www.iso.org

International Organization for Standardization

Dr Naqeeb Ullah KhanXYZ Hospital Islamabad

International Organization for Standardization

ISO (International Organization for Standardization) is the world's largest developer and publisher of International Standards.

It is a network of the National Standards Institutes of 163 countries with a Central Secretariat in Geneva.

It is an NGO that forms a bridge between the public and private sectors. Many of its member institutes are from governmental sectors while some are also from private sector.

What is ISO

ISO would have different acronyms in different languages, e.g

in English: International Organization for Standardization. (IOS)

in French:Organisation internationale de normalisation). (OIN)

But the founders decided to give it a short and all-purpose name. Whatever the country, whatever the language, the short form of the organization's name is always ISO.

ISO derived from the Greek isos, meaning "equal".

ISO's name

Overview of

ISO 9001and

ISO 14001

ISO 9001 and ISO 14001

ISO 9001 and ISO 14001 are among ISO's most well known standards ever.

They are implemented by more than one million organizations in some 175 countries.

ISO 9001 helps organizations to implement quality management.

ISO 14001 helps organizations to implement environmental management.

Quality Management

Quality refers to all those features of a product (or service) which are required by the

customer.

Quality Management means what the organization does to ensure that its products or services satisfy the customer's quality requirements and comply with any regulations applicable to those products or services.

Quality management also means what the organization does to enhance customer satisfaction, and achieve continual improvement of its performance.

Environmental Management

Environmental Management.

This means what the organization does to:

minimize harmful effects on the environment caused by its activities,

to conform to applicable regulatory requirements, and to achieve continual improvement of its environmental performance.

Generic standards

ISO 9001 and ISO 14001 are generic standards.

Generic means that the same standards can be applied:

to any organization, large or small, whatever its product or service, and

in any sector of activity, and whether it is a business enterprise, a public administration, or a government department.

Generic standards (cont.)

Generic also means that no matter what the organization's scope of activity

if it wants to establish a quality management system, ISO 9001 gives the essential features

and if it wants to establish an environmental management system, ISO 14001 gives the essential features.

Management Systems

Management System:

The way the organization manage its activities in order that its products or services meet the organization’s objectives, such as:

• satisfying the customer's quality requirements,• complying to regulations, and• meeting environmental objectives

is called management system

Management Systems (cont.)

The most efficient and effective way the organization can manage is by systemization, e.g.

Make sure that nothing important is left out.

Everyone is clear about who is responsible for doing what, when, how, why and where.

Management system standards provide the organization with an international, state-of-the-art model to follow.

Management Systems (cont.)

Large organizations, or ones with complicated processes, could not function well without management systems.

Companies in such fields as aerospace, automobiles, defense, or health care devices have been operating management systems for years.

The ISO 9001 and ISO 14001 management system standards now make these successful practices available for all organizations.

Processes, not products

Both ISO 9001 and ISO 14001 concern the way an organization goes about its work.

They are not product standards.

They are not service standards.

But they are process standards.

They can be used by product manufacturers and service providers.

Process

Processes, not products (cont.)

Processes affect final products or services.

ISO 9001 gives the requirements for what the organization must do to manage processes affecting quality of its products and services.

ISO 14001 gives the requirements for what the organization must do to manage processes affecting the impact of its activities on the environment.

Clauses

Certification and registration

It means that an independent, external body has audited an organization's management system and verified that it conforms to the requirements specified in the standard (ISO 9001).

ISO does not carry out certification and does not issue or approve certificates,

ISO 9001 certification shows commitment to quality, customers, and a willingness to work towards improving efficiency.

It demonstrates the existence of an effective quality management system that satisfies an independent, external audit.

ISO 9001 certification enhances company image in the eyes of customers, employees and shareholders alike.

It also gives a competitive edge to an organisation's marketing

Why seek ISO 9001 certification?

First Identify the requirements of ISO 9001 and how they apply to your business.

Establish quality objectives and how they fit in to the operation of the business.

Produce a documented quality policy indicating how these requirements are satisfied.

Communicate them throughout the organization.

Steps required for ISO 9001 certification

Evaluate the quality policy, its stated objectives and then prioritize requirements to ensure they are met.

Identify the boundaries of the management system and produce documented procedures as required.

Ensure these procedures are suitable and adhered to.

Once developed, internal audits are needed to ensure the system carries on working.

Steps required for ISO 9001 certification (cont.)

When all the requirements of ISO 9001 have been met, it is time for an external audit.

This should be carried out by a third party, accredited certification body.

The chosen certification body will review the quality manuals and procedures. This process involves looking at the organization evaluation of quality and ascertains if targets set for the management programme are measurable and achievable.

