John J. Knappenberger is president and CEO of the ANSI-ASQ National Accreditation Board (ANAB), located in Milwaukee, Wisconsin. His primary focus at ANAB is to ensure the value and credibility of its accreditation and to focus those two attributes toward building third-party accredited certification into a force that yields business results for all who use it. In this exclusive interview, Knappenberger discusses the upcoming revision to ISO 9001:2015, the reasons for the revisions, important changes to the standard, and what auditors should be doing now to prepare for the new standard’s release in 2015.
What does ANAB do and why does it matter?
ANAB accredits certification bodies that audit and issue certificates of conformance to ISO 9001 and other management system standards. Although management system auditors and those who work with standards are often familiar with the work we do, this tends not to be the case with the average consumer and even many company CEOs. We like to draw the analogy that you wouldn’t want to be treated by a doctor who isn’t board certified or send you child to a college university that isn’t accredited. Like those accrediting bodies, we conduct audits to make sure the certification bodies we accredit are following international standards and are competent to do their work.
ANAB is just one part of the ANSI-ASQ National Accreditation Board, which also provides accreditation services under the ACLASS and FQS brands for calibration and testing laboratories, forensic testing laboratories, inspection bodies and forensic inspection agencies, reference material producers, proficiency test providers, and medical laboratories and medical examiners.
All of these accreditation services we provide play an important role in ensuring the safety and quality of goods and services and in protecting the environment. The work we do helps facilitate international trade and eliminates the expense of redundant audits and test results.
How is ANAB preparing for the upcoming release of ISO 9001:2015?
ANAB is in a watching and preliminary planning mode but until the standard is closer to FDIS we are doing nothing more.
Based on what we know about the draft of the ISO 9001:2015 standard, what if anything should organizations be doing now to prepare for the release of the standard?
I believe most people would not want to eat a half-baked cake, yet many are “eating” a draft ISO 9001:2015. I recommend the old saying “Ready, aim, fire,” and to that end, I recommend that companies wait to do anything with the new standard until it is at least into the FDIS phase. On the other hand, I suggest they do everything they can to improve their current management systems to maximize their business results. This includes meeting customer requirements and enhancing customer satisfaction, as that will definitely be in line with the new ISO 9001:2015 standard.
The draft of the ISO 9001:2015 standard is significantly different than the current version of the standard. Why is ISO making such a radical change to a standard that’s in use by more than a million organizations around the globe?
The ISO 9001:2015 revision intent as stated was the following: maintain relevance, integrate with other management systems, provide an integrated approach to organizational management, provide a consistent foundation for the next 10 years, reflect the increasingly complex environments in which organizations operate, ensure the new standard reflects the needs of all potential user groups, and enhance an organization’s ability to satisfy its customers.
The following was considered in developing the standard: results of an extensive web-based user survey, the increasing diversity of the ISO 9001 users, developments in knowledge and technology, broader user interests, and changes in industry.
ISO 9001:2015 is built on Annex SL, a common framework for management system standards. Why is it being used and do you think its use is causing unnecessary changes to the standard?
The primary driver for Annex SL was feedback from industry that ISO should help by communizing across all standards to allow for an integrated approach to organizational management.
What do you think the biggest change(s) will be for organizations that are already registered to ISO 9001:2008?
Based on what I see in the draft, there are three over-riding focal points and six significant changes.
The three over-riding focal points (which have been included in previous versions but are more prominent in the draft revision) are (1) to provide confidence in the organization’s ability to consistently provide customers with conforming goods and services and to enhance customer satisfaction, (2) to achieve business results, and (3) to focus on the company’s processes and related results, as opposed to simply conforming with each element of the standard.
The six significant changes in ISO 9001:2015 are:
- Risk-based thinking
- Context of the organization
- More generic requirements to make it easily applied to the service industries
- Less prescriptive
- Changes in technology (proposed: documented information from control of documents and control of records)
- New ideas (proposed: organizational knowledge; removal of preventive action and add actions to address risks and opportunities; and change from outsourcing to control of external provision of goods and services)
What should auditors—both internal and external—do to prepare for the release of ISO 9001:2015?
I suggest that all auditors evaluate what and how they are currently auditing and focus on improving their skills in three areas. The first is process auditing. Second is to hone their skills at leading each auditee toward business results of conforming products and services that meet customer expectations and enhance customer satisfaction. Third is to understand and get involved in what the U.S. TAG, under ASQ’s secretariat, is doing to help draft the new standard to make it the very best it can be for all stakeholders. For everyone in the United States, this is the main method to influence the standard’s outcome.
Are there any new requirements for auditors in ISO 9001:2015?
Is there anything else you’d like to add?
With the release of ISO 9001:2015, it will be more important than in the past for everyone to obtain and read ISO 9000, the companion standard on QMS fundamentals and vocabulary. I believe this standard is read and used infrequently, but it provides a key part of the knowledge required in term of terms and definitions to understand ISO 9001.
Check out ANAB’s website at www.anab.org.