Featured Video
This Week in Quality Digest Live
Standards Features
Peter Merrill
People, processes, and technology need to be linked together for the QMS to be effective
Joe Bollard
And how to solve them
Dirk Dusharme @ Quality Digest
Critical components of a digital workplace, plus Hurricane Harvey forces us to look at risk management, infrastructure, and resiliency
DNV GL
It’s the people
Mike Richman
Hurricane recovery, tree-structure FMEAs, doing good for profit, and a vision sensor with vision system performance

More Features

Standards News
ISO 18295–1 and –2 include requirements for contact centers and for clients using centers services
3D CIC focuses on CAD collaboration and interoperability for the entire product life cycle
More than seven billion lives may depend on it
BYK-Gardner’s byko-spectra lite
Nominations accepted through June 30, 2017
The FDA’s RMAT designation goes live
Learn the same methods and techniques used by examiners; network with examiners and Baldrige staff members

More News

Paula Oddy

Standards

Getting Ready for ISO 9001:2015

A snapshot of the revised standard’s context, focus, and goals

Published: Tuesday, May 13, 2014 - 15:16

The 2015 version of ISO 9001 is still more than a year away from publication, but ISO/TC 176, the technical committee responsible for the standard, has been hard at work on the revision since 2012. Registrants to the current version, ISO 9001:2008, are wondering about changes to the language and intent of the revision, and the committee draft version, out since the middle of last year, offers some clues as to the shape the standard will be taking.

Goals

Although the revised standard will not change the current requirements, it will standardize the language as well as the approaches to management. The revision has several goals:
• Provide a stable framework of requirements for the next 10 years. Based on the introduction of eight major quality management principles:
1. Improved consistency with traceability
2. Enhanced customer focus
3. Focused leadership
4. The involvement of people
5. A system approach to management
6. Continual improvement
7. A factual approach to decision making
8. Mutually beneficial supplier relationships


• Be sufficiently generic, yet still relevant to all types and sizes of organizations, regardless of their industry or sector
• Maintain the present focus on effective process management to achieve the desired results
• Take into account changes to the practices and technology of quality management since the last major revision in 2000, such as:
—Barcoding systems for customer property control
—More comprehensive, integrated quality management system (QMS) software
—Quality manuals, procedures, and forms now in digital format
—Customer expectations of providing value to the audit, in addition to being a threshold for businesses requiring certification.
—Metrics for continual improvement that are now more evident in the process approach

• To reflect changes in the increasingly complex and dynamic working environment in which organizations operate, such as:
—Increasing cultural diversity of the workforce
—Customer demands for faster, cheaper, and better
—Increasing focus on environmental and safety within companies due to incidents and cost
—Leaner environment within management resulting in growth of multifunctional roles

• To apply the uniform structure, core texts, and definitions laid down in Annex SL of the ISO Directives (high-level structure) to ensure compatibility with other ISO management systems (e.g., ISO 14001)
• To simplify effective implementation in organizations and effective compliance reviews
• To use simple phrasing to ensure common understanding and consistent interpretation of the requirements

Terminology

ISO 9001:2015 offers many changes in terminology that are enlightening. As of the committee draft version, the word “product” has been replaced by “goods and services,” which recognizes the growth of the service industry, and allows users in those sectors to better adapt the standard to their unique requirements. The words “document” and “records” have been replaced with “documented information,” by which the new standard allows the organization to determine the issues, requirements, and expectations of the stakeholders that might affect the QMS. Finally, “continual improvement” has been replaced with “improvement.”

Other changes to the standard’s language are equally important. ISO 9001:2015 will address global and technological changes in the market, reinforcing a new risk-based sensitivity, and depart even further from the traditional ideas of command and control from a small cadre of top managers on down. Risk management, change management, and knowledge management are each given a sharper focus. The revision allows organizations greater flexibility and recognizes the need for businesses to integrate their QMS into the overall business strategy. Last but not least, the use of “simple” phrasing allows for a thorough understanding and consistency of the requirements.

All of this is important to top management at registered organizations as well as the auditors who certify or recertify users. Although better-defined language is important and makes the standard much more user-friendly, the language is less important than the intent: the method in which users employ ISO 9001 and the audits that come with it to improve their businesses.

