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SO 9000 - a set of standard series, first published in 1987 by the International

Organisation for standardisation (ISO) has become a necessity for today's every
organisation, except for smallest or only local commercial enterprises, since
globalisation and liberalisation has become a reality in the world and India too
has accepted this. Today we see in market place not only products but also
services offered by ISO certified organisations which includes goods on one hand
and banks, hospitals, schools etc on the other. We also see products and services
from multinational companies having their headquarters in other countries.
Hither to imported goods and services are now available in the Indian market and
hence the competition has become cut throat not only amongst Indian
organisations but for competitors outside country also.
Quality today has gained a wider meaning and conceptual framework with the
needs and requirements of customer oriented buyer's market from the earlier
seller's market. Basic business objectives of any organisation are survival,
profitability and leadership in the market. All functions of an organisation
production/service, purchase, finance, maintenance, marketing, including Quality
are devoted for these objectives. The success of any business enterprise depends
upon the good quality, which is based on the nature of product or service; it's
market conditions and image created by advertising etc., unless the organisation
has monopoly or acute scarcity product/service.
The Quality is defined as "totality of features and characteristics of a product or
service that bears on its ability to satisfy a given need. In Dr. Juran's words
'Quality is fitness for use".
Traditional organisations for quality rely upon inspection with a purpose to check
conformity with specifications. In modern times this conventional inspection
concept is obsolete. Today Quality control is a company wide activity and Quality
function now consists of planning, maintenance and improvement.
To understand the impact that ISO 9000 can have on the organisation, it is
necessary to focus on the interrelationship that exists between, Quality Control,
Quality Assurance and ISO 9000. Internationally accepted definition of terms
related to Quality management is given in ISO 8402 (1994). Accordingly, Quality
Control is the operational techniques and activities that used to fulfill
requirements of Quality. Quality Assurance is all planned and systematic actions
necessary to provide adequate confidence that a product or service will satisfy
the needs of customer for given requirements of Quality.
Total Quality involves an approach to organising work, which ensures that

The mission and objectives of the organisation are clear and known to all.
The systems through which work will be done are well thought out.

The responsibility to work is clearly communicated.

The quality and approach method is well defined and documented.

Measurement systems to check that work is according to plan and proven


ways to set right if things go wrong.
The ISO 9000 quality assurance approach is a documented method with all above
requirements and also to monitor how well the system is being adhered to and
method not only to correct mistakes but also for changing the system if it has
become obsolete.
To implement the ISO 9000 quality assurance system, the organisation should
have an overall Quality Policy and directions on Quality as formally expressed by
the management, who establishes and implements quality policy. The
organisational structure, responsibilities, procedures, processes and resources for
the discharge of Quality management shall be made clear in the Quality System.
ISO 9000 is a guideline document for selecting and using of the series (ISO 9001
to 9004) of standards on quality management systems and quality assurance. It
should be well understood that ISO 9000 is not a standard for any product or
service in particular or in general but it is a certification for systems under ISO
9000 series obtainable or in general but it is a certification for systems under ISO
9001, 9002, 9003.
The constitution of ISO 9000 series is as follows:
ISO 9000- 1: Quality management and quality assurance standards part-1,
guidelines for selection and use
ISO 9000-2: Quality Management and Quality Assurance Standards-Part2, General guidelines for the application of ISO 9001,9002
and 9003.
ISO 9000-3: Quality Management and Quality Assurance Standards-Part3, Guidelines for the application of ISO 9001 to the development, supply and
maintenance of software.
Thus, ISO 9000 is not really a standard but guidelines, therefore, no organisations
gets a certificate to ISO 9000 per se. ISO 9000 is used as a generic term only.
ISO 9001: Quality Systems-model for quality assurance in design development,
production, installation and servicing.
It is applicable to the organisations who themselves design the products/services
which they produce and sell to the customers. This means customer is also
buying their design capability besides product/service.
ISO 9002: Quality Systems-model for quality assurance in production,
installation and servicing.
This is applicable to the organisations who produce and sell standard
products/services. There is no designing involved. They use either standard
design or design provided by the customer.
ISO 9003: Quality Systems-model for quality assurance is final inspection
and testing.

