The ISO 9000 series of quality standards is the most used management system worldwide; thousands of organizations rely on these standards to establish an effective quality management system. Here are some facts every organization pursuing to implement ISO 9001 should know.

  1. The ISO 9000 family of standards are a set of standards and guidelines that have global reputation as being the basis for the establishment of quality management systems (QMS).
  2. The adoption of all standards published by ISO, including standards in the ISO 9000 family, is voluntary in nature.
  3. In the ISO 9000 series, all standards can be implemented without certification. Any business can use the models from the standards to improve quality management systems.
  4. Many countries have adopted the ISO 9000 family of standards and have also appropriated its numbering system for their national standards. For instance in the United Kingdom, ISO 9001 is referred to as BS EN ISO 9001:2008, with BS standing for British Standard and EN for European Norm. In Sri Lanka, the standard is numbered SLS ISO 9001:2008, with SLS denoting Sri Lankan Standard.
  5. Any organization, regardless of the type of products or services they offer, can use ISO 9001 as their guideline to implement, maintain and improve a successful QMS.
  6. ISO 9001 provides a process approach for its execution, which enables the QMS to connect with other organizational processes; and its focus on continuous improvement and customer satisfaction will lead to an improved business performance.
  7. ISO 9001 specifies what an organization “should” do, but not “how” they should do it, giving great flexibility for any company, large or small, to use this standard. Additionally, ISO 9001 does not establish specific quality requirements; this is a decision taken by each organization; the standard is only a guide to achieve the goals and objectives set by each organization.
  8. Specific industry requirements were added to ISO 9001 to create standards for organizations in the automotive, telecommunications, aerospace, medical devices, oil and gas, and information technology sectors. These QMS standards have not diluted or modified the requirements of the ISO 9001 generic standard, but have added some sector-specific requirements, guidelines and clarifications. Some of these are:
    • Automotive industry: ¬†ISO/TS 16949
    • Medical devices: ISO 13485
    • Primary packaging materials for medicinal products: ISO 15378
    • Petroleum, petrochemical and natural gas industries: ISO/TS 29001
    • Telecommunications industry: TL 9000
    • Aerospace Industry: AS 9100; AS9110 and AS9120
  9. Certification of your QMS by an accredited certification body generates confidence among your existing and potential customers and other interested parties that you are capable of supplying consistently conforming products or services.
  10. Adherence to the ISO standards can be publicized to gain market access abroad, because many foreign buyers place a premium on these standards.

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