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ISO 9001:2000
Quality management System

Introduction to

ISO 9001:2000

What is Quality ?
Quality is customer satisfaction Quality means conformance to specified requirements Quality means fitness for use
Latest definition

Quality is customer delight ness

with respect to Standard Availability Price and Safety

Degree to which a set of inherent characteristics (of a product, system or process) fulfills requirements (of customers and other interested parties).
(ISO 9000:2000)


ISO 9000:2000 ISO 9001:2000 ISO 9004:2000 ISO 19011-2002 Fundamentals & Vocabulary QMS - Requirements QMS - Guidelines for performance improvement QMS & EMS auditing guidelines

QUALITY MANAGEMENT Principle 1 - PRINCIPLES Customer focus

Principle 2 Principle 3 Principle 4 Principle 5 Principle 6 Principle 7 Principle 8 Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationships

Principle 1 Customer Focus

Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.

Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organizations objectives.

Principle 2 Leadership

Principle 3 Involvement of People

People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organizations benefit.

Principle 4 Process approach

A desired result is achieved more efficiently when activities and related resources are managed as a process.

Principle 5 System approach to management Identifying,

understanding and managing interrelated processes as a system contributes to the organizations effectiveness and efficiency in achieving its

Principle 6 Continual Improvement

Continual improvement of the organizations overall performance should be a permanent objective of the organization.

Principle 7 Factual approach to decision are based on making Effective decisions

the analysis of data and information.

Principle 8
Mutually beneficial supplier relationships An organization and
its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

Quality Management Systems The Continual Improvement approch PLAN



Continual Improvement of the Quality management System

Management Responsibility

Resource Management
Measurement Analysis and Improvement



Product Realization


Value-adding actions Information flow

The structure of ISO 9001:2000

1. 2. 3. 4. 5. 6. 7. 8. Scope Normative Reference Terms and Definitions Quality Management System Management Responsibility Resource Management Product Realization Measurement, Analysis and Improvement

Section 4 - General requirements.

4.1 General Requirements of QMS 4.2 Documentation requirements

4.2.1 General
4.2.2 Quality manual 4.2.3 Control of Documents

4.2.4 Control of Records

5 Management Responsibility.
5.1 5.2 5.3 5.4 5.5 5.6 Management commitment Customer focus Quality Policy Planning (QMS and Q. Objectives) Responsibility, authority and communication Management Review

A surprise for Management !!

Section 6 - Resource Management

6.1 6.2 6.3 6.4 Provision of resources Human Resources Infrastructure Work environment

The organization shall determine and provide resources needed to implement and improve the Quality Management System.
and to enhance

Customer satisfaction

Section 7 Product realization

7.1 7.2 7.3 7.4 7.5 7.6 Planning of product realization Customer related processes Design and development Purchasing Production and service provision Control of monitoring & measuring devices

The organization will need to plan and develop processes required for Product realization.

7. Product Realization
7.1 Planning of Product Realization
To plan and develop the processes needed for Product Realization Planning to be consistent with the requirements of other processes of QMS (see 4.1) During planning, determine the following, as appropriate:
Quality Objectives and requirements for product; Need to establish processes & documents and provide resources; Required verification, validation, monitoring, inspection and test activities and criteria for product acceptance; Records to provide evidence that realization processes and resulting products fulfill requirements

Output of planning in a form suitable for organizations method of operations (It may be referred as Quality Plan)

7. Product Realization (Contd.)

7.2 Customer-related Processes
7.2.1 Determination of Requirements Related to the Product Organization to determine
requirements specified by customer, including delivery and postdelivery activities (e.g. warranty / guarantee / servicing); requirements not stated by the customer but necessary for specified use or known intended use;

statutory and regulatory requirements related to product;

any additional requirements determined by the organization

7. Product Realization (Contd.)

7.2 Customer-related Processes (Contd)
7.2.2 Review of Requirements Related to the Product
Requirements related to product be reviewed prior to supplying the same (e.g. submission of tenders, acceptance of contracts / orders, acceptance of changes to contracts / orders) to ensure that product requirements are defined Contract or order requirements differing from those previously expressed are resolved The organization has ability to meet defined requirements

