The Quality Connection

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As a consulting company, simpleQuE specializes in quality and environmental management systems and we are frequently asked what services we provide and how we are different from a certification body. This article explains the objectives, roles and responsibilities of the organization, consulting company and certification body to provide a better understanding of the connection between all three.

Organization (Manufacturing or Service Company)

Seeks to achieve one or more of the following objectives:

  • Implement and develop a new quality (QMS) and/or environmental management system (EMS)
  • Upgrade certification or expand to a new standard
  • Improve and/or simplify an existing QMS or EMS registration
  • Obtain certification

Consulting Company (simpleQuE)

Assists organizations with implementation, improvement or transition by:

  • Providing customized consulting, training and internal auditing services and solutions
  • Assessing existing processes through a gap analysis and developing an action plan
  • Offering internal and supplier audits
  • Training for internal auditors and management including implementation and full standard reviews

Helps organization partner with Certification Body:

  • Assuring a common language for auditing and interpretation of the standard so it corresponds with the expectations of the Certification Body and requirements of the standard

Certification Body (Registrar)

Issues certifications: Provides organizations a resource for management system certification by evaluating policies and procedures to verify implementation and effectiveness against the specific requirements of the standard.  Assessment consists of a series of audits:

  • Document review (sometimes combined with Stage 1)
  • Initial certification audit – Stage 1
    • Confirm that organization is ready (or not) for a full Certification Audit. Typically 30-60 days prior to the Stage 2 Certification Audit.
    • Verifies required documentation exists, certain requirements have been met such as a full internal audit completed, a management review completed, and risks considered.
    • Verifies processes have been established and is appropriate for the scope of certification, and that appropriate monitoring and measuring of processes are in place with appropriate objectives.
    • Plans the Certification Audit based on information and data gathered
  • Certification audit – Stage 2
    • A full QMS or EMS audit. Confirms that the management system fully conforms to the requirements of the standard.
    • Certification is issued upon successful completion of Stage 2 assessment and closure of any findings.
  • Surveillance audit
    • Certification is maintained through a series of annual surveillance audits (sometimes semi-annual). Every third year a full recertification audit is performed and a new certificate issued.

In summary, good communication between all partners is important to ensure all requirements and objectives are met in a simple straightforward way to comply with the standard. At simpleQuE we partner with the client and Certification Body to make quality excellence “simple”.

ISO Certification Instills Trust

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Obtaining an ISO certification is so important to businesses that many will specify the distinction next to their business name, and some customers and industries mandate it through the supply chain.  A client or potential business partner may ask why having an ISO certification is important.  Simply stated, an ISO certification means the client can trust a business and have confidence that  It has the processes in place that are independently audited, to improve the likelihood that products and services will meet or exceed customer expectations.

What is an ISO Standard?

ISO standards define and structure a company’s management systems. These standards apply to all industries and require businesses seeking certification to define how their systems meet the standards’ rigorous requirements. Meeting the standards assures customers that all vendor company activities – design, manufacturing, production, purchasing, quality control, packaging, handling, storage, shipping, and customer service – are appropriately managed and controlled.

Certification Builds Confidence

When a business certifies to an international standard, they are representing a trusted symbol of quality, safety, and compatibility. These standards are developed through a process that is balanced, open, and transparent and help elicit trust among the groups and businesses that have placed value in the certification process.

Building Trust with simpleQuE

There are several paths to obtaining ISO certification. A company can create its own documents and systems, then prepare for and manage their audit internally, or they can work with a specialist to provide consulting, auditing and training services to expedite the certification process.  It is important to note that actual ISO certification is the result of an audit conducted by an external registrar or certification body and not the International Standards Organization who develops the standards.

SimpleQuE’s consultants are experts in their respective fields and are ready to provide unique solutions that fit your specific needs. For more information on choosing an ISO consultant, visit simpleQuE’s YouTube channel.

Risky Business vs Risk-Intelligent Business

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Digitalization, globalization, competition and the speed of technological advances has changed the nature of business.  ISO 9001:2015 has been in effect for a full year and it places a heavy emphasis on using “risk-based thinking” for managing quality-related processes. Risk has always been implicit in ISO 9001.  But the latest revision asks organizations to make a cultural shift—rather than focusing on isolated problem solving and resolution, they’ll focus on prevention and performance improvement.

The International Organization for Standardisation (ISO) explains it this way:

“Risk based thinking ensures these risks are identified, considered and controlled throughout the design and use of the quality management system”.

Under the new guidelines, risk management serves as the cornerstone of quality management system design. As organizations determine the processes needed for a quality management system, they’re also asked to determine the associated risks and opportunities and to plan and implement appropriate actions to address them.

