Audits and Gap Analysis

Gap Analysis Report and deficiencies to ISO 9001

Mock Inspection and Role Play to train Subject Matter Experts (SME)

Audit and Inspection prior to re-certification

Audit of Supplier, and Laboratories prior to Pre-Approval Inspection (PAI)

Audit against ISO 13485 standard for medical devices

Documentation Audit to ensure suitable documents to the correct revision control

Audit the Training Program to ensure no deficiencies in training and its effectiveness

Audit of Management Review, Effectiveness and Communication with Customer

HACCP Analysis