The international standard for quality management systems, known as ISO 9001, is currently being revised and is scheduled for release in late 2015. Are you ready for the changes? How do the changes affect you?
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NQA, a globally recognized certification body, is preparing, and we’re sharing with you by presenting a series of roadshows across the United States in 2015.
The changes to the content of the current 2008 version are considered to be significant. The first—and only—time such a significant change was made to the bestseller of ISO’s standards, was in 2000, and little planning and preparation guidance was made available in the months leading up to the release. In fact, no one had experienced implementing such a significant change to ISO 9001 since its first publication in 1987. Up till then changes had been “evolutionary” in nature, and even variations in the predecessors to ISO 9001—a variety of national and military procurement standards such as MIL-Q-9858A—were limited because each document stated, in fundamental terms, the same things.
We know that the changes to ISO 9001’s requirements are going to present some significant challenges because the accreditation bodies that oversee the certification bodies (and their processes) have allowed currently certified organizations a transition period of three years to adjust to the revised standard. Furthermore, unlike during the months leading up to the ISO 9001:2000 release, certification bodies are now required to have their own plan for ensuring the certification process is maintained.
Currently, the revision process has reached the Draft International Standard (DIS) stage. Can we anticipate what the content of ISO 9001:2015 will include? For a start, the standard is going to be structured differently. It has adopted an internal to ISO standard format known as “Annex SL.” It’s a bit like the International Organization for Standardization’s (ISO) own “procedure for procedures.”
Annex SL includes the following major sections:
1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of QMS
4.4 Quality management system and its processes
5. Leadership
5.1 Leadership and commitment
5.2 Quality policy
5.3 Organizational roles, responsibilities, and authorities
6. Planning for the QMS
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7. Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
8. Operation
8.1 Operational planning and control
8.2 Determination of requirements for products and services
8.3 Design and development of products and services
8.4 Control of externally provided products and services
8.5 Production and service provision
8.6 Release of products and services
8.7 Control of nonconforming process outputs, products, and services
9. Performance evaluation
9.1 Monitoring, measurement, analysis, and evaluation
9.2 Internal audit
9.3 Management review
10. Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
Some of the most obvious changes are the inclusion of “products and services” and “risks and opportunities.” What won’t be so obvious is that there are no longer requirements for explicit documentation types, including procedures and a quality manual. Instead, the term “documented information” is used, which includes records. Another significant and apparent omission is the requirement for “preventive action.” This often misunderstood requirement has been replaced, for the most part, by the inclusion of the “risks and opportunities” section. The addition of the term “risk” is subject to much debate as to what might be done to address this requirement and what an auditor will expect a client to demonstrate. Happily, NQA’s Roadshows include a presentation on risk and opportunity.
As part of NQA USA’s plan for transition, we’re providing communications through a variety of media, including social media such as Facebook, Twitter, and LinkedIn, as well as having a number of our technical staff members traveling to venues across the United States and Canada in a roadshow of live presentations to clients, consultants, and anyone else interested in what the new standard has in store. These one-day events will be structured to provide a number of informational “tracks” covering a variety of topics based on the changes to ISO 9001, including the potential effects on specific industry standards, such as AS9100 for the aerospace/defense supply base.
NQA’s roadshows are planned to include:
2015 standard revision overview. A high-level overview of changes that will be included in ISO 9001:2015, ISO 14001:2015, and AS9100:2016. Also includes an introduction to the new ISO High Level Structure (Annex SL), updates on current status of versions, and certification transition timelines.
Using risk in a management system setting. With the publication of ISO 9001:2015, risk becomes critically important in the development, implementation, and maintenance of management systems. This presentation will interpret the meaning of risk within a quality management system and provide ideas for how organizations can integrate the concept into their management systems.
Standard revisions: Preparing for changes in your system. Preparing for the 2015 revision is as easy as plan-do-check-act! This session looks at how your existing quality management system can provide the tools to ensure a smooth transition to the next generation of ISO 9001:2015.
Practical workshops. In the workshops, led by one of NQA’s managers, we’ll be reviewing and discussing the new ISO 9001 and ISO 14001 requirements in detail.
For more details or to sign up for one the events, visit NQA’s 2015 ISO Transition Roadshow page.
Andy Nichols is the East Coast regional sales manager at NQA, a Quality Digest content partner.
Comments
Transition time
Is the 3 years transition time on this occasion longer than usual? What was the previous time?
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