In the context of ISO, the concept of “risk” relates to the uncertainty in achieving the main objectives of International Standards—namely, to provide confidence in the organization’s ability to consistently provide customers with conforming goods and services, and to enhance customer satisfaction. Risk is the possibility of events or activities preventing an organization from achieving its strategic and operational goals.

This shift in thinking does not replace the standard’s process-oriented approach, but enhances it. While the process is still a critical part of ISO 9001:2015, processes must now be implemented with an acute awareness of risk.

Organizations are asked to identify, analyze and prioritize all potential risks as they undergo building or adapting their existing quality management implementations for updated certification.

Risks can be defined by two parameters—the severity, or seriousness, of the harm, and the probability that the harm will occur. Risks can be assessed based on the likelihood they will occur, the likelihood they can be detected, and potential impact should they occur. From there, risks are evaluated based on their importance (what is acceptable, what is unacceptable?) and actions are planned to address the risks, whether that’s avoiding or eliminating the risk or mitigating it.

Once plans are implemented, it’s essential for organizations to check the effectiveness of their actions and continually learn from experience.

What’s the best way to document risk-based thinking and demonstrate the approach during audits?. Evaluate how you evaluate risks today with the processes you have. Understand how you decide when risks are acceptable or unacceptable.  ISO wants to see that you record identified risks when action is required, and the action steps to be taken. 

Putting into place the Plan-Do-Check-Act (PDCA) methodology can be a great way to define, implement and control corrective actions and improvements. Companies should Plan what to do and how to do it, Do what was planned, Check that things happened according to plan, and Act on how to improve the next time around.

Companies have two years to make the transition to ISO 9001:2015, as certifications for the 2008 edition will expire after September 2018.

SimpleQuE was one of the first consulting companies to be ISO 9001:2015 certified and we’re ready to assist organizations with transition or implementation.  Please visit our website for more information about our services.

ISO/TS 16949 Certifications Across the Globe

 

ISO/TS 16949 is being adopted across the world and setting in place the quality management requirements for the design, development, production, installation, and service of automotive-related products. Take a look below at the world leaders in ISO/TS16949 certification.
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ISO 9001 Certification Changing the Standards for Higher Education

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More than 1 million organizations and companies worldwide understand the benefits of being ISO 9001 certified. Educational institutions are beginning to recognize the importance of established standards and are seeking certification, as well. As we enter the new school year, a these schools have taken the initiative and will start the year as ISO 9001 certified: Oakwood University, Greater Altoona Career and Technology Center,  DRS International School, and Wenatchee School District #246. Continue reading “ISO 9001 Certification Changing the Standards for Higher Education”

News Update from the International Automotive Task Force (IATF)

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In October 2016 IATF 16949:2016 will be published by IATF and it will replace the current ISO/TS 16949, defining the requirements of a quality management system for organizations in the automotive industry. It will be aligned with ISO 9001:2015 and its structure and requirements. IATF 16949:2016 will be implemented as a supplement to, and in conjunction with, ISO 9001:2015.  www.iatfglobaloversight.org

IATF has also released a new transition strategy document for automotive suppliers and certification bodies to help with the transition.  It includes information about timing and transition audit requirements. After October 1, 2017 no audits (initial, surveillance, recertification or transfer) will be conducted to ISO/TS 16949:2009. IATF Transition Strategy ISO/TS 16949 › IATF 16949

It is also important to note that IATF/IAOB will recognize TS certified companies that have upgraded to ISO 9001:2015 prior to IATF 16949 and allow reduced audit days when the company does eventually upgrade to the new IATF 16949 standard.  Companies should coordinate with their registrar to determine the optimal audit approach and cost benefit.  (Separate audits may be not be cost effective, but it will depend on each company’s situation.)

SimpleQuE consultants and instructors are ready to assist companies now with implementation, transitioning and training for ISO 9001:2015 and TS 16949:2009.  Consulting and training for IATF 16949 will be available after its release in October.  Contact simpleQuE

SimpleQuE Spotlight: Blake Russell

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What is your position and what do you do for simpleQuE?
Senior Director and I work with clients to implement and manage their ISO/AS Quality Management Systems and EMS Environmental Management Systems

What do you like most about working for simpleQuE?
simpleQue is an industry leader in providing ISO consulting and training services.

What is your greatest accomplishment – work or personal?
With my wife, we raised three beautiful daughters who are now intelligent, funny, and productive adults.

What is your favorite QMS standard and why?
ISO 9001 because I have worked with it for almost 30 years and understand how it improves a business.

What attracted you to SimpleQuE?
The leadership and their vision.

When you are not working, where can people find you?
Working around my home, exercising, mountain biking, and enjoying time with my wife.

What was your first job?
Ranch hand in Abilene, TX Continue reading “SimpleQuE Spotlight: Blake Russell”