ISO Certification is Key to Entrepreneurial Success

Businessman in blue suit handshaking at business meeting, trying to make positive first impression on partner at negotiation, welcoming new colleague in office. Successful partnership, close up

The number of ISO registered companies in the United States continues to grow at a rapid rate. At the same time, there is a growing trend toward forming sustainable relationships with quality-focused and environmentally conscious businesses. However, there is still a misunderstanding that ISO standards are only applicable to and beneficial for large corporations and manufacturers.

Is ISO certification a good investment for entrepreneurs?

While it is a common misconception that ISO certifications are only for big businesses, this is simply not true. The standards set forth by ISO are generic by design so that they may be applied to businesses of any size, type, or product line. Having an ISO certification provides the solid foundation entrepreneurs need to build a successful business.

Benefits of ISO Certification

ISO standards take a holistic approach to improving business functionality and growth through consistency; and are just as much about improving processes as they are about improving products and services. Consider the following benefits to your business:

Reduced Risk

Entrepreneurial companies are at a greater risk than established organizations – and have a more compelling need to identify and manage risk. If a young company doesn’t have policies, processes and procedures that are standardized, it risks wasting resources. And smaller companies are often not in a position to absorb that loss.

Improved Productivity

In order to adhere to standards, entrepreneurs are required to establish processes that are clearly defined, documented and monitored. Objectives are also established and progress is measured, so you can see how your business grows.

Increased Revenue

According to a 2015 analysis of 92 studies, three out of five businesses saw an improvement to their bottom line as a result of ISO standards. This revenue increase was slightly higher than non-certified businesses and was primarily due to improved operations.

Growth Opportunities

Standards open the door to new markets. Certain opportunities, such as government contracts for example, are only available to ISO certified businesses. In addition, many ISO standards are recognized internationally, which increases your credibility in international markets.

 

ISO certification provides your current and potential business relationships the assurance that you have the relevant processes in place to deliver what is required, giving your business the competitive edge. No business is too small to be ISO certified. If you are an entrepreneur and ready to take the next step in improving your business and quality management system, contact simpleQuE to find out how to get started.

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WRWP Makes the Calculated Jump to ISO 9001:2015

WRWP, LLC (Western Reserve Wire Products) has been designing, building and distributing wire harnesses since 1987.  Through the years they have evaluated and implemented more efficient means of production with state of the art equipment and manufacturing plants in China to reduce time and costs for their customers, while maintaining a high standard of quality.

The engineers at WRWP often work with their customers’ engineers in the design phase of new products to produce the best possible fit and function for the wire harness that will be needed, thus reducing unnecessary changes down the road.  And with that approach, in 2015 WRWP searched for a consulting firm that was the best fit and function to review their quality management system and develop a customized implementation plan to achieve ISO 9001:2008.  They selected simpleQuE, and with consulting and training support, achieved their certification.

Due to that success, when it was time to transition to ISO 9001:2015, they again turned to the experts at simpleQuE who utilized a Fast Track approach and developed an action plan while utilizing a detailed gap checklist to identify where WRWP was already compliant and where gaps existed.  Over the next several months with the guidance of simpleQuE consultants, their quality team worked hard to close the gaps while maintaining their quality system and improving internal processes. That preparation resulted in zero findings and certification to the new standard by Smithers Quality Assessments.  Congratulations to the team at WRWP!

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.

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 IATF 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 IATF 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 IATF 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 IATF 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.