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8/10/2019 Binisha ISO
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Smt N.C. Gandhi & B.V. Gandhi
mahila arts & commerce college
Subject: ISO 9001:2008 & its 20 elements
By: Binisha Mehta
BMS -3 SEM-6
Roll no: 13
Guided by: Mr.Pradeep Gohil
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Contents
Introduction
Definition
20 Elements
Principles of ISO 9001:2008
Benefits of ISO 9001:2008
Summary of ISO 9001:2008 in informal language
Review of the topic Bibliography
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ISO 9001:2008 basically re-narrates ISO 9001:2000. The 2008
version only introduced clarifications to the existing
requirements of ISO 9001:2000 and some changes intended
to improve consistency with ISO 14001:2004. There were no
new requirements. For example, in ISO 9001:2008, a quality
management system being upgraded just needs to be checked
to see if it is following the clarifications introduced in the
amended version.
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Definition One of the standards developed by the International
Organization for Standardization (ISO). The purpose of this family of
standards is to increase customer satisfaction through the
deliverance of quality products and services.
ISO 9001 Definition: ISO 9001 is a set of internationally agreed
standards that provide guidelines for a Quality Management
System. If your organization meets ISO 9001-2008 then you can
become certified to the standard. Interestingly, ISO 9001-2008 can
apply to any type of organization. This includes manufacturing,
service, software or even non profit organizations
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ISO 9001:2008 is the International Standard for Quality
Management Systems (QMS).It provides your company with a
set of principles that ensure a common sense approach to the
management of your business activities to consistently
achieve customer satisfaction.
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20 Elements1. Management Responsibility
Top Management is required to:
1. develop a Quality Policy reflecting the organization's attitude to
quality and ensure it is communicated throughout the organization.
2. allocate appropriate resources and trained personnel to perform
the work.
3. appoint a management representative to monitor the Quality
System.
4. conduct regular management reviews to ensure the health of the
quality system .
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2. Quality System
The system must:
1. be fully documented within the framework of ISO 9000.
2. satisfy customer's requirements and specifications.
3. be adapted to your organization.
4. define how quality requirements will be met.
5. demonstrate thorough planning to meet customer
requirements.
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3. Contract Review
1. Sales must review the orders and contracts with thecustomer.
2. Any change must be reviewed and agreed to with the
customer.
4. Design Control
All phases of product or service design (engineering) must
be controlled and conducted by qualified personnel. (This
pertains to ISO-9001 only.)
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5. Document and Data Control
1. All documents and data used must be controlled and
authorized.
2. Obsolete documents must be removed form circulation;
latest issues must be located at appropriate areas
throughout the facility and available at the workplace.
3. Changes must be recorded and released in a controlled
manner.
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6. Purchasing
1. Purchasing information must be complete and
accurate.
2. Suppliers must be qualified and selected based on
demonstrated quality.
3. Suppliers must be monitored continuously.
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7. Control of Customer Supplied Product
If and when customers supply the materials for their
products, you must ensure that:
1. you report to the customers any discrepancy or damage to
their products.
2. their products can be identified easily.
3. their products are handled and stored accordingly.
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8. Identification and Traceability
Products must be identified at all times and through all phases of
production.
9. Process Control
You are required to have a complete process, with appropriate
written procedures, to perform and monitor all production activities,which affect quality.
10. Inspection
You are required to have documented verifications at all critical stagesof your process:
1. Receiving of raw material.
2. Work in process.
3. Final inspection.
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11. Calibration
All inspection and measuring equipment (Gauges, thermometers,
scales , test software...) must be controlled and maintained in
calibration. You are required to:
1. provide unique identification and list of all inspection and
measuring equipment.
2. determine the required accuracy.
3. protect and maintain the equipment to ensure continuing accuracy.
4. calibrate each instrument on a pre-determined cycle to established
procedures.
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12. Inspection and Test Status
The test status of all product must be identified through all
phases of production.
The test status indicates whether the product has passed or
failed inspection.
13.Control of Nonconforming Product
Any nonconforming product must be properly identified and
segregated (if practical) with a documented disposition.
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14. Corrective and Preventive Action
You are required to have a formal process to correct and
prevent problems form occurring. The process will insure that:
1. root cause is investigated
2. corrective and/or preventive action is taken
3. the effectiveness of corrective and/or preventive is verified
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15. Handling, Storage, Packaging, Preservation and Delivery
You are required to have documented procedures for:
1. Handling
2. Storage
3. Packaging
4. Preservation
5. Delivery
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16. Control of Quality Records
Records which demonstrate compliance to procedures and
ISO-9000 must be:
1. identified
2. legible
3. accurate
4. filed and indexed properly
5. easily retrievable
6. retained for a specified period of time
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17. Internal Quality Audits
You are required to conduct formal internal audits to examineall activities affecting quality, and evaluate their complianceto:
1. documented procedures.
