ISO 9000

WHY I CHOOSE THIS TOPIC…………..

Today every organization work hard to get ISO approval certificates, as it plays an important role for conducting business internationally. I have chosen this topic to understand the following things:  What is ISO?  What is ISO 9000?  Series of ISO 9000  Benefits of ISO 9000  What is ISO 14000?  Series of ISO 14000  Benefits of ISO 14000

1

WHAT IS ISO?

ISO i.e. International Organization for Standardization is the world's largest developer and publisher of International Standards. ISO is a network of the national standards institutes of 157 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. The word ISO is derived from GREEK word “ISOS”, meaning, “EQUAL”, so only we notice abnormality when we use full form international organization for standardization i.e. IOS , shouldn’t be but it is ISO because of its origin in GENEVA. ISO is a non-governmental organization that forms a bridge between the public and private sectors. On the one hand,

many

of

its

member

institutes

are

part

of

the

governmental structure of their countries, or are mandated by their government. On the other hand, other members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations. The mission of ISO is to promote the development of standardization and related activities in the world. With a view to

2

facilitating international exchange of goods and services and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity. ISO standards are developed by technical committees. The people who serve on these technical committees come from many national standards

standards

organizations.

Consequently, ISO

tend to have worldwide support. ISO revises its

standards during a period of time. ISO Management Systems are published six times a year by the Central Secretariat of ISO (International Organization For Standardization) and is available in English, French and Spanish editions.

Plan – Do – Check – Act

3

The Plan – Do – Check – Act (PDCA) cycle is the operating principle of ISO's management system standards.

Plan:

Establish objectives and make plans (analyze your organization's situation, establish your overall objectives and set your interim targets, and develop plans to achieve them).

Do:

Implement your plans (do what you planned do).

Check: Measure your results (measure/monitor how far your actual achievements meet your planned objectives). Act:

Correct and improve your plans and how you put them into practice (correct and learn from your mistakes to improve your plans in order to achieve better results next time).

WHO ARE THE MEMBERS? 4

A

map

of

standards

bodies

who

are

ISO

members

Key: members

correspondent members

subscriber members

other places with an ISO 3166-1 code who aren't members of ISO ISO has 157 national members out of the 195 total countries in the world. ISO is made up of its members which are divided in to three categories: •

Member bodies are national bodies that are considered to be the most representative standards body in each country. These are the only members of ISO that have voting rights.

•

Correspondent members are countries that do not have their

own

informed

standards about

ISO's

organization. work,

standards promulgation.

5

but

These

members

do not participate

are in

•

Subscriber members are countries with small economies. They pay reduced membership fees, but can follow the development of standards.

A member body takes the responsibility for: ♦ Informing potentially interested parties in their country for international standardization. ♦ Ensuring that a concerted view of the countries interest is presented

during

international;

negotiations

dealing

to

standard agreements. ♦ Providing countries share of financial support for the central operations of ISO through payment of membership dues. ♦ Member bodies are entitled to exercise fill voting rights on any technical committee and policy committee of ISO. Participating members are called "P" members as opposed to observing members which are called "O" members.

6

WHAT IS ISO 9000?

I S O 9 0 0 0 is a set of quality management standards governing quality assurance. It provides a frame work for a systematic approach to process management that requires an organization to keep a detailed accounting of its procedures and work. This includes documenting the process for how a company designs, produces, inspects, packages, and installs product. The structure focuses on management of process, these results in continuous process improvement through a quality system. It focuses on writing down procedures and defining policies regarding how an order is processed? It starts with taking customers orders and follows the order through manufacturing and assembling to shipment and deliver the underlying. The unwritten message is that the product should meet the customers need. The decision to implement ISO 9000 is driven by two dominant factors: the desire to remain competitive and the desire to implement a quality system to lower operating cost.

7

ISO 9000 was written by international organization of standardization (ISO) of Geneva, Switzerland which was founded in 1946 to develop a common set of manufacturing, trade and communications standards that are widely used today. Standards developed by ISO are voluntary; there are no legal requirements to force a country or organization to adopt them.

8

SERIES OF ISO 9000 The standards are usually referred to ISO 9000, it is infact composed of five parts. ISO 9000 is essentially an introductory document which provides statement of purpose. ISO 9001, ISO 9002, ISO 9003 are three specific quality system models based on the company’s function.

