ISO13485
ISO 13485 is a comprehensive Quality Management System for the design and manufacture of medical devices. ISO13485 is generally used in conjunction with the ISO9001, ISO9001 requires the organization to have a process for continuous improvement and emphasizes on customer satisfaction. ISO13485 places emphasis on meeting regulatory as well as customer requirements, risk management, maintaining effective processes (specific to safe design), manufacture and distribution of medical devices.

K & S will provide the Policy Manual, Procedures Manual and assist in the writing of Work Instructions, as necessary. Additional on-site assistance is available for quality system implementation, gap analysis, internal audits and auditor training.

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