7. Product Realization (Contd.)

7.2 Customer-related Processes (Contd)
7.2.2 Review of Requirements Related to the Product (Contd.)
Records of result of reviews and actions arising to be maintained Where customer provides no documented statement of requirement, these to be confirmed by organization before acceptance When product requirements are changed, amend relevant documents Relevant personnel are made aware of changed requirements

7. Product Realization (Contd.)

7.2 Customer-related Processes (Contd)
7.2.3 Customer Communication Determine and implement effective arrangements for communicating with customers related to
Product information Enquiries, contracts or orders handling, including amendments Customer feedback including customer complaints

7. Product Realization (Contd.)

7.3 Design & Development (D/D)
7.3.1 Design and Development Planning
Plan and control Design and Development of the product During planning, determine Stages of design and development Review, verification and validation appropriate to each Design and Development stage Responsibilities and authorities for Design and Development Manage interface between different involved groups to ensure effective communication and clear responsibilities Update planning output, as appropriate, as Design and Development progresses

7. Product Realization (Contd.)

7.3 Design & Development (D/D) (Contd)
7.3.2 Design & Development Inputs Determine the inputs related to product requirements and maintain records Design & Development inputs to include
Functional and performance requirements Applicable statutory and regulatory requirements Where applicable, Information derived from previous similar designs Other requirements essential for Design and Development

Review inputs for adequacy. Requirements to be complete, unambiguous and non-conflicting

7. Product Realization (Contd.)

7.3 Design & Development (D/D) (Contd)
7.3.3 Design & Development Outputs Outputs of D/D provided in a form that enables verification against D/D inputs. This shall be approved prior to release D/D Outputs shall :
meet D/D input requirements provide appropriate information for purchasing, production and for service provisions contain or reference product acceptance criteria specify product characteristics essential for safe and proper use

7. Product Realization (Contd.)

7.3 Design & Development (D/D) (Contd)
7.3.4 Design & Development Review
At suitable stages, conduct systematic D/D reviews to evaluate the ability of results of D/D to fulfill requirements to identify any problems and proposed necessary actions Involve and include representatives of functions concerned with design stage(s) being reviewed Records of results of reviews and necessary actions to be maintained

7.3.5 Design & Development Verification

Perform verification to ensure that D/D outputs have satisfied D/D input requirements Records of results of verification & necessary actions to be maintained

7. Product Realization (Contd.)

7.3 Design & Development (D/D) (Contd)
7.3.6 Design & Development Validation
Perform D/D validation in accordance with planned arrangements (see 7.3.1) to ensure
Resulting product is capable of fulfilling the requirements for the specified or known intended use or application

Wherever practicable, validation to be completed prior to delivery or implementation of the product Records of results of validation and necessary actions to be maintained

7. Product Realization (Contd.)

7.3 Design & Development (D/D) (Contd)
7.3.7 Control of Changes Changes in D/D to be identified and records maintained The changes to
be reviewed, verified and validated, as appropriate be approved before implementation include evaluation of the effect of changes on constituent parts and delivered products

Records of the results of validation and necessary actions to be maintained

7. Product Realization (Contd.)

7.4 Purchasing
7.4.1 Purchasing Process
Organization to ensure that purchased product confirms to specified purchase requirements Type and extent of controls on suppliers and purchased product dependent upon effect of the purchased product in subsequent product realization or the final product Evaluate and select suppliers based on their ability to supply Establish criteria for selection, evaluation and re-evaluation Records of results of evaluations and actions arising from evaluation to be maintained

7. Product Realization (Contd.)

7.4 Purchasing (Contd)
7.4.2 Purchasing Information
Purchasing information to describe the product to be purchased including where appropriate requirements for approval of product, procedures, processes and equipment requirements for qualification of personnel, and quality management system requirements Ensure adequacy of specified purchasing requirements prior to their communication to supplier

