ISO 9001:2008 - What does it mean in the supply chain?

Introduction

As someone who is involved in the selection of suppliers, and possibly responsible for purchasing decisions, you may have seen or used goods and services that are promoted using reference to ISO 9001:2008, or, more simply "ISO 9000". What does this mean? How can this help you? How can you be sure that your suppliers understand what you expect from them, and are capable of providing you with a consistent, conforming product? This information brochure provides some answers to these questions, and will inform you about how you can get the most out of using ISO 9001:2008 as a supply chain tool.

What is ISO 9001:2008?

ISO 9001:2008 is an international standard that gives requirements for an organization's Quality Management System ("QMS"). It is part of a family of standards published by the International Organisation for Standardisation ("ISO") often referred to collectively as the "ISO 9000 series". For this reason, you may sometimes hear your suppliers refer to being "ISO 9000 certified", or having an "ISO 9000-compliant QMS". This will normally mean that they are claiming to have a QMS meeting the requirements of ISO 9001:2008, the only standard in the ISO 9000 family that can be used for the purpose of conformity assessment. It is important to understand however, that ISO is the body that develops and publishes the standard - ISO does not "certify" organizations, as will be explained later in this brochure.

The objective of ISO 9001:2008 is to provide a set of requirements that, if they are effectively implemented, will provide you with confidence that your supplier can consistently provide goods and services that:

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.

ISO 9001:2008 does not specify requirements for the goods or services you are purchasing. That is up to you to define, by making clear your own needs and expectations for the product. You might, for example, refer to product specifications, drawings, national or international product standards, supplier's catalogues or other documents as appropriate.

What does "Conformity to ISO 9001:2008" 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 9001:2008 should not, however, be considered as a substitute for a declaration or statement of product conformity.

How does ISO 9001:2008 help you in selecting a supplier?

ISO 9001:2008 provides some requirements for the purchasing process that include you as the customer. These requirements address the following topics:

Note that whenever ISO 9001:2008 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:

How can you have confidence that your supplier meets ISO 9001:2008?

There are various ways in which your supplier can claim that its QMS meets the requirements of ISO 9001:2008. These include:

Explained in simple terms.

THE IAF

The IAF is an association of Accreditation Bodies and other interested parties from around the world, who work together to promote confidence and consistency in the ISO accreditation and certification process.

ACCREDITATION BODY

The accreditation process provides additional confidence that the certification body is competent and has the necessary integrity to issue an ISO 9001 certificate. Accreditation is usually carried out by national or regional accreditation bodies and their accreditation mark will appear on the certificate.

CERTIFICATION BODY/REGISTRAR

A common way for a supplier to demonstrate conformity to ISO 9001 is via an independent (third-party) certification process. A certification body (sometimes known as a registrar) conducts an audit of the supplier and if all is OK, they will issue a certificate of conformity.

THE ORGANIZATION (YOUR SUPPLIER)

If you know your supplier well and have confidence in them, it may be sufficient for you to accept a "Supplier Declaration of Conformity to ISO 9001" issued by them. Alternatively, you may choose to audit your supplier yourself or you rely on audits that have been carried out by other reputable customers. These are known as "second-party audits".

THE CUSTOMER (YOU)

You are the one who is buying the goods or services from your supplier. You need to make sure you tell them clearly what you want. Depending on how well you know your supplier, the confidence you have in their products, and the importance of their products for your own business, you might not even need them to demonstrate their conformity to ISO 9001 at all.

Can suppliers claim that their goods or services meet ISO 9001:2008?

No. The reference to ISO 9001:2008 indicates that the supplier has a quality management system that meets the requirements of ISO 9001:2008. As mentioned earlier, this should provide you with confidence in your supplier's ability to provide consistent, conforming goods or services. ISO 9001:2008 requires your supplier to monitor the levels of satisfaction of its customers (this includes you!), and to feed back this information in order to improve the effectiveness of its QMS.

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 this 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.

If, however, you are dissatisfied with the overall performance of your supplier, (for example if they continue to provide non-conforming 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 responses you receive, you should be aware that you can escalate your complaint as follows:

Remember that none of the above will affect your statutory rights as a purchaser, and it may be appropriate to take legal action 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.

To summarize.....

ISO 9001:2008 is a useful basis for organizations to be able to demonstrate that they are managing their business so as to achieve consistent (good!) quality goods and services.

There are several ways in which your suppliers can claim conformity to ISO 9001:2008, and you need to ensure that the method chosen by your supplier provides you with the necessary degree of confidence.

If you are not satisfied with the performance of your supplier, you must provide them with the appropriate feedback. Learning from complaints helps organizations to improve their future performance - that is what ISO 9001:2008 is about.