Not ready for IATF Certification? MAQMSR May Be an Option

worker with protective mask welding metal. in Industrial automotive part. in car production factory.

For automotive suppliers who are having a difficult time meeting the requirements of the new IATF 16949 quality standard, Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers (MAQMSR) may be an option you want to consider in conjunction with ISO 9001 certification.  With initial audit results coming in from certification bodies, it is evident that companies are failing to comply and in some cases IATF certification can’t be achieved.

IAOB released the top IATF 16949 findings based on 3,172 audits conducted as of August 2017 – the top 5 non-conformances overall were written against:

  • 5.1.5 Total productive maintenance
  • 5.1.1 Control plan
  • 1.2.3 Contingency plans
  • 5.1 Control of production and service provision
  • 2.3 Internal auditor competency

As an option for suppliers, the Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers (MAQMSR) was released in September 2017 as a possible intermediate step for a supplier’s Quality Management System (QMS) under the authorization of IATF 16949, Section 8.4.2.3.c and Sanctioned Interpretation, SI #8.

Conformance to MAQMSR helps a lower tiered supplier transition to IATF 16949 by allowing many of the key Automotive Requirements to be met while developing the remainder of the QMS. The ultimate goal of the supplier development process is to achieve 3rd party registration to IATF 16949.  It is important to note that the customer determines the path and steps, so approval must first be obtained before proceeding.  The suggested steps of supplier development referencing 8.4.2.3 are as follows:

  1. Certification to ISO 9001 through 3rd party audits
  2. Certification to ISO 9001 + compliance to MAQMSR through 2nd party audits* (suppliers who did not achieve upgrade transition may consider this)
  3. Certification to ISO 9001 + compliance to IATF 16949 through 2nd party audits*
  4. Then finally certification to IATF 16949 through third party audits

MAQMSR aligns the Automotive QMS Requirements with the corresponding IATF 16949:2016 section(s); however, it is not certifiable or a third party auditable standard, though the guideline may be referenced during a second party audit *(by customer or with a qualified 2nd party like simpleQuE).

SimpleQuE consultants have been assisting companies to understand their options and make the change to drop ISO/TS 16949 and prepare for ISO 9001:2015 certification.  Upon receiving  customer approval to use 2nd party audits to be compliant with MAQMSR, our consultants can provide guidance for that process and perform the audits.  For more information on MAQMSR, contact us.

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The 7 Major Components of IATF 16949

 

IATF 16949:2016 defines the quality management system requirements for the design and development, production and, when relevant, the assembly, installation and services of automotive-related products including products with embedded software. The focus of this automotive standard is the development of a QMS that provides for continual improvement, emphasizing defect prevention and the reduction of waste in the supply chain. Combined with applicable Customer Specific Requirements, IATF 16949 is also fully aligned with the structure and requirements of ISO 9001:2015.
The standard is divided into ten sections – the first three are introductory, with the remaining seven containing the requirements for the Quality Management System. Below is a brief summary of Sections 4-10:

Section 4: Context of the Organization

The organization determines its context in terms of the QMS, including interested parties and their needs and expectations. It also defines the requirements for determining the scope of the QMS, as well as general QMS requirements.

Section 5: Leadership

Top management is required to demonstrate leadership and commitment to the QMS, along with defining corporate responsibility and the quality policy. The top management must also assign process owners along with other roles and responsibilities.

Section 6: Planning

The planning section defines requirements for addressing risks and opportunities and the requirements for risk analysis. This clause also includes requirements for preventive actions, contingency plans, and quality objectives and plans to achieve them.

Section 7: Support

This section covers requirements for supporting processes and resources. It defines requirements for people, infrastructure, work environment, monitoring and measuring resources, organizational knowledge, auditor competence, awareness, communication, and documented information.

Section 8: Operation

The product requirements deal with all aspects of the planning and creation of the product or service. This section includes requirements on planning, product requirements review, design, purchasing, creating the product or service, and controlling the equipment used to monitor and measure the product or service. IATF 16949 allows for requirements in clause 8.3, regarding design and development of products, to be excluded if they are not applicable to the company.

Section 9: Performance Evaluation

This section includes requirements for monitoring the effectiveness of the QMS – assessing customer satisfaction, internal audits, monitoring and measurement of manufacturing processes, and management review.

Section 10: Improvement

The last section focuses on continual improvement of the QMS, including requirements for nonconformities and corrective actions, problem solving, and error-proofing processes.


These sections are based on a Plan-Do-Check-Act cycle, which uses these elements to implement change within the processes of the organization in order to drive and maintain improvements within the processes.

