ISO 13485: 2003 Management System Certification for Medical Devices
ISO 13485 is a Quality Management Standard is based on the sequence of the ISO 9000 quality standard internationally recognized and accepted. Change the model ISO 9000 with ISO 13485 based process to a regulated environment for the manufacture of medical devices. While ISO 13485 for medical devices management system is based on the process of ISO 9001 that prepares the Model Plan, Do, Check, Act, it is designed for regulatory compliance.
The primary objective of ISO 13485:2003 is to facilitate harmonized regulatory requirements for medical devices for QMS. Accordingly, it incorporates some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Therefore, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
Integrated ISO 13485 standards:
The certifying bodies select and recruits professionals for conducting ISO 13485 audits. Applicants must have the design or manufacturing or process knowledge, and general knowledge about the use of medical devices. Punyam Management has assessment personnel who have the experience of the actual exceptional industry and then go through rigorous internal training and qualification process including best technical quality systems audit practice, understanding the processes critical manufacturing, performance expectations of regulatory compliance.
ISO 13485 is important for designers, medical device manufacturers and distributors. In addition, suppliers and service providers can improve the marketing of an organization increasingly manufacturers require certification to do business with a supplier.
Benefits of ISO 13485 Certification:
When it comes to the manufacture of medical devices, patient safety depends greatly on the quality and consistency of medical products, and ensure the efficiency, control and maintenance of your quality management system is essential for customers, stakeholders, patients and users, and regulators.
The value of ISO 13485 manual in india is not only in implementation but also in providing a tool for a thorough audit to test the effectiveness of the system. It provides the manufacturer with a higher level of confidence in the ability to consistently achieve and maintain compliance with regulatory requirements.
ISO 13485 is designed to meet the regulatory requirements for a quality management system for medical devices. Although ISO 13485 is based on the standard of the ISO 9001 quality management systems, it focuses less on business performance and risk management. ISO 13485 ensures that medical device manufacturers regularly produce medical devices that meet regulatory requirements and are designed and manufactured to be safe for their intended use.
Many international regulators have directly or indirectly approved the use of ISO 13485 as the model to meet their own regulatory requirements for the manufacture of medical devices. Many countries have developed their regulations for medical devices ISO 13485 using standard criteria or on the inside and other countries are using or start using the same standard in their regulations for medical devices.