On company visits, Carmine Liuzzi says people will occasionally clean off the quality manual before they give it to him. If you have a 50-page quality manual that needs dusting, the ISO 9001: 2015 standard may help. The revision draft does not call for a quality manual, says Liuzzi, vice president of training and improvement solutions at SAI Global, which means companies can decide how to implement quality.
The latest changes build on a history of almost thirty years of ISO 9001.
The first version came out in 1987. From there, the 1994 version included very minor revisions.
In 2000, the concept of quality management principles was introduced. In 2008, there were minor changes.
The future of your quality management system is being debated now. As I write, the ISO 9001: 2015 standard is being hashed out at a meeting in Lithuania. The draft international standard received more than 3,000 comments from around the world. The group will look at these comments, address them, and create a final version.
The revision will be released in September. Learn what to expect from the new version, what is changing and how you can prepare.
What to Expect
Alka Jarvis has been the chair for the US Technical Assistance Group to ISO TC 176 for nine years and with the group for 18 years. She is the lead delegate for the United States to the International Standards Organization committee responsible for the ISO 9000 family as well as a distinguished quality engineer at Cisco Systems. Not only has she helped develop the standards, but she has implemented them and seen the results.
One of the biggest changes to ISO 9001 is the structure of the document, Jarvis says. The standard will use the Annex SL structure in order to have the same template as other standards.
In addition, Jarvis says the terminology is changing. In the past, the word “product” was used, but now it changes to “products and services.” Manufacturers must now determine who their customers are as well as the other people that will be affected by their products and services.
How Manufacturers Can Prepare For The Transition to ISO 9001: 2015
ISO 9001 was designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service. ISO 9001 deals with the fundamentals of quality management systems, including the eight management principles upon which the family of standards is based. However with the advent of ISO 9001:2015 upon us, it is clear that the paradigm regarding quality is changing as words and phrases like “Risk-Based Thinking,” “Leadership” and “Evidence-based Decision Making” make their way into the forefront of strategic business planning.
The new ISO 9001:2015 moves the subject of management systems into the boardroom. While this will be a cultural change, it is also a great opportunity for the enterprise leaders to improve their business overall.
Transition is an opportunity – What do you need to do?
1. Take a completely fresh look at the QMS
a. Map out where you are today, where you need to be
2. Attend a one–day transition course to understand the differences
3. Highlight the key changes as opportunity for improvements
a. This provides the opportunity to take a fresh look at your organization from an enterprise level and improve your business as a whole.
4. Make changes to your documentation to reflect new structure
a. By using the process approach, major changes may not
5. Implement new requirements on leadership, risk and context
a. Top management must show how they ensure the management system achieves its intended outcome(s) and how they direct and support persons to contribute to the effectiveness of the management system and promote continual improvement.
b. An organization must understand all the inputs and outputs i.e.; the context in which it operates and address the internal and external aspects that make up that context.
c. Risks and opportunities are the main elements of uncertainty, which can affect the business overall for better or for worse. The basic premise of risk based thinking is to reduce, control and eliminate occurrence upstream.
6. Review effectiveness of current control set
a. Performance evaluation is a more critical part of the process and also where ROI is measured. Policies and procedures for monitoring with the proper metrics, measuring, analyzing and evaluating the management system are addressed. Decisions should be data driven.
7. Assume every control may have changed
8. Carry out an impact assessment and plan accordingly with a good detailed project plan and assign owners for accountability.
— John DiMaria, BSI Group. For more complete information on the ISO 9001:2015 changes and transition, please visit here.
The new standard says companies must identify the relevant needs and expectations of interested parties. Jarvis, who used to work at Apple, uses the iPhone as an example. Apple didn’t ask customers if they wanted an iPhone—they just came up with it. When customers saw it, they realized it was something they didn’t know they wanted. “This is what ISO is talking about,” Jarvis says.
Risk is another commonly discussed topic in the standard. In the past, the term used was “preventive action.” This focus on risk-based thinking means more thinking about risk upfront. In other words, “change your process so those risks are not encountered at all,” Jarvis says.
Liuzzi says most people are concerned with the requirements relating to risk-based thinking. “If you look at the standard it’s gone from worrying about product quality to high-level, how do I run a business?” Liuzzi says. He says the standard is asking people to complete the next step in business management, and the intent is to continue to be useful to businesses.
To that end, Liuzzi also points out that there is no longer a specific requirement for quality manuals. He says people might ask “Does this mean I need to throw mine away?” “If it’s 50 pages long and you’re not using it? Yes.”