This applies to an organisation, which has no design or manufacturing capability


of its own. They only inspect and test the final product assembled by them or
provided by sub-contractor or customer.
ISO 9004-1: Quality Management and Quality System elementsPart-I: Guidelines
ISO 9004-2: Quality Management and Quality System elementsPart-II: Guidelines for services
ISO 9004-3: Quality Management and Quality System elementsPart-III: Guidelines for processed materials
ISO 9004-4: Quality Management and Quality System elementsPart-IV: Guidelines for Quality Improvements
ISO 9004-5: Quality Management and Quality System elementsPart-V: Guidelines for Quality plans
ISO 9004-6: Quality Management and Quality System elementsPart-VI: Guidelines for Configuration Management
Apart from above ISO 10011, ISO 10012, and ISO 10013 are guidelines for
auditing quality systems, quality assurance requirements for measuring
equipment and guidelines for developing quality manuals. These are connected
with implementation of ISO 9000 series.
ISO 9001 REQUIREMENTS
The 20 requirements/clauses of ISO 9001 are as follows:
Clause No.

Tile of requirement

4.1

Management responsibility

4.2

Quality System

4.3

Contract Review

4.4

Design Control

4.5

Document and Control

4.6

Purchasing

4.7

Control of Customer supplied product

4.8

Product Identification and traceability

4.9

Process Control

4.10

Inspection and Testing

4.11

Control of Inspection, Measuring and Test equipment

4.12

Inspection and Test status

4.13

Control of Non-Conforming products

4.14

Corrective and preventive action

4.15

Handling, Storage, Packing, Preservation and Delivery

4.16

Control of Quality Records

4.17

International Quality Audits

4.18

Training

4.19

Servicing

4.20

Statistical Techniques

The 20 separate clauses are fairly easy to relate to organisations according to the
certification of ISO 9001, 9002 or 9003. While some are less applicable than
others to the organisation, most are directly related to the purchasing Quality
Management. They are 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.14, 4.15, 4.16, 4.17, 4.18,
4.19 and 4.20.
Clause 4.1: Management Responsibility
What Management should do?

o
o

Define Quality Policy


Policy, objectives and commitment
-Understood and implemented

Create an organisation

Provide resources

Define responsibility and authority

Establish verification system

Appoint Quality Coordinator/Management Representative

Responsibility for ensuring requirements are met

Conduct periodic review

Review Quality System for effectiveness

Records of review
Clause 4.2: Quality System

Document Quality System


o
Quality Manua Provides a concise overview of Quality System, Easy
Entry to longer mass of documents; aimed at audience outside the organisation
and new employees.

Quality Plans: Used to define how quality sysem requirements will be


met in specific contract or for a specified product.

Quality Records: Record of Quality Activities pertaining to design,


inspection, testing, and audit review.
Clause 4.3: Contract Review

Establish procedures for review of each contract


Requirements are defined

Differences resolved

Supplier has capability to meet the contract

Records of reviews
Clause 4.5: Document and Data Control

Document and data approval and issue (Clause 4.5.2)


o
Quality Manual, procedures, plans, forms, records, test certificates,
drawings, blue prints, inspection instructions, work instructions etc.

Distribution of documents

Removal of obsolete Documents

Document and data changes (Clause 4.5.3)

Modification Procedure

Nature of change certified

Master list set up with current revisions

Documents reissued after practical number of changes

Updating documents
Clause 4.6: Purchasing

Conformance to requirements is suppliers responsibility


Purchasing documents shall clearly describe product ordered

Sub-contractor selection based on ability to meet quality requirements

Listing of acceptable Sub-contractors

Assurance of Quality System controls in the sub-contractors

operations

Verification of purchased produce


Clause 4.7: Control of Customer supplied product

Check to ensure freedom form any defect


Storage with proper traceability

Prevent any unauthorised use

Clause 4.12:Inspection & Test Status


Identify product inspection &test status indicating conformance or nonconformance.
o
Inspected/not inspected

