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What is ISO 9001 Certification and Why is it so Important?

The ISO 9001 standard exists to provide organizations with the opportunity to develop baseline quality management systems, improve processes and meet the needs of customers. Achieving ISO 9001 certification is an important step for manufacturers and service providers, as it emphasizes performance while proving a dedication to quality and customers.

As ISO 9001 certification has been adopted across a wide range of industries, the standards have been altered to fit specific industry requirements. From the automotive and aerospace industries to telecommunications companies, laboratory settings, medical device manufacturers and more, each industry has adopted its own set of standards that all derive from the basic principles of the ISO 9000 series.

What are the Benefits of ISO 9001 Certification?
There are a variety of advantages to having ISO 9001 certification. It creates a more efficient, effective operation for a company, if implemented properly, and also improves employee awareness and motivation, and increases customer satisfaction. Here are some additional reasons to get ISO 9001 certified:

  • 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.

Most importantly, as your company grows, becoming certified is vital to fostering continued success in the future.

SimpleQuE – ISO 9001 Certification Experts

SimpleQuE (an ISO 9001 certified company) assists organizations with implementation, improvement or transition of the standards by providing customized ISO 9000 consulting, training and internal auditing services and solutions. Contact us for more information or to hire an ISO 9001 consultant.

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Rolling Out ISO 19011:2018 – Guidelines for Auditing Management Systems

Administrator business man financial inspector and secretary making report calculating or checking balance. Internal Revenue Service inspector checking document. Audit concept.

ISO 19011:2018 was released in July, and the new revisions have truly transformed the contents of the standard. The changes, including most significantly a new risk-based auditing approach, recognize the importance of managing risk in any management system, as well as the marketplace.

ISO 19011 provides guidelines for auditing management systems, enabling effective auditing across multiple systems at the same time. The document offers guidance regarding:

  • The principles of auditing
  • Managing an audit program
  • Conducting management system audits
  • Guidance on evaluating the competence of those involved in the audit process, including the managers, auditors and audit teams

It can be used by any organization that needs to conduct internal or external audits of management systems, including 2nd party and supplier audits.

The new standard revision puts an increased focus on risk – a Principle of Auditing has been added into Clause 4, and a series of new sub-clauses emphasizes the standard’s new risk-based approach principle, including calls for consideration of risk and opportunities when performing an audit and managing the audit program.  

Auditors are now advised to employ a Risk Based Approach, an audit approach that considers risks and opportunities. This risk-based approach, according to the new language, should “substantively influence the planning, conducting and reporting of audits in order to ensure that audits are focused on matters that are significant for the auditee and for achieving the audit program objectives.”

This Risk Based Approach joins Integrity, Fair Presentation, Due Professional Care, Confidentiality, Independence and Evidence Based Approach as ISO 19011’s expectations.  Your certification body will want to see your knowledge of the new standard, implementation plans and timing for your company to adopt this new approach to your internal audits.

Other revisions to the standard include:  

  • Additional guidance on managing an audit program
  • Expanded guidance on conducting an audit
  • An expansion of the generic competence requirements for auditors
  • Adjusted terminology to reflect the process and not the object
  • Removal of the annex providing competence requirements for auditing specific management system disciplines
  • An expansion of Annex A to provide guidance on auditing new concepts such as organizational context, leadership and commitment, virtual audits, compliance and supply chain.  

SimpleQuE’s auditors have extensive training and experience and follow ISO 19011’s guidelines for conducting audits, can you say the same for your auditors?  Contact us for more information about training your internal auditors or outsourcing your audits.


SimpleQuE Attends Toyota’s 2018 Power of Exchange

Diversity drives Toyota which is why simpleQuE’s VP, Deanne Sparr, is at Toyota’s 2018 Power of Exchange – a unique supplier diversity and development conference for diverse businesses. This is a targeted networking event to gain and share knowledge and build relationships with current Toyota Tier I Suppliers like Dana Incorporated. Dana has 100+ facilities and 29,000 employees in 34 countries making it one of the world’s most influential automotive suppliers.

Over the years, a relationship was developed with Dana and in 2013 simpleQuE won the opportunity to perform IATF 16949:2009 internal audits for the Dana site in Auburn Hills, MI. That opportunity has expanded to now include internal audits and/or IATF 16949:2016 transition consulting at 10 more Dana facilities in OH, PA, IN, TN and KY. Seven of the eleven sites have already successfully transitioned to IATF 16949!