But he said a brief manual could help companies show new people where to go to get additional information. He mentions a LinkedIn discussion over whether or not a company could have a one-page quality manual. He thinks it could be done. Plus, as Liuzzi says, “A lot of people are going to read one page.”
The Changes Ahead
The 2015 version calls for companies to establish, implement and maintain a quality management system, but also improve it. For example, companies should consider external issues—such as waiting for a steel shipment or dealing with winter storms—that might affect their business.
One potential issue could be outsourcing. Outsourced products are addressed in the revision. As manufacturers outsource material they are using, they must meet certain guidelines.
The new standard also shifts the emphasis from training to organizational knowledge.
Basically, in addition to training, companies should be sure they are keeping current on the industry.
While previous versions mentioned a “management representative,” that term is now gone from the standard. But the responsibilities previously outlined for this position remain.
“The leadership of the organization can take their rightful ownership of the management system since it is how you run a business,” Liuzzi says. He points out, “This isn’t an extra thing we do every day, or something done at 3 p.m. on a Friday.” The idea is: “How do you use this to achieve value in your business?”
A Look Back
The latest changes build on a history of almost thirty years of ISO 9001. The first version came out in 1987. From there, the 1994 version included very minor revisions. In 2000, the concept of quality management principles was introduced. In 2008, there were minor changes.
But, as Jarvis points out, consider the technology landscape that has changed between then and now. “I would consider it a major change because of the format,” Jarvis says. “If you are a company that is already very attuned to quality and quality principles, 2015 will not affect you at all. ISO 9001: 2015 is just the foundational standard for quality. In order for the company to really improve further, they must go beyond ISO 9001: 2015 and do Six Sigma or the Baldrige award.”
She adds that the ISO principles were developed as a foundation, the minimum a business should do to run successfully.
Jarvis has been involved in the ISO community for decades. It all started for her twenty years ago when ISO was gaining in popularity. She worked at Apple and decided to take a class on her own to learn more about it. She became a lead auditor, began teaching ISO classes at a university, and then wrote a book about ISO 9001-3. Since then, she has written seven books.
But her work as quality engineer continued alongside all of this. “My background is not just standards only,” Jarvis says. “It’s: How do we take the standards in real life to make them work?”
With her experience of working at a large company, she can see how implementation works firsthand. “That’s where it is value-add for me,” Jarvis says. “I can see the development side and the implementation side also. If you walk the walk, you understand what needs to change with the standard.”
The Next Steps
As you consider the changes to the standard, what should you do next?
Lorri Hunt, owner of Lorri Hunt & Associates, is a member of the US technical advisory group (US TAG to ISO TC176) and an expert to Working Group 24, the international group editing ISO 9001 as well as head of delegation for ISO TC 176/SC2, the sub-committee responsible for ISO 9001. She says companies should get a copy of the final draft international standard, do a gap analysis and sketch out an implementation plan. She also encourages certified organizations to contact their certification body to see how they will be handling the transition and planning.
“The things people ask the most is: when do I have to transition?” Hunt says. Companies already certified to 2008 have three years after the standard was published.
In 2000, Hunt was part of one of the first companies to transition—“I wanted to be one of the first,” she says—and says the company she was with had a very mature quality system.
However, the ease of the transition process may vary, she points out. “It depends on what your current quality management system looks like,” Hunt says. For some companies it will be a breeze while other companies may have more of a struggle.
“Those who just want the certificate may find they are having to do a little bit more,” Hunt says, “because of a greater emphasis on the output of the quality management system.”
Although some might wish the standard referenced today’s technology more, Hunt points out that that approach may miss the point. “The goal is to write a standard regardless of what changes,” Hunt says. “It’s meant to be timeless. When you start using buzzwords in a standard you can quickly become outdated. Jargon may or may not be there in three to four years, so you have to make sure the standard is generic enough.”
And for future revisions, you might want to consider getting involved. Being on the committee provides a good perspective on understanding the standard, Hunt says. “You don’t speculate on what the requirement means. You’ve sat in the room and discussed it and understand the intent.”
For those who have worked on the standard, the latest version is something to be proud of.
“I really do believe that 2015 is an excellent standard provided that you are in it to get results out of it, not just for certification, not just for the audit,” Jarvis says. “You will see that it does give you benefits. It is not the only standard, if you want to go beyond, you will need other quality management tools to implement on top of it.”