Quality Systems and ISO 9000 Quality Standards

Background of ISO 9000 Quality Standards

As the world’s population increased day by day, trading of products and services increased drastically. The expansion of trade led to globalisation of economies. Because of all the business activities that were taking place between countries, there was a lot of disorderliness. Different countries were packaging their products in different quantities making trade very expensive. For example, the height of a normal size door would differ from country to country; that simply meant that one could not import the same from a different country. There was reason to come up with common measurements and other procedures to enable exchange of goods and services to be easy. The international organisation for standardisation (ISO) was born so as to give guidelines of such measurements and procedures. Despite the fact that one can make his/her own measurements and procedures, there should be international principles recognised worldwide.

The fact that a commodity or a service had to attain certain qualities for it to be accepted to be of standard, compatibility was a big issue. This explains that a standard is an attainment of certain set principles. It is indicated by Seaver (2001) that the most widely known standardisation rules are the ISO 9000 series. It further explains that an item must comply with certain criteria against which the quality of the item or service can be measured. These standards are meant to enhance the working together in the world commonly known as interoperability. This is the reason why a car can be manufactured in one country and be finished using some parts bought from another country. For instance, if one country manufactures size fourteen bolts and nuts to be used in fastening wooden beds, then another country manufacturing spanners, should be able to produce the same size fourteen spanners. ISO was first established as the United Nations Agency in 1947 and is made up of representatives from more than 90 countries including BSI for the United Kingdom and ANSI for the United States (Tricker, 2005). This was also activated for the need for standard interconnection of communication facilities in Europe and the United States of America.

Quality in organisations

The quality of an organisation is determined by standards set by the International organisation for Standardisation (ISO). ISO provides conditions and criteria which act as a guideline to independent governments to determine whether its organisations are of quality. Since ISO standardisation procedures were pegged on the existing ANSI standards and the BSI standards of the United States and the Great Britain respectively, it means that once the International organisation for Standardisation lays out agreed guidelines on quality, then the ball is set rolling to the Standards organisations of each country. Each country needs to be relevant in the world market; therefore, they have to abide by the set standards. Each country should have its own body that controls the quality of products and services given to its citizens such that, once the ISO body has set the rules that imply a quality organisation, the local standard bodies take over the control of quality in organisations.

This is important because the local standards bodies are the ones that understand the law of the country the organisations are operating in. They also enable the improvement of the standards through periodical auditing procedures. It should also be noted that standards are set based on past experiences combined with scientific research that tends to inform the setting of certain rules that ensure quality.

Structure of ISO 9001:2000

The ISO standards are usually reviewed from time to time so that it incorporates the mutating nature of organisations and the industries that were not considered previously. That is why one can notice different sets of ISO standards like the ISO 9001:2000. Basically speaking, ISO 9001:2000 is the merging of the previous ISO standards 9001, 9002, 9003 into just ISO 9001 and the emergence of the new ISO 2000 series. This is what makes the ISO 9001:2000 standards. Organisation that had the old ISO standards certification had to realign to the new standards in order to comply with the ISO 2000. The ISO 9001:2000 emphasises the involvement of the top management into the ISO standards.

Bon and Verheijen (2006) emphasises that, “the 2000 version sought to change thinking by putting the concept of process management in the forefront of the Standard. Documents produced by the ISO Technical committee which drafted the third edition make it clear that they did not see any change in the essential goals of the standard”. The basic focus on the management of processes within an organisation was the key thing in these revisions. It also emphasised the documenting of systems as opposed to having a system of documents. Each process or system in any organisation had to have documentation properly kept and standardised so that different information is documented in the same way or format. The previous versions were discrete certifications that did govern quality at different levels of the organisation. The ISO 9001:2000, however, is one robust way of controlling quality in an organisation. It is applicable to all organisations, products and services. This is usually reviewed after every five years to ensure that the standards are abreast with the changing times.

Quality Control and Quality Assurance

Quality control and quality assurance in the ISO 9001:2000 standards are controlled by what is commonly known as the Quality Management System (QMS) in each organisation. The quality is controlled and assured by use of various tools in an organisation. The procedures being a critical issue require an independent body to perform quality control and assurance procedures. Such procedures may include auditing by an auditing firm, conformity, continual improvement, corrective actions, customer satisfaction, effectiveness, efficiency and proper keeping of records. Therefore, for quality to be controlled and assured, there is need for the top management of an organisation to take serious measures that ensure that the quality is maintained.

Quality System Management

A proper system must be put in place to enhance the quality control and assurance procedures. This is what may be called the quality management system (QMS). The Quality Manual (2004) states that “the QMS documentation must include a documented quality policy, the quality manual, documented procedures, effective planning, operation and control of processes documents, and quality records.” This will greatly help in the quality control and assurance in the ISO 9001:2000 dispensations.

ISO 9001-2000 Checklist

A checklist is a list of items that are checked against before embarking on any process that requires such items. In the ISO 9001:2000, there is a list of items that the checklist used in auditing quality must have. Since it emphasises mainly in the proper documentation, all processes carried out by any organisation must be properly documented including quality management of the organisation. Basically, the checklist must contain the four quality management system documents, management responsibility in management commitment, customer focus, planning and the quality policy, resource management and the set controls, product realisation procedures, and measurement, analysis and improvement coupled with the prevention actions. This checklist is done to enable the auditors to ensure they have checked compliance in all the area that ensure quality (Micro Memory Bank, 2004).

The quality systems are therefore enhanced by the set down procedures. The laid down procedures are prepared by the organisation and how they plan to accomplish each in product production, how they deal with other stake holders including the community surrounding the organisation and the end products or services they will provide or produce. This requires serious manager and people who are willing to produce excellent results.

In conclusion, the ISO 9001:2000 standardisation procedures came to remove the ambiguities associated with the previous ISO standardisation procedures. The procedures are backed up by the quality management system which ensures that all standards are adhered to, and ensure that non compliance is done away with. Auditing is usually done by external agents like the BSI to ensure that each organisation adheres to set rules that ensure quality. It as well emphasised on the proper documentation of every procedure in a systematic way. The proper way of ensuring compliance in an organisation is by educating the stakeholders of the organisation and the serious involvement of the organisation. The ISO standardisation procedures have enable the provision of quality services and production of quality goods. It, however, faces its own challenges.


Bon, J., and Verheijen, T. (2006). Frameworks for IT Management. Amersfoort, NL: Van Haren Publishing.

Micro Memory Bank. (2004). ISO 9001 Quality Systems Manual, Revision D. Montgomeryville, PA: Micro Memory Bank, Inc.

Seaver, M. (2001). Implementing ISO 9000:2000, Hampshire: Gower Publishing, Ltd.

Tricker, R. (2005). ISO 9001: 2008 for Small Businesses. 5th edition, Burlington, MA: Elsevier Butterworth-Heinemann.