Chapter 7 – Quality Management System ISO 9000

The objective of ISO 9001:2000 is to provide a set of requirements, if they are effectively implemented, will provide you with confidence that the supplier can consistently provide goods and services that:

  • Meet your needs and expectations
  • Comply with applicable regulations

The requirements cover a wide range of topics, including:

  • Top management’s commitment to quality
  • The company’s 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 customers complaints
  • Corrective/preventive actions
  • A requirement to drive continual improvement of the Quality Management System

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.

ISO 9001:2000 does not specify requirements for the goods or services you are purchasing.

That is up to the company to define. Your responsibility is to make your own needs and expectations clear for the product and get the factory to agree to meet them. This is discussed in detail in chapter 15 under specifications and AQL requirements.

What does “Conformity to ISO 9001:2000” 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 to, and fulfilled.

A statement of conformity to ISO 9001:2000 should not, however, be considered as a substitute for a declaration or statement of product conformity.

How Does ISO 9001:2000 Help You in Selecting a Supplier?

ISO 9001:2000 provides some requirements in the purchasing process that includes 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 customer’s needs
  • The ways in which supplied products can be verified as meeting the requirements of the customer (Note that whenever ISO 9001:2000 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. This is often underestimated by importers and must be addressed during your meetings with the factories.

It also has to be included in your P/O and should be as detailed as possible.

You may need to consult with your own technical staff in this process. If you do not 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 specific to the intended use of the product.

To help with this task 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 products on a consistent basis?
  • If you decide that conformity to ISO 9001:2000 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 Quality Management System that meets ISO 9001:2000 requirements?
  • Are the goods and services you require covered by your supplier’s Quality Management System? (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 9001:2000?

There are various ways in which your supplier can claim that its Quality Management System meets the requirements of ISO 9001:2000. These include:

  • Suppliers declaration of conformity: A declaration by the supplier itself affirming that its Quality Management System meets ISO 9001:2000 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 Quality Management System meets ISO 9001:2000 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 9001:2000 requirements. This third party then issues a certificate to your supplier describing the scope of its Quality Management System, and confirming that it conforms to ISO 9001:2000.
  • 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 multilateral 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.
Can Suppliers Claim Their Goods or Services Meet ISO 9001:2000?

The answer is no. The reference to ISO 9001:2000 indicates that the supplier has a Quality Management System that meets the requirements of ISO 9001:2000. As previously mentioned, this should provide you with the confidence in your supplier’s ability to provide consistent, conforming  goods or services. ISO 9001:2000 requires your supplier to monitor the levels of satisfaction of its customers (this includes you!) and use the feedback to improve the effectiveness of its Quality Management System.

What To Do If Things Go Wrong

In the event you are not happy with specific goods or services you receive, you should first of all bring the concern to your supplier’s attention. You will typically do this via the normal technical and/or commercial communication channels that have been established. Your supplier is obliged to investigate your complaint, and should take appropriate actions to avoid or reduce the chances of it happening again.

However, if you are dissatisfied with the overall performance of your supplier, (for example if they continue to provide non-confirming products, do not address your complaints, or are not taking appropriate corrective actions) then this is an indication of problems in their Quality Management System. Depending on the response you receive, you should be aware that you can escalate concerns as follows:

  • If your supplier has a Quality Management System that meets ISO 9001:2000 requirements, they are required to have nominated a person (the “management representative”) with the responsibility and authority to ensure the system is working properly. You should find out who this is, and make a formal complaint.
  • If you are still not satisfied with the response from your supplier, and they are certified by an independent (third party) certification body (“registrar”), you should bring the matter to the certification body’s attention. You can find the certification body’s name by reading your supplier’s certificate. The certification body will investigate the problems during their surveillance audits of your supplier’s Quality Management System, or in critical cases, may decide to carry out an additional specific investigation.
  • If you do not receive a satisfactory response from the certification body, and it is accredited, you should complain to the relevant accreditation body. Details of such accreditation will appear on your supplier’s ISO 9001:2000 certificate. If you have difficulty getting this information, you can consult the list of accreditation bodies who are members of the International Accreditation Forum on the IAF website
  • If you feel that you have not received a satisfactory response from the accreditation body, and it is a member of the International Accreditation Forum, you can complain to the IAF

Remember that none of the above will affect your statutory rights as a purchaser, and it may be appropriate to take legal actions against your supplier instead of, or, in parallel with the above channels. The way in which you do this may vary from one country to another.

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