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ISO 9001

ISO 9001 standard deals with the fundamentals of quality management systems with the eight management principles as the base. ISO 9001 standard is one of the most widely used management tools across the globe. The ISO 9001 standard is generic in nature and is applicable to any sector regardless of type, size and product or service. The ISO 9001 standard is basically adopted from the MIL standards, later released as an ISO standard in 1987. First revision in 1994, second revision in 2000, third revision in 2015 (presently in use) The ISO 9001 standard requires six mandatory procedures and numerous records in any organization as a requirement.

Main Requirements of the ISO 9001 Standard

  • Clause 1 : Scope
  • Clause 2 : Normative Reference
  • Clause 3 : Terms and Definitions
  • Clause 4 : Quality Management System ( 2 Elements )
  • Clause 5 : Management Responsibility ( 6 Elements )
  • Clause 6 : Resource Management ( 4 Elements )
  • Clause 7 : Product Realization ( 6 Elements )
  • Clause 8 : Measurement, Analysis and Improvement ( 5 Elements )

The requirements cover a wide range of topics, including your supplier's top management commitment to quality, its customer focus, adequacy of its resources, employee competence, process management (for production, service delivery and relevant administrative and support processes), quality planning, product design, review of incoming orders, purchasing, monitoring and measurement of its processes and products, calibration of measuring equipment, processes to resolve customer complaints, corrective/preventive actions and a requirement to drive continual improvement of the QMS. Last but not least, there is a requirement for your supplier to monitor customer perceptions about the quality of the goods and services it provides.

What does "Conformity to ISO 9001 mean?

This means that your supplier has established a systematic approach to quality management, and is managing its business to ensure that your needs are clearly understood, agreed and fulfilled. A statement of conformity to ISO 9001 should not, however, be considered as a substitute for a declaration or statement of product conformity.

How does ISO 9001 help you in selecting a supplier?

ISO 9001 provides some requirements for the purchasing process that include you as the customer. These requirements address the following topics:-

  • requirements regarding the purchasing information that should be provided so that suppliers clearly understand their customers' needs
  • The ways in which supplied products can be verified as meeting the requirements of the customer

Note that whenever ISO 9001 refers to "products"? this also includes intangible products like services, or software.

You have an important role to play, by specifying to your supplier what you actually want. You may need to consult with your own internal technical staff (the actual users) in this process. If you don't do this, you might find that you receive a product that meets all your stated requirements and the applicable regulatory requirements, but which is absolutely wrong for your intended application. So, first of all, you should concentrate on specifying your needs related to the intended use of the product.

To help in this task you may consider the following:-

  • What is the specific product (goods or service) you are buying?
  • What impact does this product have on your own business?
  • What are the risks to your business if you experience problems with this product?
  • How can you be sure that the product you receive will actually meet your requirements?
  • What do you know about the reputation and historical performance of your supplier?
  • What level of confidence do you need in your supplier's ability to provide you with conforming product on a consistent basis?
  • If you decide that conformity to ISO 9001 is important, (based on your assessment of the risks associated with the goods and services you are buying) how can you be sure that your supplier does have a QMS that meets ISO 9001 requirements?
  • Are the goods and services you require covered by your supplier's QMS? (You may need to ask for a copy of your supplier's actual certificate or declaration of conformity to find this out!)

How can you have confidence that your supplier meets ISO 9001?

There are various ways in which your supplier can claim that its QMS meets the requirements of ISO 9001. These include: -

  • 'Supplier's declaration of conformity? A declaration by your supplier itself affirming that its QMS meets ISO 9001 requirements, usually supported by legally-binding signatures. This declaration can be based on your supplier's internal audit system, or on second party or third party audits;
  • Second party assessment: your supplier has been assessed directly by its customer (for example by you, or by another customer,whose reputation you respect) to check if its QMS meets ISO 9001 requirements and your own requirements - sometimes used in contractual "business-to-business?transactions;
  • Third party assessment: (often referred to as certification or registration): your supplier hires an impartial third party (a Certification Body, or "Registrar? to conduct an assessment to verify conformity to ISO 9001 requirements. This third party then issues a certificate to your supplier describing the scope of its QMS, and confirming that it conforms to ISO 9001.
  • Additional confidence may be derived from the fact that some Certification Bodies ("Registrars? are accredited by nationally or internationally recognized Accreditation Bodies, who verify the certification body's independence and competence to carry out the certification process. Many accreditation bodies have multi-lateral arrangements under the umbrella of the IAF (International Accreditation Forum) to promote worldwide mutual recognitions in support of WTO (World Trade Organization) free trade principles.

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