Accepted/hold

Rejected/repair

Establish records identifying release authority


Clause 4.13: Control of Non-conforming product

Non-conformity is the departure or absence of one or more quality


characteristics or quality system elements from specified requirements
Control entails

Identification

Documentation

Evaluation

Segregation

Disposition and notification

Non-conformity review and disposition done in accordance with procedures,


Non-conforming product may be

Reworked and reinspected

Accepted by purchaser

Regarded

Scrapped
Record to be kept of any non-conforming product accepted and of repairs.
Clause 4.14:Corrective and Preventive Action

Investigate causes- prevent recurrence

Analyse processes to detect and eliminate potential causes

Initiate preventive actions

Controls to ensure corrective actions are taken and are effective

Make and record changes in procedures causes of non-conformance

Failures, Malfunctions, deviations in incoming materials, processes,


tools, equipment etc., in which material is processed, handled stored, tested etc.

Inadequate process control

Poor scheduling

The conditions resulting from the above causes may be revealed by


analysis of

Inspection & Test records

Non-conformity records

Process monitoring

Audit observations

Customer complaints

Regulatory authority observations


Clause 4.15: Handling, Storage, Packaging, Preservation and
Delivery

Prevent damage or deterioration in handling due to vibration, shock,


abrasion, corrosion, temperature, radiation or any other condition
Provide storage (controlled physical and environment conditions that
prevents damage or deterioration of product pending use of delivery)

Packaging to protect the product and full description of contents

Delivery to the client in good condition

Clause 4.16: Control of Quality Records

Prepared to demonstrate quality achievements


Stored and maintained in proper form
Made available whenever required
Commonly used quality records include inspection reports, test data, validation
reports, calibration data, quality cost reports etc.
Clause 4.17:Internal Quality Audit

Internal audits are carried out


To verify if quality activities meet plans
To determine effectiveness of quality system

Internal Quality Audits


Regularly scheduled

Frequency/requirements determined by status, importance and

history
o

Conducted for documented procedures


Audit results are documented and brought to the attention of personnel
responsible
Clause 4.18: Training

Determine training needs


Provide training

Training should cover all functional areas of management including


marketing, design, procurement, production, quality assurance, installation,
serving etc.

Personnel qualification based on education, training and/or experience as


required

Document all training activities


Clause 4.19: Servicing

Where specified in the contract supplier established and maintains


procedures for
o
Performing service

Verifying that service meets requirements

Clarify service requirements

Plan how to provide service

Control the service equipments

Provide trained service personnel


Clause 4.20: Statistical Techniques
(* Where appropriate establish procedures for identifying adequate statistical
techniques)

Collection of Data
Analysis of Data

Draw inference

Take appropriate action

ISO 9000 to 9004 are not technical in content i.e., they do not specify any
criteria like minimum purity, pH, tolerances, hardness etc., requirements for
products. Rather the standards complement relevant product or service
requirements given in the technical product or service requirements given in the
technical specifications. Each standard focuses on documentation of operational
techniques and managerial activities to fulfil customer expectations and
requirements.
The three ISO contractual models - ISO 9001, ISO 9002 and ISO 9003 are not for
any specific industry. The standards are generic and intended to apply to all types
of industries and organisations. Involved in production of goods and services or
providing software in government, public sector, joint sector and multinationals.
Organisations wanting to survive in the fierce competition and increase their
business in global market must implement ISO 9000
Benefits of ISO 9000

Customer orientation
Marketing advantage

Confidence creation

Consistency in quality

Legal aspects

Productivity improvement

Improve economic performance

Human resource development

Preference in foreign exchange

Reduction in Quality costs


Training for ISO 9000

Awareness programme to all employees


IQA approved programme to all employees

Internal auditor training

Workshop on documentation

Sr.Executive Seminars on ISO 9000