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.

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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.  ISO/TS 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.

ISO 9001 Myths and Their Reality

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ISO 9001 is the world’s most used management system standard, existing for almost 30 years, it tends to fall into the gap where many people have heard about it, but not many fully understand what the standard involves. As a result, there are common myths about ISO 9001 that simpleQuE can help to clarify.

Is it complicated and difficult to implement?
In most cases, no. 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. It is possible to simplify ISO implementation, transition, training and maintenance, by integrating simple solutions that fit into your company’s culture.  This can be done with a gap audit checklist to identify where you’re already in compliance and more effectively target only those areas that need work.

Isn’t ISO 9001 an outdated model?
While it is true that ISO 9001 has been around since 1987, it has evolved through several revisions to match the changing needs of business. Today there is instant access to information, higher expectations from customers, more complex supply chains and a globally competitive economy.  ISO 9001:2015 takes all of these factors into account.

Isn’t ISO 9001 a standard that only benefits big corporations?
This is not the case. ISO 9001 is intended to be a set of requirements that can be used by any company, of any size, in any industry. The requirements are written as a set of best practices needed to control all the processes of a business system – no matter what the company does. The standard is designed to be flexible; the focus is on improving quality and customer satisfaction, which every organization can benefit from including:

  • More efficient use of resources and improved financial performance,
  • Improved risk management and protection of people and the environment, and
  • Increased capability to deliver consistent and improved services and products, thereby increasing value to customers and all other stakeholders.

Will everything have to be monitored and measured?
Processes do have to be monitored and measured to ensure that they are performing as designed, however, the standard allows a company to consider the impact that a process has on product/service conformity and the effectiveness of the Quality Management System (QMS) when determining what to monitor or measure and the method to be adopted.  A good QMS will help with monitoring performance and driving improvement.

Is ISO 9001 is the sole responsibility of the quality manager or department?
This couldn’t be farther from the truth, since the requirements cover every aspect of the business – from planning through delivery and post-delivery of your product or service.

Doesn’t ISO 9001 cost a lot to implement?
The question of cost will depend on the size and complexity of the organization and the competency of the personnel. Basic implementation pricing should be competitive and reasonable, depending if the work is done internally or through an external consulting service. The overall outcome of these activities should be to reduce costs through improvements and increase revenues through satisfied customers. Your return on investment should be well above the costs. Note that ISO certification is a separate additional cost.

SimpleQue can customize consulting for your organization and provide simple solutions while clearing up any misconceptions about ISO 9001 and how it can benefit your organization. Contact us today to find out more information and how simpleQue can help!

7 Lessons Businesses Can Learn From Watching Football

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Watching the big game? Here are a few takeaways that apply to any business.

 

  1. You’re only as strong as your weakest link
    Football is a team sport, and so is business. A weak link in the supply chain can be detrimental to a business that fails to assess supply chain risk management.. SimpleQuE’s supply chain audits and corrective actions drive supplier development and can identify risks to your company.
  1. Sometimes you have to take the punt to score the touchdown
    Football is all about taking risks. Going for a field goal is an easy way to score three points, but punting the ball could result in a touchdown for seven points. Just as the coach examines the possible outcomes before making the decision to go for a field goal or a punt, ISO 9001 calls for a manager to use a risk-based thinking cap. Organizations are asked to identify, analyze and prioritize all potential risks as they undergo implementation or upgrading their existing quality management system for certification.
  1. When the plan fails, change the plan
    Things do not always go as planned on the football field. It’s not an ideal situation, but by quickly adapting to the current circumstances, the most effective teams can often salvage a few yards rather than giving up. Similarly, companies often need to come together, improvise and move forward in the face of adversity.
  1. Always play the long game
    Sure, the other team may score a touchdown in the first few minutes of the game. Instead of focusing on what went wrong, the best teams keep a long-term perspective. And in business, try not to get caught up in the day-to-day—rather, focus on long-term quality and excellence.
  1. Training is important
    Far before the game starts, football players have spent days and weeks practicing and training to ensure they’re ready to play. Consider offering plentiful opportunities for training, such as SimpleQuE’s slate of courses covering internal auditing, root cause analysis and problem solving, and more.
  1. Understand the competition
    The best coaches understand that beating the other team is often more about understanding their strengths and weaknesses than it is about playing your best. Businesses can employ the same strategy when it comes to their competition. Understand what advantages other companies have while also learning their key weaknesses is essential to your own success.
  1. Always watch the highlight reel
    In football and in business, it’s essential to learn from your past mistakes as well as to repeat your past successes. Every situation has an upside, and provides opportunities to learn and move forward. As we always emphasize when working with companies on ISO, AS, or IATF implementation, Once plans are implemented, it’s essential for organizations to check the effectiveness of their actions and continually learn from experience.

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”.

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

3 simpleQuE Ways To Transition to ISO 9001:2015

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SimpleQuE was one of the first consulting companies in the world to become ISO 9001:2015 certified.  The transition is simple when utilizing our expert consultants or gap checklist to guide you through the process. 

  1. FastTrack your way to success – with our expedited approach to implement the 2015 changes based on lessons we have learned with numerous clients and through historical changes to various standards.    Through the FastTrack program your team will develop and complete a clear roadmap in four months (1 day/month for 4 months) and be ready to upgrade your certification in 5 months.  (The FastTrack model can be customized and accelerated with your implementation team to meet your timelines.)  Click here for more information.
  2. Customized on-site consulting and training – We offer unique quality consulting insights that result in customized solutions. We are known as the consultant that simplifies ISO implementation, transition, training and maintenance, by integrating simple solutions that fit in your company’s culture.  We perform a thorough gap analysis to identify what needs to be implemented or changed.  With our expertise, we help identify where you’re already in compliance and target only those areas that need work. Part of our job with the gap assessment is to educate you on how you already comply with your current systems. The result of the gap analysis is a thorough action plan of each task that needs to be accomplished.  The action plan is laid out against your timing and resources to successfully achieve your upgrade to ISO 9001:2015.
  3. Utilize our ISO 9001:2015 Gap Audit Checklist – Companies that have mature Quality Management Systems and experienced Quality Managers will find this a useful tool to identify the differences between the 2015 standard versus 2008.  The checklist can be shared with your certification body as evidence of internal audits to the new ISO 9001:2015 requirements. The purchase of this gap checklist comes with a free half hour of phone or email consulting.  Purchase checklist.

For more information or to obtain a quote for implementation consulting services or training, please call 740-305-0868 or contact us by email.

October Training

ISO 9001:2015 ImplementationOctober 16, 2015
Columbus, OH
This course is for companies and their teams who are implementing ISO 9001:2015 and working toward upgrading from 2008, or obtaining certification or compliance for the first time.  We share the proven, simple approach and educate you on the requirements to know what is required to become certified.  In a half day, we can give you the tools and approach to accelerate your program, and get your implementation team moving forward with a clear roadmap to achieve your certification goal to ISO 9001:2015.

  Continue reading “October Training”