ISO 15189: QMS for Medical Laboratories
ISO 15189 is an international standard to be followed for the implementation and maintenance of quality management system of medical…
Substantial Changes for Design and Quality System: an Overview
The definition of substantial changes has always been very critical for medical device manufacturers. We have already been talking about…
Quality Policy according to ISO 13485
The definition of the Quality Policy of the organization is one of the essential tasks associated to the top management…
SOP of SOP
SOP – Standard Operating Procedure – are at the basis of any quality management system, independently from the business of…
The role of management representative according to ISO 13485
Introduction In this post, we will go through the main requirements associated with the management representative role taking into consideration…
ISO 2859 and AQL Sampling Methodology
Over the course of time, the ISO 2859 standard has established itself as an indispensable tool, not only for medical…
MDSAP : Medical Device Single Audit Program
The MDSAP is an audit program that allows auditing organization to perform a single audit of a medical device manufacturer…
How to write a Quality Manual fully compliant with ISO standards?
The quality manual is one of the most important documents for a company with a quality system in place, and…
What are the best Methods for Root-Cause Analysis ?
Performing an investigation in case any type of deviation occurs is of fundamental importance nowadays and root-cause analysis methodologies play…
Management Review
General Requirements It is important to demonstrate that top management reviews the suitability, adequacy and effectiveness of the organization’s quality…