The document discusses several key topics regarding revisions to the ISO 9001 standard including a shift to risk-based thinking, a focus on process approach and leadership, expanded focus on people, changes to documented information requirements, and clarification on terms. It also provides implications of the changes such as improved integration across processes and departments, increased responsibility of senior management, and more flexibility for organizations.

2. TO PICS TO BE CO VERED
MajorRevisions of the ISO9001 standard
Main business processes and theirinteraction
Preventive Action vs RiskManagement
Process Approach & interaction of processes
Leadership and operationalization of strategic plans
Management Representative
Importance of people
Detoxing documentation
Stakeholders vs Suppliers
Minorchanges and Clarifications

3. QUALITY EFFORTS
Analyse Attitude Behaviour
= Quality Management

4. REVISIONS
Reclassification of preventive action to Riskbased thinking
Focus on Process Approach
Focus on Leadership
Expansion of focus on people
Documented Information
External providers
No reference to Management Representative
Clarification between Competence and Awareness
Removal of Quality Manual

5. BUSINESS

6. ROOT CAUSE ANALYSIS IN THE BUSINESSROOT CAUSE ANALYSIS IN THE BUSINESS
CONTEXTCONTEXT
Proactive Analysis
Perform Proactive analysis to identify
significant risks and safeguard to prevent
and mitigate associated consequences
-What co uld g o wro ng ?
-What are the co nse q ue nce s o f the se
actio ns?
-What co uld cause the se co nse q ue nce s
-Like liho o d o f the se co nse q ue nce s
Management Systems
Set up systems to manage equipment and
human behaviour to adequately control
risks
-Eq uipm e nt de sig n, Mainte nance
strate g ie s, m e tho ds, & pro ce dure s
-Co re & Adm inistrative pro ce sse s
-Training , Em plo ye e scre e ning
--Le ade rship, Me asure m e nt e tc.
Reactive Analysis
Perform reactive analysis to identify improvements in the safeguards
to prevent and mitigate associated consequences
-What did g o wro ng ?
-What we re the co nse q ue nce s o f the se actio ns?
-What cause d the se co nse q ue nce s?
What chang e s sho uld be m ade to the pro active analysis pro ce ss and
the m anag e m e nt syste m to ade q uate ly co ntro lthe risks?
Incident
Occurs
Unacce ptabl
e failure s,
lo sse s and
ine fficie ncie
s
Operations

7. RISK MANAGEMENT - UNDERSTANDING THE
BUSINESS FROM AN EXTERNAL CONTEXT
Tools include:
-SWOT Analysis (Strengths, Weaknesses, Opportunities and
Threats)
-PESTEL ( Political, Economic, Sociocultural, Technological,
Environmental and Legal)
-Porter’s Five Forces
-Failure Mode and Effects Analysis

8. RISK MANAGEMENT - UNDERSTANDING THE
BUSINESS FROM AN INTERNAL CONTEXT
 Governance Structure
 Procedures
 Organization’s Culture
 Relationships with internal and external stakeholders
 Capabilities (Capital, time, people, processes, technology,
systems)

9. RISK MANAGEMENT - UNDERSTANDING THE
BUSINESS FROM AN EXTERNAL CONTEXT
Implications:
-Betterforecasting (customerneeds, technological changes,
competitive advantage)
-More predictive than reactive
-Lowerfailure costs (defects, rework, returns, warranties,
downgrading, recalls, complaints processing etc.)
-Increased credibility/trust
-Focus on improvement (less firefighting)

10. COST OF QUALITY

11. PROCESS APPROACH
 Improved communication across departments
 Motivated internal customers
 Betterteamwork
 Betterunderstanding of contribution and importance of roles
 Less bottlenecks
 Problem-solving
 Improved planning
 Value added vs. non-value added
 Improved customerservice delivery

12. PROCESS IN AN ENTERPRISE
CONTEXT
Process performance measures
should reflect the performance of
the process within an enterprise
context.
The customer sees only a single
process regardless of how complex
the internal processes are.
Focus on process performance
and connect them to performance of
the business.

13. LEADERSHIP
ISO 9001 recognizes:
 Leadership deficit
Wrong personnel in management
Complaints fromtop management, staff about senior
management performance
Impact on Global Crisis about world views on management
Impact caused by lackof direction, vision
Lackof commitment

14. LEADERSHIP
Implications:
Increased responsibility, accountability of the senior
management
Risk-based thinking at the management level, less reactive
management
Performance of seniormanagement connected to the
performance of the organization
Less dependence on the management representative and more
ownership
BetterIntegration of quality across departments

15. PEOPLE
Organizational Knowledge * Competence * Awareness* Communication
Clause 7.1.2 “…determine and provide the persons….”
Effective Implementation of the QMS
Operation of Control of its processes

16. PEOPLE
Organizational Knowledge * Competence * Awareness* Communication
Organizational Knowledge
Undocumented experience
Undocumented knowledge
Intellectual property
Lessons learnt
Understanding organization’s knowledgewealthordeficit

17. PEOPLE
Organizational Knowledge * Competence * Awareness* Communication
Competence
Hiring requirements
Needs Assessment
Effective Training
Verification of training
Performance Management
Mentoring
Focus ontheindividual to buildtheteam’s performance

18. PEOPLE
Organizational Knowledge * Competence * Awareness* Communication
Awareness
Not confused with training
More focus on understanding policies
Understanding contribution to overall performance

19. PEOPLE
Organizational Knowledge * Competence * Awareness* Communication
Communication
Managed and structured communication
Criticality
Improved transferof information
Consideration of appropriate methodologies

20. DOCUMENTED INFORMATION
 Removal of the Quality Manual
 Less focus on documentation
 Removal of Mandatory procedures

21. DOCUMENTED INFORMATION
Implications
Understanding that documents are a means to an end
Focus on process to develop procedures (inputs, outputs)
Detoxification of documents
Understanding the required documentation foroptimum
performance
Gives companies more flexibility

22. THE EFFECT OF RISK CONTROL ON PERFORMANCE
Managing Risk to
Enhance
Performance
Excessive
controls
minimise risk
and constrain
performance
Exposed &
destroying
performance
Ignorant Managing Obsessed
Level of Risk Control
Performance
Low
High
11/09/15
22

23. DOCUMENTED INFORMATION
Process Analysis

24. EXTERNALLY PROVIDERS
Implications:
Consideration of the impact of both Upstreamand
Downstreamstakeholders
 Raw materials, contractors, consultants, distributors,
shippers, truckers etc.)
Improved Integration of providers
Feedbackloop improvements

25. CLARIFICATIONS
 Analysis and Evaluation
 More prescriptive
 Shows the application of analysis
 Actionable

26. CLARIFICATIONS
 WorkEnvironment
 Not limited to production
 Other processes
 Monitoring and Measuring Resources
 Not limited to equipment
 Other applications (software, communication devices)
 Flexibility based on global changes