ISO 9001

The standard ISO 9001 belongs to the Série of the standards ISO 9000, relating to the systems of Gestion of quality, it gives the organisational requirements necessary for the existence of a system of management of quality.

As a list of requirements, it is used as a basis for certification of conformity of the organization. Other standards of series 9000: vocabulary (ISO 9000), guiding lines (ISO 9004)… not containing requirements, cannot be used as a basis for certification.

The standard ISO 9001:2000

The version in force of ISO 9001 is the version gone back to 2000 (appeared at the beginning of 2001). A new version is awaited in 2008 (version 2007).

The requirements are relative to four great fields there:

Responsibility for the direction: requirements of acts on behalf of the direction as a first actor and permanent of the step.
Quality system: administrative requirements allowing the safeguard of the assets. Requirement of taking into account of the concept of system.
Process: requirements relating to the identification and the management of the process contributing to satisfaction of the interested parts.
Continuous improvement: requirements of measurement and recording of the performance on all the useful levels as well as engagement of actions of effective progress.

Detail of the standard ISO 9001 - version 2000

To implement a system of management of quality according to the requirements of the standard ISO 9001-Version 2000 consists with:

To show the aptitude required regularly a product conforms to the requirements of the customer and the applicable lawful requirements.
To seek to increase the satisfaction of the customers by the effective application of the system, and in particular, to implement a process of continuous improvement (according to the principle PDCA or Wheel of Deming)

The text of the standard ISO 9001 approaches the 4 principal aspects:

Responsibility for the direction: chapter 5;
Management of the resources: chapter 6;
Realization of the product: chapter 7;
Measurement of analysis and continuous improvement: chapter 8.

It is based on 8 principles of management:

the orientation customer;
the Leadership;
the implication of the personnel;
the approach process;
management by approach system;
continuous improvement;
factual approach for decision making;
mutually profit relations with the suppliers.

History

The previous models (1987 and 1994) of this standard were entitled:

ISO 9001: Systems of management of quality - Requirements for the design, the development, the production, the installation and the After-sales service.
ISO 9002: Systems of management of quality - Requirements for the production, the installation and the support after sale.
ISO 9003: Systems of management of quality - Requirements for the audit processes quality (final control + tests).

These three standards were created at the request of the industrialists, subcontractors of large clients, who wished an official recognition of their management system of quality without having to be audited individually by each customer.

These standards thus had as an objective the installation of procedures guaranteeing the respect of the schedules of conditions of the clients. With the diffusion of this system of certification beyond the industrial sector, even in sectors of great consumption, these standards found their limits. They were removed and replaced by the version 2000 of the standard ISO 9001.

An amendment is in the course of drafting. It will not bring a new requirement but aims clarifying the current text and at improving coherence with the standard ISO 14001 (in its version 2004).

Differences between the version 2000 and the previous models.

First difference

The previous versions with 2000 were based on the principle: “One defines in writing what one must do, and one does what one wrote. ” That has conduit has quality systems very " administratifs" , with enormously of documents (procedures, instructions, instructions, procedures, etc), often with a system of document management very heavy and very centralized.

The version 2000 is in a different approach: “One defines the qualification level (or of competence) necessary to hold a station, and one makes sure that the people holding this station have the desired qualification. If necessary, one implements Formation S.” This analysis must be regularly renewed.

This approach makes it possible to simplify the documentary system considerably. Certain sites thus removed hundreds of documents of their documentary management system. That also makes it possible to more easily decentralize this management of the documents.

To caricature and by pushing the things to the extreme, for the old versions it would have been necessary to write a procedure for the electrician having to change a Fusible. With the version 2000 one will define, for example, that it is necessary to hold this station a professional diploma of electricity or 5 years of experience in a post of electrician. Any person satisfying this requirement thus has necessary competence to change the fuse, it is thus useless to write a procedure. To write a recall safety is enough then.

It should nevertheless be shown that this electrician has competence and can keep it in time. It is there that the concept of revaluation of competences and the control of the assets intervenes.

Obligatory documentation is reduced:

1 Handbook Quality (of which Political Quality)
6 documented procedures (written): internal audit, control of the documents, control recordings, control product not-in conformity, corrective actions and preventive actions.

Second difference

The previous models took little into account the real satisfaction of the end user. To summarize, the supply was to be specified with the customer and the production was to correspond to the specification envisaged. Even if the standard spoke about satisfaction of the " needs; expressed and implicites" customers, one was not worried to know if what had been required by the customer corresponded well to its real need.

The version 2000 gives the customer to the top of the pyramid. The supplier, because of knowledge which it has of its trade and its product, has a duty of council near his customer. He must thus help it to identify his real need and to make sure that this need was satisfied by measuring the level with satisfaction of its customer. Implicitly, that led the organization to precisely define its role (which is its “ trade ”?) to identify with precision which must be its customers (and especially who should not be a customer because one will not be able to satisfy it) and to be able to determine with them their real needs.

Reference

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