This webinar provides a quick guide for your review to either prepare you for the transition or to check yourself to make sure your bases are covered for your next third party audit. This webinar is presented by a third party auditor in a simple manner that you will understand. Main points covered: • What are the benefits of the ISO 9001 • The key concepts of ISO 9001 • New terminology and important definitions introduced in ISO 9001 • Important tips on how to prepare for changes Presenter: This webinar was presented by Debra Hay Hampton, PECB Certified Trainer and Lead Auditor of Quality and Environmental Management Systems. Link of the recorded webinar published on YouTube: https://youtu.be/dTsFHDz01ws

1. ISO 9001:2015 What
Changed?

2. Debra Hay Hampton
ISO 9001 Lead Auditor
Debra Hampton has over 30 years of improving processes and systems with
experience from hospitals, schools, and many types of manufacturing
facilities, a methodical approach is used to focus on building a system of
processes that collect data to make decisions that create sustainable,
continual improvement and consistent product. Companies she works with
become better at “turning effort into dollars”.
Contact Information
+1 229 798 0277
debra@ce-q.com
www.ce-q.com
linkedin.com/debra-matthews-hay-hampton
twitter.com/name.surname
fb.com/debrahayhampton

3. Structure Changed
• New Common format for use in all management system standards
• Standardized core text and structure for multiple ISO management systems
for integration
• Standardized core definitions
• Allows Integrating multiple management systems (quality,
environmental, information security, health and safety) and easier
implementation
• Annex SL of the www.iso.org/directives

4. What are the Benefits of the New Standard
• More risk control
• Better cost control
• Improved morale and motivation
• Customer retention and loyalty
• Interested party messaging
• Improved image and reputation
• Credibility
• Ability to respond quickly
• Improved customer satisfaction
• Improvement

5. Structure of ISO 9001:2015
1. Scope
2. Normative References
3. Terms and Definitions
4. Context of the Organization
5. Leadership
6. Planning for the QMS
7. Support
8. Operation
9. Performance Evaluation
10. Improvement

6. Changed Definitions
• Organization
• Interested Party
• Management System
• Objective
• Competence
• Corrective Action
• Continual Improvement

7. New Definitions
• Risk
• Documented Information
• Performance
• Context of the Organization
• Monitoring
• Improvement
• Knowledge

8. Additional Terms Not Defined in 9000:2005
Additional Terms not Defined in 9000:2005 Terms that were Defined but are Different to 9000
3.23 involvement
3.25 function
3.35 strategy
3.36 object
3.38 statutory requirement
3.39 regulatory requirement
3.42 innovation
3.46 output
3.48 service
3.49 data
3.52 information system
3.56 feedback
3.58 complaint
3.66 performance indicator
3.67 determination
3.26 customer
3.27 supplier/provider
3.30 quality management
3.33 quality management system
3.34 quality policy
3.37 quality
3.41 traceability
3.44 design and development
3.45 quality objective
3.47 product
3.57 customer satisfaction
3.60 audit criteria
3.6.3 concession
3.68 review

9. Quality Management Principles
Were 8 Principles Now 7 Principles
Customer Focus Customer Focus
Leadership (Involvement) Leadership (engagement)
Involvement of People Engagement of People (empower, engage, capability
to deliver value)
Process Approach Process Approach (integrates into System into
definition)
System Approach to Management (Included in the Process Approach)
Continual Improvement Improvement
Factual Approach to Decision Making Evidence Based Decision Making (Evaluation is
included in the principle)
Mutually Beneficial Supplier Relationships Relationship Management (expands influence)

10. Conceptual Changes: Greater Emphasis on -
• Customer
• Risk-Based Thinking
• Aligning QMS Policy and Objectives with the Strategy of the
Organization
• Greater Flexibility with Documentation
• Consistently Providing Conforming Products and Services

11. Key Changes
• Understand Context of the Organization – Necessary to understand
“one size doesn’t fit all”
• Process Approach Strengthened/More Explicit
• Concept of Preventive Action Now Addressed Throughout the
Standard by Risk Identification and Mitigation
• Term Documented Information Replaces the Terms Document and
Record
• Control of Externally Provided Products and Services Replaces
Purchasing/Outsourcing