At simpleQuE we like to challenge what looks to be impossible and make quality excellence “simple.”


What is the Return On Investment of a Quality Management System?

3D illustration of a magnifying glass over a golden positive chart symbol. Concept of investing opportunities and excellent investment.

Your company could have many motivations behind implementing a quality management system (QMS) such as ISO 9001. But in the end, making the decision to invest in a QMS always comes down to potential for profit, and an organization’s quality performance absolutely affects the bottom line. That’s why it’s essential to understand the return on investment for a quality management system.

First, the term “quality” extends far beyond an organization’s products or services. Every process and system in an organization, whether a manufacturing, distribution or service industry, can meet quality objectives and expectations. And once an organization applies the quality concept to its entire management system and all of its processes, then the effect on bottom line will really be noticeable.

Here are a few benefits of a certified quality management system that make a financial impact.

  1. Quality management systems can help reduce manual processes, which means there’s less of an opportunity for human error. In the end, this translates to greater employee productivity.
  2. Your leadership team will have access to real-time reporting, which means they can make better, more informed decisions. Getting that real-time data means less downtime overall.
  3. Improving the processes and increasing efficiency means production can go more effectively. The end result is higher production yield.
  4. A QMS provides consistent quality control, leading to fewer product defects and/or service complaints. And ultimately, this means you’ll see fewer complaints, returns, reworks and escapes.
  5. Being more compliant with ISO 9001 (or any of the other QMS standards) means more satisfied customers, and you’ll see more sales, new sales and referral sales.

Quality does have a cause-and-effect relationship with finance – consider the simple economic equation of income minus expense equals profit. Therefore, either increasing income and/or decreasing expense increases your profit.

Investing in “good” quality systems can increase income in many different ways, including attracting more customers, encouraging repeat business and giving your organization a competitive advantage. Meanwhile, it can also lower your expenses by lowering production costs by streamlining processes, lowering inspection cost, and lowering working capital through reduced inventory. So even when factoring in the cost of implementing and maintaining a QMS, the numbers show that you’ll come out ahead by investing in quality.


Congratulations!

These ISO 9001:2015 certified companies recognize the value of implementing and maintaining a Quality Management System. Congratulations from our team at simpleQuE to your team, we’re pleased with your success and to have provided consulting services along the way!

Batesville Products, Inc. – ISO 9001:2015

From Left:  Trevor Bovard, Plant Manager and Matt Scholl, Purchasing Agent

BHC (Brulin Holding Company) – ISO 9001:2015

BHC Office Staff

BHC (Brulin Holding Company) – ISO 9001:2015

BHC Plant Staff

Silfex – ISO 9001:2015

Quality Team


Associate Spotlight – Kimberly Roan

We are excited to introduce one of our newest team members, Kimberly Roan, a simpleQuE consultant.  Kimberly brings not only years of experience, but a great curiosity and drive to find the best solutions for our customers.  Here’s more on Kimberly:

What is your position and what do you do for simpleQuE?
I am a consultant for simpleQuE and I consult with clients, perform internal audits, and teach on site training on automotive QMS topics.

What do you like most about working for simpleQuE?
This is an opportunity to make a difference.  Every day I get to help clients identify issues and improve processes.  Sustained process improvements lead to greater customer satisfaction and improved effectiveness and efficiency in the organizations we work for.

What is your favorite QMS standard and why?
My favorite QMS standard is ISO 9001:2015.  This standard builds the foundation of an effective QMS and is the cornerstone for a series of important industry QMS standards.

What attracted you to simpleQuE?
Top managers who understand QMS development and believe in simple, sustainable, and value added quality management solutions.

What expertise do you bring to simpleQuE’s clients?
I spent 17 years in automotive and was always involved in auditing both first and second party and spent many years participating in 3rd party audits and acting as the management rep. If I could draw you a picture, I would show you a pyramid that includes a 17 year work experience – base, and approximately 8 year formal education – middle, and a 3 year certified auditor – crown. The large sections of the pyramid underpin everything I knew to make me an effective auditor. With this balanced experience I can provide clients with answers from a company management perspective, an internal auditor perspective and a third party auditor perspective. Every day I use the whole pyramid but the biggest part of it will always be my work experience.

