Auditing ISO 9001 Clause 8.3, Design and Development of ...

"Auditing ISO 9001 Clause 8.3, Design and Development of Products and Services"

Bob Deysher Senior Consultant Quality Support Group Inc. bob.deysher@

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ASQ Reliability and Risk Division Webinar January 14, 2021

Objectives

Focus on issues found in Design and Development Processes during Quality Management System (QMS) Internal Audits

Identify effective tools and techniques that enhance the effectiveness of a Design and

Development Process

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ASQ Reliability and Risk Division Webinar January 14, 2021

Agenda

? Quick Tutorial on Auditing in ISO 9001:2015 ? ISO 9001:2015 has introduced "Risk". What is it all

about?

? ISO 9001:2015 Clause 8.3

? Issues identified during audits ? Positive features of effective processes

? What do we see in other industry standards ? ISO 9100:2016 Aerospace ? IATF 16949:2016 Automotive ? ISO 13485:2016 Medical Devices

? Conclusions

? Questions

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ASQ Reliability and Risk Division Webinar January 14, 2021

Acknowledgements

? Angelo Scangas - QSG CEO/President for Medical Device Inputs

? Laura Halleck - QSG Sr Consultant for Automotive Inputs

? Derek Churchill - QSG Sr Consultant for Automotive Inputs

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ASQ Reliability and Risk Division Webinar January 14, 2021

Definition ? Process Audit

"Internal auditing is an independent, objective assurance activity designed to add value and improve an organization's

operations. It helps an organization accomplish its objectives by bringing a

systematic, disciplined approach to evaluate and improve the effectiveness of

processes"

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ASQ Reliability and Risk Division Webinar January 14, 2021

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