One Day

Awareness
Programme on
ISO 9001:2008
EXERCISE – 1
ICE BREAKER
 Contents
1. What is QMS?
2. What is ISO?
3. What makes an effective QMS?
4. Overview of ISO 9001:2008
5. Benefits of ISO
6. Overview of ISO Audit
7. Importance of ISO 9001 in Bull Management
8. Importance of ISO 9001 in Quality Laboratory
9. Documentation - Importance
10. Importance and process of Internal Audit
11. How to get certified as Internal Auditor?
12. Role of Individual in maintaining ISO 9001:2008
Overview  of QMS,
Standards and their
importance, Customer
Focus, Quality Policy
and Objectives
ISO 9000 FAMILY
ISO 9000:2005:- Quality management systems -
Fundamentals and vocabulary
ISO 9001:2008:- Quality management systems -
Requirements
ISO 9004:2009:- Quality management systems -
Guidelines for performance improvements

ISO 19011:2011:-Guidelines for Auditing Management

System
Quality???
Customer Focus
 External
Customers
Quality Policy and

Objectives
 ple 1
Sam
 p l e 2
Sam
Objectives - Meaning
Objectives
S = SIMPLE
 M = MEASURABLE
A = ACHIEVABLE
R = REALISTIC
T = TIME BOUND
QMS Principles,
Internal and External
Audits, Data Analysis
 QUALITY MANAGEMENT
PRINCIPLES

1. Customer Focus
 QUALITY MANAGEMENT
PRINCIPLES

2. Leadership
 QUALITY MANAGEMENT
PRINCIPLES

3. Involvement of
people
QUALITY MANAGEMENT
PRINCIPLES

4. Process Approach
 “A desired result is
achieved more
efficiently when
activities and related
resources are
managed as a
process.”
 QUALITY MANAGEMENT
PRINCIPLES

5. System Approach to the management

 QUALITY MANAGEMENT
PRINCIPLES

6. Continual Improvement
 QUALITY MANAGEMENT
PRINCIPLES

7. Factual Approach to decision making

“Effective decisions are based on the analysis of
data and information.”
 QUALITY MANAGEMENT
PRINCIPLES

8. Mutually Beneficial Supplier Relationship

Importance of ISO 9001
in
Bull Management
and
Laboratory
ISO 9001 in Bull Management
ISO 9001 in Laboratory
Role of individual in maintaining ISO 9001
ISO 9001: 2008 STRUCTURE

Section 1: Scope
Section 2: Normative Reference
Section 3: Terms and Definitions
Section 4: Quality Management System
Section 5: Management Responsibility
Section 6: Resource Management
Section 7: Product Realisation
Section 8: Measurement, Analysis & Improvement
Importance areas of ISO 9001
 Documentation – Importance
 Importance and process of Internal Audit
 How to get certified as Internal Auditor?
 Role of Individual in maintaining ISO
9001:2008
INTRODUCTION TO THE
AUDIT
 WHY INTERNAL AUDIT?
• To verify the degree of conformance
• To identify deficiencies in system
• To assess the continued suitability of system to
achieve organizational objectives
• To find out opportunities for improving the
organization’s Quality performance
AUDIT PLANNING
Audit Plan:
• Dates and Time
• Name of the auditee and auditor
• Roles and responsibilities of the audit team
member
• Any other information
CHECKLIST
Advantages
• Aid to preparation
• Indication of duration of audit
• Aid to control depth and pace of audit
• Aid to ensure that all planned arrangements
are covered
• Means of recording responses by auditee
AUDIT FOLLOW-UP
How to become internal auditors for ISO 9001?
Thank You