12. Structural Changes

13. ISO/TC176/SC2/N1220
4 Context of the
Organization
5 Leadership 6 Planning 7 Support 8 Operation
9 Performance
Evaluation
10
Improvement
4.1 Understand
Organization and
its Context
4.2 Understand
Needs &
Expectations of
Interested Parties
4.3 Determine
Scope of QMS
4.4 QMS and It’s
Processes
5.1 Leadership and
Commitment
5.2 Policy
5.3 Organizational
Roles,
Responsibilities &
Authorities
6.1 Actions to
Address Risks &
Opportunities
6.2 Quality
Objectives &
Planning to
Achieve
6.3 Planning of
Changes
7.1 Resources
7.2 Competence
7.3 Awareness
7.4
Communication
7.5 Documented
Information
8.1 Operational
Planning and
Control
8.2 Requirements
for Products &
Services
8.3 Design &
Development
8.4 Control of
External Processes,
Products & Services
8.5 Production
and Service
Provision
9.1 Monitoring,
Measurement,
Analysis &
Evaluation
9.2 Internal Audit
9.3 Management
Review
10 General
10.2
Nonconformity &
Corrective Action
10.3 Continual
Improvement

14. ISO/TC176/SC2/N1220
4 Context of the
Organization
5 Leadership 6 Planning 7 Support 8 Operation
9 Performance
Evaluation
10
Improvement
4.1 Understand
Organization and
its Context
4.2 Understand
Needs &
Expectations of
Interested Parties
4.3 Determine
Scope of QMS
4.4 QMS and It’s
Processes
5.1 Leadership and
Commitment
5.2 Policy
5.3 Organizational
Roles,
Responsibilities &
Authorities
6.1 Actions to
Address Risks &
Opportunities
6.2 Quality
Objectives &
Planning to
Achieve
6.3 Planning of
Changes
7.1 Resources
7.2 Competence
7.3 Awareness
7.4
Communication
7.5 Documented
Information
8.1 Operational
Planning and
Control
8.2 Requirements
for Products &
Services
8.3 Design &
Development
8.4 Control of
External Processes,
Products & Services
8.5 Production
and Service
Provision
9.1 Monitoring,
Measurement,
Analysis &
Evaluation
9.2 Internal Audit
9.3 Management
Review
10 General
10.2
Nonconformity &
Corrective Action
10.3 Continual
Improvement

15. Planning
Changes
Plan
(4, 5, 6, 7)
Do
Check
Act

16. Planning – Concept (Clause 4.0)
• Concept of the Organization must be determined
• Internal and External Issues
• Relevant Internal and External Interested Parties and their requirements

17. Planning – Process ID and Defined (Clause
4.0)
• Emphasis and One of the Most Significant Changes for Some
Organizations if 1994 Style, Lots-of-Documents, Lots-of-Words, SOP,
Procedural Based System
• IF PROCESS MAP BASED System, little change needed

18. Example of
a Process
Map
Meeting
Requireme
nts of ISO
9001:2015,
4.2.4.
For more information on
Process Mapping, email
debra@ce-q.com.

19. Planning – Leadership (Clause 5.0)
• Engaged Leadership
• Hard questions for some managers (Section 5.1 of ISO 9001:2015)
a) What evidence would I find that you, Mr. Top Manager, has taken accountability for the
effectiveness of the qms?
b) Tell me how the policy and the objectives are compatible with the context of the organization?
What is the strategic direction of the organization? Explain how the policy and objectives
parallel this strategic direction.
c) How are the QMS processes integrated into the business processes?
d) What methods are used by you to promote the use of process approach and risk-based
thinking? (What is the process approach? What is risk-based thinking?)
e) How do you ensure resources needed are available?
f) How do you communicate the importance of an effective quality management and conforming
to quality management system requirements?
g) What is the intended result of the QMS? Is it achieving its intended results
h) How do you engage people to contribute to the effectiveness of the qms? How do they know
this is what you want?
i) What drives improvement in the organization?
j) How do you ensure other managers demonstrate leadership and commitment and would
answer these questions the same way?

20. Planning – Leadership Roles and
Responsibilities (Clause 5.0)
• Must be a Plan for achieving objectives
• Five distinct roles must be appointed (can all be one person – no
longer a requirement for Management Representative
1. Ensures qms conforms to standard
2. Process are delivering their intended outputs
3. Report on performance of and opportunities for improvement
4. Ensure promotion of customer focus
5. Ensure the integrity of qms when changes are planned or implemented
…a valid question would be who has each of these roles? And asking
them examples of how they fulfilled their roles.

