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.
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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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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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
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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