This document provides an overview and agenda for a presentation on quality management systems and ISO 9001:2008. The presentation covers definitions of quality and the evolution of quality management systems. It discusses the key drivers for quality management systems and the PDCA cycle that ISO 9001 is based on. The eight quality management principles and benefits of ISO 9001 certification are also reviewed. The presentation provides an overview of the clauses and elements of ISO 9001:2008, including requirements for documentation, management responsibility, and product realization. Implementation and certification processes are discussed along with potential pitfalls.

1. 1
Awareness on
Quality Management System
ISO 9001: 2008 @ SCH
June 2014
By Maheswran N.

2. 2
• Definition of Quality & Evolution of QMS
• Evolution of ISO 9001 Standard
• Key Drivers for QMS
• PDCA cycle of ISO 9001
• 8 Quality Management Principles
• Benefits of ISO 9001
• Process Approach
• Overview of Clauses / Elements of ISO 9001: 2008
• Implementation & Certification Process
• Pitfalls in Implementation
AGENDA & LEARNING OBJECTIVES

3. 3
Definition of Quality &
Evolution of QMS

4. 4
Evolution of QMS & Definition of
Quality

5. 5
5 R’s in Health Care Quality
CARE
PERSON
PLACETIME
PRICE
5 R’S
RIGHT

6. 6
6 Dimensions of Health Care
Quality - STEPEE
Safe
Timely
Equitable
Patient
Centric
Effective
Efficient
QUALITY IN
HEALTHCARE

7. 7
QUALITY
Quality is the Degree to which health services
for individuals and populations increase the
likelihood of desired health outcomes and are
consistent with current professional knowledge
Institute of Medicine (IOM)

8. 8
WHAT IS MANAGEMENT SYSTEM
Management is all about
Dealing or Controlling
Management as a Noun : refers to a Group of Managers.
Management as a Process : refers to the Functions i.e.
Planning, Organising, Directing, Controlling, etc.
Management as a Discipline

9. 9
WHAT WE MANAGE
SYSTEMS
Man (Woman)
Method
Machine Money
Material
Mother Nature
(Market)
6 M’s

10. 10
HENCE WHAT IS MANAGEMENT SYSTEM
A management system is the framework
of processes and procedures used to
ensure that an organisation can fulfill all
tasks required to achieve its policy &
objectives.[
A management system is the framework
of processes and procedures used to
ensure that an organisation can fulfill all
tasks required to achieve its policy &
objectives.

11. 11
WHY DO WE REQUIRE PROCESS /
PROCEDURE…….
Product/ Service
Process: A set of interrelated or interacting
activities which transforms inputs into output
Input Activity Output
Procedure: Specified way to carry out an
activity or a process
: Result of Process

12. 12
Policy & Objective
Policy:
Overall intentions and direction of
an organization related to quality as
formally expressed by top
management
•- Appropriate to the organization
•- Commitment to comply with
requirements
•- Commitment to continually
improve
•- Framework for establishing and
reviewing quality objectives
•- Communicated and understood
•- Reviewed for continuing
suitability

13. 13
At relevant function and levels
- Measurable
- Consistent with the
quality policy
Objective: something sought, or aimed for,
related to ... e.g. Quality, Environment, Health &
Safety

14. 14
WHAT IS ISO
ISO stands for
International Organisation for Standardisation
ISO is the world’s largest developer of voluntary ISO
Publications. Founded in the year 1947, and since then
have published more than 19000 ISO Publications. Today
there are members from 164 countries and about 150
people work full time for the Central Secretariat in
Geneva, Switzerland.

15. 15
WHAT is the objective of the ISO Body
• Develop Worldwide standards,
• Improve International communication and collaboration,
• Eliminate the differences e.g. vocabulary that promote
international trade.
• ISO standards are used by exporters and importers in both
government and industry.
ISO’s means EQUAL in Greek-
hence the Acronym ISO and not IOS

16. 16
KEY DRIVERS OF A
MANAGEMENT SYSTEM

17. 17
KEY DRIVERS FOR any MSS
•INTERNAL OR EXTERNAL TO
THE ORGANISATION
•LEGAL & REGULATORY
•IMPROVEMENT
•PREVENTION OF
SOMETHING CRITICAL THAT
ALIGNS WITH THE SCOPE OF
THAT MANAGEMENT
STANDARD
Manage-
ment
System
Standard

