ISO 9001:2000 Quality Management System Requirements

ISO stands for International Organization for Standardization.

It is an international body which deals with the setting up of a common set of standards. ISO’s main principles as per PMCi can be given thus: - Define what all actions are done. Document all the actions carried out. Explain what documentation is done. - Define the quality policy for each department and adhere to it.

- Define the role and responsibility of each individual in a department and follow it. - Follow the procedures every time (Requirements of the research, n. d).An ISO standard is concerned with dealing with the documentation of the system. In dealing with the documentation, the standard ensures that all the processes in the organization are in place. An ISO standard should not be confused with dealing with the quality of the end-product.

An ISO system is only responsible that all the processes carried out to get the end-product are as per the standard chosen by the organization. In other words, an ISO standard does not guarantee that the end-product is defect-free; it only guarantees that the processes involved in making the end-product are adhering to the ISO standard.Once an organization has decided to adopt an ISO standard there is a chain of hierarchy for the certification process as explained by PMCi. The first component of the hierarchy is the company. Now, let us try to understand this process with an example.

A company, let us say ‘X’, wishes to be registered with ISO 9001:2000 (or for that matter any ISO system). For company ‘X’, the procedure to implement ISO is not known, so they hire a consultant. This consultant is an expert in ISO and will help them set their system in the proper format.Above the consultant there is another body called as the certification body.

This certification body is a check on the company’s documents. This certification is not mandatory in ISO. It is only the company’s decision whether it needs a certification. This certification, since it is independent can tell the company how it fares in terms of its ISO standards.

A certification body in turn can be an accreditated body. Not all certification bodies go for accreditation. It is fully dependent upon the certification body whether it needs accreditation or not.Once a certification body is accreditated, it means that the certification body also has been checked and found to be within the norms of ISO. If the certification body finds the company ‘X’ as per the norm, then it will be given the ISO certificate by the certification body. It should be noted that ISO itself never provides certification to any organization (Requirements for the research, n.

d). As per the Praxiom research group, the first step to set up an ISO system is to start the Quality Management System.Quality Management System can be said to be the guidelines for the documentation of the company. They define how the company should operate with respect to their data management. The most common method of beginning is to draw a flow-chart showing all the processes involved in the QMS.

This flow-chart should also give a fair idea of the company’s organizational chart. Now, once the QMS chart of the organization is complete, the organization should then proceed to make up proper documentation for all the processes involved in the chart.The documents should be such that by going through the documents any person within the organization should be able to understand how the process should be carried out. Once the documents required for the particular department are ready to use, then distribute these documents to the relevant users and make sure that they are the most recent documents and the users are aware of how to follow the procedures given in the documents. The documents should be kept up-to-date with constant revisions. Whenever a revision is made, distribute the revisions and ensure that nobody uses the obsolete revisions.

While making revisions in a particular document, care should be taken that the revision is done as per the standard. Once the documentation is in place, the next step is that there should be checks done on timely basis. This will ensure that all the processes are being followed in the required format. Each department should be subjected to internal audits at well-defined intervals. Those processes that do not meet the expectations should be given non-conformities. There should be well-defined plans on how to handle these non-conformities.

Even these non-conformities should have records (ISO 9001:2000 in Plain English, n. d). Quality Management System (QMS) works in the simplest way as per PMCi. The main aim of the system is customer satisfaction. In order to get customer satisfaction, what needs to be done is constant monitoring of the system and eliminating the gaps.

The system in this case not just involves the machinery, but also the human resource. The management of both the human resource and the other resources rests solely with the Management of the organization.The Management has to continually monitor the needs of both the customer’s and the employees in order that the organization progresses (Requirements for the research, n. d). The ISO standard also insists as per the Praxiom Research Group Ltd that there be proper hierarchy within the organization.

It means that each individual should have a well-defined role and responsibility. The standard also asks the organization to look into the employees requirements like infrastructure, workspace etc.The better the employees working condition, the better they are motivated to work in the organization’s interest. For the progress of the organization, there should be constant checks done on the customer’s end in order to understand the customer’s demands and needs. Once the requirements are understood, they can be met by proper planning and process.

Make a proper detailed document on how to contact customer and meet their requirements. Each department should have a well-defined role and responsibility.For example, the purchase department should be responsible for the regular checking of the suppliers. They have to carry out spot-checks at both the supplier end and also at the company’s incoming end. The purchase department will have to ensure that the supplier’s carry out their process as per ISO. In plain words, each department will be individually responsible for the processes carried out.

Another important aspect in ISO is the calibration of the instruments. All the important instruments which are used in the process need to be checked and calibrated at regular intervals.In addition, the calibration records need to be preserved for later inspections (ISO 9001:2000 in Plain English, n. d). The various standards are meant to be compatible with each other.

ISO 9001:2000, for example can be used with ISO 14000 which is an environmental standard. QMS standard, PMCi states, makes sure that the organization meets the customer’s requirements consistently by following the defined set of rules. It ensures that the customer is satisfied by the end-product through continual improvements done in the process (Requirements for the research, n. d).