ISO9001:2000 Quality System Achieved
The company of course, continues to meet the requirements of EN46001, ISO13485 as well as the Medical Devices Directive 93/42/EEC.
ISO9001:2000 is designed to enable a company to develop its quality system so that it becomes fully integrated within the normal business operations
The main changes in emphasis between the old 1994 standard and the new ISO9001:2000 standard includes :
• The requirement for a "process" based quality system geared around what is actually taking place in the day to day running of the business. This is different from the procedure type system (stating how you control your activities) often written to support each of the requirement clauses of the old standard.
• The requirement for continual improvement of the quality system, specifically process and product performance.
• The role of top management to ensure that measurable quality objectives are set for the company, particularly those relating to the customer and that the appropriate resources are provided.
• A more user friendly and flexible quality management system suitable for application in all company types / sizes and that demands less bureaucratic documentation.
The new ISO9001:2000 standard is designed to improve the effectiveness of the quality management system and can be used as a framework by top management to work towards improved business performance within their company.