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International standards organisation (ISO), releases guidelines and specifications about the quality of each product those are available in the market. The manufacturing companies follow guidelines and produce sample products first, after these products pass the ISO certification test for quality of work and material of construction, the company manufactures for the market orders. Quality conscious people usually look for these types of certifications of the company, so this test and product certifications are important for the company’s profile. The company has to register to ISO first in order to acquire surveillance of quality. ISO 13485 certifications is done for medical devices (for regulatory purposes with quality management system). The organisations should be essentially ISO 9001 to meet the expectations of medical device industry. ISO 13485 keeps focusing on medical device safety, accuracy and efficiency. It doesn’t give more emphasis on customer satisfaction and improvement as medical instruments may be less energy efficient but they should be perfect in measurements failure to which results in huge losses. Another one advantage is there with ISO 13485certification. If one implements the processes and procedures mentioned in the requirement list of the standard, than he would be audited by a third party organization like TUV or UL recognized by the ISO. This helps in gaining the FDA certifications too with QSRs by 21CFR820. They provide 1 year free e-mail consulting support too. Likewise ISO 14001 is implemented for evaluating environmental management systems. This standard is very usual and every company which is expected to contribute towards pollution is supposed to take this certification. The rules of ISO 14001 make it unique. It is very comprehensive as all the members of the company have to take part in the verification and processes are mandatory to be present to identify all environmental impacts. Emphasis is given on being proactive, forward thinking and taking action instead of reacting to command & control policies. Stress is given on establishing exact no of environmental management systems across all parts of the functional part of the industry. If a company needs to be ISO 14001 approved, following are the requirements. • It should have a environmental policy • Environmental goals, objectives to give results to the policy • Role, responsibility and authorities taken towards environment • The company should have a program for auditing the EMS and respective correction actions regarding it if necessary. • Communication of the EMS to all interested parties For more information about ISO 13485, please visit www.qualityassociates.org
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