While

ISO

9004

is

asset

of

guidelines

for

implementation and auditing of a actual process. ISO 9000

GUIDES

CONFORMANCE MODEL

ISO 9000

ISO 9001

ISO 9004

ISO 9002 ISO 9003

9

the

TABLE OF FIVE PARTS OF ISO This table lists the three conformance models and two guides of the ISO series of standards. TYPE OF

NAME OF

STANDARD

STANDARD

CONFORMANCE

ISO 9001

MODEL

DESCRIPTION OF

Quality

STANDARDS

assurance

in

development,

design,

production,

installation & servicing.

ISO 9002

Quality

assurance

in

production,

installation & services.

ISO 9003

Quality assurance in final inspection and test.

Guidelines for selection & use of the GUIDES

ISO 9000

standards on quality management system

elements

&

quality

assurance.

ISO 9004

Guidelines for quality management & quality system elements.

10

THE DIFFERENCES AMONG THE SYSTEM MODELS ISO 9000 covers all the 20 elements, while ISO 9002 and ISO 9003 require only those elements applicable to the specific model. The selection of ISO 9001 versus 9002 is done by not a company does but by what it does not do. If the site does not perform design or research and development, it does not implement ISO 9001. One of the biggest area of confusion surrounding the standards is the mistaken belief that ISO 9001 is better than ISO 9002 & 9003, it is not, nor are companies registered to 9001 are better companies. 9003 was written for companies that do not perform manufacturing or assembling, just find inspection and test. It is easier to achieve 9002 than 9001, because there are fewer functions involved. 9003, however does not take into account certain quality system elements that are required by 9002 and 9001. However, companies that perform design and servicing can apply for 9002 or 9003. Because the process of implementing ISO 9001 is difficult, some companies choose to incorporate it in stages and set up through the standards. If the company can separate this process, this is an acceptable choice.

11

TABLE OF DIFFERENCES IN SYSTEM MODEL SR. NO.

AREAS

APPLIED TO ISO 9001

1.

9002

9003

X

X

Management Responsibility

2.

Quality System

3.

Contract Review

4.

Design Control

5.

Document and Data Control

6.

Purchasing

7.

Control on Customer Supplied Product

8.

Product Identification and Trace Ability

9.

Process Control

10.

Inspection and

X

Testing

12

11.

Control on Inspection, Measuring and Test Equipments

12.

Inspection and Test Status

13.

Control on NonConforming products

14.

Corrective and Preventive Action

15.

Handling, Storage, Packaging, Preservation & Delivery

16.

Control on Quality Records

17.

Internal Quality Audits

18.

Training

19.

Servicing

20.

Statistical Techniques

X

QUALITY SYSTEM STANDARDS OF ISO 9000 13

Quality systems standards are published by ISO in order to built quality products and encourage quality improvements in organization. ISO 9000 has 3 models for quality assurance and quality improvements: ISO 9001, ISO 9002 and ISO 9003. QUALITY SYSTEM REQUIREMENTS: 1)

MANAGEMENT RESPONSIBILITY: Quality is top management’s responsibility. Hence it must organize plan and be committed to quality.

1.1)

Quality Policy: Management shall define an document quality policy. It shall contain objectives for and commitment to Quality shall relevant to organizational goals and customer needs. It shall also ensure that it is understood and implemented at all levels.

1.2)

Organization:

1.2.1) Responsibility and Authority: Under this management should define,

document

responsibility,

authority

and

inter-

relationship of personnel and also of those whose work affects quality. 1.2.2) Resources: In this management should identify requirement, provide requirement. Resources include trained personnel. 1.2.3) Management Representative: He is a member of suppliers own management. He shall:

14

 Have authority to ensure that quality system is established, implemented and maintained.  He shall report to management on performance of the system. 1.3)

Management Review: In this  Management

shall

review

quality

systems

at

defined

intervals to ensure suitability and effectiveness of system.  2)

Records of such reviews shall be maintained.

