The Benefits of Working with a Management System Consultancy

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Ultimately companies hire a management consultancy firm like simpleQuE to save both time and money. Working with experienced professionals can help businesses achieve their objectives quickly and avoid costly mistakes along the way. And thanks to their specialized knowledge, quality and environmental management consultants can help innovate, improve and enhance organizations at every level.

Businesses of all sizes seeking to outperform their competitors and stay at the top of their industry are increasingly choosing to work with QMS and EMS consultants. When selecting a consultancy, they’re looking for someone who can provide tangible results and a clear return on investment. The best consultant-client relationships are based on clarity and transparency, where both parties have set clear roles and expectations and put in place a system to effectively measure results.

Management consultants help organizations improve their business by analyzing their systems and processes and developing plans to help them improve. Whether it’s preparing for first time certification, upgrading to a new standard, simplifying cumbersome quality systems and documentation, or defining processes and process mapping, simpleQuE can help.

Each management consultancy offers different specializations and simpleQuE’s consultants are proven experts in their respective fields. We bring experience from all sides of the table—third party auditor, business owner, management representative, implementer, facilitator, project manager, etc.—in areas including general manufacturing and service, automotive, aerospace, environmental and safety.

After performing a gap analysis, we offer customized solutions for each client we work with. Our strength is in evaluating and understanding your business and culture to find the solutions that will be most efficient and sustainable over time. We’re known as the consultant that simplifies ISO implementation and maintenance.  And simpleQuE is even ISO 9001:2015 certified – proof that we practice what we preach.

No company is exactly the same, and every company’s needs for certification are unique as well. At simpleQuE, we tailor our approach closely to your specific needs and deliver exactly the consulting, auditing and training services your company requires. Our approach eliminates confusion and ensures your company is investing only in the work that is required for certification. Contact us to see how we can add value to your business!

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Quality + Certification = Success!

SimpleQuE congratulates the following companies on their successful certification and commitment to quality.

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SimpleQuE (an ISO 9001:2015 certified company) assists organizations with implementation, improvement or transition of these standards by providing customized consulting, training and internal auditing services and solutions. Contact us for more information.

The History of AS9100

Once again, the IAQGs AS9100 standard has undergone a new revision. The latest version of this standard adds requirements for product safety, counterfeit parts, formal processes for operational risks, awareness, and ethics and human factors. Read more about the journey this pivotal standard has taken over the years.
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Don’t forget, June 15, 2018 is the final transition audit deadline for the new AS9100 standard. Learn more by viewing our transition timeline.

IATF 16949:2016 Transition Q & A from IAOB

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Cherie Reiche, program manager for International Automotive Oversight Bureau (IAOB) recently presented at Eagle Certification Group’s June Boot Camp to discuss progress of the IATF 16949 transition and the unique intent behind some of the new requirements.   While no FAQs or SIs have yet been published for IATF 16949:2016, Cherie shared some of the common questions that IAOB and IATF members have received for interpretation and clarification from Certification Body automotive auditors.

Must both ISO 9001:2015 and IATF 16949:2016 be used when conducting audits?
Answer:  Yes, as it states in the IATF 16949 Foreword – Automotive QMS Standard, IATF 16949 is not a stand-alone standard, it must be used in conjunction with ISO 9001:2015.

Will the IATF be granting waivers for those organizations who cannot meet the transition plan timing?
Answer:  No, there are no plans to approve/grant waivers.  If the organization does not complete their transition audit in a timely manner (including allowing time for Non Conformance management and CB certification decision), then the organization will lose their certification.  IATF 16949 certificates are not valid past their expiry or September 14, 2018.

Is IATF 16949, Section 4.4.1.2 related to product safety during manufacturing or final customer product safety concerns?
Answer:  4.4.1.2 was created to address final customer safety concerns (braking systems, airbags, fuel systems, etc.).  If the product (or process) is a safety item on the final product, then the organization has to identify the statutory and regulatory product safety requirements that must be met, along with items a) through m) in 4.4.1.2.  This is one of IATF 16949’s required documented processes, so inputs/outputs, metrics, etc. are required.

