ISO 9001 Compliance

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

Quality management systems have been put in place to enhance customer satisfaction through the effective application of the systems which includes processes for continual improvement of the systems and the assurance of conformity to customer requirements and relevant statutory and regulatory requirements. Quality management is very important in today’s competitive world and any organization providing sub-standard services or goods will fail.

All the requirements of Quality management systems such as ISO 9001 2008 are generic and they are intended to be applicable to all organizations, regardless of size, type, and the good or service on offer. Wherever any requirement or requirements of such systems cannot be applied due to reason such as the nature of an organization and its product, the specific organization can be considered for exclusion if it explains its case to the relevant body.

Most of these quality management systems include a requirement for the continual improvement of the system if it was planned. Quality management systems such as ISO 9001 2008 are all about the development of a simplified set of standards that will be equally applicable to small as well as medium and large organizations.

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

One requirement before certification of quality management systems such as ISO 9001 2008 is documentation. The documentation for such systems should generally have the following:

• Documented statements of a quality policy and the quality objectives
• Quality manual where applicable
• Documented procedures required by the standard in question
• Documents needed by the organization to ensure the effective operation, planning and control of its processes
• The necessary records as required by the standard in question

An organization may be able to demonstrate conformity with quality management systems put in place without extensive documentation. All that is required to do this is evidence of effectiveness of the processes and its quality management systems.

Where exclusions are made, claims of conformity to standards such as ISO 9001 2008 are not acceptable unless these exclusions are limited to the specified requirements. These exclusions do not affect the organization's ability to provide quality management or to provide product that meets customer requirements and relevant statutory and regulatory requirements.

There are several other requirements of standards that an organization could use to add value to its quality management systems and demonstrate conformity by the preparation of other documents. You should note that these requirements are not a must for certification, they include:



• Production schedules
• Approved lists of suppliers
• Test and inspection plans
• Quality plans
• Process maps and flow charts and descriptions of the process
• Organization charts
• Specifications of the processes