A “simple” Way to Transition to ISO 9001:2015

SimpleQuE was one of the first consulting companies in the world to become ISO 9001:2015 certified, so we know what it takes to transition to the new standard. Utilize our expert consultants or gap checklist to guide you through the process.

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The simpleQuE consulting approach applies to companies getting certified for the first time, adding a new standard, or upgrading an existing certification.  For a customized quote and information, call 740-305-0868 or contact us by email.

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How Does ISO 9001 Affect the Bottom Line?

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ISO standards impact businesses, governments and societies worldwide in a powerful and positive manner by providing practical tools for sustainable development.  This sustainability is incorporated economically, environmentally and socially, but many business owners want to know how these standards will affect their bottom line.  Continue reading “How Does ISO 9001 Affect the Bottom Line?”

4 Aspects of a Better Business With ISO 9001

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Successful business leaders know that a good quality management system results in overall efficiency and improvement for the organization.  However, when there is a lack of consistent processes, inefficiency is inevitable.  Without uniformity, audit trails or accountability, it is difficult to identify and fix the gaps in the system, which can result in loss of time and money and not meeting performance objectives. Continue reading “4 Aspects of a Better Business With ISO 9001”

Congratulations G-NAC!

Photo from left: Cannan Christ - Management Rep., Jim Lee – SimpleQuE President, Toshikazu Mitsugi - G-NAC President
Photo from left: Cannan Christ – Management Rep., Jim Lee – SimpleQuE President, Toshikazu Mitsugi – G-NAC President

Congratulations! G-TEKT North America Corp. (G-NAC) achieved its ISO 9001:2015 certification! G-NAC enlisted the services of simpleQuE consultants, Don Milinkovich and Jim Lee to provide Quality System Implementation Support to prepare their office in Dublin, OH for certification, which they received through BSI.

G-NAC provides design and R&D services to automotive OEMS; and sales, new model design services and production equipment for the factories that manufacture automotive vehicle frame, transmission and engine components. What’s next for G-NAC? Over the next two years they’ll be working on IATF 16949 implementation for their new plant with ISO 14001 to follow after that.

G-TEKT has an environmental philosophy that places the highest priority on the conservation of the global and local environments. “As a member of the society responsible for passing on the green Earth to the next generation, it shall strive to both engage in environmentally considerate business activities and help conserve the global environment under the slogan, ‘The Earth is our shared resource’.”

G-TEKT sets a great example for responsible stewardship!

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.

Why Be ISO 9001:2015 Certified?

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ISO certification can bring a host of benefits to your organization, these include the following:

  • Client Requirements – More and more customers are demanding that their vendors be certified. If your business doesn’t meet this criteria you could be losing out on sales.
  • Increased Revenue – Studies show that ISO 9001 certified organizations are paid 7% more on average, have better sales growth and an improved ROA. (source: iso.org)
  • Reduce Waste – By establishing the rigor of an ISO 9001 Quality Management System, you can reduce inefficiency and make the most of your business’ time and resources.
  • Brand Image – Maintaining quality in your organization minimizes the chance of a slip up or error that could hurt your reputation.
  • Manage Risk – ISO 9001:2015 is all about managing risk. By adopting these standards you will learn how to best identify and mitigate threats to your business model.

Add to your training with a 100 Day Learning Action Plan

When it comes to training, we are firm believers in experiential learning – using actual company examples versus canned case studies.  People learn and retain more, by using this proven method for retention.  To improve retention even more and to help drive culture change, simpleQuE offers a 50 and 100 day follow-up program to our training courses. See the details below.
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As a training company we wanted to go beyond lecturing, and provide systems and processes to help improve competency for what is learned and assist with tools to help with culture change.  As you know, we can’t change a company’s culture, that has to be done from within, but we do have the tools to help facilitate culture change when it is necessary.  Call 740-305-0868 to learn more.

ISO 9001:2015 Approved – What Now?

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It’s official! The ISO 9001:2015 standard was approved internationally and will be released September 23, 2015. Companies will have a transition period of three years to update their management systems in order to continue their ISO 9001 certification. Beyond September 2018, organizations that are not certified against revised standards will cease to be ISO certified.

With this approval come the questions about what requirements have changed. This informative table provided by the ISO organization spells out the correlation from ISO 9001:2008 clauses to ISO 9001:2015, and visa-versa. It highlights where the new, revised and deleted clauses can be found and includes the areas that are unchanged.

ISO9001:2008 vs. ISO 9001:2015 Cross Reference Guide

At SimpleQuE, we have developed an expedited approach to implement the 2015 changes based on lessons we have learned from historical changes to the standard. There will be two service offerings in the coming months to help with the process.

We will be offering FastTrack, a collaborative, roundtable of several companies to help you gain even further insights and benchmarking techniques from others as you go through this process This four month program for upgrade teams or individuals will involve one day per month for 4 months, allowing organizations to prepare and complete their upgrade to ISO 9001:2015.  This offering will be held in various cities around our region based on interest. Stay tuned to our website and social media platforms for more details.

In addition, SimpleQuE will be offering the ISO 9001:2015 Gap Analysis checklist as a tool to identify compliance with the differences between ISO 9001:2008 and ISO 9001:2015.  This completed checklist would be a supplement to existing ISO 9001:2008 internal audits, since this checklist does not show requirements that are currently contained in ISO 9001:2008. This checklist alone cannot show evidence of compliance with ISO 9001:2008 and ISO 9001:2015, it is only for additional requirements in ISO 9001:2015 that are above and beyond ISO 9001:2008. Click here to see more about purchasing this checklist.

If you would like more information on the revised standards and how your company can begin implementing the changes, please contact us at [email protected] or 740-305-0868.

What Do You Need to Know to Implement ISO 9001:2015?

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As the leading training source for ISO 9001, among other standards, we are excited to offer a training course for companies and their teams who are implementing ISO 9001:2015 and working toward upgrading from 2008, or obtaining certification or compliance for the first time. Join us in Cincinnati, Ohio on September 11 to get informed on the changes between ISO 9001:2008 and ISO 9001:2015 Continue reading “What Do You Need to Know to Implement ISO 9001:2015?”