18. 18
KEY DRIVERS FOR EACH OF THE MGMT
SYS.
• INTERNAL OR EXTERNAL TO THE
ORGANISATION
• LEGAL & REGULATORY
• IMPROVEMENT
• PREVENTION OF SOMETHING CRITICAL
THAT ALIGNS WITH THE SCOPE OF
THAT MANAGEMENT STANDARD
MSS
• Customer Satisfaction
• Statutory & Regulatory Requirement
• Continual Improvement
• Prevention of Non conforming
product
QMS

19. 19
BASIS OF ANY MSS

20. 20
Bases on any Management System
Based on the
Deming Cycle-
PDCA
Cycle

21. 21
PLAN & DO
Plan: Establish the objectives and processes necessary to deliver
results in accordance with the expected output (the target or
goals).
Do: Implement the plan, execute the process, make the product.
Check: Study the actual results and compare against the
expected results (targets or goals from the "PLAN") to ascertain
any differences. Look for deviation in implementation from the
plan and also look for the appropriateness and completeness of
the plan to enable the execution, i.e. Collect data for charting
and analysis in the following "ACT" steps.
Act: Collect data for charting and analysis, request corrective
actions on significant differences between actual and planned
results.

22. 22
PRINCIPLES ON WHICH THE
ISO 9001: 2008 STANDARD IS
BASED

23. 23
QMS IS BASED ON 8 QMP’s
Management
Mutually Beneficial
Supplier
Relationships
Customer Focus
Leadership
Involvement
of People
Process Approach
System Approach
Factual
Approach to
Decision making
Continual
Improvement

24. 24
• Customer focus - You depend on your customers, therefore
should understand current and future customer needs, meet
their requirements and strive to exceed customer
expectations.
• Leadership - Leaders establish unity of purpose and direction
of the organization. They should create and maintain the
internal environment in which people can become fully
involved in achieving the objectives.
• Involvement of people - People at all levels are the
essence of an organization and their full involvement enables
their abilities to be used for the organization’s benefit.
• Process approach - A desired result is achieved more
effectively when activities and related resources are managed
as a process.

25. 25
• System approach to management - Identifying,
understanding and managing interrelated processes as a
system contributes to the organization’s effectiveness and
efficiency in achieving its objectives.
• Continual improvement - of the organization’s overall
performance should be a permanent objective of that
organization.
• Factual approach to decision making - Effective decisions
are based on the analysis of data and information.
• Mutually beneficial supplier relationships - An
organization and its suppliers are interdependent and this
relationship enhances the ability of both to create value.

26. 26
Process Approach
• What is a “Process”?
– Any activity that receives input and converts them to
outputs can be considered as a process
• What is “Process Approach”?
– The systematic identification and management of the
processes employed within an organisation and
particularly the interaction between such processes is
referred as the “Process Approach”. ( ISO
9000:2005 )

27. 27
Resources:
People
Facilities/Equipment
Material
Methods
•Schematic Representation of a
Process
ProcessInput Output
Results:
Products
Services
Performance
Process Approach - Concept

28. 28
With what?
Resources
Outputs
To whom/
where
What results?
Performance
indicators
Inputs
From
whom/
where
How done?
Methods/
Documentation
With Who?
Personnel
Process
(specific value
added activities)
Process Auditing “Turtle Diagram”

29. 29
QMS Process Model

30. 30
Continual improvement of the quality management system
Customer Customer
Requirements
Satisfaction
Management
responsibility
Resource
Management
Measurement,
analysis and
improvement
Product
realization
Product
output
input
QUALITY MANAGEMENT PROCESS MODEL

31. 31
QUALITY MANAGEMENT PROCESS MODEL

32. 32
Benefits of QMS

33. 33
QMS IMPLEMENTATION / CERTIFICATION
BENEFITS

34. 34
Objective & Benefits of Quality Management Systems
• To ensure the effective planning, operation and control of the
organisation’s processes.
• Communicates the same message to many people simultaneously
• Saves time – methods and processes do not need to be re-invented
each time
• Can be used as a training aid to induct people into new roles or
activities
• Documenting processes can help to ensure there are no gaps, and
that the interfaces have been properly considered
• Record and reminder of what has been agreed.
• Acts as a reference so that people can work independently
• Help to ensure consistency of output
• Provides a mechanism to communicate and implement changes.

