What leadership should know before coming face-to-face with a certification body auditor – by Jim Lee

Quality Managers should be happy about the new leadership and top management requirements in ISO 9001:2015.  It is now a requirement that the quality system be aligned with the company’s strategic direction; and the certification body auditors will be scrutinizing the company’s leadership for their involvement and support, beyond the management review meetings and establishing goals that support the quality policy. Those companies where the entire quality management system is placed solely on the quality manager are the ones that will feel the changes when the certification body auditors want to schedule time to talk with the executive team.

“Leadership” is one of the 7 quality management principles on which ISO 9001 is based and has been since the beginning of ISO. It’s now more enhanced with the phrases “top management” or “leadership” referenced 16 times, including Clause #5 titled “Leadership”.  Leadership at a variety of levels in the company should provide unity of purpose and direction, helping the company align its strategies, policies, processes and resources to achieve its goals. That’s a good quality system, and good business.

The company’s strategic direction (written or not) needs to encompass the quality management system.  This is accomplished through the new layout and requirements of the ISO 9001 standard for understanding context, the needs and expectations of interested parties, establishing the processes, setting the quality policy and establishing the objectives.  Are these really new requirements?  Maybe not, but there’s definitely more substance in the requirements to have top management involved and committed, and the quality system supported in the company’s strategic direction.

How will the third party auditors evaluate this when there are no requirements for a documented strategic plan, or a written context of the business, or documentation of who the interested parties are, or for managing risks? The auditors are going to have to talk to a lot of the management team to get a clear and reliable representation.  I wouldn’t be surprised if some auditors to set an agenda item to meet with the leadership team. They’ll want to see that the leadership is committed and connected to what’s happening in the business and whether the key processes of the quality management system are effective in meeting objectives. If not, then they’ll want to know that management is aware and taking actions to try to turn things around. They’ll want to learn where the risks exist and what’s being done about them, and how the leadership promotes risk-based thinking.

The hard part for the certification body auditors will be that some of them will have difficulty auditing when no documentation is required. That’s why your company needs a consistent and clear story when documentation doesn’t exist.

The majority of companies are already compliant with these requirements, but the leadership will be the ones that will have to answer third-party auditor questions to defend and justify what they’re doing.  As long as the leadership in your company is aware of the ISO expectations and can relate what your business does in answering the auditor’s questions, you will do fine.  I believe this will be the challenge for most of the executives who won’t know how to take credit for what they already do to satisfy ISO requirements, or don’t understand the auditor’s questions from ISO as it relates to their business.

Educating the leadership and helping them understand the new requirements and how you already comply will help them be able to speak the right message when asked about context, interested parties, risk-based thinking, or strategic direction.

Jim Lee is President of simpleQuE Inc., an ISO 9001:2015 certified company. SimpleQuE is a medium-sized  consulting, training and auditing company of quality management systems with a focus on “quality excellence made simple”.  Jim is an IRCA certified QMS lead auditor, a former IATF certified IATF 16949 auditor, and a former RABQSA certified Aerospace Auditor and has performed 3rd party audits in the past.

Sign Up For Our Newsletter

Space Coast Women in Defense Awards

At simpleQuE, we understand and believe in the importance of Science, Technology, Engineering and Math (STEM) as it is everywhere in our information-based and high-tech society.  These four cornerstones of knowledge shape our everyday experiences and even make the extraordinary possible; from talking on a cell phone to launching rockets into space.  Therefore we are especially honored to sponsor the upcoming Anniversary and Awards Reception for STEM Innovation hosted by the Space Coast Women In Defense (SCWID) to be held Thursday, January 28th.

scwidSCWID is a non-profit professional networking and development organization for women and men across Florida’s Space Coast who contribute to national defense and security. It is a chapter of Women in Defense whose mission is to foster education in the STEM fields in order to increase education before and during college. SCWID’s STEM Education Council strives to connect STEM needs with STEM resources from its partners including local industry, colleges and universities, civic leaders, parents, and students.

“Our association with SCWID not only promotes the areas and industries that simpleQuE currently serves, but the alliance strengthens our company’s resolve to continue to support STEM initiatives,” stated Jim Lee, President.  “While parents and teachers have an important role in encouraging students to study one or more of the STEM fields, companies also have an obligation and should create opportunities to engage and mentor young people so they’re excited about seeking advanced schooling.  Not only will it be beneficial to their future, it will be beneficial to the future of our industries.”