QUALITY SYSTEM:

2.1) General: The organization should establish document and maintain a quality system to ensure that product conforms to specified requirements in addition a:  Quality manual is to be prepared covering requirements of this standard.  Quality manual shall refer to or include quality system procedures.  Quality manual should outline documentation structure. 2.2) Quality System Procedures: Procedures consistent with quality policy should be prepared carefully implement the same. 2.3) Quality Planning: Preparing of quality plans and how the requirements of quality are to be met. While doing quality planning supplier should pay attention towards products, projects or contracts. 3) 3.1)

CONTRACT REVIEW: General:  Pre-tender review before submission of tender. 15

 Customer review after receipt of order but before its acceptance. 3.2)

Review: Ensure that:  Requirements are adequacy defined and documented.  Differences between tender and order are resolved.  Capability to meet requirements exists.

3.3) Amendments

to

a

Contract:

establish

procedures

for

amending a contract and for correctly transferring that information to appropriate functions. 3.4) 4)

Records: Maintain records of contracts reviewed. DESIGN CONTROL:

4.1) General: Documented procedures for control and verifications of design to ensure meeting customer requirement. 4.2)

Design and Development Planning:  To define responsibility for design and development activity.  To assign the activity to qualified staff.

4.3)

Organizational and Technical Interfaces:  Identify the above in various groups.  Identify type of information flow across groups.  Review the information flow regularly.

4.4)

Design Input:

16

 Identify

inputs

including

statutory

and/or

regulatory

requirements.  Review inputs for adequacy.  Identify personnel who will be responsible for documenting, verifying and resolving ambiguous or conflicting input requirements.  Take in to account contract review results. 4.5) Design Output: It shall be verified and validated against input requirements. Output shall:  Meet input requirements.  Give acceptance criteria.  Identify crucial characteristics for safe functioning.  Review output before release. 4.6)

Design Review:  Decided on appropriate stages of review.  Plan, conduct and document review.  All functions concerned shall participate.  Maintain records of review.

4.7)

Design Verification:  Verify design appropriate stages.  Consider alternate calculations.  Record verification measures.  Review the stage documents before release.

4.8)

Design Validation:  Follow design verification.  Perform under defined operating conditions.

17

 Normally performed on final product. 4.9)

Design Changes: Authorized personnel to identify document, review and approve design changes before implementation.

5)

DOCUMENTS AND DATA CONTROL:

5.1)

General:  Ensure availability of latest versions of document and data such as standards, procedures, referenced materials etc. at the location of there use.  Functional responsibilities for documents and data control are to be spelled out.  Document and data can be maintained in hard copy or electronic media.

5.2)

Document and Data Approval and Issue:  Authorized personnel to review for adequacy and approve.  Establish master list to identify revision status. Control to ensure that:  Right document at right place.  Obsolete documents are not issued or used.  Identification of retained obsolete documents.

5.3)

Document and Data Changes:  Generally original and approving authority shall review and approve changes.  If specifically designated, others can do it, provided they have access to all required information.

18

 Where practicable identify changes on document itself or an attachment. 6)

PURCHASING:

6.1)

General: Purpose is to ensure that product purchased meet specified requirements.

6.2)

Evaluation of Sub-Contractors:  Evaluate and select based on there ability to meet the requirements.  Define the type and extent of controls exercised over subcontractor.  Establish

and

maintain

records

of

acceptable

sub-

contractors. 6.3) Purchasing Data: Purchasing documents shall clearly describe the product ordered. 6.4)

Verification of Purchased Product:

6.4.1) Suppliers Verification At Sub-Contractor’s Premise: Supplier to specify verification arrangements and methods of product release in the purchasing documents.

6.4.2) Customer Verification of Sub-Contracted Products : Customer has prerogative to verify at suppliers and sub-contractors premises that sub-contracted product conforms to specified requirements.

19

7)

CONTROL OF CUSTOMER SUPPLIED PRODUCT:  Control of verification, storage and maintenance of customer supplied product.  Report loss of damage or rejection to customer and maintain record.

8)

PRODUCT IDENTIFICATION AND TRACE ABILITY:  Identify product at all stages of receipts, production, delivery and installation.  Providing unique identification of trace ability is a specified requirement.

9)

PROCESS CONTROL:  Identify and plan production, installation and servicing processes.  Carryout processes under controlled conditions.  Carryout maintenance of equipment to ensure continued process capability.  Specify requirements for qualification of process operations, equipment and personnel.

