Quality Management System

1. Course Objectives
An understanding of ISO 9001:2015 requirements &
interpretation of the ISO clauses.
An understanding of the requirements and application of
Quality Management System (QMS)
An Understanding on Risk Based Approach

2. Course Contents
Overview of ISO 9001
Introduction to QMS & Requirements
Interpretation of the ISO 9001:2015 clauses

3. OVERVIEW OF ISO 9001 QMS
&
REQUIREMENTS

4. About ISO
 Non-governmental organization (NGO) established in
1947, based in Geneva, Switzerland
 Has a membership of 163 national standards
institutes from countries in all regions of the world
4

5. About ISO
5
 Developed various standards for all dimensions of
sustainable development: economic, environmental and
societal
• Examples :
 ISO 9001 – Quality Management Systems (QMS)
 ISO 14001 – Environmental Management Systems (EMS)
 ISO 27001 – Information Security Management Systems (ISMS)
 ISO 31000 – Risk Management (Principles and Guidelines)
 SIRIM and STANDARD Malaysia are major
representative to ISO

6. What is ISO 9001?
6
 ISO 9001 is the world’s most popular and most
commonly used standard for Quality Management
Systems (QMS)
 International consensus on good management practice
 Focuses on meeting customer requirements and other
interested parties
 Covers any organization – whatever the size, industry or
culture

7. Benefits of the New ISO 9001:2015
 Puts greater emphasis on leadership engagement
 Helps address organizational risks and opportunities in a
structured manner
 Uses simplified language and a common structure and
terms
 Addresses supply chain management more effectively
 Is more user-friendly for service and knowledge-based
organizations

8. Advantages of Certification
 Compliance with customer requirements
specifying certification
 Independent check of conformity
 Indicates an effective Quality System
 National/International recognition
 Provides competitive advantage
 Improves company image
8

9. Why Was ISO 9001 Revised?
9
 Adapt to a changing world
 Enhance an organization’s ability to satisfy customers
 Maintain relevance, provide integrated approach to
organizational management, and integrate with other
management systems
 Reflect needs of all user groups and increasingly
complex operating environments
 Set a consistent foundation for the next 10 years

10. Key Improvements to ISO 9001:2015
10
 Increased emphasis on achieving value for the
organization and its customers
 A greater emphasis on leadership and organizational
context
 The focus on risk-based thinking
 Emphasis on objectives, measurements and change
 Stakeholder-focused communication and awareness
 Decreased emphasis on documentation

11. Emphasis on ProcessApproach
 Understanding and meeting
customer requirements
 How do processes value add
 Measure process performance
and effectiveness
 Continual improvement of
processes based on
measurement

12. Risk-based Management
 To improve customer confidence
and satisfaction
 To assure consistency of quality
of products and services
 To establish a proactive culture
of prevention and improvement
 Successful companies intuitively
take a risk-based approach
 Improve governance
Risks Opportunities

13. ISO 9001 Approach is Based on the
Plan-Do-Check-Act (PDCA) Cycle
Organization and
its context (4)
Customer
Requirements
Customer
Satisfaction
Products
and services
Results of
the QMS
Needs and expectations
of relevant interested
parties (4)
Leadership
(5)
Performance
evaluation
(9)
Support &
Operation
(7,8)
Planning
(6)
Improvement
(10)
Plan Do
Check
Act

14. PDCA and ISO 9001 Clause Structure
ACT PLAN
DO
CHECK
9. Performance
Evaluation
4. Context of the
Organization
5. Leadership
6. Planning
7. Support
8. Operations
10. Improvement
0. Introduction
1. Scope
2. Normative References
3. Terms & Definitions

15. Quality Management Principles
Customer focus
Leadership
Engagement of people
Process approach
Improvement
Evidence-based decision making
Relationship management

16. The structure of ISO 9001 :2015
1. Scope
2. Normative reference
3. Terms and definitions
4. Context of the organisation
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement

17. ISO 9001 Clause Structure (4-10)
PLAN DO CHECK ACT
4. Context of
the
organization
5. Leadership 6. Planning for
the QMS
7. Support 8. Operation 9. Performance
evaluation
10.
Improvement
4.1 Understanding
the organization
and its context
5.1 Leadership and
commitment
6.1 Actions to
address risks and
opportunities
7.1 Resources 8.1 Operational
planning and
control
9.1 Monitoring,
measurement,
analysis and
evaluation
10.1 General
4.2 Understanding
the needs and
expectations of
interested parties
5.2 Quality policy 6.2 Quality
objectives and
planning to
achieve them
7.2 Competence 8.2 Determination
of requirements for
products and
services
9.2 Internal audit 10.2 Nonconformity
and corrective
action
4.3 Determining the
scope of the QMS
5.3 Organizational
roles,
responsibilities and
authorities
6.3 Planning of
changes
7.3 Awareness 8.3 Design and
development of
products and
services
9.3 Management
review
10.3Continual
improvement
4.4 QMS and its
processes
7.4 Communication 8.4 Control of
externally provided
products and
services
7.5 Documented
information
8.5 Production and
service provision
8.6 Release of
products and
services
8.7 Control of
nonconforming
process outputs,
products and
services