7. Product Realization (Contd.)

7.4 Purchasing (Contd)
7.4.3 Verification of Purchased Product Establish and implement the inspection or other activities for ensuring that purchased product meets specified purchase requirements Where organization / customer intends to perform verification at supplier premises, state the intended verification arrangements and method of product release in purchase information

7. Product Realization (Contd.)

7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision Plan and carry out production & service provisions under controlled conditions which include, as applicable
availability of information that describes product characteristics availability of work instructions use of suitable equipment availability and use of monitoring and measuring devices implementation of monitoring and measurement implementation of release, delivery and post-delivery activities

7. Product Realization (Contd.)

7.5 Production and Service Provision (Contd)
7.5.2 Validation of Processes for Production and Service Provision (earlier known as special processes)
Validate any processes for production and service provision where resulting output can not be verified by subsequent monitoring / measurement. These include
any processes where deficiencies become apparent only after the product is in use or service has been delivered

Validation to demonstrate the ability of processes to achieve planned results

7. Product Realization (Contd.)

7.5 Production and Service Provision (Contd)
7.5.2 Validation of Processes for Production and Service Provision (Contd.)
Establish arrangements for these processes to include following, as applicable :
Defined criteria for review and approval of the processes Approval of equipment and qualification of personnel Use of specific methods and procedures Requirements for records Revalidation

7. Product Realization (Contd.)

7.5 Production and Service Provision (Contd)
7.5.3 Identification and Traceability Where appropriate, identify the product by suitable means throughout product realization Identify the product status w.r.t. monitoring and measurement requirements Where traceability is a requirement, control and record the unique identification of the product
NOTE: In some sectors, the above is met by configuration management

7. Product Realization (Contd.)

7.5 Production and Service Provision (Contd)
7.5.4 Customer Property Customer Property - It may be hardware, software, intellectual property, tools, jigs, fixtures, packing material etc. For Customer property provided for use or incorporation, organization to ensure
Identification Verification Protection and Safeguard of product

Any customer property lost, damaged or found unsuitable to be reported to customer and records maintained

7. Product Realization (Contd.)

7.5 Production and Service Provision (Contd)
7.5.5 Preservation of Product Ensure that during internal processing and delivery to the intended destination, product conformity is preserved These include
Identification Handling Packaging Storage Protection

This also apply to constituent parts of a product

7. Product Realization (Contd.)

7.6 Control of Monitoring & Measuring Devices
Determine the monitoring & measurements to be undertaken Monitoring & Measuring devices needed to provide evidence of conformity of product to determined requirements Establish processes to ensure that monitoring & measurement capability is consistent with monitoring & measurement requirements

7. Product Realization (Contd.)

7.6 Control of Monitoring & Measuring Devices (Contd)
Where necessary to ensure valid results, measuring equipment be
Calibrated or verified at specified interval or prior to use - Traceable to national / international standards - Where no such standards exists, basis used for calibration or verification to be recorded Adjusted or re-adjusted as necessary Identified to enable calibration status to be determined Safeguarded from adjustments that would invalidate measurement results Protected from damage and deterioration during handling, maintenance and storage

7. Product Realization (Contd.)

7.6 Control of Monitoring & Measuring Devices (Contd)
Assess and record the validity of previous measuring results if equipment is found not to confirm the requirements. Also take appropriate actions on equipment and product affected

Keep records of the results of calibration and verification

If Computer Software are used, the ability of Computer Software to satisfy the intended application be confirmed
To be undertaken prior to initial use and re-confirmed as necessary NOTE: See ISO 10012-1 & ISO 10012-2 for guidance

Section 8 - Measurement, analysis & improvement 8.1 8.2 8.3 8.4 8.5 General Monitoring and measurement Control of nonconforming product Analysis of data Improvement

The organization shall plan and implement the monitoring, measurement, analysis and improvement processes: Conformity of product, of the QMS and achieve improvement

Here comes a big one !!

