Quality Management Systems Standards Update: How and When to Get in Compliance

Bringing you information about SQA, Quality Management, and more.

March 14, 2017

Updating a Quality Management System (QMS) to a new standard can be a very daunting and time-consuming task, one that many companies do not have the time or resources to manage. ISO 9001:2015 is a hot one right now.

“If a company’s QMS is not updated to meet the new standard and re-certified within the three-year timeframe, the company will lose their ISO registration and possibly lose current and potential clients that require an ISO certification” stated Aaron Ramsey, Lead Service Manager for Quality at Purdue Manufacturing Extension Partnership (MEP).

Having certifications to these standards is beneficial to companies because it increases level of quality, efficiency, and productivity internally; it can open up new markets and market share; and provides assurances to clients and potential clients.

As mentioned, one of the recent QMS changes is the update from ISO 9001:2008 to ISO 9001:2015. ISO 9001 is a standard that sets out the criteria for a Quality Management System (QMS) where an organization:

  • Needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements
  • Aims to enhance customer satisfaction through assurance of conformity and including continual improvement

9001:2015 focuses much more on risk and how actions might affect interested parties, as well as top management leadership buy-in for the QMS (no more delegating).

“When new QMS standards are released, companies have three years to get their QMS in compliance,” said Ramsey, “Companies have the option up to one year after the release of a new standard to certify under the old standard, but are still required to gain compliance for the updated standard by the end of three years.”

Still, companies are certifying to different QMS standards every day. Other standards exist that may affect your organization:

  • ISO 9001:2015
    • IATF 16949:2016 Quality – Automotive
      • Transitions must be complete by October 2019
    • ISO/DIS 13485:2016 Quality – Medical Devices
      • Transitions must be complete by March 2019
    • AS 9100D:2016 Quality – Aviation, Space, Defense
      • Transitions must be complete by September 2018
    • TL 9000 (5.5) Quality – Telecommunications
  • ISO 14001:2015 Environmental
    • Transitions must be complete by Sept 2018
  • ISO 50001: 2011 Energy
  • OSHAS 18001:2007 Occupation Health & Safety
    • To be ISO 45001

AS9100 and ISO9001 Implementation at 3rd Dimension Industrial 3D Printing

At 3rd Dimension, a growing company with a strong client base in the aerospace industry, the company and industry both saw a competitive and operational advantage to obtaining AS9100 and ISO9001 certifications.  Purdue MEP came on to help them implement a QMS with these standards in mind.

“Purdue MEP provided consulting services for implementation of AS9100 and ISO9001 quality management systems at 3rd Dimension Industrial 3D Printing.  With the complexity of the systems and our business, we really needed a consultant that could tailor our system to an emerging technology, and that is exactly what we received.  We passed our audit with no findings and a very impressed auditor.  I can’t imagine going through this process without Purdue MEP and the consultant’s expertise” stated Bob Markley, President at 3rd Dimension.

Next Steps

Implementing or updating your QMS is a lengthy, detailed process, one you should not have to go alone. Third party external consultants can guide you through the process, work with management and act as liaison between your company and the certifying body for your standards. If you already have a QMS in place, these experts can perform gap analyses to determine next steps, provide consulting to help update and/or create applicable QMS documentation and train or retrain internal auditors, so companies can autonomously maintain their updated QMS.

Visit mep.purdue.edu/workshops-and-events/upcoming-workshops/ for upcoming workshops and events.

See this article on the Purde MEP website at mep.purdue.edu/news-folder/qms-standards-update/.

 

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About The Author | Aaron Ramsey

Aaron Ramsey is the Lead Service Manager of Quality for the Purdue Manufacturing Extension Partnership. Aaron is a certified Lead Auditor for ISO 9001 and has completed NSF HACCP training. Aaron has 20+ years of Manufacturing Production experience, with more than 10 years of experience in the pharmaceutical and Medical Device industries and 9+ years of experience in the machining industry. Aaron has held roles as a Quality Assurance Manager, ISO Manager, QA Project Analysis, Project Manager, and held CNC/machinist positions and has instructed others on CNC programming and machining. Aaron has earned a Master of Business Administration degree in Healthcare Management from Indiana Wesleyan University, and Bachelor of Science degrees in Finance and Management from Saint Joseph’s College.

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