Preparing For ISO 9001 2000 Registration
The steps need to be taken to prepare an organization for ISO 9001 2000 registration:
Whilst the following text is not exhaustive in its content it should give you a reasonable idea of what’s involved in setting up an ISO 9001 2000 registration within an organization.
First and most importantly you should either purchase a copy of the ISO 9001 2000 standard or read a copy at your local library.
At first glance many of the terms referred to in the standard ISO顧問公司 sound quite confusing but if you study the content of this web site you will soon become familiar with the terminology used.
Now that you are a little more familiar with the ISO 9001 2000 Quality Management Standard and its terminology you should start to analyze the current practices of your organization to those documented within the ISO 9001 2000 standard,This process is known as a gap analysis audit. You can either carry this process out yourselves or employ the skills of an ISO 9001 2000 consultant to carry out the task for you.
It is very important to get this audit right as the results will be used to set the direction of your organization on its route to full ISO 9001 2000 registration. In short if this audit is wrong or incomplete your organization will happily steam along in the wrong direction, wasting resources as it goes, until someone tells you otherwise. If I were to give one piece of advice here it would be to recommend using a professional, a small amount of money spent at this stage could save you unnecessary expenditure if you were to get it wrong.
As the gap analysis audit on your organization progresses you will be able to identify the processes which are already documented, and those that are not. It will be useful to your organization to compile a list of documents that you will need for the Quality Management System as you complete the gap analysis audit, there is no sense in doing the same job twice.
It is important to remember that just because a process is documented does not necessarily mean it is compliant with the requirements of the ISO 9001 2000 standard. Almost certainly your organization will have to tweak existing processes and or instigate new ones in order to comply with the documented requirements of the ISO 9001 2000 standard.
For this purpose you may decide to bring together a team of employees and have them review the processes and suggest improvements which will make the process compliant with ISO 9001 2000. Alternatively you may wish to employ an ISO 9001 2000 consultant to carry out this task for you. Whilst a consultant may initially seem expensive he or she will have the experience to complete the task expediently and cost effectively.
Now that the organizations processes and any short falls against the ISO 9001 2000 standard have been identified they have to be documented in a within a controlled document control system. Whilst there is not a definitive, prescribed method to document an ISO 9001 2000 Quality Management System there are, as with most things, easy and hard ways of doing this.
If you are unsure how to do this there is an example procedure here or once again you can employ a consultant to complete this task expediently.
Design and implement the Quality Management System to comply with the requirements of ISO 9001 2000.
This will typically require:
Establishing a quality policy and measurable quality objectives.
Documenting a quality manual, describing your Quality Management System.
Documenting procedures which describe the processes in your organization.
Creating a document issue, withdrawal and re-issue of documents system.
Documenting test and inspection methods.
Documenting a corrective and preventive action process.
Identification of training needs and necessary job skills.
Calibrating and controlling measuring and test equipment.
Measuring and monitoring customer satisfaction.
Measuring process, and product conformity.
Training employees on the operation of the quality management system.
Planning, conducting and following up internal Quality Management System audits.
Continual improvement of the Quality Management System.
As each process in your organization is revised, documented and implemented you need to ensure that your employees are trained accordingly in the operation of the revised process and that their documented training records are updated. All employees must have had at least basic ISO 9001 2000 training so that they can demonstrate that they understand what is required of them. You can either attempt this training your self or employ a consultant trainer to do this task for you.
You must generate and keep documented records of employee training in accordance with your new processes procedures which, of course must be compliant with ISO 9001 2000.