Download - ISO 9001 2000 Overview -Induction Sep07
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ISO 9001:2000Induction - Sep 2007
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Contents
What is ISO?
Definition of Quality
ISO 9001:2000 Model
Quality Management Principles
Quality Manual
Quality Audits
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What is ISO?What is ISO?
International Organization for Standardization (ISO)
Is a worldwide federation of national standards bodies from some 130 countries, one from each country
Say what you doDo what you say
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What is ISO 9000?What is ISO 9000?
International standards for Quality Assurance Quality by focus on “process” Need for quality policy; standards and procedures Defines “whats” and not the “hows”
Focus on: Documented quality system covering all ISO
requirements Functioning in compliance to the documented quality
system
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Definition of QualityDefinition of Quality
QUALITY is “FIT for USE
Customer’s perspective of Quality
QUALITY is “CONFORMANCE to REQUIREMENTS”
Producer’s perspective of Quality
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ISO 9000:2000 ModelISO 9000:2000 Model
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YEAR 2000 STANDARDSYEAR 2000 STANDARDS
ISO Core standards
ISO 9000:2000 - Quality Management Systems – Fundamentals and vocabulary
ISO 9001:2000 - Quality Management Systems – Requirements
ISO 9004:2000 - Quality Management Systems – Guidelines for performance improvements
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Continual Improvement - Quality Management SystemContinual Improvement - Quality Management System
The ISO 9001:2000 ModelThe ISO 9001:2000 Model
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Benefits of a Process ModelBenefits of a Process Model
Provides a structure to address all aspects of an Organization
Applies to any size or type of Organization
Directs Management attention to both people and products
Highlights process ownership and responsibility
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PDCA Cycle & the Process Approach
ACTHow to
improve next time?
PLANWhat to do?
How to do it?
DODo what was
planned
CHECKDid things
happen according to
plan?
Establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization’s policies
Implement the processes
Monitor and measure processes and product against policies, objectives and requirements for the product and report the results
Take actions to continually improve process performance
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Quality Management PrinciplesQuality Management Principles
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Eight Principles are used by senior management as a framework to guide their organization towards improved performance. The ISO model is based on these principles.
Customer Focus Leadership Involvement of People The Process Approach A System approach to Management Continual Improvement Factual approach to decision making Mutually beneficial Supplier Relationship
Quality Management PrinciplesQuality Management Principles
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Quality Management PrinciplesQuality Management Principles
1. Focus on your customers Understanding customer needs and expectations Measuring customer satisfaction and acting on results
2 Provide leadership Being proactive and leading by example Establishing a clear vision of the organization’s future
3 Involve your people Accepting ownership and responsibility to solve problems Actively seeking opportunities to make improvements
4 Use a process approach Defining processes needed to achieve desired results Identifying and measuring inputs and outputs Evaluating risk and its impact
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Quality Management PrinciplesQuality Management Principles
5 Take a systems approach Structuring the system in most efficient way. Understanding interdependencies of processes in the system
6 Encourage continual improvement Continual improvement of processes, systems and products Periodic assessment against established criteria Promoting prevention based activities
7. Get the facts before you decide Measuring and collecting data & Information Analyse data and information Make decisions and take actions based on analysis
8. Work with your suppliers Identifying and selecting key suppliers Establishing relationships that balance short term gains and long term
considerations
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Compliance with ISO 9001:2000Compliance with ISO 9001:2000
Operate a Quality Management System that is:
Documented DemonstrableEffectiveMaintained
Achieve certification and maintain it
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Quiz
Q1 The PDCA cycle provides a framework for:
a) Improvement of software
b) improvement of a process or system
c) Improvement of testing cycle
Q2 The Quality Management Principle that creates a sense of belonging and pride to be
part of the organization is:
a) Customer Focused Organization
b) Process Approach
c) Involvement of People
Q3 The qualities of a good leader are:
a) Being proactive and leading by example
b) Establishing a clear vision of the organization’s future
c) Both the above
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Quality Manual & AuditsQuality Manual & Audits
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The Quality ManualThe Quality Manual
The Quality Manual is :
The superior document Contains a written description of your operational practices An explanation of how you comply with ISO 9000 Represents ACTUAL practices of the registering unit Communicates policy Defines the organization and responsibilities Lists exceptions Provides a basis for assessment
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SISL Quality PolicySISL Quality Policy
SISL shall endeavour to deliver high quality solutions and services to its customers on time and in a consistent manner. This shall be achieved through a documented Quality Management System that supports continual levels of improvement across all business processes. SISL shall ensure customer delight by working and partnering closely with them; while striving to develop competencies and improve employee satisfaction.
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Internal Quality AuditInternal Quality Audit
Ensures Quality Management System is maintained
Must be documented, demonstrable, effective, and maintained
Opportunity to assess system for opportunities for improvement
Required by ISO 9001 ( clause 8.2.2 )
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Audit ObjectivesAudit Objectives
Add value
Verify effectiveness of the implementation
Establish the degree of compliance
Identify areas for corrective action
Find opportunities for continuous improvement
The findings are against project/process/function and not against an individual
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Audit RequirementsAudit Requirements
The audit must :
Be described in the Quality Manual
Follow a documented process
Be done by trained auditors
Be reviewed by senior management
Feed directly into a Corrective Action Process
Result in a written internal audit report
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Corrective Action ProcessCorrective Action Process
The corrective action process should :
Be documented and approved
Be capable of eliminating deficiencies
Be used to evaluate the effectiveness of the quality management system on a continual basis
Have wide ownership, rather then be owned by the quality department alone
Have a clearly defined escalation process
Be accessible to all those who directly affect quality
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TerminologyTerminology
Correction
Action taken to eliminate a detected nonconformity
Corrective Action (Reactive)
Action taken to eliminate the cause of a detected
nonconformity or other undesirable situation
Preventive Action (Proactive)
Action taken to eliminate the cause of a potential
nonconformity or other potentially undesirable situation
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Non ComplianceNon Compliance
Minor non-compliance is an isolated non-fulfillment of a specific requirement which has a negligible effect on quality i.e. it does not, on its own indicate a breakdown in the QMS eg. Document numbering is not as per project /quality plan.
Major non-compliance refers to a significant failure to comply with a specified requirement or a breakdown of a quality system element (which can be indicated by a pattern of minor non-compliance) eg. No. of projects without a contract or review procedure in place, absence of a project/quality plan.
Observation refers to a potential non-conformance or suggestion for improvement
In case of any dispute Lead Auditor would moderate the findings
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Quiz
Q4 Preventive Action is:a) Proactive, where a cause of potential nonconformity is
removedb) Reactive and done in fire-fighting modec) A corrective action on a defective software
Q5 The Internal Quality Audit aims ata) Ensuring Quality Management System is maintainedb) QMS is documented, demonstrable and effectivec) Both the above
Q6 Quality is defined as :a) Fitness for Useb) Conformance to requirementsc) Both the above
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Recap…
What is ISO?
Definition of Quality
ISO 9001:2000 Model
Quality Management Principles
Quality Manual
Quality Audits
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Any Questions?
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Thank You!