10) 10.1)

INSPECTION AND TESTING: General: Required inspection and testing to be detailed in the quality plan or procedure.

10.2)

Receiving, Inspection and Testing: Verification of incoming

material in accordance with quality plan and procedures before use. Positive recall procedure for urgent production purposes. 10.3)

In Process Inspection and Testing:

20

 Verification of the process in accordance with quality plan.  Focus on defect prevention methods-specification error, proofing, visual control, etc. 10.4)

Final Inspection and Testing:

 Carry out the final inspection & testing as per quality plan.  Product not be dispatched until all inspection and test activities are satisfactorily completed and documentation authorized. 10.5)

Inspection and test Records:

 Record of inspection and test to be maintained.  Records to identify authority responsible for product release. 11)

CONTROL OF INSPECTION AND MEASURING:

11.1)

General: Documented procedures to control calibrate and maintain inspection, measuring and test equipment including software.

11.2)

Control Procedure:

 Select appropriate procedure.  Identify equipment that can affect product quality.  Calibrate such equipment that can affect product.  Indicate calibrate status.  Maintain calibration records.  Assess validity when equipments is found to be out of calibration.  Ensure

proper

handling,

equipments.

21

storage

and

preservation

of

12)

INSPECTION AND TEST STATUS:  Defining quality plan their stages at which the inspection and test status needs to be indicated.  Indicate the status by suitable means.

13)

CONTROL OF NON-CONFORMING PRODUCTS:

13.1)

General: Non-conforming product shall be prevented from unintended use or installations. Hence it has to be identified, documented, evaluated and segregated when practical and concerns functions notified.

13.2)

Review and Disposition of Non-Conforming Product: Dispositions options are:

 Rework  Accept with or without repair  Regard for alternate application  Reject or scrap  Obtain

concession

from

customer

when

required

contractually.  Re-inspect repaired product as per quality plan.

14)

CORRECTIVE AND PREVENTION ACTION:

14.1)

General:

Documented

procedures

preventive action.

22

for

corrective

and

14.2)

Corrective Action:

 Analyze quality records, audit records, concessions and customer compliances.  Detect and analyze potential causes non-conformities.  Decide on preventive action.  Implement and ensure its effectiveness.  Submit for management review. 15)

HANDLING, STORAGE, PACKAGING, PRESERVATION AND DELIVERY:

15.1) General: Maintenance of procedures for safe handling, storage, packaging and delivery of products. 15.2) 15.3)

Handling: Methods to prevent damage or deterioration. Storage:

 Designated storage areas.  Prevent damage or deterioration.  Stipulate methods of receipt and dispatch to and from such areas.  Inspect

products

at

appropriate

intervals

deterioration.

15.4)

Packaging:

 Control of packing, packaging and labeling.  Use of customer packaging standards.

23

to

detect

 Material shipped to be labeled according to the customer requirements. 15.5)

Preservation: Use of appropriate methods for preservation and segregation.

15.6)

Delivery:

 Protect product quality after final inspection and testing.  If contractually required extend delivery to destination. 16)

CONTROL OF QUALITY RECORDS:  Identify quality records.  Index the file.  Store and maintain in a suitable environment to prevent damage, deterioration or loss.  Determine detention period.

17)

INTERNAL QUALITY AUDITS:  Plan and schedule audits.  Carryout as per plan by independent personnel.  Record results of audit and notify auditor to take up timely corrective action.

18)

TRAINING:  Identify training needs.  Provide training.

24

19)

SERVICING: Establish procedures for performing, verifying and reporting that servicing meet specified requirements.

20)

STATISTICAL TECHNIQUES:

20.1)

General:

 Identification of need.  Identify appropriate statistical techniques for inspection, process control and other activities. 20.2) Procedures:

Establish

documented

procedures

for

implementation of identified statistical techniques.