IATF 16949 is a standard that benefits businesses large and small. The experts at simpleQuE can help your business achieve this standard, ensuring your business cost savings and efficiencies.

The Time Is Now – Preparing for a Successful IATF 16949 Transition

Automotive industry manufacture line with different metal parts

The transition to IATF 16949 has been a rough one according to industry experts.  More than 68,000 organizations certified to ISO/TS 16949:2009 (and 6,382 companies in the US) will need to undergo a transition audit to IATF 16949:2016. As of April 2017, 181 upgrade audits had been completed, resulting in an average of 5.3 nonconformities and approximately one major nonconformity (.73) per audit.

The top five nonconformities overall are “total productive maintenance” (48 nonconformities), “control plan” (38), “contingency plans” (37), “control of production service provision” (26), and “internal auditor competency” (23). Based on automotive industry datathe top-five major nonconformance clauses are customer-specific requirements (7 nonconformities), internal auditor competency (7), quality management system (QMS) audit (7), TPM (6), and management review inputs (6).

For companies that have yet to transition to IATF 16949, you do not want to wait any longer. The deadline for suppliers to transition to the new standard is your next scheduled annual audit.  All audits as of October 2017 have to be to the new IATF standard.   And note that the IATF will not be granting waivers for organizations that can’t meet the transition plan timing.

According to Russ Hopkins, head of supplier technical assistance for Ford Motor Company, “Globally, over 1,200 audits need to take place each week, which averages out to about one per week per auditor,” he said. “This is doable with the proper planning.  It’s doable as long as people do not wait until the last minute.”

This process can seem daunting to suppliers, but Hopkins notes there are several steps to a successful IATF 16949 transition:

  • Confirm dates for the transition audit with your certification body. Upgrade has to occur at your next scheduled audit.
  • Develop a work plan back from the date of the transition audit
  • Review the requirements and provide feedback regarding any concerns (suppliers contact AIAG, certification bodies contact their oversight offices, and OEM through their IATF representative)
  • Allow enough time after the transition audit to address any non-conformances. All findings must be closed in 60 days.

For those with an existing ISO/TS 16949 certificate with one or more nonconformities of the audit to IATF 16949 which are not either 100% resolved or closed within the required timeframe, the transition audit will be considered “failed” and the IATF database will be updated accordingly.  The certification decision shall be negative which means the ISO/TS 16949:2009 certificate is withdrawn and the client has to start over with an initial certification audit. (International Automotive Task Force)

For more information on transitioning to IATF 16949 visit our website.

Top 5 Reasons Not to Miss a Single Issue of Our Newsletter

At simpleQuE it’s not just our name that represents quality excellence, it’s our unique combination of consultants, knowledge and expertise.  We believe in serving our clients before, during and after the certification process. This value added service consists of an ongoing education process on the quality standards through our website, newsletters social media, and blog. Each month, we provide updates on the latest news from the ISO, AIAG, ASA, IAOB and IATF standards community, and what we’re is seeing in the industry.

In a year that will be filled with companies scrambling to upgrade their certifications, we feel it’s even more important to stay informed.  That is why we encourage anyone who is currently not receiving our monthly newsletter to sign up today.  And if you’re still on the fence, here are our top five reasons:

  1. Obtain the latest quality standard news and updates from simpleQuE.
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The Countdown Begins

Hour glass on calendar concept for time slipping away for important appointment date, schedule and deadline

By Jim Lee, President of simpleQuE

With the deadline for ISO 9001:2015, ISO 14001:2015, AS9100:2016 and IATF 16949:2016 approaching on September 14, 2018, companies have been slow to transition.  The statistics are sobering, although not unexpected.  The new ISO standards have been in effect for 2 years but only 6-20% have made the leap. (The number varies among registrars and the ANAB.) The final draft for the AS 9100 series followed a year later, but with the same deadline, and only 3% have upgraded.  Even fewer IATF companies have transitioned – and all have only 1 year left to get the upgrade completed.

What should you be doing if you’re one of these companies that has pushed out the inevitable?

