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What is ISO 9001? – A Simple Guide


Regardless of product, manufacturing companies generally have a quality assurance programme.

The company sets quality standards that are based on their customers’ requirements. They then inspect their product before it is dispatched to the customer to ensure that it meets the pre-determined standards. Historically, quality standards have been rather subjective and relied on inspection of the completed product to determine its quality.

Quality standards were consequently subjective, as the manufacturer was determining its own quality criteria, without input from the customer. This system led to a lack of consistency and quality became rather hit or miss.

What is ISO 9001?

ISO 9001 originates from the first quality standards that were originally published by the British Standards Institute in the 1970’s. Since that time, manufacturers have abandoned their own quality assurance systems and all now follow those set by the BSI of which ISO 9001 is the latest version.

ISO 9001 provides companies with a recognised global, consistent quality standard, which is now applied to service organisations too. Registration can be a lengthy process that requires input from all areas of an organisation as follows:

Quality Plan

Companies must develop a comprehensive quality manual, outlining the organisation’s quality management system. A quality plan with clear objectives and goals is also required.

Quality Policies and Procedures

Six quality policies and procedures form the core of the quality management system:

  1. Document control
  2. Product quality records
  3. Non-conforming product controls
  4. Corrective action
  5. Preventive action
  6. Internal audits

Documentation of policies

In order to establish an ISO 9001 quality management system, clear and specific documentation is required for all policies, procedures and work instructions.

The policy documentation serves as a control that can be used to manage a company’s conformance to industry standards, internal audits, and processes. It is very important that the company regularly reviews and revises the documentation in order to reflect changes that occur in work processes and company policies.

System testing

It will be necessary for the company to rigorously test its quality system prior to an audit that will be carried out by an approved ISO 9001 registrar. Once the audit has been completed and the company’s quality assurance systems have been approved, further audits will be required periodically to ensure that the company is operating under ISO standards.

In conclusion

ISO 9001 works to clarify and standardise all business processes, exposing any non-conformance and variation that could lead to inconsistent quality standards, and removing the need for continual inspection of products and services.

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