ISO Standards

ISO (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 161 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system.

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.

Therefore, ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society.

FUNCTIONS OF ISO

· Make the development, manufacturing and supply of products and services more efficient, safer and cleaner.

· Facilitate trade between countries and make it fairer.

· Provide governments with a technical base for health, safety and environmental legislation, and conformity assessment.

· Share technological advances and good management practice.

· Disseminate innovation.

· Safeguard consumers and users in general, of products and services.

· Make life simpler by providing solutions to common problems.

What is ISO 9000?

ISO 9000 is a generic name given to a family of standards developed to provide a framework around which a quality management system can effectively be implemented.

International Organization for Standardization evolved ISO 9000 series of standards in 1987. These are quality assurance system standards. First revision came in July 1994 and second revision on Dec 15, 2000. Henceforth, there will be only one standard ISO-9001:2000.

These standards are customer oriented and focus on customer satisfaction by fulfilling the customers’ requirements.

These are applicable to any manufacturing or servicing organization. Hence, these are the product neutral standards.

These standards can be adopted by any organization -be it large, medium, small; limited company, private limited company, partnership firms, and proprietorship firms.

ISO 9001:2000, the requirement standard, includes the following main sections:

Quality Management System

Management Responsibility

Resource Management

Product Realization

Measurement Analysis and Improvement

What is the necessity of adopting ISO 9000 quality system standards?

In this competitive era, especially when liberalization, privatization and globalization (LPG) concepts are taking deep roots, survival of the organization will be at stake if outdated systems and procedures are followed. Hence, there is a need to have the systems- based approach in all business functions to meet the cost effective quality and timely delivery requirements.

It is quite likely that in future many organizations will act as subcontractors to the major global players. In such situation, the adoption of ISO 9000 quality systems and its certified performance would help in establishing credentials and capability of an organization to get the contracts.

It is therefore aptly said "one cannot do today’s work with yesterday’s methods and still be in the business tomorrow".

Quality management principles

There are eight quality management principles on which the quality management system standards of the ISO 9000:2000 and ISO 9000:2008 series are based. These principles can be used by senior management as a framework to guide their organizations towards improved performance. The principles are derived from the collective experience and knowledge of the international experts who participate in ISO Technical Committee ISO/TC 176, Quality management and quality assurance, which is responsible for developing and maintaining the ISO 9000 standards.

The eight quality management principles are defined in ISO 9000:2005, Quality management systems Fundamentals and vocabulary, and in ISO 9004:2000, Quality management systems Guidelines for performance improvements.

This document gives the standardized descriptions of the principles as they appear in ISO 9000:2005 and ISO 9004:2000. In addition, it provides examples of the benefits derived from their use and of actions that managers typically take in applying the principles to improve their organizations' performance.

Principle 1: Customer focus

Principle 2: Leadership

Principle 3: Involvement of people

Principle 4: Process approach

Principle 5: System approach to management

Principle 6: Continual improvement

Principle 7: Factual approach to decision making

Principle 8: Mutually beneficial supplier relationships

ISO 9000 Series of Standards

ISO is responsible for the promotion and development of international standards and related activities, including conformity assessments such as testing, inspection, laboratory accreditation, certification and quality assessments.

The ISO 9000 series standards have been adopted by more than 45 countries and its equivalent standard in the Indian context is the Bureau of Indian Standards' (BIS) 14000 series. In the United States, the series is known as the ANSI/ASQC Q 9000 series.

The standard finds its origin in the European Community (EC) July 1985 product liability directives (also known as the single market directives) which state that for certain regulated products, manufacturers exporting to the EC and, eventually, to the European Free Trade Association, would need to have a well documented and implemented Quality Assurance System.

The ISO 9000 series standards provide the requirements to which organizations desirous of certification must conform. One very important aspect of the standards is that they were very generic in nature and ingenuity is required while interpreting the standards' applicability to the industry or firm in question.

Developed by the ISO Technical Committee 176, published in 1987 and updated approximately every five years, the standards comprise five documents whose focus is Quality Assurance Systems.

These five documents are:

a) ISO 9000 - 

Quality Management and Quality Assurance Standards - Guidelines for selection and use

b) ISO 9001 - 

Quality systems - Model for quality assurance in design, production, installation and servicing. This is the most comprehensive standard with 20 clauses.

c) ISO 9002 - 

Quality systems - model for quality assurance in production and installation. This standard has 18 clauses.

d) ISO 9003 - 

Quality systems - Model for quality assurance in final inspection and test. Requires conformity with 12 clauses.

e) Quality management and quality system elements - Guidelines.

