ISO 9000 Series Standards

FOUNDED in 1946, ISO (International Organisation for Standardisation) consists of approximately 90 member countries at present and this number is expected to grow. With the exception of the electrical and electronic engineering industries (which are covered by International Electrotechnical Commission - IEC), the 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 some 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 organisations 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.

What are the ISO standards?

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.

Related ISO standards:

10011-1 -
Guidelines for auditing quality systems, Part1 - Auditing.

10011-2 -
Guidelines for auditing quality systems, Part 2 - Qualification criteria for auditors.

10011-3
Guidelines for auditing quality systems, Part 3 - Managing audit programmes.

10012-1 -
Quality assurance requirements for measuring equipment Part 1-Management of measuring equipment.

9000-3 -
Guidelines for application of ISO 9001 for the development, supply and maintenance of software.

9004-2 -
Quality management and quality system elements, Part 2 - Guidelines for services.

There exists a relationship between the 9001, 9002 and 9003 standards for the 12 and 18 clauses of 9003 and 9002 respectively. These are a subset of the 20 clauses in the 9001 standard. At present, a decision as to which standard applies is up to the unit seeking registration.

Accreditation Bodies:

Registrars all over the world are required to obtain the authority to audit and recommend registration of a firm from the Accrediting Bodies. Some Accrediting Bodies are:

1. Amercian National Standard Institute - now merged with USA

2. Registrar Accreditation Board (RAB)

3. Road voor de Certificate (RvC)

4. The Dutch Accreditation Council (RVA)

5. French Association Francaise Assurance Qualite (AFAQ)

6. National Accreditation Council for Certification Bodies (NACCB), India

7. SINCERT (Italy)

8. Swedish Board for Accredition & conformity Assessment Sweden (SWEDAC)

9. United Kingdom Accredition Service (UKAS) (formerly known NACCB)

10. Joint Accredition System of Australia & New Zealand (JAS-ANZ)

11. Standards Council of Canada

12. The Japan Accreditation Board for Conformity Assessment, Japan

Some famous International registrars include :

1. ABS Quality Evaluations. Inc.

2. American Association for Laboratory Accreditation

3. AT & T Quality Registrar

4. British Standards Institution (BSI) Quality Assurance

5. Bureau Veritas Quality International (BVQI)

6. Canadian General Standards Board

7. Det Norske Veritas Industry (DNV) etc.

ISO 9000 in India

While certain bodies like BVQI and DNV have already started operations in India, others are expected to be following suit. This is because the number of companies desirous of getting an ISO9000 series registration is ever increasing. In addition to the registrars, the number of people providing ISO related services such as consultancy on ISO implementation and lead assessor courses is also showing exponential growth. Apex industry associations such as the CII (Confederation of Indian Industry) have also started providing services such as the lead assessor course.

The Process

One of the important aspects of the ISO registration process is to verify whether the unit seeking registration is indeed doing what is being claimed in its quality manual.

The best strategy to adopt when embarking on the road to ISO registration is to adopt a simple model: design a quality assurance model from bottom up to ensure that what is done is indeed what is documented. Most auditors, while doing third party audits for registration, like to follow the "show me mapping" process.

The process should begin with a familiarisation with the standard, followed by an assessment of the current quality assurance system with a special focus on how it addresses the ISO requirements. Thereafter, corrective actions to remove the gaps should be initiated and continuous monitoring via internal quality audits should take place to prevent the degradation of the systems' entropy to a higher level. It is advisable to have the assistance of a consultant to guide the implementation efforts.

The registrars, after conducting the audit, send their recommendations to the accrediting body, which gives the certification. After certification, periodic "unannounced" audits are conducted to ensure that the unit is complying with the requirements of the standard.

Incidentally, it makes good sense to decentralise registration efforts both from the point of view of acquiring as well as retaining certification.

The designed Quality Assurance system should:

Indeed the implicit driving force behind the registration process should be the formulation of a well throughout, effective system designed to bring about improved performance.

The benefits of registration:

The ISO certification should note be seen as a panacea to all quality-related problems. In fact, it is only a base line model for quality assurance, which can and should be upgraded continuously. It represents a documented system for quality assurance and the real benefit (besides improved quality) it offers is that it raises the confidence of the third party dealing with the registered unit. There is indeed a facelift in the organisation's corporate image and not surprisingly, an advertising campaign follows the registration.

There are other technical benefits of registration as well. Since the adoption of the Resolution of May 7, 1985, concerning a new approach towards technical harmonisation and standardisation, the EC has adopted 8 modules, which apply to products covered under different directives of the Council. Companies exporting any of the products covered under the directives will need to conform to the requirements of the applicable module. Th eight modules are:

Full quality assurance (ISO 9001)

Thus, if a company is exporting to the European Union, a product covered under one of the directives, which require conformity with modules D, E or H, the need for registration is obvious.

Though ISO 9000, in its present form, does not deliver a comprehensive Total Quality Management System, it is rapidly gaining ground as the base line model. Its popularity is one the rise and even the Ministry of Small Scale Industries has declared an assistance of up to Rs 75,000 to the small scale unit which secures an ISO 9000 series registration which goes towards the cost of registration.

What is true is that these international standards affect national standards, international trade and even national laws and regulations. The vigilance of the TC/176 committee (the international committee in charge of updating the ISO 9000 series) would probably ensure that standards are adopted. Therefore, companies wishing to increase or even maintain their niches in the European or global markets must seriously consider obtaining ISO registration as soon as possible.