ISO 13485 Medical devices -- Quality management systems

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

everything needed to prepare for certification: Manual, Procedures & Forms, Checklists, Employee & Internal Auditor Training.

ISO 13485 PROCEDURES
This complete Procedures includes 27 procedures designed to use with an ISO 13485 Quality Management System, as required by the ISO 13485 Standard. Each easy-to-customize procedure relates directly to a section of the ISO 13485 Standard. 

 Gap Checklist with guidance on what to look for to evaluate current processes and compliance to the ISO 13485 Requirements. 

Internal Audit Checklist Package includes an Internal Audit Checklist, Procedure, Planning Forms & Report Form 

An ISO 13485 certificate proves your commitment to the quality of medical devices. It enables you to demonstrate that your quality management system has been assessed and found compliant in order to meet regulatory requirements and customer needs.​ ISO 13485 is the internationally recognised standard for quality management systems in the medical device industry.

It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices, and that related services consistently meet customer requirements and applicable regulatory requirements. It is designed and intended for use by organizations for the design and development, production, installation, servicing and sales of medical devices.

The primary objective of ISO 13485 is to facilitate harmonised medical device regulatory requirements for quality management systems. ISO 13485 is a standalone standard. It is largely based on the structure of ISO 9001, but includes some particular requirements for medical devices such as risk analysis, sterile manufacturing and traceability.
Organizations being certified to ISO 13485 can not claim conformity to ISO 9001.

ISO13485 certification can be registered include: Non-active Medical Devices (dressings, bandages, disposable products, contact lenses, blood bags, catheters, dental appliances, etc.); and Active Medical Devices, such as magnetic resonance, ultrasound diagnosis and treatment Miriam, infusion pumps, etc.; sterilization equipment (X-rays γ-ray radiation sterilization) (EOG ethylene oxide gas heat) aseptic processing; vitro diagnostic medical devices (including reagents, reagent composition, calibration items, control material, testing tools, equipment , apparatus, equipment or system, either alone or in combination, to extract a sample from the human body (including blood and tissue donations) be checked in vitro.

In order to ensure your business's readiness for certification we offer the following services:

• On-site Internal Process Audit - Once you have prepared your documents, identified management responsibilities, planned resource management and established metrics for measurements, analysis and continual improvement we can provide an in-depth internal audit that focuses on the process identified by your ISO management system.
• On-site and Remote Assistance for Management Review - Once your internal audit and corrective actions have been completed, we can offer you guidance through your Management Review and assist with the preparation of an assessment effectiveness report for analysis of your management system.
• Management System Pre-assessment Prior to Stage 1 - Once you have completed Management Review and an assessment of the effectiveness of your management system, we can provide an over-all expert pre-assessment review of your management system and assistance with corrective actions prior to Stage 1 by your Certification Body.
• Corrective Action Support - If you are engaged in a Stage 1 or 2 audit then we can provide you with assistance with corrective actions, as needed, and preparing appropriate response to your Certification Body.

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