Q.2 What are the benefits that organizations can accrue on implementing ISO 9000?

Organizations that adopt to implement the quality management system are expected to apply the principles of ISO 9000 from which each comes with different benefits.

These benefits are discussed under each principle:

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.

Increased revenue and market share obtained through flexible and fast responses to market opportunities.

Increased effectiveness in the use of the organization's resources to enhance customer satisfaction.

Improved customer loyalty leading to repeat business.

Principle 2: Leadership

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 organization's objectives.

People will understand and be motivated towards the organization's goals and objectives.

Activities are evaluated, aligned and implemented in a unified way.

Miscommunication between levels of an organization will be minimized.

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 organization's benefit.

Motivated, committed and involved people within the organization.

Innovation and creativity in furthering the organization's objectives.

People being accountable for their own performance.

People eager to participate in and contribute to continual improvement.

Principle 4: Process approach

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

Lower costs and shorter cycle times through effective use of resources.

Improved, consistent and predictable results.

Focused and prioritized improvement opportunities.

Principle 5: System approach to management

Identifying, understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives.

Integration and alignment of the processes that will best achieve the desired results.

Ability to focus effort on the key processes.

Providing confidence to interested parties as to the consistency, effectiveness and efficiency of the organization.

Principle 6: Continual improvement

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

Performance advantage through improved organizational capabilities.

Alignment of improvement activities at all levels to an organization's strategic intent.

Flexibility to react quickly to opportunities.

Principle 7: Factual approach to decision making

Effective decisions are based on the analysis of data and information

Informed decisions.

An increased ability to demonstrate the effectiveness of past decisions through reference to factual records.

Increased ability to review, challenge and change opinions and decisions.

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

Increased ability to create value for both parties.

Flexibility and speed of joint responses to changing market or customer needs and expectations.

Optimization of costs and resources.

PRACTICAL EXAMPLES

Standardization of screw threads helps to keep chairs, children's bicycles and aircraft together and solves the repair and maintenance problems caused by a lack of standardization that were once a major headache for manufacturers and product users.

Standards establishing an international consensus on terminology make technology transfer easier and safer. They are an important stage in the advancement of new technologies and dissemination of innovation.

Without the standardized dimensions of freight containers, international trade would be slower and more expensive.

Without the standardization of telephone and banking cards, life would be more complicated.

A lack of standardization may even affect the quality of life itself: for the disabled, for example, when they are barred access to consumer products, public transport and buildings because the dimensions of wheel-chairs and entrances are not standardized.

Standardized symbols provide danger warnings and information across linguistic frontiers.

Consensus on grades of various materials gives a common reference for suppliers and clients in business dealings.

Agreement on a sufficient number of variations of a product to meet most current applications allows economies of scale with cost benefits for both producers and consumers. An example is the standardization of paper sizes.

Standardization of performance or safety requirements of diverse equipment makes sure that users' needs are met while allowing individual manufacturers the freedom to design their own solution on how to meet those needs.

Standardized computer protocols allow products from different vendors to "talk" to each other.

Standardized documents speed up the transit of goods, or identify sensitive or dangerous cargoes that may be handled by people speaking different languages.

Standardization of connections and interfaces of all types ensures the compatibility of equipment of diverse origins and the inter operability of different technologies.

Agreement on test methods allows meaningful comparisons of products, or plays an important part in controlling pollution - whether by noise, vibration or emissions.

Safety standards for machinery protect people at work, at play, at sea... and at the dentist's.

Without the international agreement contained in ISO standards on metric quantities and units, shopping and trade would be haphazard, science would be unscientific and technological development would be handicapped.

Discuss the requirements of ISO 9001:2008

Document: ISO/TC 176/SC 2/N525R2

October 2008

Introduction

Two of the most important objectives in the revision of the ISO 9000 series of standards have been

to develop a simplified set of standards that will be equally applicable to small as well as medium and large organizations, and

for the amount and detail of documentation required to be more relevant to the desired results of the organization’s process activities.

ISO 9001:2008, Quality management systems – Requirements has achieved these objectives, and the purpose of this additional guidance is to explain the intent of the new standard with specific regard to documentation.

ISO 9001:2008 allows an organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to develop the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS.