What was your first job?
My first automotive job was part time administrative assistant for an engineering team at Saturn.  My first job ever was doing office work for a neighbor in direct sales at the age of 12 to 13.

Have met…
John Glenn, in an elevator at a Marriott hotel.  We talked about Harley Davidsons and how he wouldn’t get one now because he promised his wife he was done with high risk activities.

Where did you go to college?
Baker College of Flint for my Mechanical Engineering degree and The Chicago School of Professional Psychology for a Masters in Psychology with an emphasis in organizational leadership.

What is your hometown?
Cadillac, MI

Would love…
To visit the hometowns of my great grandparents in Germany.

My hidden talent is…
Slow racing my VT1100

What is your favorite sports team?
Let’s go Red Wings!!!

What advice would you give to a new college graduate entering the technology industry?
Learn something new every day and do something good with what you learn as often as you can.

Explain how simpleQuE is different from their competition.

SimpleQuE is different because they focus on simple solutions to meeting complex QMS requirements.  The company supports a value added approach to meeting requirements.

Where do you see simpleQuE the next five years?
SimpleQuE will grow to become the leading QMS consulting firm and they will continue to support the success of their clients.

How would other people describe you in three words?
Independent, tenacious, and helpful.


Matching NASA Suppliers with Small Businesses

A blue planet earth in outer space

In 2017, NASA spent over $2.7 billion with small businesses – 16.5 percent of its total contracting budget. NASA is looking to expand its small business contracting even further by seeking new partnerships with a wide range of goods and services providers at a two-day conference where simpleQuE President, Jim Lee, is attending.

Hosted by Ohio University’s Voinovich School of Leadership and Public Affairs, “Reaching High – Aerospace Business Matchmaker,” takes place July 17-18 at Ohio University in Athens, Ohio and is a partnership between NASA and Procurement Technical Assistance Centers in Ohio, West Virginia, Pennsylvania and Kentucky.

Jim is learning directly from NASA officials about the goods and services the agency needs and how businesses can qualify as vendors.  Aerojet Rocketdyne, SAIC, and STG are all prime contractors, these and other NASA suppliers have indicated they want their suppliers ISO 9001 and/or AS9100 certified.

On the second day of the conference, Jim and other businesses will have the opportunity to meet with representatives from NASA, as well as other agencies from all levels of government and NASA prime contractors, to learn of the contracting opportunities in aerospace industry services.

These opportunities will be available to businesses in a large variety of industries, providing good and services including:

  • Mechanical and electrical engineering
  • IT infrastructure services
  • Building maintenance
  • Medical services
  • Office supplies and equipment
  • Office administrative services
  • Testing laboratories
  • Apparel
  • Security and much more

For a complete list of buying opportunities, visit http://AerospaceMatchmaker.com.


How Aircraft Manufacturers Are Reducing Environmental Impact

By Jim Lee

 

At the annual ASA / AFRA conference in June, we heard Kahina Oudjehani, Head of Eco-Design and Environmental Affairs at Bombardier.  She shared Bombardier’s environmental strategy through the entire lifecycle of an aircraft to improve the company’s environmental footprint.  A significant environmental impact occurs with aircraft design and we learned of some examples on the CRJ100 regional jet design as seen with these attached slides.

Reducing aircraft weight by redesigning components is another significant impact to improving the environmental footprint by using less raw material in parts, less energy and water in making parts, reduced weight to improve fuel efficiency, and selecting materials that can be recycled and reused, or repurposed. Congratulations to Bombardier on their efforts and recent recognition by Canada for its sustainability and eco-design approach applied to the C series jet.

As a technology geek, I’ve learned of aircraft design initiatives which utilize artificial intelligence and supercomputers with 3-D printing (or additive manufacturing).  Airbus analyzed the stresses and loads on a product, then utilized 3-D printing and some wild new algorithms based on slime mold and bone growth. Slime mold naturally creates a strong, efficient structure between two fixed points, and other algorithms are used to create bones and implants for reconstructive surgeries.  Combine these algorithms to calculate and determine the most efficient designs, which result in structures a human couldn’t conceive.  Then creating those designs with 3-D printing result in what Airbus calls bionic 3-D printing.

https://www.airbus.com/newsroom/news/en/2016/03/Pioneering-bionic-3D-printing.html

As Bombardier and Airbus have demonstrated, implementing environmental sustainability or ISO 14001 correctly, can yield positive financial impact while improving the environmental footprint. SimpleQuE can guide you on the path to ISO 14001 certification.  Contact us for more information.