This year’s awards will be given to STEM innovators for their outstanding contributions.  Honorees include:

STEM Leadership Star of the Year: Mike Freeman

STEM Educator of the Year: Charles Parker

STEM Mentor of the Year: Nathan Pell

STEM Business Innovator of the Year: Harris Corporation

STEM Non-profit Innovator of the Year: National Space Club, Florida Committee

These influential teachers, mentors and organizations have impacted the lives of many Space Coast students of all ages, inspiring and expanding the interest and exploration of STEM fields.  simpleQuE is proud to sponsor this event which recognizes these innovators and the members of SCWID.  Congratulations and thank you for your dedication!

SimpleQuE Spotlight – Shirley Kennedy

20151107_144826 (2)It’s a new year and with it comes our latest simpleQuE Spotlight.  This month we are shining the light on simpleQuE Program and Marketing Manager, Shirley Kennedy. Shirley has had a successful career in a variety of roles, all of which have revolved around one simple word, service.  Here’s a look at our spotlight conversation with Shirley. Continue reading “SimpleQuE Spotlight – Shirley Kennedy”

SimpleQuE Forms Partnership With St. Petersburg College


SimpleQuE has formed a new collaboration with St. Petersburg College (SPC).  This collaboration will allow SPC to provide online self-paced learning courses covering the ISO 9001:2015 and ISO 14001:2015 standards.  Continue reading “SimpleQuE Forms Partnership With St. Petersburg College”

SimpleQuE Spotlight – Jen Briese

Our consultants are an integral part of our team, carrying out our mission of service to each of our clients. This month, we shine our spotlight on Jen Briese, who, according to Deanne Sparr, “…really cares about our clients and it shows. Her attention to their needs through daily on-site activities to the close details in her reporting and correspondence is always in a positive, helpful manner. She demonstrates the ‘Quality Excellence’ that we strive to provide to our clients.” Take a moment and read more about Jen and how she brings Quality Excellence to our clients.

Thinking back over your career, what is the professional accomplishment you are most proud of achieving and why?
There have been so many varied organizations over the years that it is nearly impossible to narrow it down to one single accomplishment. What does stand out in my mind is the different organizations that, through adopting either a complete or partial documented QMS, were able to satisfy unique customer demands which resulted in retaining customers and ultimately maintaining their workforce.

Client satisfaction is pinnacle to your background. What are your client-focused approaches at simpleQuE?
To treat every single person within an organization as your customer and strive to understand each individual’s needs while working towards the projects corporate goal.

What advice would you give to a new college graduate entering the technology industry?
Expose yourself to as many types of manufacturing, industry and management styles as possible early on in your career, preferably through a co-op experience. This allows you to know and understand how to adapt in any environment.
Explain how simpleQuE is different from their competition.
SimpleQuE has a straightforward, logical approach to QMS implementation that does not restrict an organizations progress.

Where do you see simpleQuE in the next five years?
SimpleQuE is a forward-thinking, progressive organization that will always be working to find a new way to help their customers easily adapt new requirements.

How would other people describe you in three words?
Energetic, compassionate, inquisitive

Deanne Sparr Promoted to Executive VP and COO at SimpleQuE

1bf49bbA transformational change is underway at simpleQuE and it evolves around the role of Deanne Sparr, who was lured to the company in 2014 following several years of active recruitment. After just 15 months, she has been promoted to Executive Vice President and Chief Operations Officer, which will allow simpleQuE to continue using her depth of experience in training, auditing and consulting services to help the company implement new systems and processes to handle significant growth.

Continue reading “Deanne Sparr Promoted to Executive VP and COO at SimpleQuE”

The Tech Revolution


With so many technological advances occurring at an exponential rate, it’s important to keep abreast of new technologies and industries that are impacting our society and businesses.  I recently represented simpleQuE at the Florida TechXpo sponsored by Melbourne Regional Chamber. Many companies shared their products and ideas: from unmanned vehicles and drones; to the Internet of Things and smart homes and factories; to artificial intelligence – not just in machines, but in humans merged with technology.  Imagine a world where humans will be able to download programs directly into their brains!

Continue reading “The Tech Revolution”