iso 9000 introduction sumant
TRANSCRIPT
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ISO 9000: An Introduction
Presented by:
Sumant KumarDate: 05/08/2011
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ISO 9000An Introduction
Expectations:
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ISO 9000An Introduction
What we will cover:
1. Introduction to Quality & Quality
Management System2. What is ISO, ISO 9000, etc.
3. QMS Principles
4. Advantages & Benefits of ISO 9001
5. ISO 9001 Standard
6. ISO 9001; Introduction: The Process &Systems Approach
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ISO 9000An Introduction
What we will cover (continued):
7. ISO 9001: QMS Model
8. ISO 9001; Introduction: The PDCACycle
9. ISO 9001; Clause 7: Product
Realization10. ISO 9001; Clause 8: Measurement,
Analysis & Improvement
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What is Quality?
Degree to which a Product or Servicefulfills Requirements.
Quality is what a Customer wants and iswilling to pay for.
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Quality Management System
To Manage the Quality, we need a Quality ManagementSystem; also called the QMS.
It is one that ensures good business practice. For example:Set quality goals
Ensure customer requirements are understood and met
Train employees
Control your production processes
Purchase process and control to ensure quality product
Correct problems and make sure they do not happen again
What is a good QMS?
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Documented QMS: What it contains?
The Quality Management System (QMS) isdocumented in the:
Quality Policy
Quality Manual
Procedures Work Instructions
Records
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What is ISO?
What is ISO 9000ISO 9001..ISO
9001:2008..?
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What is ISO?
ISO is the International Organization ofStandardization
ISO is an organization that developsStandards for use worldwide to help
companies plug into the worldmarket.
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ISO 9000 Family
ISO
9000
ISO
9004
ISO
9001
QMSRequirementsQMSGuidelines for
Performance Improvement
QMSFundamentals
& Vocabulary
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Quality Management Principles: From ISO 9000
1. Customer Focus
2. Leadership
3. Involvement of People
4. Process Approach
5. System Approach to Management
6. Continual Improvement7. Factual Approach to Decision Making
8. Mutually Beneficial Supplier Relationships
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ISO 9001 is an outline for a QMS
ISO Standards are made by a Technical
Committee comprising of Quality Experts &
Business Leaders.
When you build your QMS based on ISO
9001:2008, it means you are building your
QMS to the Internationally recognized ISOStandard.
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Advantage of having ISO 9001
Once the quality system is in place a Registrarwill come and audit. (The Registrars areaccredited organizations.)
If all the criteria are being followed, thecompany will be
ISO 9001 Registered.
Registered companies put their Registrationmark in marketing materials.
Potential customers will know that you have agood Quality Management System in Place.
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ISO 9001:2008 Introduction
Process
Approach
Input PROCESS Output
Resources
Controls
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ISO 9001:2008 Introduction
System Approach
PROCESS
A
PROCESS
D
PROCESS
B
PROCESS
C
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PDCA Cycle
ISO 9001:2008 Introduction
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The ISO 9001 Standard
ISO 9001:2008 Standard
Section 1: Scope
Talks about the standard and how it applies to organisations Section 2: Normative Reference References another document that should be used along with the standard, ISO 9000:2008,
Quality Management Systems-Fundamentals and Vocabulary Section 3: Terms and Definitions Gives a few new definitions Section 4: General Requirements
Gives requirements for the overall Quality Management System Section 5: Management Responsibility
Gives requirements for Management and their role in the Quality Management System Section 6: Resource Management
Gives requirements for resources including personnel, training, the facility and workenvironment
Section 7: Product Realization
Gives requirements for the production of the product or service, including things likeplanning, customer related processes, design, purchasing and process control
Section 8: Measurement, Analysis and Improvement
Gives requirements on monitoring processes and improving those processes
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ISO 9001:2008
Input Output
C
US
T
O
ME
R
R
E
QU
I
R
E
M
E
N
T
S
Continuous Improvement of the
4. QMS
5. Management Responsibility
6. Resource
Management
8. Measurement,
Analysis, Improvement
C
US
T
O
M
E
R
S
A
T
IS
F
A
C
T
I
O
N7. Product
RealizationProduct
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Product Realization
The processes in our organization thatactually result in the product or
service that goes to our client.
ISO 9001:2008 Clause 7
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Product Realization (Contd.)
The Sections includes the following clauses:7.1 Planning for Product Realization
7.2 Customer related processes
7.3 Design and Development
7.4 Purchasing7.5 Production and Service
7.6 Control of Monitoring & Measuring Equipment
ISO 9001:2008 Clause 7
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Production and Service Provision
7.5.1 Control of Production and ServiceProvision
7.5.2 Validation of Processes for Productionand Service Provision
7.5.3 Identification & Traceability
7.5.4 Customer Property
7.5.5 Preservation of Product
ISO 9001:2008 Clause 7.5
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ISO 9001: 2008; Section 8
Sub-section 8.1 General
The organization shall plan and implement the monitoring,measurement, analysis & improvement processes needed
to demonstrate conformity to product requirements
to ensure conformity of QMS, and
to continuously improve the QMS.
This shall include determination of applicable methods, includingstatistical techniques, and the extent of their use.
Measure, Analyze and Improve
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Corrective & Preventive Action
Corrective and Preventive action systems should beused by all employees to address problems andpotential problems.
Correction: The immediate solution to a problem that has
occurred.
Corrective Action:Fix a problem that has occurred, and prevent
it from happening again.
Preventive Action:When you see something that may cause a
problem, fix it and prevent the problem from happening.
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Any Questions?
Let us keep interacting.
Best wishes.