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.

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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.

Silberline

Silberline was founded in 1945 by aluminum industry pioneer Ernest Scheller.  His vision was to create a business that would provide the highest quality products and customized service with unyielding integrity.  Today Silberline continues that vision as a global manufacturer and supplier of high quality special effect and performance pigments that enhance the visual appeal of coatings, paints, inks, plastics and textiles. Still a family owned business, Silberline has over 700 employees world-wide with manufacturing, technical and research centers in Europe, Asia and North America.  Their products are utilized in a variety of markets including automotive, graphic arts and printing inks, plastics, and industrial coatings.

In 2015 Silberline began the search for a consulting firm that could assist them not only with transitioning to ISO 9001:2015 (along with ISO 14001:2015 for 1 site) , but also a company that understood the complexities of international, multisite and corporate certifications. SimpleQuE fit that criteria and assigned 4 consultants and a project manager to work with the quality teams at the headquarters in Tamaqua, PA and 3 other manufacturing sites in PA, IN and Scotland to prepare them for the transition. By September 2017 they had addressed the gaps in their quality systems, implemented new quality management software and were ready for their surveillance audits with BSI Group.  As a result, all 4 sites passed and received their ISO 9001:2015 certifications! In addition, the Scotland site also transitioned to ISO 14001:2015.  Congratulations to the entire Silberline team!

Photo taken at Silberline Global Headquarters – Tamaqua, PA

Front Row: Sheila Setcavage (Quality System Manager), Jennifer Mikovich (Site Manager, Hometown), Lisa Scheller (Chairman), Jan Moos (VP Innovation/New Product Development), Herb Whildin (Manager, Pilot Plant/Process Improvement/Technical Support)

Back Row: Blake Russell (simpleQuE Consultant), Tom Schwarz (Global CFO), Gary Karnish (CEO), Chris Gross (Interim VP Operations), David Stanko (VP Technical Service/Quality Functions)

12 Years At The Toyota Opportunity Exchange

For the last 12 years simpleQuE has attended the Toyota Opportunity Exchange (TOE) to network with Tier I suppliers like Dana Incorporated. Dana has 100+ facilities and 29,000 employees in 34 countries making it one of the world’s most influential automotive suppliers. Through the TOE, a relationship was developed with Dana and in 2013 simpleQuE won the opportunity to perform ISO/TS 16949:2009 internal audits for the Dana site in Auburn Hills, MI. That opportunity has expanded to now include internal audits and/or IATF 16949:2016 transition consulting at five more Dana facilities in PA, IN, TN and KY. SimpleQuE consultants worked with the dedicated Quality team at Dana – Gordonsville, TN which recently successfully transitioned to IATF 16949. The first of our clients to do so!

Providing a forum for suppliers and minority business enterprises to connect is just one of the many ways that Toyota ensures its supplier base continues to reflect the diversity of its customers, partners and team members.

What You Need To Know About ISO 45001

Worldwide over 6300 people die each day from work-related accidents or diseases – nearly 2.3million every year.  ISO is developing a new standard, ISO 45001, Occupational health and safety management systems – Requirements, to provide a framework to improve employee safety, reduce workplace risks and create better, safer working conditions, all over the world. ISO 45001 is targeted to be published in the first quarter of 2018 and will replace OHSAS 18001. Current users of OHSAS 18001 will need to update their systems according to the requirements of the new international health and safety standard within a three year transition period that will commence after ISO 45001 is published.

 

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.
  2. Learn useful tips, tools and best practices for transitioning and maintaining an effective quality management system.
  3. Preview the latest simpleQuE blogs and infographics.
  4. Receive data and reports from industry leaders and registrars on current certification standards and how they will impact you.
  5. Check out the latest companies who have earned their QMS and EMS certifications as we proudly recognize our clients’ success!

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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.

Pilgrim Harp is AS9120:2016 and ISO 9001:2015 Certified!

Pilgrim Harp 1

Pilgrim Harp, located in Avon, Ohio, provides the global and domestic sourcing of components and assemblies, handling every aspect of the sourcing process from beginning to end and ensuring the highest quality levels at all times.  Pilgrim Harp and its manufacturing partners all maintain TS, ISO and/or AS certifications.

