Preparing for an ISO 13485 audit

Being the current standard for medical devices; the ISO 13485 prescribes a set of standards that are to be implemented by manufacturers of medical devices. The aim of ISO 13485 is to ensure that medical devices meet the prescribed quality standards. This standard was conceived with the intention of making medical device manufacturers understand ways by which to establish a medical device risk management process.

Implementation needs proper training

Implementation of the ISO 13485 needs expert knowledge. Medical device organizations that need to implement it need to have trained staff, which needs to be aware of what to do when they are approached by an auditor. They should also know what documentation must be completed, kept up-to-date, and be made available, so that the organization can avoid major and minor findings. In addition, they should also be thoroughly aware of the issues that auditors constantly look for. They need to also be knowledgeable about the new updated standard.

risk

Get trained on how to prepare

To make medical device professionals that face an ISO audit familiar with the dynamics of an ISO audit and to acquaint them with what it takes to be prepared for one when it happens, GlobalCompliancePanel, a globally known provider of professional trainings for the areas of regulatory compliance, will be organizing a two-day, in person seminar.

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To enroll for this seminar and to get a thorough understanding of the ways by which to implement ISO 13485, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900708.

The Director at this seminar, Jason Teliszczak, who is CEO/Founder, JT Environmental Consulting, will give a complete understanding of how to prepare for an ISO audit in a manner that helps organizations defend their actions with the auditors and to avoid a number of errors and goof-ups that could result in harsh actions. In taking a detailed look at each section of the standard; Jason will let participants understand the core elements of an ISO audit.

He will offer real world examples of what to expect, and what to prepare and repeal within the audit guidelines, the ways of ensuring a compliant documentation system, infrastructure maintenance, PPE, ensuring quality by the judicious use of materials, ways of choosing suppliers and vendors, ways of going about an internal audit, and the role of management in certification.

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