Customer Property in ISO 13485: A Comprehensive Guide
One of the key aspects of this standard is the management of customer property, which is outlined in Clause 7.5.10.…
ISO 13485 Audit
ISO 13485 audit is the methodology through which certification body performs the assessment of a quality system of an organization…
ISO 13485 Mandatory Documents
In this short article we will go through the requirements related to mandatory documents for ISO 13485, especially in relation…
Device History Record (DHR): An Overview
The Device History Record (DHR) is a specific set of documentation requested by the FDA Quality System Regulation; however nowadays…
Quality Agreement: An Overview
Quality agreement is one of the most important documentation in a context of medical device quality management system, including QMS…
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…
Equipment Maintenance: ISO 13485 Requirements
Equipment maintenance according to ISO 13485 is one of the process described in the section 7 of the standard, and…
The PDCA Approach: Plan, Do, Check and Act
The PDCA cycle stays at the base of any quality management system and it is an extremely important approach useful…
Customer Related Process according to ISO 13485
The requirements for customer related process are reported in the section 7.2 of the ISO 13485:2016. Customer related processes are…
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…
