All about the ISO 13485 Lead Auditor Training

There are international standards for several items and processes already and now even the medical equipment design and manufacturing has a standard. The ISO 13485 is about the quality management system of the design and manufacture of Medical Devices. It has a broad implementation and hence it is not necessary for an organization to be actively involved in the manufacturing of medical devices or components to seek the ISO 13485 standard certificate.

ISO 13485 statistics and facts:

  • A survey conducted in 2006 showed that there were 8175 organizations with the ISO 13485 standard across the 82 countries.

  • There was an increase of 31% for new registration for ISO 13485 in 2006 as compared to 2005

  • A big share of firms in USA registered for this. The share of ISO 13485 registrations in USA was 30% as compared to that of others like ISO 9001 which was only at 6%.

  • Besides USA, ISO 13483 is also popular in Europe, Japan, Canada, Sweden and Israel.

[Content Source: Survey conducted by International Organization for Standards]

What is ISO 13485 Lead Auditor Training?

The ISO 13485 Lead Auditor Training helps better understand the process involved, besides several other factors mentioned below:

  • The training helps define the role of a Lead Auditor

  • It helps interpret the ISO 13485 requirements and put it into context.

  • The training is meant to helps you plan, conduct and create a report to support the quality management system audit.

  • Helps better understand the 8 main principles of quality management and further help shaping­­­

  • Helps prepare for all the phases of an internal audit and report the audit results

Who is the ISO 13485 Lead Auditor Training for?

  • The management representatives involved the ISO 13485 process are good candidates for the Lead Auditor Training.

  • Even Engineers and the quality Directors involved with the Medical devices will find this training beneficial.

  • It is almost a must for the consultants in order to gain the upper hand.

  • For carrying out first party, second party and third party audits (mainly done by individuals) , this training is highly advisable.

Benefits of ISO 13485 Lead Auditor training:

  • Proper and effective quality standards can be maintained via regular audits.

  • An organization usually relies on a ISO lead auditor to guide them through all the fine print. Thus they are invaluable to the firm.

  • Stand out from the crowd by adding credibility and thus gaining a competitive advantage.

The Knowledge content of ISO 13485 Lead Auditor training:

To be an ISO 13485 certified manufacturer of medical devices is becoming increasingly important in the Medical industry. Hence more number of organizations are seeking for expert advice on topic. The ISO 13485 lead auditor training offered by Kelmac Group is a comprehensive one which teaches all there is to know from the basic principles, processes to the expert techniques used to assess the quality management.


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