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 18.104.22.168.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 22.214.171.124 are as follows:
- Certification to ISO 9001 through 3rd party audits
- Certification to ISO 9001 + compliance to MAQMSR through 2nd party audits* (suppliers who did not achieve upgrade transition may consider this)
- Certification to ISO 9001 + compliance to IATF 16949 through 2nd party audits*
- 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.
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 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 data, the 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.
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.
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