It is stressed that ISO 9001 requires (and always has required) a “Documented quality management system”, and not a“system of documents”.

The following are some of the main objectives of an organization’s documentation, independent of whether or not it has implemented a formal QMS;

a) Communication of Information

As a tool for information transmission and communication. The type and extent of the documentation will depend on the nature of the organization’s products and processes, the degree of formality of communication systems and the level of communication skills within the organization, and the organizational culture.

b) Evidence of conformity -Provision of evidence that what was planned, has actually been done.

c) Knowledge sharing -To disseminate and preserve the organization’s experiences. A typical example would be a technical specification, which can be used as a base for design and development of a new product.

ISO 9001:2008 Documentation Requirements

ISO 9001:2008 clause 4.1 General requirements requires an organization to “establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard”

Clause 4.2.1 General explains that the quality management system documentation shall include:

ü Documented statements of a quality policy and quality objectives;

ü A quality manual

ü Documented procedures required by this International Standard

ü Documents needed by the organization to ensure the effective planning, operation and control of its processes, and

ü Records required by this International Standard;

The notes after Clause 4.2 make it clear that where the standard specifically requires a “documented procedure”, the procedure has to be established, documented, implemented and maintained. It also emphasizes that the extent of the QMS documentation may differ from one organization to another due to:

§ the size of organization and type of activities;

§ the complexity of processes and their interactions, and

§ the competence of personnel.

All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4.

Guidance on Clause 4.2 of ISO 9001:2008

The following comments are intended to assist users of ISO 9001:2008 in understanding the intent of the general documentation requirements of the International Standard.

a) Documented statements of a quality policy and objectives:

Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2008. The documented quality policy has to be controlled according to the requirements of clause 4.2.3. 

Note: Organizations that are revising their quality policy for the first time, or in order to meet the amended requirements in ISO 9001:2008, should pay particular attention to clause 4.2.3 (c), (d) and (g).

Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008. These documented quality objectives are also subject to the document control requirements of clause 4.2.3.

b) Quality Manual:

Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format and structure of the manual is a decision for each organization, and will depend on the organization’s size, culture and complexity. Some organizations may choose to use the quality manual for other purposes besides that of simply documenting the QMS

A small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard.

Large, multi-national organizations may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation.

The quality manual is a document that has to be controlled in accordance with the requirements of clause 4.2.3.

c) Documented procedures:

ISO 9001:2008 specifically requires the organization to have “documented procedures” for the following six activities:

4.2.3 Control of documents

4.2.4 Control of records

8.2.2 Internal audit

8.3 Control of nonconforming product

8.5.2 Corrective action

8.5.3 Preventive action

These documented procedures have to be controlled in accordance with the requirements of clause 4.2.3

Some organizations may find it convenient to combine the procedure for several activities into a single documented procedure (for example, corrective action and preventive action). Others may choose to document a given activity by using more than one documented procedure (for example, internal audits). Both are acceptable.

Some organizations (particularly larger organizations, or those with more complex processes) may require additional documented procedures (particularly those relating to product realization processes) to implement an effective QMS.

Other organizations may require additional procedures, but the size and/or culture of the organization could enable these to be effectively implemented without necessarily being documented. However, in order to demonstrate compliance with ISO 9001:2008, the organization has to be able to provide objective evidence (not necessarily documented) that its QMS has been effectively implemented.

d) Documents needed by the organization to ensure the effective planning, operation and control of its processes:

In order for an organization to demonstrate the effective implementation of its QMS, it may be necessary to develop documents other than documented procedures. However, the only documents specifically mentioned in ISO 9001:2008 are:

- Quality policy (clause 4.2.1.a)

- Quality objectives (clause 4.2.1.a)

- Quality manual (clause 4.2.1.b)

There are several requirements of ISO 9001:2008 where an organization could add value to its QMS and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Examples may include:

- Process maps, process flow charts and/or process descriptions

- Organization charts

- Specifications 

- Work and/or test instructions 

- Documents containing internal communications

- Production schedules

- Approved supplier lists

- Test and inspection plans

- Quality plans

All such documents have to be controlled in accordance with the requirements of clause 4.2.3 and/or 4.2.4, as applicable

e) Records:

Organizations are free to develop other records that may be needed to demonstrate conformity of their processes, products and quality management system.

Requirements for the control of records are different from those for other documents, and all records have to be controlled according to those of clause 4.2.4 of ISO 9001:2008