18. Representationof thestructureof this International
Standard in the PDCAcycle
Leadership
(5)
Support and
Operation
( 7,8)
Improvement
(10)
Planning (6)
Performance
evaluation (9)
Plan Do
Check
Act
Quality Management System (4)
Organization and
its context (4)
Customer
requirements
Needs and
expectations
of relevant
interested
parties (4)
Customer
satisfaction
Products and
services
Results of
the QMS

19. 4 Context of the Organization
4.1 Understanding the Organization and its context
Consider the external and internal issues of the organization
Determine the issues relevant to its purpose
Determine the issues effecting its ability to achieve the QMS
intended results

20. 4 Context of the Organization
4.2 Understanding the needs and expectations of the
interested parties
Determine the interested parties that are relevant to
the quality management system
Determine the requirements of these interested
parties that are relevant to the quality management
system

21. 4 Context of the Organization
4.3 Determining the scope of the QMS
Scopes to be considered are as follow:
- external and internal issues
- requirements of relevant interested parties
- products and services covered
Scopes to be documented stating
- product/ service covered by QMS
- justification for applicability

22. 4 Context of the Organization
4.4 QMS and its processes
The organization shall
Determine Inputs, outputs, sequence and interaction of processes
Ensure effective operation of process
Ensure availability of resources
Plan action to address risk and opportunities
Determine methods to monitor, measure and evaluate process
Determine opportunities to improve process and QMS

23. 5 Leadership
5.1 Leadership and commitment
Top management to demonstrate leadership and commitment.
Accountability
Quality policy and quality objectives
Integration of the quality management system
Promoting awareness of the process approach
Ensuring resources are available
Communicating the importance
Ensuring results are achieved
Engaging, directing and supporting
Promoting improvement
Supporting other managers

24. 5 Leadership
5.2 Quality Policy
 Documented
 Suitable and appropriate
 Commitment to meet requirements and continual
improvement
 Frame work for quality objectives
 Communicated & understood
 Available to relevant interested parties

25. 5 Leadership
5.3 Organizational roles, responsibilities and authorities
Top management shall assign the responsibility and authority to
Ensure QMS conforms to requirements
Processes delivering intended output
Reporting on performance of QMS
Ensure customer focus
Ensure integrity of QMS maintained when QMS change

26. 6 Planning
6.1 Actions to address risk and opportunities
Organization shall determine the risk and opportunities to
 Assure QMS achieve intended results
 Prevent or reduce undesired results
 Achieve continual improvement
Organization shall plan how to
 integrate and implement actions into QMS
 evaluate effectiveness of action taken

27. 6 Planning
6.2 Quality objective and planning to achieve them
Quality objectives shall be
Established at relevant functions, levels and processes
Consistent with quality policy
Relevant to applicable requirements & conformity of products &
services to enhance customer satisfaction
Monitored, communicated & updated

28. 6 Planning
6.2 Quality objective and planning to achieve them
Determine
What to be done
What resources will be required
Who will be responsible
When it will be completed
How the results will be evaluated

29. 6 Planning
6.3 Planning of changes
Organization determine need for change and consider
Purpose of change
QMS integrity
Available resources
Responsibility /authority

30. 7 Support
7.1 Resources
Organization determine, provide and maintain infrastructure for
operation of its processes
People
Infrastructure
Environment for the operation of processes
Monitoring and measuring resources
Organizational knowledge

31. 7 Support
7.1.2 People
Sufficient manpower
Competent personnel
For the effective implementation of QMS and for the operation
and control of its processes.

32. 7 Support
7.1.3 Infrastructure
Preventive maintenance program for
Building & associated utilities
Equipment (hardware & software)
Transportation resources
Information & communication technology

33. 7 Support
7.1.4 Environment for the operation of processes
Provide and maintain environment necessary which can include:
Social (non-discriminatory, calm, non-confrontational)
Psychological (stress-reducing, burnout prevention, emotionally
protective)
Physical (temperature, heat, humidity, light, airflow, hygiene,
noise)

34. 7 Support
7.1.5 Monitoring and measuring resources
Calibration schedule
Planned intervals
Traceable to international or national standards
Label calibration status
Safeguarded from unauthorized adjustment
Protected from damage and deterioration
Maintain calibration records

35. 7 Support
7.1.6 Organizational knowledge
Determine, maintain and made available the knowledge
necessary:
Specific knowledge gained by experience / information used
and shared to achieve objectives
Based on internal sources and external sources

36. 7 Support
7.2 Competence
The organization shall
Determine necessary competence of personnel
Take actions to acquire necessary competence, and evaluate
effectiveness of actions taken
Maintain training record for all trainings

37. 7 Support
7.3 Awareness
Employees to be aware of
Quality policy
Relevant quality objectives
Their contribution to QMS
Implications of not conforming to QMS

38. 7 Support
7.4 Communication
Organization shall determine what, when, with whom, how to
communicate and who communicates to internal and external
people.

