The Changes - Iso 13485 2016 - Iso 9001 2015

UNDERSTANDING HIGH-LEVEL
CHANGES
ISO 9001:2015 & 13485:2016
BOB MEHTA
MSQA, MBA, B.S. (CHEM), ASQ FELLOW -CSSBB, CQE, CRE, CSQE, CBA, CQA, CPGP, CHA
PRINCIPAL CONSULTANT & RECRUITER
GMP ISO EXPERT SERVICES
E-MAIL: CONTACT@GMPISOEXPERT.COM
LINKEDIN PROFILE: WWW.LINKEDIN.COM/IN/BOBMEHTA
PHONE: (949) 510-9138
Prepared for SPE – 11 August 2016

About – Bob Mehta
2
Principal Consultant & Recruiter – Over 25 years of experience including

6+ years as a Principal Consultant/Recruiter at GMP ISO Expert Services.
Help Device, Pharma, Combination Products, Food/Dietary Supplement,
Cosmetic, and Aerospace clients with gap analysis and remediation of
Quality Systems, Process Control, Supplier Management, and Process
Improvement as a result of FDA warning letters, Consent Decree,
ISO/AS9100/ICH Audits and continuous improvement projects
Help clients to transition the quality system from ISO 9001:2008 to ISO
9001:2015 and ISO 13485:2003 to ISO 13485:2016.
Author of Articles – Published in Pharmaceutical Technology, MD&DI,
Nutraceutical World, and Quality Progress publications.
Adjunct Professor at Cal State Dominguez Hills teaching courses for the
Masters of Science in Quality Assurance program, at Cal Poly Pomona
teaching Six Sigma Blackbelt course, and provides training on American
Society for Quality (ASQ) certification courses
Became a Fellow of ASQ in Nov 2014
© 2016 - GMP ISO Expert Services Phone: (949) 510-9138 E-mail: contact@gmpisoexpert.com
About – Bob Mehta
3
Author of Books: Released by ASQ Press in July 2016
Recommendation Letter
Transition - ISO 9001:2008 to ISO 9001:2015
4
Understanding the High-Level Changes
ISO 9001:2015 & ISO 13485:2016
5
Changes
Transition timeline
Conclusion
ISO 9001:2015
6
The ISO 9001 standard is becoming especially

important as their customers demand better
value
What do
you see
in this
photo?
ISO 9001:2015 & ISO 13485:2016
7
Structural Comparison of ISO 9001:2015 &

ISO 9001:2008
What obvious changes do you see in the table below?
ISO 9001:2015 & ISO 13485:2016
8
Understanding the Changes

Introduces a new 10 clause structure vs. 8
clauses (see the previous slide)
In ISO 9001:2015, most of the sub-clauses
number are different than ISO 9001:2008.
Adoption of a process-approach
Define required inputs, expected outputs, and
expected output of each process
Risk-based thinking
ISO -13485:2016
9
Some Key Changes

Alignment of global regulatory requirements
Inclusion of risk management and risk based decision
making throughout the quality management system
Additional requirements and clarity with regard to
validation, verification, and design activities
Strengthening of supplier control processes
Increased focus regarding feedback mechanisms
More explicit requirements for software validation for

different applications
ISO 9001:2015 & ISO 13485:2016
10
Focus on a Key Change – Risk Management

What is risk-based thinking?
Something we ALL do automatically
Examples -
ISO 9001:2015 & ISO 13485:2016
11

What is risk-based thinking?
Risk is considered from the beginning and throughout the
process approach
Risk-based thinking makes proactive action part of strategic
planning
Risk considered can be positive or negative
Proactive vs. reactive approach
ISO 9001:2015 & ISO 13485:2016
12

What should I do?
Analyze and prioritize the risks and opportunities
By identifying acceptable vs. unacceptable risks
Plan actions to address the risks
Is it possible to eliminate/mitigate the risks?
Implement the plan
Verify effectiveness of the actions to eliminate/mitigate the
risks
ISO 9001:2015 & ISO 13485:2016
13

Importance of Risk-based thinking
Risk-based thinking makes prevention a habit.
Risk-based thinking equals preventive action. As a result,
ISO 9001:2015 doesn’t have a clause for preventive action
In ISO 9001:2008, there was no mention of risk vs. in ISO
9001:2015 risk is mentioned 16 times
ISO 9001:2015 & ISO 13485:2016
14
Conclusion
Word “Risk” is mentioned 15 times in the new standard
vs. 3 times in the ISO 13485:2003
Word “Risk” is mentioned 16 times in the new standard
vs. none in the ISO 9001:2008
Risk Management activities should be incorporated:
Risk based decision making throughout the quality
management system and through the entire produce life-
cycle
Strengthening of supplier control process
Alignment of global regulatory requirements
ISO 9001:2015 & ISO 13485:2016
15
Conclusion
Verbiage and process in the new version of standards aligns
to the FDA requirements
Prepare for successful transition:
Comply to the new ISO 13485:2016 standard latest by Q1 2019 and ISO
9001:2015 by September 2018
If the entire quality system audit is scheduled between now and the next three years,
notified body will expect organizations to comply to ISO 9001:2015 or ISO
13485:2016 requirements
Plan the transition – It may take 3-6 months (depending on internal
expertise and resources available)
Identify documents that needs to be created/revised
Provide training
Take help from a consultant for smooth transition of the
quality system from ISO 9001:2008 to ISO 9001:2015 or
ISO 13485:2003 to ISO 13485:2016 standards
ISO 9001:2015 & ISO 13485:2016
16
Thank you for your participation
BOB MEHTA
MSQA, MBA, B.S. (CHEM), ASQ- FELLOW - CSSBB, CQE, CRE, CSQE, CBA, CQA, CPGP, CHA
PRINCIPAL CONSULTANT & RECRUITER
GMP ISO EXPERT SERVICES
WEBSITE: WWW.GMPISOEXPERT.COM
E-MAIL: CONTACT@GMPISOEXPERT.COM
PHONE: (949) 510-9138

The Changes - Iso 13485 2016 - Iso 9001 2015

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

The Changes - Iso 13485 2016 - Iso 9001 2015

Uploaded by

Copyright:

Available Formats

UNDERSTANDING HIGH-LEVEL

Prepared for SPE – 11 August 2016

Principal Consultant & Recruiter – Over 25 years of experience including

Author of Books: Released by ASQ Press in July 2016

The ISO 9001 standard is becoming especially

Structural Comparison of ISO 9001:2015 &

Understanding the Changes

Some Key Changes

Increased focus regarding feedback mechanisms

More explicit requirements for software validation for

Focus on a Key Change – Risk Management

Focus on a Key Change – Risk Management

Focus on a Key Change – Risk Management

Focus on a Key Change – Risk Management

Thank you for your participation

You might also like