All Access Pass to AS9100 and ISO 9001 Training Presentations

SimpleQuE President, Jim Lee, presented at three workshops in June during the 2018 Aviation Suppliers Assn. (ASA)/Aircraft Fleet Recycling Assn. (AFRA) Conference.   Jim is making all three presentations available to anyone with an interest in the topics described below. To obtain a PDF and prezi link to these presentations, just click on the links for immediate access.

 

Strategic Direction, Quality Policy and Quality Objectives: A Three-Course Meal of Quality Planning:
The interrelationship between a company’s context, strategic direction, quality policy and quality objectives are covered in this presentation.  An emphasis is placed on the core business processes being consistent with the quality processes, so that the business direction and quality direction are the same, including the objectives.  This information applies to companies that are working toward, or are already certified to, ISO 9001:2015, AS9100D, AS9110C and AS9120B.  This is geared to help companies better understand the requirements and expectations for practical compliance, instead of cumbersome quality systems – making certification easier to obtain and maintain.

http://bit.ly/ASA2018QualityPlanning

 

Operational Risks – Third Party Auditor Training:
Third party aerospace and ISO auditors will learn how to understand and audit operational risks (clause 8.1.1) in the aerospace standards (AS9100D and AS9110C) versus risk management (clause 6.1) in the ISO 9001 and AS9120B standards.  This training emphasizes the issues and risks the aviation, space and defense customers see from their suppliers and sub-tier suppliers as it relates to product safety, counterfeit parts, obsolescence, awareness and communication of SR/CI/KC (special requirements, critical items, and key characteristics), flow downs to suppliers and sub-tier suppliers, supply chain risk management, human factors, and ineffective change control.  With an added awareness of the aviation, space and defense customer risks and issues, third party certification body auditors are better prepared to dig deeper into the industry risks and issues to create better value for all affected.

http://bit.ly/ASA2018OperationalRisks

 

Auditing Quality Objectives – Third Party Auditor Training:
This presentation teaches third party aerospace and ISO auditors how to audit quality objectives, which can’t be done effectively without understanding the company’s context, strategic direction, and quality policy.  The clauses are reviewed for all the ISO 9001:2015, AS9100D, AS9110C and AS9120B standards as it relates to these requirements.  The IAQG desired third party auditor emphasis on quality objectives and the significance of the performance outcomes are also examined.  The gaps between certification body audit results, top-tier internal audit results, and DCMA government audit results are covered as it relates to the risks and issues the aviation, space and defense customers are seeing from their suppliers and lower-tier suppliers.

http://bit.ly/ASA2018AuditingObjectives


Congratulations to Meteor, FireCraft Safety, American Micro, and Pentair

Congratulations from our team at simpleQuE to the companies that have worked so hard to earn their certifications!  It was a long road, but worth all the meetings, training, internal audits, updating of procedures and documents, and conversations about quality and risk.  We’re proud to have played a part in their successful transition/implementation to these quality standards.

FireCraft Safety Products – ISO 9001:2015

Photo from left – Toni Gill, CFO; Tom Lochner, President; Tom McCoy, Director of Sales; and Don Milinkovich, simpleQuE Consultant

Meteor Sealing Systems LLC – IATF 16949:2016

Photo from left – Thorsten Conrad, Vice President – Meteor Sealing Systems LLC;  Masahiko Ito, Managing Director – Toyoda Gosei Meteor GmbH; Deanne Sparr, Vice President – SimpleQuE; Ryan Ayers, Quality Manager – Meteor Sealing Systems LLC

American Micro – AS9100:2016 and IATF 16949:2016

Photo from left –  Matt Gilbert, QE;  Evan Smartnik, QE;  Sheila Floyd, Purchasing Supervisor;  Michael Shelton, Process Engineer; Ryan Siebe, Production Manager;  Rob Berger, Production Supervisor;  John Woods, Engineering Manager;  Kevin Neal, Quality Manager;  Harold Williams, Production Supervisor;  Greg Stamper, Production Supervisor;  Rita Gragg, SQE

Pentair – ISO 9001:2015

Photo from left – Peggy Jones, Quality Manager; Gregg Swint;  Dave Christine;  Matt DeHart;  Kayla Smith; Ed Henricksen