PRODUCT CATOGORIES ISO 9000 has categorized all possible products that can be supplied by any organization in to four generic categories:25

1. HARDWARE: Consisting of tangible, discrete products in to distinctive forms. Normally it is manufactured, constituted or fabricated parts. 2. SOFTWARE: An intellectual creation of information expressed through supporting medium. It may be in the form of concepts, transaction or procedures. 3. PROCCESED MATERIALS: Tangibles products generated by transforming raw material in to a desired state. The state of processed material can be liquid, gas, ingot, filament and sheet and it’s typically stored in drums, bags, tanks, cylinders, pipelines or rolls. 4. SERVICES: The results by activities at the interface between supplier and the customer and by supplier interval activities, to meet customer needs. ISO 9000 family of standards is applicable to all four generic product categories. The standard states that quality system requirements

are

essentially

same

for

all

generic

product

categories. However the terminology management system details and emphasis may differ.

GENERAL REQUIREMENTS OF ISO 9000 The general requirements for obtaining ISO 9000 certifications are as follows: 26

1. Management commitment. 2. Defined responsibilities. 3. Complete written statement of  Policy & object  Objective  Procedures & detailed instructions  Control information 4. Regular internal audits of system 5. Assurance that employees have skills, qualification and training appropriate to their tasks.

ISO 9000 PRINCIPLES According to ISO, the new ISO 9000 2000 standards are based on eight quality management principles. ISO chose these 27

principles because they can be used to improve organizational performance and achieve success. But how can you make sure that your organization applies these

principles?

The

answer

is

to

implement

a

quality

management system that meets the ISO 9000 standard. If the organizations do so, then that organization will automatically apply these principles. This is because they permeate the new standard and will therefore be built in to any quality system that is based on this standard. If you want to improve the performance of your organization, you need to develop and implement an ISO 9001 quality management system that applies the eight principles listed below.

QUALITY MANAGEMENT PRINCIPLES

28

1.

Focus on your

Organizations rely on customers. Therefore:

customers •

Organizations

must

understand

customer needs. •

Organizations

must

meet

customer

exceed

customer

requirements. •

2.

Provide leadership

Organizations

must

expectations. Organizations rely on leaders. Therefore: •

Leaders

must

purpose

and

establish set

a

unity

the

of

direction

the organization should take. •

Leaders must create an environment that encourages people to achieve the

3.

Involve

organization's objectives. Organizations rely on people. Therefore:

your people

•

must

encourage

the

involvement of people at all levels. •

4.

Organizations

Organizations

must

help

people

to

Use a process

develop and use their abilities. Organizations are more efficient and effective

approach

when they use a process approach. Therefore: •

Organizations

must

use

a

process

approach to manage activities related 5.

Take a systems approach

resources. Organizations are more efficient and effective when

they

use

a

systems

approach.

Therefore: •

Organizations must identify interrelated processes and treat them as a system.

•

Organizations

must

use

a

systems

approach to manage their inter-related 6.

Encourage continual

processes. Organizations 29 are more efficient and effective when

they

continually

try

to

improve.

STEP TOWARDS REGISTRATION The

step

towards

registration

include

selecting

the

appropriate model, assembling a steering committee, choosing a registrar

and

(possibly)

consultant,

documenting

process,

implementing all new processes, and undergoing a third party audit by the registrar. Once certification is achieved, he company continuous to be audited by the registrar at regular intervals. After achieving ISO certification the benefits of process management by quality kick in. In fact, registration is just the first step on the path to continuous improvement. Organizations

find

they

can

significantly

reduce

the

potential for production errors or reworks. They are able to drive defect

statistics

low

to

impressive

locus.

Their

streamlined

processes enable reduced in-process testing and inspection, saving time and lowering costs. ISO 9000 makes continuous improvement a matter-of-fact process that delivers results to the bottom line. Companies that have been registered for several years will justify to the power and positive impact of ISO 9000 on their operations.

30

NINE STEPS OF REGISTRATION 1. Establish a ISO steering committee, assigning a project leader. 2. Review

your

current

quality

system,

assessing

what

procedures are written and what need to be written. 3. Develop time lines and goals for each department. 4. Start documenting, develop a standard format, revise existing procedures, create new ones, create the top-level quality manual. 5. Select a registrar. 6. Assign and train internal auditors, conduct at least one internal audit of the procedure. 7. Submit the manual for a best audit to registrar. 8. Undergo an audit by the registrar. 9. Receive an ISO 9000 certification or registration.

