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8/16/2013
Purpose of Training
 How to implement quality management system
based on ISO 9001
 Provide working knowledge essential t...
Agenda of Training
 Introduction on basic requirements of ISO
9001:2008 & its interpretation,
 Knowledge about QMS 9001:...
Criteria
&
Facts of Quality
8/16/2013
Criteria & Facts of Quality
Quality
Degree to which a set of inherent characteristic fulfill
requirements
Degree- The ex...
Criteria & Facts of Quality
Many Facts of Quality
Quality of Work
Quality of Service
Quality of Information
Quality of...
Quality Management Principle
Customer Focus- Clause : 5.0, 7.0,8.0
Leadership –Clause: 5.0, 8.0
Process Approach- Claus...
PDCA – cycle/Deming cycle as
applicable to QMS
The PDCA Cycle is a checklist of the four stages which we must go through t...
QMS Requirements
4.0 Quality Management System
 General Requirements
 Documentation Requirements
5.0 Management Responsi...
QMS Requirements
6.0 Resource Management
 Provision of Recourses
 Human Resources
 Infrastructure
 Work Environment
7....
QMS Requirements
8.0 Measuring , Analysis & Improvement
 Customer satisfaction
 Internal Audits
 Processes
 Products
...
Quality Audit
Types & Benefits
8/16/2013
Quality Audit
Definition:
“Systematic, Independent & documented
process for obtaining audit evidence &
evaluation it objec...
Quality Audit
Audit Evidence:
“Records, Statement of Fact or other
information which are relevant to the Audit
criteria ar...
Quality Audit
Audit Criteria:
“Set of Policies, Procedures or requirements
used as references”
Requirements
Sated Needs
Im...
Quality Audit
Auditor (quality):
“Person with Competence to conduct an audit”
Auditee:
“Organization being audited”
Audit ...
Audit Types
Types of Audits
 First Party – By a company on itself
 Second Party – By a customer on its
supplier
 Third ...
Audit Cycle
Preparation Performance
o Opening Meeting
o Information Gathering
o Non-conformity Reporting
o Deciding Correc...
Benefits
Benefits of an Audits:
 Powerful Tool to aid Continual Improvement.
 Control Mechanism utilized by Management
...
8/16/2013
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Training

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Training

  1. 1. 8/16/2013
  2. 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 8/16/2013
  3. 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 8/16/2013
  4. 4. Criteria & Facts of Quality 8/16/2013
  5. 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 8/16/2013
  6. 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 8/16/2013
  7. 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 8/16/2013
  8. 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. 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 8/16/2013
  10. 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 8/16/2013
  11. 11. QMS Requirements 8.0 Measuring , Analysis & Improvement  Customer satisfaction  Internal Audits  Processes  Products  Control of Non –conforming Data  Analysis of Data  Continual Improvement 8/16/2013
  12. 12. Quality Audit Types & Benefits 8/16/2013
  13. 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” 8/16/2013
  14. 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 8/16/2013
  15. 15. Quality Audit Audit Criteria: “Set of Policies, Procedures or requirements used as references” Requirements Sated Needs Implied Needs Obligatory/ Regulatory Needs 8/16/2013
  16. 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” 8/16/2013
  17. 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 8/16/2013
  18. 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 8/16/2013
  19. 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. 8/16/2013
  20. 20. 8/16/2013

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