2. ISO 9000 requirements.
18. Training
You are required to:
1. identify training needs.
2. provide appropriate training.
3. document training activities.
4. ensure only trained people carry activities affecting productquality.
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19. Servicing
If you provide "servicing" as part of the contract, you are
required to control:
1. the design and use of the service equipment.
2. use trained and qualified personnel.
3. ensure product and parts availability.
4. document working procedures and methods.
20. Statistical Techniques
Any data analysis, sampling methods, and SPC used must be
based on established procedures and sound statistical
techniques.
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Principles of ISO 9001:2008
When fully adopted, these principles can help improve your
organizational performance:
Customer focus: organizations depends on their customers,
and therefore need to shape activities around the fulfillment
of market need
Leadership: is needed to provide unity of purpose and
direction
Involvement of people: creates an environment where
people become fully involved in achieving the organization's
objectives
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Process approach: to achieve organizational objectives,
resources and activities need to be managed as processes, with
an understanding of how the outputs of one process affects the
inputs of another
System approach to management: the effectiveness and
efficiency of the organization depends on a systemized
approach to work activities
Continual improvement: adopting this as a part of everyday
culture is a key objective for an organization
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Fact based decision-making: effective decisions are
based on the logical and intuitive analysis of data and
factual information
Mutually beneficial supplier relationships: suchrelationships will enhance the ability to create value.
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What are the benefits of registration?
1. Customer satisfaction - through delivery of products that
consistently meet customer requirements
2. Reduced operating costs - through continual improvement of
processes and resulting operational efficiencies
3. Improved stakeholder relationships - including staff,
customers and suppliers
4. Legal compliance - by understanding how statutory andregulatory requirements impact on the organization and its
your customers
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5. Improved risk management - through greater consistency
and traceability of products and services
6. Proven business credentials(That which entitles one to
confidence, credit, or authority) - through independent
verification against recognized standards
7. Ability to win more business - particularly where
procurement specifications require certification as a
condition to supply
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8. Involves Top management in the improvement of the Quality
management System
Facilitates the organization to become a customer-focused
organization.
9. Ensures sustained customer satisfaction by producing,
delivering services and providing support functions that
meet customer's needs and expectations.
10. Increases the effectiveness and efficiency of the organization
through continual improvement in systems and products
/services quality
Summary of ISO 9001 2008 in informal
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Summary of ISO 9001:2008 in informal
language
The quality policy is a formal statement from management, closely
linked to the business and marketing plan and to customer needs.
The quality policy is understood and followed at all levels and by all
employees. Each employee works towards measurable objectives.
The business makes decisions about the quality system based on
recorded data.
The quality system is regularly audited and evaluated for
conformance and effectiveness.
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Records show how and where raw materials and products were
processed to allow products and problems to be traced to the
source.
The business determines customer requirements.
The business has created systems for communicating with
customers about product information, inquiries, contracts,
orders, feedback, and complaints.
When developing new products, the business plans the stages of
development, with appropriate testing at each stage. It tests and
documents whether the product meets design requirements,
regulatory requirements, and user needs.
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The business regularly reviews performance through internal
audits and meetings. The business determines whether the
quality system is working and what improvements can be
made. It has a documented procedure for internal audits.
The business deals with past problems and potential
problems. It keeps records of these activities and the resulting
decisions, and monitors their effectiveness.
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The business has documented procedures for dealing with
actual and potential nonconformance's (problems involving
suppliers, customers, or internal problems).
The business:
makes sure no one uses a bad product,
determines what to do with a bad product,
deals with the root cause of problems, and
keeps records to use as a tool to improve the system.
f h
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Review of the topic
Introduction
Definition
20 Elements
Principles of ISO 9001:2008
Benefits of ISO 9001:2008
Summary of ISO 9001:2008 in informal language
Bibliography
ibli h
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Bibliography
Productivity and quality management
Yogesh Zaveri
Sheth publishers
Production and Operation Management
K. Ashwathappa
K. Shridhara Bhatt
Himalaya publishing house
Productivity Management
A practical handbook,Oxford & IBH publishing co. pvt ltdJoseph
Prokopenko
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