Friday, September 29, 2017

10 Things to Ask Your Certification Body Auditor – Before Your ISO 9001:2015 Audit

The latest version of ISO 9001 was published in September of 2015 and is considered to be a significant departure from the previous version because:
  • There’s no reference to a Quality Manual
  • No Documented Procedures are required
  • The use of Work Instructions isn’t mentioned
  • A Management Representative isn’t required
  • The standard mentions “risk and opportunity”
  • The terminology of controlled documents and records has been replaced by “documented information”
  • A new requirement, the “Context of the Organization,” has been added.
These changes are likely to have a substantial impact on an organization’s Quality Management
System, and this, in turn, can be affected by the knowledge and experience of the Certification Auditor scheduled for your upgrade audit.

Do you know what to expect from your Certification Auditor? You may have chosen a particular approach, based on any number of considerations and guidance from consultants, postings on internet forums, etc. What will your auditor expect you to have done to align your Quality Management System with the ISO 9001:2015 requirements? Having clear expectations before you open your doors for your audit is worth your time and effort to ensure success.

To assist with this process, we’ve complied the following questions to pose to your auditor in advance of their next visit:
  1. Context of the Organization – What do you expect us to be able to show that we’ve considered the internal/external issues, interested parties, etc.?
  2. Are you expecting that our Quality Policy has changed from our 2008-compliant Quality Management System?
  3. What do you consider to be the “Leadership” of our organization?
  4. What is expected for demonstrating “Risk-Based Thinking”?
  5. Is any type of “documented information” to be maintained or retained for the above?
  6. Does our Quality Manual have to address the 2015 requirements?
  7. Are we expected to have quality objectives for all our processes?
  8. When considering “Organizational Knowledge,” are we required to have any documented information?
  9. Is it acceptable for an internal auditor to audit their own work?
  10. How many Management Reviews are we expected to perform in a year?
The responses to these – and anything else you’d like to add – should be a good indicator of how prepared your Certification Auditor is going to be. For assistance with anything Quality related, contact our Quality Experts at

Andy Nichols
Quality Program Manager

Andy has 40 years of expertise in a wide variety of roles and industries, with a focus on quality management systems in manufacturing organizations. In addition to his ISO 9000 Management Systems experience, he has worked extensively with ISO/TS16949, ISO/IEC 17024 and ISO/IEC 17025. His broad practical knowledge of ‘Quality Tools’ includes: SPC, FMEA, Quality Circles, Problem Solving, Internal Auditing and Process Mapping. He has also been an IRCA and RABQSA accredited Lead Auditor. To read Andy's full bio, visit click here.

Since 1991, the Michigan Manufacturing Technology Center has assisted Michigan’s small and medium-sized businesses to successfully compete and grow. Through personalized services designed to meet the needs of clients, we develop more effective business leaders, drive product and process innovation, promote company-wide operational excellence and foster creative strategies for business growth and greater profitability. Find us at

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