35. 35
Overview of the ISO 9001
Elements / Clauses

36. 36
CLAUSES / ELEMENTS of ISO 9001: 2008
• 1.0 SCOPE:
• 4 C’s / Conformity, Consistency,
Continual Improvement, Customer
Satisfaction
• 1.2 Application
• 2.0 Normative Reference
• 3.0 Terms & Definitions

37. 37
Scope: 4 C’s
• Conformity
• Consistency
• Continual Improvement
• Customer Satisfaction

38. 38
4.1 GENERAL REQUIREMENTS
• Identify the processes
• Determine sequence and interaction
• Determine criteria and methods for effective control
• Ensure availability of resources and information
• Monitor, measure and analyse processes
• Implement actions for continual improvement
4.2 DOCUMENTATION REQUIREMENTS
4.2.2 Quality Manual
4.2.3 Document Control
4.2.4 Records Control

39. 39
TYPICAL DOCUMENTATION STRUCTURE6 procedures- on
1. Document Control
2. Record Control
3. Internal Audits
4. Control of Non-- conforming Products,
5. Corrective Action
6. Preventive Action
RECORDS OF
1. Training Records
2. Input / Customer enquiry / Order Review,
3. Design & Development Records
4. Supplier, selection, evaluation, re-
evaluation & Purchase Order
5. Validation of process,
6. Calibration,
7. Internal Audits,
8. Monitoring & Measuring ,
9. Non conformance,
10. Internal Audits results,
11. Management Review Records,
12. NC in Customer property
13. Traceability
14. Corrective and
15. Preventive Action
Policy &
Quality Manual- Scope,
Interaction of Processes,
Procedures -
Activity Level Work Instructions, Job
Descriptions, Quality Checklists,
Monitoring and Measurement
checks, Formats etc
Records

40. 40
5.1 MANAGEMENT COMMITMENT
5.2 CUSTOMER FOCUS
5.3 QUALITY POLICY
5.4 PLANNING
5.5 RESPONSIBILITY, AUTHORITY & COMMUNICATION
5.6 MANAGEMENT REVIEW

41. 41
5.1 MANAGEMENT COMMITMENT
Top management - commitment to the QMS by:
• Communicating the importance of meeting customer &
regulatory requirements
• Establishing the quality policy
• Establish quality objectives
• Conduct management reviews
• Availability of resources

42. 42
5.3 QUALITY POLICY
Overall intentions and direction of an
organization related to quality as formally
expressed by top management
–Appropriate to the organization
–Commitment to comply with requirements
–Commitment to continually improve
–Framework for establishing and reviewing
quality objectives
–Communicated and understood
–Reviewed for continuing suitability

43. 43
5.4 PLANNING
5.4.1 Quality objectives: something sought or aimed for
related to quality
At relevant function and levels
– Measurable
– Consistent with the quality policy

44. 44
Objective a Key Component- for driving
Management Systems
QMP
Quality as
reqd
Resources
On time
delivery
Very soon
I hope ! ???
When will we Know
whether we have
improved
Response

45. 45
OBJECTIVES- SMART

46. 46
6 Resource management
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment

47. 47
ISO 9001 - REQUIREMENTS
7 Product realization (Permissible exclusions)
7.1 Planning of product realization
7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing
7.5 Production and service provision
7.6 Control of monitoring and measuring
devices

48. 48
ISO 9001 - REQUIREMENTS
8 Measurement, analysis and improvement
8.1 General
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement

49. 49
Correction- Remedial Action , Corrective Action and
Preventive Action
CORRECTION-
Action to
eliminate a
detected
nonconformity
CORRECTIVE
ACTION -
Action to
eliminate the
cause of
detected NC
PREVENTIVE
ACTION-
Action to
eliminate
the cause of
potential NC

50. 50
Prevent
Unintended
Usage- further
damage
CORRECTION
Prevent
Recurrence -
CORRECTIVE
ACTION
Prevent
Occurance -
PREVENTIVE
ACTION
For actual Nonconformance
For potential
Nonconformance
Root Cause Analysis is a MUST
8.3 8.5.2 8.5.3
Correction- Remedial Action , Corrective Action and
Preventive Action

51. 51
Pitfalls in
QMS Implementation

52. 52
Failure to involve everyone in the
process
Failure to transfer knowledge across the
organisation
Not setting an adequate time goal
Not actively using the system created
Pitfalls
Failure to monitor progress and
enforce deadlines
Lack of Top Management
commitment
I
K
G
I
M
C

53. 53
Certification Hierarchy &
Implementation Process

54. 54
Overall IMS Implementation Stages-
Certification Audit Stages
Stage I Audit By CB- .
IMS Documentation
Review and Reports
of Internal audits and
Mgmt. Review-
Adequacy Audit
Stage II- By CB
Compliance
Audit
Take necessary actions
based on the Stage I
reports
Within 5 working days

55. 55
You never know what a unhappy customer is
capable of--

56. 56
Looking Forward for your Cooperation
& Engagement