The Countdown Begins

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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.
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Quality + Certification = Success!

SimpleQuE congratulates the following companies on their successful certification and commitment to quality.

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SimpleQuE (an ISO 9001:2015 certified company) assists organizations with implementation, improvement or transition of these standards by providing customized consulting, training and internal auditing services and solutions. Contact us for more information.

Powder Processing & Technology Transitions to ISO 9001:2015

Powder Processing Tech PPT 6-2017

Powder Processing & Technology, LLC  has maintained ISO 9001 certification since 1998 and just transitioned to the latest version – ISO 9001:2015.  PPT’s professionals have assisted the top materials technology companies around the world for over 30 years. The company performs process development and contract manufacturing on a wide range of powders, and has a fully equipped pilot plant as well as multiple production areas specializing in spray drying, calcining and firing

PPT uses the formulas and processing parameters provided by their customers and/or develops the formulations and processing parameters of the products produced for customers.  Therefore precise process control is necessary to meet high quality standards. For that reason in 2012, PPT brought in simpleQuE to conduct its quarterly internal audits.  Kenneth Bartelt, President, said,  “PPT is a small technology company which places significant weight on its quality management system and which needs to ensure its valuable and limited technical resources are focused on customer requirements and our ability to deliver results.”

“We consider the quality system to be part of the fabric of our management system and simpleQuE has added a critical component to that system,” added Ken.  “I think that simpleQuE has a practical approach to quality management that is effective and efficient.”  In the case of PPT, the commitment to maintaining quality standards is evident and practiced from the highest level of management to their plant workers.

SimpleQuE matched PPT to auditor/consultant, Don Milinkovich, whose 34 years in the chemical manufacturing business made him the right fit.  “Don is an experienced and personable consultant who has delivered meaningful audits and provided relevant expertise. Our audits have been at the right level of detail and have made a significant contribution to the business. The performance from simpleQuE has been such that the registrar’s representative and auditor has been very complimentary of the service they have performed,” stated Ken regarding the benefits of working with an experienced auditor.  Don also worked with the PPT team to prepare them for a smooth transition to the new standard.

These internal audits have reinforced the objectives of PPT to maintain high levels of service and customer satisfaction while utilizing the principles of ISO 9001 to incorporate continual improvement into their business practices.

ISO Certification Instills Trust

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Obtaining an ISO certification is so important to businesses that many will specify the distinction next to their business name, and some customers and industries mandate it through the supply chain.  A client or potential business partner may ask why having an ISO certification is important.  Simply stated, an ISO certification means the client can trust a business and have confidence that  It has the processes in place that are independently audited, to improve the likelihood that products and services will meet or exceed customer expectations.

What is an ISO Standard?

ISO standards define and structure a company’s management systems. These standards apply to all industries and require businesses seeking certification to define how their systems meet the standards’ rigorous requirements. Meeting the standards assures customers that all vendor company activities – design, manufacturing, production, purchasing, quality control, packaging, handling, storage, shipping, and customer service – are appropriately managed and controlled.

Certification Builds Confidence

When a business certifies to an international standard, they are representing a trusted symbol of quality, safety, and compatibility. These standards are developed through a process that is balanced, open, and transparent and help elicit trust among the groups and businesses that have placed value in the certification process.

Building Trust with simpleQuE

There are several paths to obtaining ISO certification. A company can create its own documents and systems, then prepare for and manage their audit internally, or they can work with a specialist to provide consulting, auditing and training services to expedite the certification process.  It is important to note that actual ISO certification is the result of an audit conducted by an external registrar or certification body and not the International Standards Organization who develops the standards.

SimpleQuE’s consultants are experts in their respective fields and are ready to provide unique solutions that fit your specific needs. For more information on choosing an ISO consultant, visit simpleQuE’s YouTube channel.

What keeps a Quality Manager Up At Night?

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Overall, what is at the forefront of a Quality Manager’s mind is the responsibility for performance improvement – improving the quality and the systems and processes that deliver them and all the resources that support these processes.  That’s a very far-reaching responsibility that encompasses a variety of other factors like risk, corporate culture, employee impact, customer requirements and suppliers.  In every organization, there are times when there are glitches in the system.  We’ve identified some of the top issues that may concern a QM enough to keep him/her up at night, or even cause a headache or two. 

  1. Recurring issues and product defects even total production shutdown (now that’s a nightmare!)
  2. Convincing top management to integrate the QMS as a Business Management System and make the QMS part of the business’ strategic direction
  3. Ensuring that customer specific requirements and expectations have been identified – that the company is meeting or exceeding customer expectations
  4. Keeping up with ever changing customer requirements as well as local, state and federal regulations
  5. Establishing and maintaining a customer-focused culture – from leadership down to temporary workers
  6. Transitioning to a new quality standard – where to even start?
  7. How to reduce waste and increase efficiency?  Making sure the company is working as        effectively as possible to keep up with competitors
  8. Have risk and preventative actions been adequately addressed from beginning to end?
  9. No accountability – processes defined by department managers and staff and then not following them
  10. Not ready or prepared for the certification audit (and what happens if there are findings or nonconformances?)

If any of these are keeping you up at night, remember, you’re not alone and there are consulting companies, like simpleQuE that can help.  We listen, observe and assess to provide simple and effective solutions…and hopefully, a more restful night’s sleep.

Are You Ready for ISO 14001:2015?

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Is your organization prepared for the transition to ISO 14001:2015? simpleQuE can help – our ISO 14001:2015 Gap Analysis Checklist a useful tool to identify compliance with the differences between ISO 14001:2004 and ISO 14001:2015. This completed checklist would be a supplement to existing ISO 14001:2004 internal audits. In addition, a free half hour of phone or email consulting is included in the purchase of the checklist.

Learn more.