Quality Policy and Objectives A quality manual Documented Procedure required by the Standard Other documents required to monitor, control and improve the processes Records

ISO 9000 QMS Documentation Requirements (4.2.1)

4.2 Documentation Requirements (Contd)

NOTE 1:Term Documented Procedure implies procedure to be established, documented, implemented and maintained The Extent of QMS documentation to depend upon the size of organization & type of the activities the complexity of the processes and their interaction, & the competence of personnel

NOTE 2:-

NOTE 3:-

The documentation can be in any form or type of medium

QMS ACC.TO ISO 9001-2000Documentation

Document Hierarchy
Document Contents Quality manual

(Level A)
QMS Procedures

A: Describe the QMS in accordance with the stated Quality Policy and Objectives
B: Describe the Interrelated Process and activities required to implement the QMS C: Consist of detailed work documents

(Level B)
Work Instructions and Other Documents (Level C)

QMS ACC.TO ISO 9001-2000Documentation

Quality Manual (4.2.2) The Quality Manual includes (mandatory content):
a) Scope of QMS, including exclusions and their
justification Example


Documented procedures of the QMS or reference to them Description of the interaction between the QMS processes - Example
SPECIMENS\Justification for exclusions.pdf


Typical Structure of a Quality Manual Introduction of the Organization (Company Profile)

Quality Policy Quality Objectives Scope Of QMS including the exclusions

Description of the KEY BUSINESS PROCESS

Description of the SUPORTIVE BUSINESS PROCESS Interaction among the Processes

Procedures or reference to them

Example Typical Content Page SPECIMENS\Content Page.pdf

5.3 Quality Policy Top Management to ensure that Quality Policy

Is appropriate to purpose of the organization Includes a commitment to comply with requirements and continually improve the effectiveness of QMS Provides a frame-work for establishing and reviewing Quality Objectives Is communicated and understood within the organization, and Is reviewed for continuing suitability

Example 1 XYZ Limited will continuously improve its products and services to satisfy the needs to its customers better and will deliver to them, on time and every time, defect-free products and services. Example 2 It is the companys policy to manufacture and market goods which comply with the customers needs and the designers specifications. The quality system is designed to ensure the maintenance of the product quality standard through the evaluation, inspection and verification of processes at all stages of manufacture. Compliance with the provisions and objectives of this manual are mandatory for all employees of the company.

Example 3 Quality means fitness for the intended purpose in all aspects of the companys activities. The company will strive to meet the needs of its customers through a continuous process of quality improvement. All employees are responsible for quality improvement. Education and training are vital to the quality improvement process. Measurable annual objectives for quality improvement will be set. Emphasis must be on prevention rather than detection. The company will involve its suppliers in the process of quality improvement.
Example 4 It is the policy of the company to continually meet and exceed customers' needs. This is the only way to ensure the companys future prosperity. To this end, the company has instituted a quality system which complies with ISO 9001. All staff shall be familiar with the quality procedures that are relevant to their work and shall use them.

Example 5 XYZ Ltd produces (state name of product) for both domestic and export markets. As a supplier, it is our policy to ensure that supplies adhere to contractual specifications and satisfy the customer in terms of consistent quality and timely delivery. We are committed to maintaining an effective quality management system through the active involvement of all employees. We will comply with all statutory safety and environmental regulations to ensure the safety of our employees and to discharge our responsibility to society.


QUALITY POLICY Excellence in Quality is the Core value of Hero Hondas Philosophy. We are committed at all levels to achieve high quality in whatever we do, particularly in our products and services which will meet and exceed customers growing aspirations through: Innovation in products, processes and services. Continuous Improvement in our total Quality Management Systems. Team Work & Responsibility
Place: New Delhi Date: 01-07-2001

Pawan Kant Munjal (Director)

Gillette India Ltd

QUALITY POLICY We consider Quality to be the consistent Satisfaction of Customers. - both Internal and External Quality is achieved by Team Work and Commitment of each employee towards. - Customer Satisfaction, - Continuous Improvement - Doing Things Right the First Time Date: July 15,2005 Place: New Delhi Managing Director