Assessment to ISO 9001

This is followed at a later date by a full on-site audit to ensure that working practices observe the procedures and stated objectives and that appropriate records are kept.

After a successful audit, a certificate of registration to ISO 9001 will be issued.

There will then be surveillance visits (usually once or twice a year) to ensure that the system continues to work.

Assessment to ISO 9001 (cont.)

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DEMING’SCYCLE

PLAN

DOCHECK

ACT

• Define Policy• Set Objectives & Targets• Assign Responsibilities• Provide Resources

• Implement according to planned arrangements

• Monitor and Measure the actual implementation against the planned

• Identify the Gaps

• Analyze the Gaps• Take corrective and

preventive actions to fill the gap

Deming Cycle

Process Approach

Accreditation

Accreditation means the formal approval by a specialized body that a certification body is competent to carry out ISO 9001:2008 or ISO 14001:2004 certification in specified business sectors.

Certificates issued by accredited certification bodies - and known as accredited certificates - may be perceived on the market as having increased credibility.

ISO itself does not carry out or approve accreditations.

Certification not a requirement

Certification is not a requirement of ISO 9001 or ISO 14001.

The organization can implement and benefit from an ISO 9001 or ISO 14001 system without having it certified.

The organization can implement them for the internal benefits without spending money on a certification programme.

Certification is a business decision

Certification is a decision to be taken for business reasons:

if it is a contractual, regulatory, or market requirement,

Or if it meets customer preferences

Or it is part of a risk management programme, or

if it will motivate staff by setting a clear goal.

ISO does not certify

ISO does not carry out ISO 9001 or ISO 14001 certification.

ISO does not issue certificates.

ISO does not accredit, approve or control the certification bodies.

ISO develops standards and guides to encourage good practice in accreditation and certification.

The ISO 9000 family

ISO 9001 is the standard that gives the requirements for a quality management system.

ISO 9001:2008 is the latest, improved version.

It is the only standard in the ISO 9000 family that can be used for certification.

There are 16 other standards in the family that can help an organization on specific aspects such as performance improvement, auditing, training…

The ISO 14000 family

ISO 14001 is the standard that gives the requirements for an environmental management system.

ISO 14001:2004 is the latest, improved version.

It is the only standard in the ISO 14000 family that can be used for certification.

The ISO 14000 family includes 21 other standards that can help an organization specific aspects such as auditing, environmental labelling, etc.

ISO 9000 Series

The ISO Survey

The ISO Survey (cont.)

The worldwide total of certificates to ISO 9001:2001 at the end of 2007 was 9,51,486.

This was increase of 6 % over 2006 when the total was 8,96,929 certificates.

Certificates had been issued in 175 countries compared to 170 the previous year.

The ISO Survey (cont.)

The ISO Survey (cont.)

The worldwide total of ISO 14001 certificates at the end of 2007 was 1,54,572.

This was an increase of 21 % over 2006 when the total was 1,28,211.

Certificates had been issued in 148 countries compared to 140 the year before.

Resources

Thank You very much

Indeed

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Scope 1.1 General1.2 Application

1

Normative Reference2

Terms and Definitions3

Quality Management System

4.1 General Requirements4.2 Documentation Requirements

4

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Management Responsibility

5.1 Management Commitment5.2 Customer focus5.3 Quality Policy5.4 Planning5.5 Responsibility, authority and communication5.6 Management Review

5

Resource Management

6.1 Provision of resources6.2 Human resources6.3 Infrastructure6.4 Work environment

6

Product Realization

7.1 Planning of product realization7.2 Customer-related processes7.3 Design and development7.4 Purchasing7.5 Production and service provision7.6 Control of monitoring and measuring devices

7

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Measurement, Analysis and Improvement

8.1 General8.2 Monitoring and measurement8.3 Control of nonconforming product8.4 Analysis of data8.5 Improvement

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The ISO 9000 series and associated standards

ISO 9000 - Quality management systems

Fundamentals and vocabulary

ISO 9001 - Quality management systems

Requirements

ISO 9004 – Managing for the sustained success of an organization

A quality management approach

ISO 19011- Guidelines for auditing management systems

ISO 17021 – Conformity Assessment

Requirements for bodies providing audit and

certification of management systems ISO 9000 Family

Pakistan Standards and Quality Control AuthorityPSQCA ComplexPlot No. St - 7/A, Block - 3Scheme No. 36 Gulistan-e-JoharPK-Karachi

Tel: +92 21 34023842Fax: +92 21 34023843E-mail: psqcadg@super.net.pk Web: www.psqca.com.pk

Pakistan (PSQCA)