ISO 9001 Compliance

ISO 9001 2008 specifies the requirements for a quality control or management system where the organization needs to demonstrate its ability to consistently provide product or services that meets customer and the applicable statutory and regulatory requirements before approval.

ISO 9001 2008 was put in place to enhance customer satisfaction through the effective application of the system which includes processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. Quality control is very important in today’s competitive world and any organization providing sub-standard services or goods cannot survive.

All the requirements of ISO 9001 2008 are generic and they are intended to be applicable to all organizations, regardless of type, size and the good or service that they provide. Wherever any requirement or requirements of ISO 9001 2008 cannot be applied due to whichever reason, such as the nature of an organization and its product, the specific organization can be considered for exclusion if it states its case.

ISO 9001 2008 includes a requirement for the continual improvement of the quality management system if it was planned. ISO 9004:2000 provides many hints for this. Quality control in today’s world entails the development of a simplified set of standards that will be equally applicable to small as well as medium and large organizations. ISO 9001 2008 has been able to achieve this objective.

For effective quality control, the amount and detail of documentation has to be more relevant to the desired results of the organization’s process activities and ISO 9001 2008 has been able to achieve this objective too.

Documentation is a requirement for quality control through ISO 9001 2008. The documentation for ISO 9001 2008 should have the following:

• The documented statements of a quality policy and the quality objectives
• A quality manual
• The documented procedures required by this standard
• The documents needed by the organization to ensure the effective planning, operation and control of its processes
• The necessary records required by this standard

An organization may be able to demonstrate conformity with ISO 9001 2008 without extensive documentation. To do this, all that is required is evidence of effectiveness of the processes and its quality control systems.

However, where exclusions are made, claims of conformity to ISO 9001 2008 are not acceptable unless these exclusions are limited to the specified requirements. Such exclusions do not affect the organization's ability to provide quality control or to provide product that meets customer and applicable statutory and regulatory requirements.

There are several other requirements of ISO 9001 2008 that an organization could use to add value to its quality control systems and demonstrate conformity by the preparation of other documents. These requirements are not a must for ISO 9001 2008 certification and they include:

• Process maps, process flow charts and the descriptions of the process
• Organization charts
• Specifications of the processes
• Work and test instructions used
• The documents containing internal communications
• Production schedules
• Approved lists of suppliers
• Test and inspection plans
• Quality plans