History

ISO 9000 is a series of quality management systems standards created by the International Organization for Standardization (ISO), a federation of 132 national standards bodies.

The ISO 9000 quality management systems (QMS) Standards are not specific to products or services, but apply to the processes that create them.

The Standards are generic in nature so that they can be used by both manufacturing and service industries. First released in 1987 and revised in a limited manner in 1994, they underwent a major revision in 2000.

The approval Standard, ISO 9001:2000, uses a simple process-based structure, which fits easily the process management structure of most businesses.

ISO 9000 Introduction

ISO 9000 has evolved into a Standard designed to assist organizations in achieving 'quality' whilst helping to assure customers that quality will be achieved.

Whatever definition you choose to use for quality, and there are many, it is essential that your customers are happy with the product/service being supplied.

ISO 9000 is intended to assist that aim by helping to ensure that the product/service is right - for both the organization itself and its customers.

The poor implementation of the 1994 series resulted in many people claiming that the Standards did not prevent organizations producing sub-standard product.

The 2000 edition clearly requires organizations to satisfy their customers and undertake continual improvement of their quality management systems therefore compliance with ISO 9001:2000 should result in significant benefits for organizations and their customers.

 The ISO 9000:2000 series consists of

·         ISO 9000:2005 - Fundamentals and vocabulary

·         ISO 9001:2000 - Requirements

·         ISO 9004:2000 - Guidelines for performance improvement

·         ISO 9000:2005 Fundamentals and vocabulary

ISO 9000 is an introduction to the philosophy of quality management and also contains the definitions used in ISO 9001 and ISO 9004. It also contains the 8 management principles which provide the foundation for the ISO 9000 series of Standards. These are:

·         Customer focus

·         Leadership

·         The involvement of people

·         Process approach

·         System approach to management

·         Continual improvement

·         A factual approach to decision making

·         Mutually beneficial supplier relationships

These principles are NOT elements against which the organization can be directly assessed but their influence can be seen throughout the Standard.

They should be considered by any organization wishing to comply with the spirit, as well as the text of ISO 9001.

ISO 9001:2000 Requirements

ISO 9001 is the only part of the ISO 9000 family against which an organization can become certified. 

ISO 9002 and ISO 9003 became obsolete in December 2000.

ISO 9001:2000 contains all of the requirements which an organization must address within their Quality Management System (QMS) if they wish to be certified against the Standard.

The majority of these requirements would be identified by many organizations as 'common sense' topics which they would want to address in order to run their business well e.g. sales, design, purchasing, training, calibration of test equipment, control of records.

ISO 9001 is written by a committee (TC 176) and is designed for use in any type of organization. This inevitably means that there are compromises in the wording of the Standard and some interpretation is often needed.

There are 8 sections in ISO 9001:

1. Scope
2. References
3 .Terms and definitions
4. Quality management system
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis and improvement

It is sections 4, 5, 6, 7 & 8 which contain the Requirements themselves and organizations wishing to be certified against ISO 9001:2000 will need to demonstrate that they have addressed all of these requirements.

There are over 250 individual requirements in ISO 9001 that can be condensed into five key statements.

The organization shall:

·         Determine the needs and expectations of customers

·         Establish policies, objectives and a work environment necessary to motivate people to satisfy these needs

·         Design, resource and manage a system of inter-related processes to implement the policy and attain the objectives

·         Measure and analyse the effectiveness of each process in fulfilling its objectives and

·         Pursue the continual improvement of the system from an objective evaluation of its performance.

ISO 9001:2000 Approval

ISO 9001:2000 registration (certification) gives the organization the benefit of an objectively evaluated and enforced quality management system.

It is a tangible expression of a firm’s commitment to quality that is internationally understood and accepted.

ISO 9001:2000 registration is carried out by certification bodies (registrars), accredited organizations that review the organization’s quality manual and working practices to ensure that they meet the Standard.

Using ISO 9001:2000

It is important that when an organization is certified to ISO 9001, it is clear which aspects of the organization are covered by the certificate. This is addressed through the Scope of Registration, and this must clearly identify what is included so as not to mislead.

It is a requirement that all elements of ISO 9001 must be addressed by the organization. However, there are specific circumstances under which certain requirements of the Standard can be excluded, yet compliance with ISO 9001:2000 still be claimed:

·         any excluded requirements do not affect the ability of the organization to meet customer and regulatory requirements

·         any excluded requirements do not affect the ability of the organization to provide conforming products or services

·         any excluded requirements must only come from section 7 (Product realization) of ISO 9001. An example may be customer property. Clearly if a company never deals with such property then the requirement would not be applicable

The company's quality manual must also clearly identify why specific requirements of ISO 9001 have been excluded and the justification for that exclusion.

What ISO 9001:2000 is not

ISO 9001 is NOT a product Standard - it contains no product requirements.

It is a series of generic requirements for quality management systems. Approval to ISO 9001 does not guarantee  product or service quality. Customer focused leadership, not Standards produces satisfied customers.

Approval to ISO 9001 demonstrates that you meet the minimum requirements of quality management.

 ISO 9004:2000 Guidelines for performance improvement

ISO 9004 is not a guide on how to implement ISO 9001, rather a guide on how to improve on the basic requirements that ISO 9001 specifies.

The requirements statements in ISO 9001 may be seen sometimes as a little brief and it rarely, if ever, tells the user 'how' to achieve compliance with it.

ISO 9004 takes the basic requirement and expands on it. It gives options for the organization to consider if they wish to progress beyond basic compliance and into excellence.

Given that 'Continual Improvement' is a requirement of ISO 9001:2000, it is strongly recommended that one consider using ISO 9004 as a way forward in the journey of continual improvement.

Certification bodies cannot certify organizations against ISO 9004 but auditors may use it for guidance. You should consider using ISO 9004 to assist internal auditors when seeking improvement of the more mature processes.

ISO 9004 reproduces the full requirement of ISO 9001. It may also be that some of the guidance contained in ISO 9004 may one day become part of the requirements of ISO 9001 when the Standard is updated again in the future.

Benefits of ISO 9001:2000

·         Improved consistency of service and product performance

·         Higher customer satisfaction levels

·         Improved customer perception

·         Improved productivity and efficiency

·         Cost reductions

·         Improved communications, morale and job satisfaction

·         Competitive advantage and increased marketing and sales opportunities

 Dun and Bradstreet findings :

 85% of registered firms report external benefits like :

·         Higher perceived quality

·         Greater customer demand

 95% report internal benefits like:

·         Greater employee awareness

·         Increased operational efficiency

Case Studies show that ISO Registration resulted in:

·        30% Reduction in customer claims

·        95% improvement in delivery time

·        Reduced defects from 3% to 0.5%

·        40% reduction in product cycle time

·        20% increase in on-time delivery

·        International acceptance and recognition

·        Facilitated trade in international markets

·        Promoting of safety, reliability and quality in food products.