Quality Policy of the Sri Lanka Standards Institution, Standardization Division is To enhance industrial development and economic growth of the country, we are committed to provide our technical services to exceed customer expectation every time, with high standards of professionalism, updated knowhow and through co-operate effort of all stakeholders

5.4.1 Quality Objectives

Top Management to ensure that :
Quality objectives, including those needed to meet product requirements (see 7.1 a), at relevant functions and levels within the organization are established. Quality Objectives shall be measurable and consistent with Quality Policy (including commitment to continual improvement)

Aim to reduce
Errors:variations,defects,failure,repair, damages,rework,reject,complaints,warranties, claims,accident,idle time, non-conformity, etc. Breakdown of : equipment, process, machine, instrument, software, etc. Delays of : internal schedules, delivery schedules, promised services, benefits, awards, payment to suppliers, etc.

Aim to reduce
Inventories : raw, process, semi-finished & finished product; spares, consumables, etc.. Paper Work : Excessive procedures, recording/approvals, etc. Emissions : To air, to water, to ground, noise, vibrations, spillages, leakages, odour, etc

Aim to improve
Customer satisfaction : Increased turnover, customer retention, compliments, timely payment, etc. Yield : Production efficiency, throughput per unit of inputs/per hour/per unit of space etc. Employee Satisfaction : Competency, career advancements, involvement etc. Profits : Per unit of sale, per unit of input, per employee, per machine, ROI, etc.

Examples of Quality Objectives

Redyeing reduced from 5% to 2.5% Maintenance cost/spindle shift reduced by 22% despite inflation of 7-8% during last 4 years. Ring frame productivity improved by about 5-7% across various products during last 3 years. Adherence to delivery commitments increased from 90-94% to 97-100% based on product. Customer complaints/year reduced from 95 to 43 despite 12% increase in volume over last 3 years. 6 to 7 new products were launched in the market every year.

Mitra Industries Ltd

QUALITY OBJECTIVES To improve average customer satisfaction level by 3% from last year. To improve sale by 30% from that of last year. To maintain or reduce manufacturing and marketing cost by 5% through effective development of personnel and processes. To increase production by 30% from last year. To reduce the rejection and product non conformities by 5% from last year average. To improve scheduled delivery by 5% over last year average To meet and maintain statutory/regulatory requirements.
Lalit Mahajan Managing Director

Date: 01.06.2001 Place: New Delhi

Gillette India Ltd

QUALITY OBJECTIVES 1. Excellent Quality Rating for all Products in LCI 2. No Shave Test failure 3. Ensure 100% Service Level 4. Steel Spoilage as per Budget 5. Ensure Cp value more than 1 for Key Product Characteristics. Date: July 15,2005 Place: New Delhi Managing Director

Key Business Process

A brief description of each key Business Process to be indicated providing the following information
(Name of the Process)

Policy/Purpose: Responsibilities: Implementation:

Examples SPECIMENS\K ey Business Process.pdf


Supportive Business Process

A brief description of each Supportive Business Process to be indicated providing the following information
(Name of the Process)

Policy/Purpose: Responsibilities: Implementation:


Examples SPECIMENS\ Supportive B Process.pdf


Interaction among the Processes

QMS Planning 4.1, 5.4.2, 6.1, 7.1, 8.1 Top Mgt. Commitment 5.1, 5.2, 5.3, 5.4, 5.5 Provision of Resources



6.4 Q M S D O C U M E N T A T I O N

Sales & Marketing 7.2 R&D 7.3

7.5.3 Procurement 7.4 Stores 7.5.5 7.5.3 Production 7.5.1 7.6 Customer Property 7.5.4
Verification. 7.4.3 After Sales

7.5.3 Stores 7.5.5


7.6 Customer Perception 8.2.1

NCPs 8.3
Product MM 8.2.4 7.6


Data Analysis

NCPs 8.3 4.2.1 4.2.2 4.2.3 4.2.4

System effectiveness 8.2.2

8.4 Monitoring of all QMS Processes 8.2.3

CPA 8.5.2, 8.5.3

Mgt. Review 5.6