39. 7 Support
7.5 Documented information
In general, QMS shall include
Documented information required by standard
Documented information for effective QMS

40. 7 Support
7.5 Documented information
Creating and updating
When creating and updating, ensure
Identification and description
Format
Review and approval
Documented information has to be controlled to
Be available and suitable for use
Adequately protected

41. 7 Support
7.5 Documented information
Control of documented information
Documented information is controlled by addressing
Distribution, access, retrieval and use
Storage and preservation
Control of changes
Retention and disposition
Control external origin document

42. 8 Operation
8.1 Operational planning and control
The organization shall
Determine requirements
Establish criteria
Determine resources
Implement control
Retain documented information

43. 8 Operation
8.2 Determination of requirements for products and
services
The organization shall
Establish process to communicate with customers
- Product/ service information, enquiries/ contracts/ orders,
customer feedback/ complaints, customer property,
requirements for contingency actions
Determine product and service related requirements
Review product and service related requirements

44. 8.3Designand developmentof productand services
8.3.1 General
8.3.2 Planning
Plan design and development activities, required process stages,
verification & validation activities, responsibilities
Determine resources required
8.3.3 Design and Development Inputs
Functional and performance requirements
Statutory and regulatory requirements
Information from previous design
Other requirements
Input shall be documented
8 Operation

45. 8.3.4 Design and Development Controls
Ensure:
 Results are achieved
 Design and development is reviewed to meet
requirements
 Verification and validation are conducted
 Problems are resolved
 All above activities are documented
8 Operation

46. 8.3.5 Design and Development Outputs
Meet input requirements
Provide information for purchasing, production and service
provision
Contain product acceptance criteria
Specify product characteristic
8.3.6 Design and Development Changes
Identified and recorded
Reviewed, verified and validated as appropriate
Authorization of the changes
Actions taken to prevent adverse impacts
8 Operation

47. 8 Operation
8.4 Control of externally provided product and services
Organization shall establish criteria for
Evaluation
Selection
Performance monitoring
Re-evaluation
Organization shall
Determine type and extend of control
Communicate to external providers the requirements for QC,
competence, QMS, control and verification

48. 8 Operation
8.5 Production and service provision
For production and service provision organization shall
Implement controlled condition
Practice identification and traceability to ensure conformity
Exercise care with property belonging to customer/external provider
Ensure preservation of process outputs
Meet requirements on post-delivery
Control unplanned changes

49. 8 Operation
8.6 Release of product and services
Organization shall implement planned arrangements for
verification of conformity
8.7 Control of nonconforming outputs
Organization shall
Ensure nonconformance is identified and controlled
Take appropriate corrective action

50. 9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
The organization shall
Determine what, when and methods for monitoring and measurement
Monitor customer satisfaction
Analyze and evaluate the appropriate data

51. 9 Performance evaluation
9.2 Internal audit
Internal audit conducted at planned intervals
QMS must
Meet organizations and QMS requirements
Meet standard requirements
Effectively implemented and maintained

52. 9 Performance evaluation
9.3 Management review
shall be planned and consider
Status of previous meeting actions
Changes in internal/external issues
Performance & effectiveness of QMS
- Customer satisfaction & feedback, quality objectives achievement, nonconformity
& corrective action, monitoring & measurement results, audit results, external
providers performance
Resources adequacy
Process performance
Effectiveness of action taken for risk and opportunities
New opportunities for continual improvement

53. 10 Improvement
10.1 General
Organization shall select opportunity for improvement to
Prevent nonconformance
Meet known and predicted product and service requirements
Improve QMS results

54. 10 Improvement
10.2 Nonconformity and corrective action
When nonconformity occurs, organization shall
React to nonconformity
Evaluate need for action to eliminate cause
Implement action needed
Review effectiveness of corrective action taken

55. 10 Improvement
10.3 Continual Improvement
Organization shall
continually improve suitability, adequacy and effectiveness of
QMS
consider output from analysis, evaluation and MR to confirm
underperformance or opportunities for continual improvements
Select and utilize tools and methods to investigate cause of
underperformance for continual improvement

56. Questions