Quality Management System and Iso

Subject: ISO 9001:2008 & its 20 elements Name : Bhavika Kalathiya R.

B.M.S:3 [sem-5]

Roll no: 08

Guided By : :- Pradeepsir Gohil

College :SMT.N.C.Gandhi & B.V. Gandhi Mahila Arts & commerce college. Bhavnagar
Contents
What is ISO ?
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
case study
What is ISO ?
ISO is the international organization for standardization based in Geneva Switzerland. On 23 Feb. 1947, ISO began operation. ISO member organization: national standards institutes from countries large & small from all regions of the world. ISO develops technical standards to contributes in marking the manufacturing & supply of goods & services more efficient ,safer and cleaner. since 1947, ISO has published more than 15000 standards.
INTRODUCTION OF ISO 9001 ISO 9001:2008 Quality management systems — Requirements is a document of approximately 30 pages which is available from the national standards organization in each country. It is supplemented by two other standards: ISO 9000:2005 Quality management systems — Fundamentals and vocabulary and ISO 9004:2009 Managing for the sustained success of an organization — A quality management approach. Only ISO 9001 is directly audited against for third party assessment purposes The other two standards are supplementary and contain deeper information on how to sustain and improve quality management systems; they are therefore not used directly during third party assessment. 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.
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 nonprofit organizations
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.
20 Elements of ISO
1. 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.
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.
3. Contract Review
1. Sales must review the orders and contracts with the customer.
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.)
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.
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.
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.
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 stages of your process:
1. Receiving of raw material.
2. Work in process.
3. Final inspection.
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.
1. determine the required accuracy.
2. protect and maintain the equipment to ensure continuing accuracy.
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.
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
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
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
17. Internal Quality Audits You are required to conduct formal internal audits to examine all activities affecting quality, and evaluate their compliance to:
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 product quality.
19. Statistical Techniques Any data analysis, sampling methods, and SPC used must be based on established procedures and sound statistical techniques.
20. 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.
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
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
Fact based decision-making: effective decisions are based on the logical and intuitive analysis of data and factual information
Mutually beneficial supplier relationships: such relationships will enhance the ability to create value.
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 and regulatory requirements impact on the organization and its your customers
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
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.
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. .
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.
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.

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
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 ltd – Joseph Prokopenko
Case study
Case Study: Building a QMS to deliver high- quality IT services Tulip Telecom, a data telecom and IT service provider, built their management system to ensure customer satisfaction and protect against potential security breaches.
The Challenge Tulip wanted their customers to have confidence in the quality, delivery, reliability, and price of their services. They also wanted to make improvements in employee training and increase skill levels within the company.

The Solution Key clients required and expected Tulip to be able to demonstrate that it had a quality management system (QMS) in place. In addition to seeking ISO 9001 certification, Tulip also chose to implement the ISO 27001 standard in order to more effectively manage information security risks. They chose Intertek as their registrar for these standards because of our well-established reputation in the telecom industry.