This training covers the implementation of a quality management system based on ISO 9001. The agenda includes an introduction to ISO 9001 requirements, the process approach and application of a quality management system. It will discuss quality management principles, documentation control, criteria and facts of quality. It will also cover the PDCA cycle, ISO 9001 requirements, types of quality audits and their benefits. The purpose is to provide knowledge about implementing and auditing a quality management system.

1. 8/16/2013

2. Purpose of Training
 How to implement quality management system
based on ISO 9001
 Provide working knowledge essential to motivate
the team implementing the quality management
system.
 Describe the purpose of a quality management
system and explain the eight principles of quality
management
 Interpret the requirements of ISO 9001 in the
context of an audit
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3. Agenda of Training
 Introduction on basic requirements of ISO
9001:2008 & its interpretation,
 Knowledge about QMS 9001:2008 Process
Approach & application
 Knowledge about QMS.
 Linkages to Quality Management Principles
 Documentation & its control
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4. Criteria
&
Facts of Quality
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5. Criteria & Facts of Quality
Quality
Degree to which a set of inherent characteristic fulfill
requirements
Degree- The extent to which
Characteristic:
Distinguishing Feature
Inherent ( permanent) and/or Assigned
Qualitative or Quantitative
Various Classes- Physical, sensory, Functional, Behavioral,
Temporal, Ergonomics
Requirement: Stated, Implied & Obligatory
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6. Criteria & Facts of Quality
Many Facts of Quality
Quality of Work
Quality of Service
Quality of Information
Quality of Process
Quality of System
Quality of People
Quality of Objective
Quality of Company
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7. Quality Management Principle
Customer Focus- Clause : 5.0, 7.0,8.0
Leadership –Clause: 5.0, 8.0
Process Approach- Clause: 4.0, 7.0
Involvement of People- Clause : 5.0, 6.0
Continual Improvement- Clause: 5.0, 8.0
System Approach to Management- Clause :4.0, 5.0, 8.0
Factual Approach to Decision making – Clause: 8.0
Mutually Beneficial Supplier relationship-Clause: 7.4
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8. PDCA – cycle/Deming cycle as
applicable to QMS
The PDCA Cycle is a checklist of the four stages which we must go through to get
from `problem-faced' to `problem solved'.8/16/2013

9. QMS Requirements
4.0 Quality Management System
 General Requirements
 Documentation Requirements
5.0 Management Responsibility
 Management Commitment
 Customer Focus
 Quality Policy
 Quality Planning
 Quality Objective, Res. & Authority,
Communications
 Management Review
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10. QMS Requirements
6.0 Resource Management
 Provision of Recourses
 Human Resources
 Infrastructure
 Work Environment
7.0 Product Realization
 Planning
 Customer Requirements
 Design & Development Purchasing
 Production & Service Provisioning
 Control of Measuring & Monitoring Devices
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11. QMS Requirements
8.0 Measuring , Analysis & Improvement
 Customer satisfaction
 Internal Audits
 Processes
 Products
 Control of Non –conforming Data
 Analysis of Data
 Continual Improvement
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12. Quality Audit
Types & Benefits
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13. Quality Audit
Definition:
“Systematic, Independent & documented
process for obtaining audit evidence &
evaluation it objectively to determine the
extent to which audit criteria are
fulfilled”
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14. Quality Audit
Audit Evidence:
“Records, Statement of Fact or other
information which are relevant to the Audit
criteria are verified.”
 Based on Actual Observation
 Unified by emotions or prejudice
 Quantitative or Qualitative
 Stated or documented
 Meaningful Data
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15. Quality Audit
Audit Criteria:
“Set of Policies, Procedures or requirements
used as references”
Requirements
Sated Needs
Implied Needs
Obligatory/ Regulatory Needs
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16. Quality Audit
Auditor (quality):
“Person with Competence to conduct an audit”
Auditee:
“Organization being audited”
Audit Findings:
“Results of evaluation of the collected audit evidence
against audit criteria”
Nonconformity:
“The non fulfillment of audit criteria”
“Condition Adverse to Quality product”
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17. Audit Types
Types of Audits
 First Party – By a company on itself
 Second Party – By a customer on its
supplier
 Third Party – By an independent
organization
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18. Audit Cycle
Preparation Performance
o Opening Meeting
o Information Gathering
o Non-conformity Reporting
o Deciding Corrective Action
o Closing Meeting
Follow - Up
o Corrective action Verification
o Summarizing for Management
review
o Audit planning and
scheduling
o Documentation Review
o Check List Preparation
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19. Benefits
Benefits of an Audits:
 Powerful Tool to aid Continual Improvement.
 Control Mechanism utilized by Management
 Correct non – compliance before external
bodies find them
 QMS Standard requires them.
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