31

STEPS IN ISO 9000 CERTIFICATION A company that is committed and keen for getting ISO 9000 certification should follow these steps: 1. Quality Policy: First of all the company’s top management should frame company’s quality policy keeping in mind organizational goals and customer needs while framing quality policy following points to be noted: •

Formulation and Documentation

•

Understanding through continuous education of all levels.

•

Implementation and Maintenance.

2. Selection of ISO 9000 Standard: The selection of appropriate ISO 9000 standard may be organized on organization to organization. •

If company produces some product for which design/ development,

production,

installation

and

servicing

criteria’s are important then it should go for ISO 9000. •

If there is only production and installation involved then go for ISO 9000.

•

If only inspection and testing is involved then ISO 9003 is the best option.

32

•

If organization deals with management of services then 9004 is the best alternative.

3. Quality Manual: A company shall prepare quality policy manual which shall contain policies, procedures, work instruction and records. •

Policies: It have to be documented in a quality policy manual which describes what the company does to ensure that quality is maintained in each of these areas covered by clauses.

•

Procedures: It describes how each process work is done. They demonstrate how policies are implemented.

•

Work Instruction: Describing how specific work practices are done in detail and or a more local level than the procedures allow. In smaller organizations procedures and work instructions may be the same.

•

Records:

Records

of

work

compiling

of

forms,

contracts, checklists etc. which need to be maintained and preserved wherever necessary. 4. Implementation of Quality System as per Manual: The job of management does not end with formulation, documentation, updating and correction in quality manual. But there real job starts after this: •

They have top educate grass root level employees about procedures and work instructed formulated.

•

Take due care for this follow up.

33

5. Internal Compliance Audit: In

this

step,

company

verifies

and

checks

another

documented systems and procedures are implemented in practice. This audit can be done by: •

Internal auditors.

•

External auditors.

6. Updating/Corrections/Improvements

based

on

compliance audits: After doing internal compliance audit, company would know about discrepancies in implementation and would have ample time for its correction and updating. 7. Maintaining that system for sufficiently long to prove that system is stabilized: Frequent changes in systems are not advisable as it would waste unnecessary time on training and lead confusion at grass root level. 8. Verification and conformation by continuous internal auditing and assessment: Once systems are designed that does not mean that all products

will

be

quality

assured

but

due

to

frequent

verification and audits they should be maintained and errors or non-conformances if any should be removed. 9. Selection of Certifying Agency: After

selecting

appropriate

ISO

9000

standard

and

formulation and documentation of policy and quality manual

34

company

should

invite

certifying

agencies

for

getting

certificate. 10. Offering Quality Manual to that agency for adequacy audit. 11. Updating/Corrections/Improvements of quality manual based on adequacy audit report. 12. Fixing date of compliance auditing with certifying agency. 13. Compliance auditing with certifying agency. 14. Updating/Corrections/Improvements based on audit reports/ NCAP’s (Non- conformance audit reports): According to ISO 8420 “Non-conformity, refers to nonfulfillment of specified requirement”. If any non-conformity is observed in system or quality manual than it should be corrected by taking proper action. 15. Verification/Certification certificate:

and

Registration Generally

of the

process of registration is proceeded by a pre-assessment. The accreditation is requested to evaluate the state of readiness so that minor inadequacies can be attended to. Finally accreditation agency carries out an assessment and will advice an registrar.

35

16. Maintaining the Quality System Maintaining quality system and continuing the internal auditing. It is never ending but continuous process. 17. Review audit at the intervals of six months by certifying agency: The

organization

needs

to

internalize

the

quality

management system and every member has to fulfill his role in ensuring compliance, as certifying agency conducts audit at interval of six months. 18. Valid for three years: An ISO certificate is not a once-and-for-award; it must be renewed at regular intervals recommended by the certification body, usually around three years. 19. Adequacy audit and Compliance audit The assessor look for information to prove whether the system are adequate enough to meet ISO 9000 standards i.e. adequacy audit and to prove that systems are being followed i.e. compliance audit. 20. Adequate records as proof must be available.

