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Weathering the Storm

Weathering the Storm. An ISO 9001:2008 to ISO 9001:2015 Transitional Audit Tale Monica Seh Corporate Quality Manager NCI, Inc. mseh@nciinc.com Prepared for ASQ0511, 11/8/2017 Member Meeting/Dinner. October 2016, I was working in my office when ….

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Weathering the Storm

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  1. Weathering the Storm An ISO 9001:2008 to ISO 9001:2015 Transitional Audit Tale Monica Seh Corporate Quality Manager NCI, Inc. mseh@nciinc.com Prepared for ASQ0511, 11/8/2017 Member Meeting/Dinner

  2. October 2016, I was working in my office when … • The Corporate Quality Manager sort of quit, sort of got fired • Switching me from CMMI-DEV to ISO 9001:2015, 20K and 27K audit preparations • And, suddenly I am the Corporate Quality Manager • I’d (not) been preparing for this moment all my life Audits when? April – May 2017

  3. What is ISO 9001:2015? • ISO standard for a Quality Management System that defines quality as Fulfillment of Customer Requirements • About 20 pages long • Plan-Do-Check-Act

  4. What is new in ISO 9001:2015? • Context of the Organization • Assessment of risk and opportunities • Change management • Organizational knowledge • Communication • Some new, badly worded procurement requirements

  5. How did I prepare? • Completed a detailed transition questionnaire provided by the auditing organizations • Did the auditor look at it? No. • How quickly did things go from bad to worse? • As soon as the auditor decided to do an integrated audit of all 3 of our ISO certifications.

  6. What went right? • Context of the organization • Organizational knowledge What went wrong? • Change Management • The expectation was that all the issues would be logged in our Process Improvement Request database • Communication • The expectation was that all types of corporate communications, along with reviewer and approver information be documented (Communication Matrix) • Procurement requirements for “external process providers” – how is performance managed? • Surprize! Payroll process not documented

  7. In the end, we passed the audit … • With 17 nonconformities Lessons Learned • Manage the auditor • Only do an integrated audit if you have prepared for it • Different auditor for each cert • Insist on reviewing nonconformities prior to the final audit report • Manage the auditor

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