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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.

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. The designed Quality Assurance system should: suit the unit's need, not be restrictive to the point of being impractical be continuously upgraded. 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. The eight modules are:

  • Manufacturer's self declaration of conformity
  • EC type examination
  • EC declaration of conformity to type
  • Production quality assurance (ISO 9002)
  • Final inspection and testing (ISO 9003)
  • Product verification by EC third party series production
  • Same as F but for unit verification

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.

Download: Form for Reimbursement of Charges of acquiring ISO-9000 / 14001

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