36

AUDIT REQUIREMENTS OF ISO 9000 ISO 9000 contemplates:1. Adequacy Audit: To verify whether the documents like manuals,

procedures

meet

the

ISO

9000

standards

requirements. 2. Compliance

Audit:

To

verify/

check

whether

the

documented systems and procedures are being followed implemented in practice. This is either calendar led or event led. Both the audits are carried out in two stages. a) By Internal Auditors- who are trained to have a selfassessment and correction? There can be multiple internal audits before external audit. b) By External Auditors- mainly for certification purpose. These audits provide information to the management to know the status of the organization with respect to the quality

system

and

to

take

appropriate

corrective/improvement actions. For the discrepancies/ non-conformances mentioned in the audit reports.

37

WHAT AUDITORS EXAMINE? Auditors always examine the following: 1.

Quality system

2.

document Control

3.

Purchasing

4.

Calibration

5.

Internal Quality Audits

6.

Corrective Actions

7.

Training

38

BENEFITS OF ISO 9000 CERTIFICATION  It meets the legal requirements for exports.  Organization is systematized and disciplined to achieve quality as a way of life.  Quality is achieved by process control and hence it is not only free, but also adds to the profit.  Prevention is better than cure is implemented automatically in practice.  It gives assurance to the customers about the product and services.  It leads to the concentrated and united work force with the sole aim of satisfying the customer totally.  Multiple inspections are avoided there by reducing the inspection cost.  It gives special privileges to import items, which cannot be imported otherwise in normal course.  It is a part of TQM system.  The entire future of being in and doing business depends upon the successful implementation of ISO 9000.  New entrant’s easy adjustability to new environment.  Compliance is voluntary but ignoring these could prove hazardous to company’s market share.

39

WHAT IS ISO 14000?

After the success of the ISO 9000 series of quality standards, the International Standards Organization published a comprehensive set of standards for environmental management. This series of standards is designed to cover the whole area of environmental issues for organizations in the global marketplace. ISO Secretary-General Alan Bryden: “In a decade, ISO 14001 has become a globally relevant tool for managing the environmental impact of human activities. At the same time, ISO International Standards as a whole constitute a toolbox not only for the environmental integrity of the planet, but also for economic growth and social equity. In the globalization world, the environmental issues seem to be one of the most important topics. The pollution created in any manner such as air emission, effluent, land contamination, etc.,

40

have several impacts to people throughout the world. Upon this pressure, the International Organization for Standardization has developed the environmental management standards which is known as the “ISO 14000 Series”. The ISO 14000 set of standards was created in 1996 and revised in 2004. The

purpose

of

this

standard

is

to

help

diverse

organizations protect the environment—to prevent pollution—and to improve their overall environmental performance. In other words, it is what an organization does to:



Minimize harmful effects on the environment caused by its activities



Achieve

continual

improvement

of

its

environmental

performance 

Remove

uncertainty

and

inconsistency

by

managing

disruption and waste 

Give competitive advantage to avoid international trade barriers



Help

companies

stay

in

compliance

with

regulatory

requirements 

Improve overall performance.



implement,

maintain

and

improve

an

environmental

management system 

assure

itself

of

its

conformance

with

its

own

stated

environmental policy (those policy commitments of course must be made) 

demonstrate conformance



ensure compliance with environmental laws and regulations

41



seek certification of its environmental management system by an external third party organization



make a self-determination of conformance

CONCEPT OF EMS Briefly, the concepts of EMS are as follows: 1.

Environmental

Policy:

Initially,

the

organization’s

top

management should have commitment and define the policy on EMS which is used for the direction of implementing and improving its EMS. 2.

Planning: In order to achieve environmental policy, at least, the organization should: •

Identify the environmental aspects of its activities and specify those which have significant impacts on the environment.

•

Identify

legal

and

other

requirements

to

which

the

organization involved. •

Establish objectives and targets of its activities having impacts to environment.

•

Establish

environmental

programmes

for

achieving

its

objectives and targets. 3.

Implementation: In order to achieve environmental planning, at least, the organization should: •

Define roles, responsibilities and authorities for facilitating EMS effectively.

42

•

Communicate to the staffs at each level for the importance of conformance to the environmental policy; provide appropriate training to personnel performing the tasks to gain their knowledge and competence.

•

Establish and control documentation relating to EMS.

•

Control operations and activities to meet the specified objectives and targets.

•

Identify potential accidents and emergency situations for preventing and mitigating the environmental impacts that may be associated with them and periodically test such procedures where practicable.

4.