21. Planning – Risk and Opportunities (Clause 6.0)
• Most Noise about this one
• Requirements:
- Consider the Issues and Parties from determining the context (don’t overlook
their requirements)
- Use the risks and opportunities to PLAN actions to mitigate them
- Integrate and implement these actions into the qms processes and evaluate
the effectiveness of actions
• Notes: avoid risk, take risk in order to pursue an opportunity, eliminate the
risk source, change the likelihood or consequences, share the risk, or retain
the risk by informed decision.

22. Example of
a Process
Map
Meeting
Requireme
nts of ISO
9001:2015,
4.2.4.
For more information on
Process Mapping, email
debra@ce-q.com.

23. Planning – Objectives and Planning Change
(Clause 6.0)
• Must be able to present a plan for how objectives will be achieved
• Must have a process for planning change
…. Both of these are significant changes, as significant as the
Risk/Opportunities

24. Planning – Support (Clause 7.0)
7.1 Organizational Knowledge: knowledge necessary for the operation of its processes and to
achieve conformity of products and services.
- Must be considered when changes occur (planning/management of change)
- This is knowledge specific to the organization, gained by experience and necessary to achieve the
organization’s objectives
- It is obtained or based upon internal and external sources
7.2 Competence – determine necessary competence of persons doing work that affects the qms
(note in past was product); ensure competency, retain evidence
7.3 Awareness: Policy, Objectives, Their Contribution to the effectiveness, Implications of not
conforming with QMS
7.4 Communication: Who Communicates; What, When, to Whom and How to Communicate
7.5 “Maintain Documented Information” and “Retain Documented Information” replaced words
“documents” and “records”
Most Changes
in this Section

25. Do
Plan
(4, 5, 6, 7)
Do
(8)
Check
Act

26. Clause 8.0 Production and Service Provision
• Few changes
• A few words are different but similar requirements
• Still need to read
• Note old 7.1 Planning of Product Realization is 8.1
old 7.2 Customer Requirements is 8.2
old 7.3 Design and Development is 8.3
old 7.4 Purchasing is 8.4 Externally Provided Products & Services

27. Clause 8.0 Production and Service Provision
Continued
• Old 7.5 is now 8.5
• Some words are written different and more to think about but nothing truly
new if process approach has been previously used
• If Procedural based approach in the organization, much will need to be
reviewed
• 8.6 Release of Products and Services is what was 8.2.4
• Requires planned release at appropriate stages and retained documented
information (not new) of evidence of conformity and who released
• 8.7 Control of Nonconforming Outputs Moved from old 8.3 but same
basic requirements

28. Check
Plan
(4, 5, 6, 7)
Do
(8)
Check
(9)
Act

29. 9. Performance Evaluation
9.1 Monitoring, Measurement, Analysis and Evaluation
(was 8.2.3 in 2008 – wording added “Evaluation”, required
monitoring of customers’ perceptions)
9.2 Internal Audit
9.3 Management Review – Changes in internal and
external issues, the performance of external providers,
extent to which quality objectives have been met,
adequacy of resources, effectiveness of actions to address
risks and opportunities
9 Performance
Evaluation
9.1 Monitoring,
Measurement,
Analysis &
Evaluation
9.2 Internal Audit
9.3 Management
Review

30. Check
Plan
(4, 5, 6, 7)
Do
(8)
Check
(9)
Act
(10)

31. 10.0 Improvement
10.1 Determine and select opportunities for improvement.
10.2 Nonconformity and Corrective Action: React to the
nonconformity, much is similar except for update risks and
opportunities determined during planning, make changes
to the qms
10.3 Continual improvement of the suitability, adequacy
and effectiveness of the qms based on results of analysis
and evaluation and outputs from management review.
10
Improvement
10 General
10.2
Nonconformity &
Corrective Action
10.3 Continual
Improvement

32. Summary of “To Do”
1. Determine Context
2. ID and Define Processes
3. Prepare Top Manager and Assign 5 Roles
4. Determine Risks/Opportunities
5. Have a plan for achieving objectives
6. Establish process for planning changes.
7. Capture Organizational Knowledge.
8. Change intent of competence assessment to be skills and knowledge for
effective QMS
9. Plan how “awareness” and “communication” will be addressed
10. Ensure all “Documented Information” requirements are known and
addressed.

33. THANK YOU
?
+1 229 798 0277
debra@ce-q.com
www.ce-q.com
linkedin.com/debra-matthews-hay-hampton
fb.com/debrahayhampton