  • Know that your next scheduled annual audits are the dates when you must transition to the new standards. If your next audit is a recertification and upgrade, you will need to perform the audit at least 2 months prior to your certificate expiring to give you enough time to address any potential nonconformances.
  • Review the new standard and do a gap analysis to see where there are differences in your quality (and/or environmental) management system and the changes to the standard. Generic basic checklists are available from your certification body, or detailed gap checklists with tips and explanations can be purchased from simpleQuE.  Learn more about simpleQuE’s Gap Checklist for: ISO 9001:2015, ISO 14001:2015, or IATF 16949:2016.  Note that IAQG offers a free AS9100D Gap Assessment Workbook.
  • Establish an action plan that will have you ready for your audits. Assign responsibilities and due dates to ensure you’re ready on time.
  • Train your internal auditors and perform a full system audit to make sure your system is on track and in compliance. You must have evidence of a full internal audit and subsequent management review prior to upgrading with your certification body.  If you can’t get your audits done in time you’ll need to outsource them.  (SimpleQuE can conduct an internal audit to the new standard after the implementation effort to prepare you for the external audit.)
  • Don’t expect to wing it and do nothing in preparation for these changed standards, or you will fail your next audit and lose your certification. Worst case if you aren’t ready in time, you may have to let your certification lapse and then become recertified at a later time when you’re ready.  No one wants to hear that, but it is a reality for some who haven’t started.
  • If you still aren’t sure how to proceed, work with a consulting firm (like simpleQuE) with certified experts who can provide consulting, training and customized plan to guide you through the transition.

IATF Transition Update from IAOB

Cherie Reiche of the International Automotive Oversight Board (IAOB) shared the following IATF 16949 transition update at several registrar conferences.  As of April 30th 2017:

  • 68,332 sites are ISO/TS 16949 or IATF 16949 certified worldwide
  • 181 audits were completed to IATF 16949 (0.3% upgraded)
    • To date the total NCs issued = 975 (avg 5.4 findings per audit)
      • Major NCs = 133 (16% of the findings are major)
      • Minor NCs = 842

A summary of the highest incidence of NCs (major/minor) by section is represented in the chart below.  It’s interesting to note that Customer Specific Requirements and Quality Management System Audit had the largest number of major NCs, while most minor NCs were written on Contingency and Control Plans.

2017-08-15-2

IATF 16949:2016 Transition Q & A from IAOB

Welding robots movement in a car factory

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.

SimpleQuE shares an important AS9100:2016 transition timeline reminder from IAQG

SQ_Infographic_AS9100Timeline Revised for Sept release

“The IAQG Other Party Management Team (OPMT) would like to remind all certificated organizations that there are two key target dates within the “International Aerospace Quality Group (IAQG) Other Party Management Team (OPMT) Supplemental Rule 003 – Rules for 9100/9110/9120:2016 and 9101:2016 Transition” document that were established in order to ensure that a certified organization transition occurs prior to the 15 September 2018 end date.

The first key target has now passed. In accordance with SR003; “10.a By March 1, 2017 AQMS certified organizations shall communicate with their CB to establish an intended date for 9100/9110/9120:2016 AQMS standard transition readiness.”  We greatly appreciate the efforts that certificated organizations have taken to meet this requirement and would like to remind those that have not yet made transition plans; there is an elevated risk of not meeting the 2018 end date if you have not established and communicated the aforementioned date to your CB.

The second key target date in SR003 is 15 June 2017. In accordance with SR003; 9.g No initial, surveillance or recertification audits shall be started to the previous versions of the AQMS standards after June 15, 2017.” We must ensure that transition has a start date or Certification Bodies may face auditor resource issues in 2018 as the transition end date approaches.”

SimpleQuE is an ISO 9001:2015 certified company that provides ISO, AS and IATF consulting services from quality experts to assist organizations in successfully meeting transition targets. Contact us for more information.  IAQG also provides AS9100 D transition support materials.

SimpleQuE’s IATF 16949 Gap Audit Checklist is Now Available!

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The automotive quality standard has come a long way since its first inception in 1994.  With the new standard and more than 200 changes, simpleQuE recognized the need for an IATF Gap Audit Checklist to assist companies with the transition. The checklist includes the new automotive requirements (IATF 16949:2016 and ISO 9001:2015) and is intended to be used as a tool to identify both compliance with the new requirements and the differences between ISO/TS 16949:2009 and the new requirements.

The utilization of this checklist, when populated with objective evidence of compliance and non-compliance, will satisfactorily demonstrate you have audited the differences between ISO/TS 16949 standard and the new requirements.  It should be used with your certification body as evidence of internal audits to the new IATF 16949 and ISO 9001:2015 requirements.  It’s one of the methods simpleQuE auditors and consultants use with our own clients.

A free half hour of phone or email consulting with a simpleQuE expert is included with the checklist for the purchase price of $300.

The simpleQuE team wishes you a smooth and simple transition!