As a manufacturing outsourcing company for the healthcare/medical, heavy industrial and aerospace industries Pilgrim Harp is a source for a wide range of products.  For aerospace, their aircraft interior products include: airplane seat legs, seat spreaders, seat backs, seat frames, seat arms, seat arm assemblies, seat tray tables, seat tracks and more.  For this customer base, Pilgrim Harp leadership recognized the need for AS9120B certification – which pertains to Quality Management System (QMS) requirements for Aviation, Space and Defense distributors. This standard includes ISO 9001:2015 QMS requirements.

SimpleQuE consultants, Jen Briese and Jim Lee began working with Pilgrim Harp in 2016 to assess where there were gaps between their current system and the new requirements.  They then worked out a customized action plan and timetable to make implementation simple and sustainable.  End result – certification was achieved in June 2017 with no findings from Eagle Certification Group!  Congratulations to the team at Pilgrim Harp!

Quality Management Dos and Don’ts – Don’t be guilty of being in the red

Business Man. Business man put idea on board. Business man use pen for create business planning. Business accessory background. Business strategy. Business working. Business people concept. Business man over sunny. Business plan background

1. Meet Customer Requirements

Surprisingly there are companies that want ISO 9001 certification just to satisfy one customer requirement. The customer states that it will only do business with vendors that are certified as ISO 9001 – so to get (or keep) the business they need that certification. The problem with these companies is that they’re looking for a short-term payoff and an end to the journey with a certificate. They see nothing but that one benefit — we need a certificate for this customer — and ignore the long-term benefits a robust quality management system will provide, like:

  • Less firefighting;
  • Fewer repeat problems when you perform better root cause analysis and systemic corrective actions;
  • Increased performance because you’re monitoring trends against goals;
  • More efficient and effective business processes;
  • Less scrap, rework, rejects, warranty; and
  • Increase customer satisfaction leading to more business opportunities.

Some organizations don’t embrace the concept of quality linked with the business systems and tied into the strategic direction of the company, to drive continual improvement and continued customer satisfaction. In other words, they haven’t bought into the program or the true intent of the standard.  Focusing only on that one benefit — your immediate gain — without putting the customer in front will end up costing you much more in the long run.

2. Increase Revenue and Business from New Customers

Once you earn your ISO 9001 certification, you can advertise your quality certification and respond to Requests for Quotes (RFQ) from companies that make ISO 9001 certification a “must-have”.  ISO 9001 certification can open up new markets you were virtually unable to do business with before your certification.

Yet, companies are not advertising their ISO certification enough, costing them potential business. Transition or implementation of a new standard is the perfect time to share that the company has achieved this important recognition with your potential customers, current customers, and stakeholders. Consider a link to a copy of your ISO certificate right on your website.

3. Improve Company and Product Quality

quality management system standard is all about quality so, of course, one result of adopting a QMS should be an improved level of quality for the entire organization — every process, and every product. Organizations should use the ISO series of standards to develop a QMS that is integrated into the way they do business, and assist in achieving their strategic business objectives – adding value.

Unfortunately, some organizations may have missed the mark and created a bureaucratic set of procedures and records that don’t reflect the reality of the way the organization actually works and simply add unnecessary costs, without adding value. When the business system is the same as the quality system processes, the value of ISO and certification become more logical and value-added for the business.

4. Describe, Understand, and Communicate Your Company Processes

The ISO 9001 QMS standard requires that you identify and describe your processes using business metrics, the purpose of which is to better manage and control your business processes. Quality objectives or your business process goals form the center of your system. Metrics are used to understand and communicate your system’s performance and trends relative to your quality objectives. The level of monitoring, measurement and improvement of each process will depend on the organization’s context, strategic intent and determined risks and opportunities.

Companies may identify too many processes. So it is important to understand the differences between a process, a procedure and an activity. We recommend less than 10 core processes, and fewer is commonly better.  Looking at your business from a 50,000 foot view to understand the high level business processes needed to deliver the products or services you provide your customers are the core processes ISO wants you to define.  Everything from sales, to new product development, to production planning, to production or providing a service, and finally delivery are the processes to identify for your business.  A flow diagram is most commonly used with the linkages and interactions between each.  Each of these core processes needs to have at least one objective that is measured to evaluate the effectiveness and efficiency of that process. Problems can also occur when companies don’t have set metrics on which to evaluate processes and manage the control of their business processes.

The International Organization for Standardization (ISO) has created a useful whitepaper to explain the Process ApproachContact simpleQuE to see how our consultants can assist your company with these problems or other areas of concern.