Procedures (rules) that must be in place to run the company in compliance with the standard; Documentation (records or evidence necessary for auditors to prove that the procedures are in place); Frequency of auditing; Internal audits; Training for internal auditors; External audits (from registrars).
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Hey everyone! I am a consultant who specializes in
iso 13485 certification. This page will be dedicated to sharing my experiences and learning from others in this field.