.
Clause 5, previously “Management Responsibility”, now becomes “Leadership” so an organisation’s top management are required to demonstrate that they engage in key QMS activities, as opposed to simply noting they happen! All references to the role of “management representative” (aka the Quality manager) have gone, to encourage embedding of QMS into routine business operations.

The phrase “externally provided products and services” replaces “Purchasing” to underline the fact that the new standard is applicable to all suppliers – not just those that provide physical products. Clause 7 termed “Support” introduces a new clause 7.1.6 “Organisational knowledge” which requires that organisations take steps to capture and preserve knowledge and learning, which is necessary for the effective operation of their processes and for ensuring their products and services conform in the future.

Clause 8.1 “Operational planning and control” requires the organisation to plan, implement and control its processes needed to meet product or service requirements. It must additionally plan how it will address any risks and opportunities that may impact these processes and, therefore, its ability to achieve these requirements. This could be addressed by Advanced Product Quality Planning (APQP) or Project Management.
Both 8.3 “Design and development of products” (if contained in the organisation’s scope) and services and 8.4 “Control of externally provided products and services” retain their own specific requirements while 8.5 “Production and service provision” defines the requirements for actually producing the product or delivering the service.

9.1 “Monitoring, measurement, analysis and evaluation” requires an organisation to define what needs to be monitored, and how to collect the necessary information. 9.1.3 “Analysis and evaluation” requires the organisation to analyse data to provide inputs to management review.
10 “Improvement” requires that organisations proactively look for opportunities for improvement and then implement the necessary actions.

Next steps
It is essential that companies think about their “purpose”, and focus on external and internal issues that need to be addressed so that they can agree on a “strategic direction”. Start by agreeing on Mission and Vision statements and then set “Values” to define how their company operates. This will help in articulating goals and targets, and how the company intends to achieve these goals – which will be documented in the Quality Policy and quantified in Quality Objectives.

Rather than volumes of narrative-base procedures (that nobody every reads – let alone complies with!) companies must now think “process” and should adopt a visual approach to the documentation of their quality management system (QMS). Their QMS will then be a system of value-added activities, performed by their relevant. ‘owners’ and ‘users’, to purposefully achieve the common business goal – i.e. their strategic direction, Quality Policy and Quality Objectives.

These processes are critical to any company as they generate revenue and often represent a significant proportion of costs! The ‘process approach’ considers processes to be a company’s strategic assets that must be understood, managed, and improved to deliver value added products and services to customers.
As there will be a 3-year transition for ISO 9001:2015 certification – let’s get it right first time, and exploit the benefits offered by the new requirements.
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