email: zoltanlaszlo.toth@gmail.com
How can we help?
• System set-up, development and implementation,
• Carrying out the appropriate trainings,
• Carrying out and coordination of internal audits,
• Preparation for certification and surveillance audits,
• System maintenance as assigned Quality Management Representative,
• Active participation in the certification audit.
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The ISO 9001 Quality Management System:
• The ISO 9001 standard is the today’s most commonly known standard, which is recognized all over the world.
• The ISO 9001 standard does not draw up directly quality requirements on the product, but it requires conscious steps in the customer relationship and the mode of implementation.
• Development and certification of Quality Management System according to ISO 9001, that is comply with the requirements of standard ISO 9001 certifies that your business is operating in high quality.
• The introduction of the Quality Management System according to ISO 9001 and its certification by third-party is essential for companies to get involved in public procurement and tendering procedures or win a supplier position.
• Those companies that are not certified according to ISO 9001 standard are starting over with significant handicap against their competitors in the market.
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The ISO 13485 Quality Management System:
• The fundamental purpose of introduction and application of ISO 13485 Quality Management System is the standardization of the regulatory requirements, practices and interpretations relating to the manufacture of medical devices.
• In the case of ISO 13485 the focus is not only on increasing of customer satisfaction but also on achievement of a safe and effective therapeutic goal.
• The ISO 13485 standard provides an opportunity in this highly regulated industry to the manufacturer, to the authority and to the disbursing aid organization to speak a common language, clear and transparent regulation.
• So the application of the ISO 13485 standard ensuring compliance with regulatory requirements, a clear document management and a common language at the same time. Therefore, the introduction of Quality Management System according to ISO 13485 standard is extremely useful for medical device manufacturers and is almost essential for manufacturer who should conduct a compliance procedure.
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During the development of the Quality Management System your Company will not only be prepared for compliance with the requirements of the standards but also the expectations of the Company’s Management are going to be built into the system so the Company Management will be combined with Quality Management. With this and effective regulatory tool is provided for your Company.
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Benefits of Quality Management System:
• Assists the Management in control and decision-making, improves the flow of information,
• Clarifies the scopes, the subordination and hierarchical relationships, the organizational structure and responsibilities,
• Ensures the regulation and ongoing verifiability of the activities, thereby reducing the chances of errors, therefore cost-effective production (service), can be achieved,
• Results the accountability of assigned tasks,
• Encourages continuous improvement,
• It helps to identifying the root causes, provides a procedure for solving the problems,
• Provides an opportunity to introduce the long-postponed changes,
• Speeds up the initial and orientation training of new employees,
• Makes the internal communication more effective,
• The accurate and retrievable documentation can be a serious help in the case of legal disputes and complaint matters,
• It improves the quality of the operation of the entire company, and with it the company's efficiency,
• Improves the company's market perception, competitive advantage may acquire.
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In summary:
• Your Business will have more advantageous market position, whether you want to operate in the domestic or foreign market.
• If your Company has a certificate - this guarantees for anyone that you are running a business with a quality and customer interests in mind.
• During the introduction of the Quality Management System you will review again your business and with our assistance you may correct deficiencies, failures you are not experienced yet, or you can develop, improve your business.
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Why should you make use a consultant for implementation of the Quality Management System according to the chosen standard? The Consultant,
• Shortens the implementation process, therefore saving you time and money,
• Interprets the requirements of the standard more easily,
• Has greater experience,
• Can properly integrate the already developed and tested good practices into your Company,
• Maintain his/her competence continuously, has up to date knowledge.
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We are looking forward to welcome you as our Customer.
