There are twenty requirements of ISO 9001:1994 quality system, which have to be implemented by the organization that wants the certification of their quality system, by an independent accredited registration body. These requirements are called as elements of quality system. These twenty elements are briefly described here.
1 Management responsibility
To ensure the organization’s commitment to quality, the management shall define and document its quality policy in relation to overall corporate policy and reorganize its organizational structure and resources required to effectively manage the implementation of quality policy. Top management should be fully involved and committed in implementation of quality policy.
2 Quality system
To set down in writing what the organization does to produce and deliver quality, the organization should establish and maintain a documented quality system to ensure that the product conforms to specified requirements. The management shall ensure that all activities are performed as per the documented quality system.
3 Contract review
To ensure that organization has fully understood the requirements of the customer and would be able to meet them, it should establish and maintain the procedures for contract review and coordination of the contractual commitments. It shall be ensured that the customers’ requirements are adequately defined and documented. Any requirement differing from that in the offer should be resolved and the management should evaluate its capability to meet contractual requirements.
4 Design control
To translate customer needs and expectations into product specifications, an organization should establish and maintain procedures to control and verify the design of the product. An effective design control system should be established to make sure that all design aspects related to performance, reliability, safety, environment, produce ability and marketability are duly considered and incorporated in product design.
5 Document control
The aim of this element is to provide the employees with precisely the information and document they need to perform their function. Management should identify the scope of documents to be controlled, understand the objectives of these controls and establish the essential controls required.
To avoid any kind of problems caused due to purchased materials or services, an organization should understand the steps that need to be taken to select suppliers capable of meeting the desired inputs. A purchaser shall identify the essential features of a purchase order from the point of view of quality assurance and also identify his own responsibility in the event the purchased material needs verification.
7 Control of customer supplied product
In case if a customer supplies inputs for the product, to ensure that the customer supplied inputs are fit for use, the organization should establish and maintain procedures for verification, storage and maintenance of customer supplied product, provided for incorporation into supplies. The management shall understand the controls necessary in respect of sub-contract.
8 Product identification and traceability
To keep track of raw materials, in-process and finished products, an organization should develop and maintain procedures for identifying the product from applicable specifications and other relevant documents during various stages of production, delivery and installation. Individual products or batches shall have a unique identification for easy traceability to establish the origin of the product.
9 Process control
To ensure that all processes are operated under controlled conditions, an organization should identify and plan the production processes and applicable delivery, installation and servicing processes that directly affect quality. Any special processes required for production should be outlined and essential controls that are required should be established over these processes to meet the requirements of the product quality.
10 Inspection and testing
To ensure that only right quality material and products are received and processed, a system is established for inspection and testing of inputs and products at receiving, in-process and final stages of processing. Inspection and test records of these inspections and tests should be maintained as an objective evidence of product quality control.
11 Control of inspection measuring and test equipment
To make sure that only correct the equipment are used to check the quality of outputs, an organization should ensure that inspection, measuring and test equipment are controlled, calibrated and maintained to desired degree of accuracy. In this regard, the identification of the measurements to be made and accuracy required is necessary for the selection of the appropriate inspection, measurement and test equipment.
12 Inspection and test status
To ensure that only the right and qualified material is processed, appropriate procedures should be established for the control of inspection and test status on the semi-finished or finished products. Records shall identify the inspection authority responsible for release of conforming product.
13 Control of non-conforming product
To ensure that all non-conforming or rejected products are prevented from use and further processing, the non-conforming products are properly identified and arrangements are made for their disposition and notification to the functions concerned.
14 Corrective and preventive action
A procedure should be established to ensure that problems resulting due to non-conformity are corrected immediately and causes of non-conformity are investigated and appropriate corrective actions are taken to prevent reoccurrence.
15 Handling storage packaging and delivery
The procedures for safe handling, storage, packaging and delivery of the product should be well established, documented and maintained to ensure that no deterioration of quality takes place during handling and storage.
16 Control of quality records
To establish the proof of actions taken to control and deliver quality, the organization should identify the data essential to be recorded and documented to demonstrate the objective evidence on quality. Records shall be legible and identifiable to the product involved.
17 Internal quality audits
To ensure that the organization is doing what it said it would do, the management shall plan and execute internal and external quality audits to verify that the quality activities comply with planned arrangements and to determine the effectiveness of the quality system.
To ensure that employees of the organization are competent and having up-to-date knowledge and skills required to produce quality, the organization should identify the training needs and provide for training of all personnel performing activities affecting quality.
If servicing is specified in the contract, the organization shall establish and maintain procedures and facilities for performing and verifying that post sales servicing meets the specified requirements.
20 Statistical techniques
In order to have proper control of quality based on actual data, where appropriate, the organization shall establish procedures for identifying adequate statistical techniques for verifying the acceptability of process capability and control of product and process quality.