ISO: 13485

The ISO 13485:2016 Quality Management System for Medical Device Manufacturing is a highly recognised international standard and an invaluable tool to assist regulatory compliancy.

ISO 13485:2016 is based upon the ISO 9001 process model approach and is a quality management system specifically developed for the manufacturing of medical devices.

Quality Control
Risk Management
Regulatory Compliance
Traceability
Validation
Operational efficiency
Tool for NHS tender submissions and frameworks

As your Quality Consultant, we can provide the following services:

Initial consultation to define your business goals and needs
Review existing SOPs / Policies and carry out a gap analysis, to provide ISO 13485 operational documentation
Create a training programme to ensure the framework is embedded throughout your organisation. This ensures consistency across your organisation and reduces risk

Audit & Gap Analysis

EN ISO 13485 is the medical device industry’s quality management system (QMS) harmonised standard; written to specify requirements for an organisation to design and implement a quality management system to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

An ISO 13485 audit helps determine the actual status and health of your current QMS and processes. The purpose of quality audits is to verify that manufacturing, development, and related control facilities meet current good manufacturing processes (GMP), as well as conform to the commitments of ISO 13485.

An ISO 13485 audit (led by a BSI Trained Lead Auditor) includes:

A review of your current quality and regulatory documentation before your on-site ISO 13485 audit by a Notified Body
A systematic and independent process audit to determine conformity or nonconformity of your QMS to ISO 13485:2016 requirements
A review of your policy & procedure documentation to verify requirements have been addressed
A review of the objective evidence for internal audit
A physical verification of compliance via interviews and fact-based observations to confirm the quality system requirements are met
An evaluation of current special controls and validated processes