ISO 13485:2003 an international standard developed by ISO - International organization for Standardization -  to utilize the benefits of quality management systems toward the design, development, production, installation and servicing of medical devices and related services. Medical Devices are products designed to diagnose, treat, investigate and augment human functions and diseases. A certification of effective implementation and maintenance of ISO 13485:2003 standard is considered to provide consistency and repeatability of the devices and related services provided by the certified organization.  

Unlike some other product and system standards, ISO 13485 is not just product focused, but it focuses on the processes used to develop medical devices and the related services including recalls. It is also necessary that the organization must comply with all relevant product and service oriented technical standards and regulations in the related product field. Although ISO 13485:2003 is based on ISO 9001:2008 quality management standard and uses the same numbering system, ISO 13485 doesn't include the ISO 9001 requirements related to continual improvement and customer satisfaction. ISO 13485 also focuses more on how procedures regulate and control activity and process performance.

BDSi provide instruction on the proper understanding of ISO 13485:2003 and help implement a robust system that will not only meet the certification requirements; but also ensure the business management system is capable to reap the intended benefits of consistency and financial improvement by ensuring minimized waste and optimized processes.

Participants of our integrated courses that provide instruction and hands on implementation are designed to provide the following learning objectives:

• Understand the benefits the ‘Process Approach’ of ISO 13485:2003 to implement a management system that ensures consistency and repeatability
• Demonstrate an understanding of the purpose and intent of the ISO 13485 standard
• Identify and understand the process within the organization and implement checks and balances to prevent upstream nonconformance.
• Identify quality management principles upon which the ISO 9000 and ISO 13485 standards were based.
• Understand the purpose of ISO 14971and ISO/TR 14969 and their relationship with ISO 13485:2003
• Understand each of the standard’s clauses and apply the intent of the standard to the manufacturing system
• Create a basic business model for each element of the standard – with inputs, process transformations, and outputs as it relates to the product and organization’s business model
• Relate key elements of the standard to the organization’s business policy using clause-by-clause review of the standard and how each clause is applied to the processes

Why ISO 13485 Compliance is Important in the US

Although ISO 13485 compliance is voluntary, it provides a framework for meeting medical device quality requirements in the international market. ISO 13485 compliance also helps meet the requirements outlined in 21 CFR Part 820 for the Quality System Regulations (QSR) applicable to medical device manufacturers and importers. Identification and mitigation of potential risks through BDSi’s Risk Analysis method is one of the biggest reasons for having ISO 13485:2003 implemented by BDSi.

Why ISO 13485 Compliance is Important in Europe

Published in 2003, ISO 13485 compliance outlines the requirements for a comprehensive management system for the design and manufacture and service of medical devices. Complying with ISO 13485 is one of the first steps in complying with European regulatory requirements. ISO conformance is important because the conformity of medical devices and in vitro diagnostic medical devices according to EEC Decrees 93/42/EEC, 90/385/EED and 98/79/EEC must be assessed before the sale of the medical device is allowed.

The preferred method to prove ISO 13485 compliance is the certification of the Quality Management System according to ISO 9001 and/or ISO 13485, ISO 13488, or ISO 14971 by a Conformity Assessment Body. A positive assessment is necessary for the authorization of the CE-identification and the permission to sell the medical device in the European Union.

Using Automation to Optimize ISO 13485 Compliance

Through efficient process management, medical device companies can achieve increased efficiency, higher performance, and reduce their operational costs. Transforming manual processes into automated processes in areas such a document control and process management can provide dramatic results in terms of assuring ISO 13485 compliance.