Context

The standard’s structure has changed and now encapsulates 10 general divisions: scope, normative references, terms and definitions, support, performance evaluation, performance improvement, context of the organization, leadership, planning, and operation.

Practical changes will greatly improve its ability to provide a framework for quality management to registered users. For example, there are three new clauses that users will likely see in ISO 9001:2015:
• Clause 4.1—Understanding the organization and its context. The purpose of this new section is that the registered organization shall determine external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended outcomes of its quality management system.
• Clause 4.2—Understanding the needs and expectations of interested parties. Typical examples of relevant interested parties could be direct customers, end users, suppliers, distributors, retailers, and partners.
• Clause 4.4.2—Process approach. These requirements are more explicit. Specifically, the QMS will be built around processes where products or services are the output. A primary objective of meeting customer requirements is the key. The process approach in the 2008 version left many businesses unclear about the importance of this concept; 2015 will provide the exact requirements.

Focus

One of the key notions encompassed in the developing language of ISO 9001:2015 involves a more explicit definition of the “process approach.” An organization’s QMS must be built around processes where products or services are the output. The primary objective, and in fact the existential reason for these processes, is to meet customer requirements. The process approach as described in the 2008 version of ISO 9001 left many registrants confused about this requirement. The 2015 version will provide clarity and better guidance.

Summary

The bigger-picture conversation that we need to have involves the reasons that standards are updated in the first place. What value do users get out of these updated versions?

Creating or revising standards is a complex process involving a multitude of social, political, and economic inputs that drive the output: a standard intended to provide guidance to organizations facing specific issues within the market. In the case of ISO 9001, the issue is whether the registered organization has a QMS in place that allows it to create products and services that meet customer requirements. Yet even as simple and basic as that statement may be, standards must evolve. The realities of the fast-changing marketplace mean that even a standard that is written nearly perfectly at a specific moment in time can’t anticipate changes that might occur in the future.

Generally speaking, ISO 9001 is revised approximately every seven years; however, not all revisions are created equal. The 2008 version of the standard was not much changed from the 2000 version. The changes to this new version will be more far-reaching.

Much has changed in the world since 2008, not to mention 2000. The pace of technology and global communications has only accelerated, and ever-lengthening supply chains confer greater complexity and risk to every step in work processes. Manufacturers understand this very well, but companies in the service and transactional sectors are mindful of the increased risk that comes from outsourcing and offshoring, too. Thus, the new ISO 9001 will provide better insight into the nature of risk and how it can best be ameliorated.

ISO 9001 is the defining standard within the quality industry, and as such any new version is a major event. The broadening of the standard’s scope in terms of language and intent bodes well for those who will recertify or gain registration for the first time. As a means of guiding users toward better quality practices within their organizations, ISO 9001:2015 will be a major force for improvement and process excellence.

Paula Oddy is the technical manager at Intertek Group, a Quality Digest content sponsor.

For more information about the ISO 9001 standard, see the Quality Digest knowledge guide, “What Is ISO 9001:2015?”

Discuss

About The Author

Paula Oddy’s picture

Paula Oddy

Paula Oddy is the technical and quality management system manager at Intertek’s business assurance group. She has more than 25 years’ experience in the auditing and certification industry, with extensive quality management system experience with Entela and Intertek. Oddy is responsible for overseeing the technical review of audit files, qualification of auditors, and ongoing training. She holds a bachelor’s degree in industrial technology from Grand Valley State University with a concentration in quality science from Grand Rapids Community College.

 

Comments

Much Ado About Nothing?

According to the registration actors, the Standard won't be published until late 2015. For the time being only the CD is circulated and - although even in the recent history of ISO, Standards went never much away from their CD's - all too many a conjecture is made on the CD itself. QD itself has published a number of specific articles, last but not least the 10/09/2013 "Beethoven's Fifth and ISO 9001:2015 - An Expert's View", under my own signature. There'll be the usual transition period and - as I'm suggesting since years - registrars and consultants should better refer to ISO for interpretation.