Certification ISO 13485

Nowadays, fulfilment of clearly defined quality standards in business – and particularly in international business – is becoming ever more important. Part of this is the ability to adapt to changing markets and customer requirements and constantly develop new learning and improvement processes.

ISO 13485, as a quality management system for medical devices, describes requirements for regulatory purposes and describes the development, implementation and maintenance of a quality management system for medical device manufacturers and suppliers.

The standard contains detailed requirements for a quality management system which fulfils both customer requirements and the requirements for all life cycle stages of a medical device, including its components and the original raw materials used in manufacture, along with any related services.

• Sustainable quality assurance
• Identification of possible cost savings and potentials for improvement
• High level of customer satisfaction
• Image enhancement
• Risk minimisation
• Improved economic efficiency through process improvement
• Greater competitive strength
• Fulfilment of specific customer requirements  

• You download the relevant questionnaires from our website, fill them in and send them to us
• TUV India creates an offer based on the information received
• Order is placed and dates agreed
• TUV India review of certifiability and audit planning
• Audit phase and nonconformity management (if necessary)
• Release of the certification process and issue of certificate (validity 3 years with annual surveillance audit)

Why is ISO 9001 not sufficient?

ISO 13485 is similar in scope and intention to ISO 9001, but it contains additional requirements for medical devices and excludes certain provisions of ISO 9001. For this reason, in most countries certification to ISO 9001 is not an acceptable substitute for certification to ISO 13485.

Based on a functioning management system, individual company structures can be precisely tailored to the specific needs and specifications of the individual customer. Operational procedures can be designed so as to be flexible, and everybody benefits.  

Is ISO 13485 certification sufficient for a manufacturer to bring products onto the European market?

The manufacturer places Class I products on the market on his own responsibility. For products of Classes Im, Is, Ir, IIa, IIb and III, a conformity assessment procedure with the involvement of a Notified Body is needed. TÜV NORD CERT is a Notified Body within Germany as per Regulation (EU) 2017/745 on medical devices. TUV India is also a Notified Body for active and non-active medical devices, appointed by the CDSCO.

Who can benefit from certification?

A QM system according to EN ISO 13485 provides the ideal basis for modern organisations of every size to demonstrate competence and efficiency at home and abroad. Internal work processes, responsibilities and authorities are taken fully into account, as is the regulation of processes for interaction with customers and business partners.  

 What are the main aspects of certification to ISO 13485?

• Continual improvement
• Prevention of nonconformity
• Control of the supply chain
• Identification and monitoring of quality-related key indicators
• Product safety
• Determination of customer satisfaction
• Product and process development are considered separately
• Interdisciplinary cooperation
• Implementation and monitoring of a QM system for medical devices including components and the original raw materials used in manufacture, along with any related services.
   

Our team will work with your organisation to facilitate the process of achieving the certification. TUV India's audits certify your organisation as being committed to continual improvement and customer satisfaction. Our team of competent auditors ensures your organization’s fulfillment of customer as well as statutory & regulatory requirements.