VEGA Americas – Where Quality and Measurement go Hand in Hand

From left:  Ron Foltz, Manufacturing Manager; Bob Herbst, QC Technician; John Kronenberger, COO; Gretchen Lisi, Quality Manager; and Nickie White, RIG Champion.

VEGA Grieshaber KG is a global manufacturer of process instrumentation. Its product portfolio includes sensors for measurement of level, point level, pressure as well as equipment and software for integration into process control systems.  Its subsidiary, VEGA Americas, focuses on the design, manufacturing and servicing (including Radiation Safety Training) of Nuclear Measurement Systems.  The facility also manufactures, tests and services the full range of VEGA Measurement Systems.

Because quality and measurement go hand in hand, VEGA has been ISO 9001 certified since 1997. When the company needed to transition to the new standard, they utilized the expertise of simpleQuE quality consultant, Don Milinkovich, to conduct a gap analysis.  Following an action plan to close any gaps, VEGA Americas achieved ISO 9001:2015 recertification through Eagle Certification Group.   Congratulations to the VEGA team where they know how to Run, Improve and Grow (and even have a designated champion just for that purpose)!

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SimpleQuE Earns ISO 9001:2015 Recertification

ISO 9001 - quality management system. Businessman select ISO 9001 certification.

We did it!  SimpleQuE has been recertified to ISO 9001:2015 by Eagle Certification Group through December 2020. Our initial ISO 9001:2015 certification was in November 2015 right after the standard was released and we were one of the first to be certified.

“The majority of companies have waited until the last possible year to upgrade to the new standards. This is consistent with the past, when changes to the standards occurred. The problem now is that all the key standards (ISO, automotive, aerospace, environmental) have the same expiration date of 9/15/18 and everyone is rushing to get it done at the last minute. The capacity constraints on registrars, consultants, and auditors is evident and organizations that have not begun the transition process are in serious jeopardy of losing their certification, especially if attempting to wing it with the registrar and not doing anything new to comply with the new standards.”
-Jim Lee, simpleQuE President.

The ISO 9001:2015 certification provides us many benefits and is a big differentiator over our competitors. This is especially critical since this standard and common structure are integrated into other management system standards like environmental, aerospace and automotive.  It also provides simpleQuE with cost savings, an innovative service offering, market access, and a high level of customer confidence and satisfaction.

As an organization that is ISO certified, it proves to our clients that Quality Excellence can be made Simple. It’s what our company name means. For over 10 years, our simple approach has allowed us to have a quality manual that is only a few pages as we put our simple best practices to work in our own company. At simpleQuE, we don’t take a cookie cutter approach, therefore, we don’t implement our processes at our client sites. We look at what works for them and leave that alone, only focusing on those areas that don’t comply.  Considering each company’s culture and unique situation results in different solutions for each client.

As the transition deadline of September 14th approaches, we encourage organizations that are still working on their implementation or transition certification to keep at it, ask questions, and ask for assistance.  Demonstrating a commitment to maintaining the effectiveness of your system, continual improvement and customer satisfaction will put you in the lead.  ISO 9001:2015 certification is an internationally recognized distinction that will benefit your organization for years to come.

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.