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.

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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.

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

ASA AFRA Annual Conference 2018

The Aging Workforce and Transfer of Knowledge

At this year’s ASA/AFRA Conference, Mr. Boyd Parsons, GM Excellence of Air Canada Maintenance shared some tips on how ACM has addressed the labor shortage in the industry and efforts to attract and engage millennials.  Employee training is held to improve skills and satisfy regulatory and ISO/AS/ASA standards’ transfer of knowledge requirements. Organizations must take into account their aging workforce’s “tribal knowledge” and technological advances to effectively tailor their training programs. Companies could boost their training programs with increased industry awareness to high school students, college coop programs, apprenticeships, and internships in addition to on-the-job training knowledge transfer. A community of experience and evidence-based information sharing should prove to be effective to integrate a multi-generational workforce with advanced technology and traditional learning techniques.

Photo credits: Mr. Boyd Parsons, GM Excellence, Air Canada Maintenance

It’s Almost Here! – 2018 ASA/AFRA Conference

We are just a few days away from the 2018 Aviation Suppliers Assn. (ASA)/Aircraft Fleet Recycling Assn. (AFRA) Conference which begins Sunday, June 24th and ends Tuesday, June 26th. This conference is one of the largest for the aviation distributor industry and draws aviation professionals worldwide with a range of business development and management, quality assurance, legal/regulatory and general industry topics. We always look forward to attending this conference where we have the opportunity to interact with aviation professionals from around the world.

This year’s conference will be held at OMNI Scottsdale Resort & Spa at Montelucia and feature keynote speakers Robert Taylor, SVP Technical – Apollo Aviation, Jim Lundeen, Head of Supplier Support – Airbus Americas, and Adam Pilarski Ph.D., SVP – AVITAS. In addition to these keynote speakers, SimpleQuE President, Jim Lee, will be presenting three workshops, two for third party auditors (on Saturday prior to the conference). Topics include:

  • June 23 – 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.
  • June 23 – Auditor Training:
    This training teaches third party aerospace and ISO auditors how to audit quality objectives, which pulls in context, policy and strategic direction.
  • June 25 – Strategic Direction, Quality Policy and Quality Objectives: A Three-Course Meal of Quality Planning:
    This workshop covers the interrelationship between a company’s context, strategic direction, quality policy and quality objectives. It applies to companies trying to get certified to ISO or AS, or are trying to make their quality systems more practical.

Look for highlights from the conference next week on our social media platforms and in the coming weeks we’ll have our conference recap here on the blog where we will be sharing Jim Lee’s workshop presentations which will be available for download. Stay tuned!

The Advantages of Outsourcing Internal Audits

Business concept. Business people discussing the charts and graphs showing the results of their successful teamwork.

If your organization is certified to ISO 9001 or a standard that is aligned with it, like AS9100 or IATF 16949, and you perform audits internally, then you should know this:

This means that Certification Bodies are scrutinizing internal auditors and their competency, especially when it involves IATF.  That’s why many companies are choosing to outsource their internal audits to a 2nd party like simpleQuE whose auditors are qualified, certified, competent and are experts on the standards and customer specific requirements. In addition, many are current or former 3rd party auditors and bring valuable insight because of that knowledge gained from auditing for certification bodies.

Here are more reasons to outsource internal audits from our very own team of auditors (who have seen it all):

Why audits should not be done internally:

  • Without proper training and experience, internal auditors don’t fulfil the competency requirements
  • Lack of time to perform the audits and write reports
  • Reports with limited or no findings or objective evidence
  • No demonstration of the process approach or risk based thinking
  • Timeliness of management in responding to findings/report
  • Internal turnover resulting in too much variation in reporting/focus and overall quality of audits

Advantages to outsourcing internal audits

  • Fresh set of eyes from outside the organization that are objective and unbiased
  • Reduces company’s investment in continual training on changing requirements
  • Professional and timely reports
  • More cost and time effective, freeing up internal resources
  • Management gives greater attention to an outside expert, especially when there are sensitive issues that an inside auditor may be hesitant to address
  • Better internal response and acceptance of findings and opportunities for improvement
  • More content, findings, comments, opportunities for improvement and observations for added value
  • Our auditors have:
    • In depth knowledge of the standard’s requirements,
    • Experience in the field and can share best practices,
    • An understanding of the process approach and risk based thinking
    • The ability to provide consulting while auditing
    • Compliance to ISO 19011 on auditing management systems

All solid reasons for turning your audits over to the experts.  Contact us at 740-305-0868 or [email protected] for more information.

Lauren Manufacturing Achieves Quality and Environmental Management System Certifications

Congratulations!  Lauren Manufacturing (New Philadelphia, Ohio), a Lauren International company, received ISO 9001:2015 and ISO 14001:2015 (environmental) certifications from Eagle Certification Group.  Since 1965 the company has grown from a seal and gasket manufacturer to a sophisticated business supply partner for leading OEMs, engineers and builders and to industries around the globe including automotive, agriculture, window and door, HVAC, renewable energy, lighting and more.  With facilities in Ohio and Michigan, total quality management is the foundation of their entire organization. To ensure quality materials are used for every customer application, they mix and test their own materials on site. They also design and build process equipment in-house to ensure products are manufactured to exact specifications.  Lauren’s adherence to lean manufacturing principles prevents defects and maximizes value for their customers from product design to delivery.

In addition, the company is committed to environmental management requirements and complies with regulations by local, state and federal agencies.  With EMS risks and opportunities identified, Lauren’s leadership planned objectives to address them. Each objective has a responsible person or team assigned with action item plans for achieving the EMS intended results.  These objectives and targets were communicated across the organization and are monitored and evaluated for status/progress updates to ensure continual improvement of the EMS and enhance environmental performance.

To assist with the transition to the new ISO 14001 and ISO 9001 standards, simpleQuE consultants began working with Lauren in early 2017, providing a gap analysis and support in preparation for their external audit in November 2017.  Originally, the company which is currently ISO/TS 16949 (automotive) certified, had thought they would also transition to the new IATF 16949 standard.  However, due to the complexities and numerous requirements of the new standard, it was determined that Lauren Manufacturing could meet their automotive customer’s requirements with MAQMSR and CQI-19 audits and compliance.  SimpleQuE consultants continue to work with Lauren to meet those objectives and to ensure that their reputation is built upon trust, service, innovation and quality.