Checking

and

Corrective

Action:

To

ensure

that

the

organization is performing in accordance with the stated EMS programmes, at least, the organization should: •

Monitor and measure its operations and activities against the organization’s plans.

•

Identify non-conformance and take action to mitigate any impact caused.

5.

•

Record the on-going activities of the EMS.

•

Conduct periodic EMS audits. Management Review: The organization’s top management should review and continually improve its EMS, with the objective of improving its overall environmental performance.

43

Environmental Management System Model

BENEFITS OF IMPLEMENTING AN EMS: Environmental

Management

Systems

(EMS)

is

the

foundation of the ISO 14000 group of international environmental management standards. An EMS can be registered as meeting the ISO 14001 EMS standard. Since the ISO 14001 EMS includes everyone in the Organization and all aspects of the Organization that affect the environment, it can improve an organization's environmental performance in many ways. This improved performance comes at a cost to the Organization, a cost that can be recovered by aggressively seeking benefits. Following are the benefits of implementing an EMS: •

Managing organization’s environment systematically.

•

Obtaining better surroundings as well as providing protection to the potential emergency.

•

Maintaining good public/community relation.

•

Reducing

environmental

cost

because

of

appropriate

environmental management such as resources management, waste management, etc. •

Enhancing market share.

44

OBJECTIVES OF IMPLEMENTING ISO 14000: ISO 14001:2004 is a tool that can be used to meet: 1. INTERNAL OBJECTIVES: •

Provide assurance to management that it is in control of the organizational processes and activities having an impact on the environment.

•

Assure employees that they are working for an environmentally responsible organization.

2. EXTERNAL OBJECTIVES: •

Provide assurance on environmental issues to external stakeholders – such as customers, the community and regulatory agencies.

•

Comply with environmental regulations.

•

Support the organization's claims and communication about its own environmental policies, plans and actions.

•

Provides a framework for demonstrating conformity via suppliers' declarations of conformity, assessment of conformity by an external stakeholder - such as a business client - and for certification of conformity by an independent certification body.

45

CHARACTERISTICS OF ISO 14000 Some unique and important characteristics of ISO 14000 are as follows:  Comprehensive:

All

members

of

the

Organization

participate in environmental protection, the environmental management system considers all stakeholders, and there are processes to identify all environmental impacts.



Proactive: It focuses on forward thinking and action instead of reacting to command and control policies.

 Systems

Approach:

It

stresses

on

improving

environmental protection by using a single environmental management

system

across

Organization.

46

all

functions

of

the

SERIES OF ISO 14000 ISO 14000 is a group of standards covering the following: ISO 14000

GUIDE

CONFORMANCE MODEL

14000

14001

14010

14020

14011

14023

14012

14024

14013

14040

14015

14043

14031

14050

14032 14060

47

48

STANDARD

DESCRIPTION

14000

Guide to Environmental Management Principles, Systems and Supporting Techniques

14001

Environmental

Management

Systems

-

Specification with Guidance for Use

14010

Guidelines for Environmental Auditing - General Principles of Environmental Auditing

14011

Guidelines for Environmental Auditing - Audit Procedures-Part 1: Auditing of Environmental Management Systems

14012

Guidelines

for

Environmental

Auditing

-

Qualification Criteria for Environmental Auditors

14013/15

Guidelines for Environmental Auditing - Audit Programmes, Reviews & Assessments

14020/23 14024

Environmental Labeling Environmental Labeling - Practitioner Programs - Guiding Principles, Practices and Certification Procedures of Multiple Criteria Programs

14031/32

Guidelines

on

Environmental

Performance

Evaluation 14040/43

Life Cycle Assessment General Principles and 49 Practices

ISO 14000 PRINCIPLES The ISO 14000 series of standards are based on the following principles:

An organization should focus on what needs to be done - it should ensure commitment to the EMS and define its policy.



An

organization

should

formulate

a

plan

to

fulfill

its

environmental policy. 

For effective implementation, an organization should develop the capabilities and support mechanisms necessary to achieve its environmental policy, objectives and targets.



An organization should measure, monitor and evaluate its environmental performance.



An organization should review and continually improve its environmental

management

system,

with

the

improving its overall environmental performance.

50

objective

of

51

52

53

54

55