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”.

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ISO 9001 Certification Changing the Standards for Higher Education

Stack of hardback books and Open book lying on bench at sunset park against blurred nature backdrop. Copy space, back to school. Education background. Toned image.

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

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.

ISO/TS 16949:2016 Will Be Out By Year-End

Gearbox cross-section, automotive transmission with sprocket and bearing mechanism for commercial trucks, SUV, cargo, and construction vehicles, selective focus ** Note: Shallow depth of field

The new ISO/TS 16949 standard is due out in December 2016, per the IATF (International Automotive Task Force) http://www.iatfglobaloversight.org. The first draft is completed and they are obtaining additional input, while also planning to complete some pilot gap assessments worldwide to refine the new TS standard and associated Rules by July of this year. This will give IATF time to finalize and publish the new standard by year-end.

What are the changes we can expect to see to address some of the automotive OEM issues?

  • New requirements for safety-related parts and processes (i.e. airbags, tires, brakes, inspection/testing, etc.)
  • Enhanced product traceability requirements to support new laws and changes to regulations
  • Requirements for products with embedded software (i.e. engine control modules, emission control software, change control, etc.)
  • Warranty management process including addressing NTF (no trouble found) and use of automotive industry guidance (AIAG CQI-14)
  • Clarification of sub-tier supplier management and development requirements (based on risks, it may be necessary to manage sub-suppliers, not just direct suppliers. Also, clause 7.4.1.2 from the beginning of TS has always had FAQS and/or Sanctioned Interpretations to allow deviations from this TS clause)
  • Addition of corporate responsibility requirements (i.e. ethics, risk management and so much more is published in various ISO documents and guidelines on social responsibility – ISO 26000 as an example,  or social accountability – SA8000 commonly used outside the US)

We don’t know the extent of these requirements, but just know these new concepts are being added to the TS standard.

The timeline to upgrade to the new ISO/TS 16949:2016 will be September 14, 2018, less than 21 months after publication of the standard.  Certification bodies will require some time to train their auditors and get approved to issue certificates to ISO/TS 16949:2016, so the transition time will be tight.

 

Want to learn more? Click here to view the certification transition plan.

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 ISO/TS 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!

The AS9100:2016 Transition Timeline

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Certified companies to AS9100C will need to upgrade to AS9100D from when their certification body can begin issuing certificates (sometime late in 2016) through June 14, 2018. This should typically coincide with a scheduled surveillance or recertification audit. A special audit can also be scheduled and paid for. You should plan your upgrade based on this transition timing window and when your audit cycle falls.

Internal Auditor Training class for ISO/TS16949:2009

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This course is designed to meet the specific needs of your company in fulfilling the ISO/TS 16949 and Customer Specific requirements for competent, knowledgeable, and well trained internal auditors and includes hands-on development of key processes, audit planning, and internal auditing exercises. The course was developed by a former president of a registrar, former owner of an accreditation body, certified auditors, and portions of this training have been used by multiple registrars for training their auditors to the process approach. Continue reading “Internal Auditor Training class for ISO/TS16949:2009”