Can an organization demonstrate competence only through degrees and certifications for their employees?
Answer:  No, there are multiple ways for an organization to identify training needs and achieving the necessary competence for their personnel.  It is up to the organization to define (and document) training needs, including awareness, and competency requirements for all personnel performing activities that impact conformity to product and process requirements.

What about competency for internal auditors and second party auditors?  Do they all have to take an IATF-sanctioned lead auditor training course?
Answer:  No.  Organizations are responsible for ensuring key personnel, including their auditors, are properly trained and competent.  The IATF supports the use of IATF-recognized training providers; however, the IATF does NOT mandate the use of a lead auditor training course for all auditors in the organization.  Organizations are still allowed to have key personnel trained and certified as lead auditors, and then use those key personnel to train-the-trainer to disseminate the information throughout the organization.

If an organization is not design responsible for the software used in their product, does 8.3.2.3 (embedded software) apply?
Answer:  Section 8.3.2.3 refers to internally developed embedded software, not “functional test” software to see if a widget works (or not) during production.  For those organizations that are design responsible for the software used in their product, they must use a software development assessment methodology to assess their own software development process.  Annex B contains suggested Software Process Assessments such as CMMI or SPICE.

What is the goal of 8.4.2.3?  Do all organizations supplying automotive product have to be IATF 16949 certified?
Answer:  The ultimate objective is to have IATF 16949 certification; however, the IATF recognizes that for various reasons, that is not feasible for all organizations.  At a minimum, the expectation is for organizations to be certified to ISO 9001:2015, unless otherwise authorized by the organization’s customers.  Items a) through e) are a cadence which is applicable to the entire automotive supply base.

How are 8.3.2.3 and 8.4.2.3.1 different?
Answer:  8.3.2.3 refers to the organization itself and their internally developed embedded software. 8.4.2.3.1 refers to the organization’s suppliers of automotive product related software.  The organization needs to ensure that their suppliers of automotive product related software implement and maintain a process for software quality assurance for their products.

SimpleQuE will be sharing more information from IAOB and other Eagle Boot Camp sessions in future posts and on social media.  Follow us on Facebook, LinkedIn and Twitter for the latest quality and certification news.

LSI Combines Unique Lighting and Graphics Capabilities to Deliver Image-Enhancing Cost Saving Opportunities to Customers Nationwide

Photo from left to right:  Larry Vance, VP SimpleQuE; Yvette Kilburn, Corporate ISO Coordinator, LSI;  Shawn Toney, President of LSI Lighting;  Virgilio Acevedo, Corporate Director of Quality
Photo from left to right: Larry Vance, VP SimpleQuE; Yvette Kilburn, Corporate ISO Coordinator, LSI; Shawn Toney, President of LSI Lighting; Virgilio Acevedo, Corporate Director of Quality

Whether it’s from New York’s George Washington Bridge to multitudes of CVS retail locations or Burger King restaurants around the country, LSI Industries’ high-performance, energy-efficient lighting and image-enhancing graphics are optimizing customers’ brands, products and services.  For 40 years, LSI has been proudly serving the commercial, industrial, institutional and specification markets with a broad offering of architectural and professional-grade lighting fixtures utilizing a range of integrated controls and lighting technologies from LED to traditional HID and fluorescent.

LSI is committed to advancing solid-state LED technology to make affordable, high performance, energy-efficient lighting and custom graphic products that bring value to their customers. With a vast offering of innovative solutions for virtually any lighting or graphics application, LSI provides sophisticated lighting and energy management control solutions to help customers manage their energy performance. And in addition, offers a full range of design support, engineering, installation and project management services to customers.

LSI’s major markets include commercial / industrial lighting, entertainment venues, petroleum / convenience stores and multi-site retail facilities (including automobile dealerships, restaurants and national retail accounts). Headquartered in Cincinnati, Ohio, LSI has facilities both there and in seven other states.

Guided by Larry Vance, Jim Bannan and a team of simpleQuE consultants, LSI achieved ISO 9001:2015 certification through Eagle RegistrationsCongratulations LSI Lighting!

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 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 IATF 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 IATF 16949:2009. IATF Transition Strategy IATF 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 IATF 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.

IATF 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 IATF 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 IATF 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 IATF 16949:2016, so the transition time will be tight.

 

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