ISO-9000 is aQuality Managementmodel comprised of 20 sets of quality system requirements known as elements. The model was initially designed for the manufacturing sector and affects virtuallyevery aspectof a business.
ISO 9001 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 Organization for Standardization (ISO) often referred to collectively as the “ISO 9000 series” or "ISO 9000 family". 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, 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 text.
The latest version of ISO 9001 was published in November 2008, making only minor changes compared to the previous (2000) version. The new revision aims primarily to improve the clarity of previously existing requirements in ISO 9001:2000, rather than introducing any new requirements. For that reason, ISO 9001:2000 and ISO 9001:2008 can be considered to be equivalent for all practical purposes, though ISO 9001:2000 will gradually be replaced by ISO 9001:2008 until being no longer valid for conformity assessment purposes by 15 November 2010 (two years after the publication of ISO 9001:2008).
The objective of ISO 9001 is to provide a set of requirements that, if effectively implemented, will provide you with confidence that your supplier can consistently provide goods and services that:
Meet your needs and expectations and
Comply with applicable regulations
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 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. ISO 9000 is actually divided into five standards: ISO 9000-1- Guidelines for Selection and Use ISO 9001- Model for Quality Assurance in Design/Development, Production, Installation, and Servicing ISO 9002- Model for Quality Assurance in Production, Servicing, and Installation ISO 9003- Model for Quality Assurance in Final Inspection and Test ISO 9004-2- Quality Management and Quality System Elements - Guidelines
Your company would be registered to 9001, 9002 or 9003 depending on your type of business. The others are, as they state, guidelines.
What you must remember is that ISO-9000 is a model for amanagementsystem of quality assurance. In other words, the emphasis is on your company's management, first and always.These are not standards about the quality assurance department. It's premise is simple:SAYwhat you do,DOwhat you say.
The results are powerful: it changes any organization from a reactive, "respond to problems as they arise" system to apro-active, preventativesystem.
Members of theservice industryhave recently discovered thebenefitsof ISO registration which the manufacturing world has enjoyed for over ten years. They have since adopted the standard and the list of over 450,000 registered "companies" now includes schools, hospitals, hotels, resorts, airlines, and even casinos.
The Benefits of ISO 9001
There has been so much written about the benefits of having ISO-9000 registration, there isn't enough space on this website to repeat it all. We will attempt to list some of the basic benefits here.
1. ISO-9000 forces an organization tofocus on "how they do business". Each procedure and work instruction must be documented and thus, becomes the springboard forContinuous Improvement.
2.Documented processesare the basis for repetition and help eliminate variation within the process. As variation is eliminated, efficiency improves. As efficiency improves, the cost of quality isreduced.
3. With the development of solid corrective and preventative measures, permanent company wide solutions to quality problems are found.
4.Employee moraleis increased as they are asked to take control of their processes and document their work processes.
5.Customer satisfaction, and more importantly customer loyalty, grows. As a company transforms from a reactive organization to apro-active, preventativeorganization, it becomes a company people want to do business with.
7.Better products and servicesresult from Continuous Improvement processes.
8. Fosters the understanding thatquality, in and of itself, is not limited to a quality department butis everyone's responsibility.
9.Improved profit levelsresult asproductivity improvesand rework costs are reduced.
10.Improved communicationsboth internally and externally which improves quality, efficiency, on time delivery and customer/supplier relations
How does ISO 9001 help 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!)
Does your supplier meet 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 ascertificationorregistration): your supplier hires an impartial third party (acertification 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 indepndence and competence to carry out the certification process. Many accreditation bodies have multi-lateral arrangements under the umbrella of the International Accreditation Forum (IAF) to promote worldwide mutual recognition in support of World Trade Organization (WTO) free trade principles.
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 theoverallperformance of your supplier (for example if they continue to provide nonconforming products, do not address your complaints, or are not taking appropriate corrective action). then this is an indication of problems in their quality managementsystem. Depending on the responses you receive, you should be aware that you can escalate your complaint via the steps described below.
If your supplier has a QMS that meets ISO 9001 requirements, they are required to have nominated a person – themanagement 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 if they are certifiedby 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 looking at your supplier’s certificate. The certification body will investigate the problems during their surveillance audits of your supplier’s QMS, 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 if it is accredited, you should complain to the relevant accreditation body. Details of any such accreditation will appear on your supplier’s ISO 9001 certificate. If you have difficulty in getting this information, you can consult the list of accreditation bodies who are members of the International Accreditation Forum on the IAF Website (www.iaf.nu)
If you feel that you have not received a satisfactory response from the accreditation body, and if it is a member of the International Accreditation Forum, you can complain to the IAF (www.iaf.nu).
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.
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