ISO 13485: 2016 - Quality management systems for medical devices

ISO 13485 is an international standard that defines requirements within quality management systems for manufacturers, suppliers, contract services and distributors of medical devices and equipment. The main objective of the standard is to facilitate harmonized quality management system requirements for regulatory purposes within the medical device sector. ISO 13485 is based on the requirements of ISO 9001 and has the same structure in terms of clauses. Some clauses of ISO 13485 have also been referred to ISO 9001. Does the ISO 13485 standard concern medical devices? the quality management systems? regulatory requirements, is the basis for regulatory compliance in local and most global markets. The export of Medical Devices to various countries is mandatory. ISO 13485 certification is an objective proof of compliance with the requirements

The services offered by TNV System Certification are accredited by IAS and UAF IAF members and MLA signatories with IAF. Accreditation is the validation of the Certification process adopted by the Certification Body (Conformity Assessment Body)

Accreditation is the process by which a certification body is recognized to offer certification services. TNV has implemented the requirements of ISO 17021 together with IAF-MD 05-2019 and accredited by IAS and UAF.

The standard:

1. It provides a particular focus on the activities associated with an effective use of all information in order to satisfy the safety and performance requirements of the devices throughout their entire life cycle; stresses the need for Usability Assessment? medical devices;
2. It allows to check with particular attention the role and responsibilities of the various parties that play a decisive role in the life cycle of the devices: suppliers, logistics service providers, distributors, importers, etc .;
3. Recognizes service providers, processes and semi-finished products as important subjects in the medical device manufacturing cycle;
4. Introduces the requirement of design transfer;
5. It foresees that the monitoring of the products after the commercialization will see the introduction of new requirements;
6. It provides for the validation of the software used for the quality management system and for the software involved in the processes of production and provision of services;
7. It places a lot of emphasis on the risk-based approach to process management.

Consequently, it introduces objective benefits:

1. For Medical Device manufacturers, the EN ISO 13485 certification offers the presumption of conformity of the quality system in the event of an assessment of the requirements for the affixing of the CE Marking conducted by a Notified Body
2. For manufacturers of Class I Medical Devices (self-certification), the EN ISO 13485 certification allows direct and independent verification of the activities and preparatory to any market surveillance activities carried out by the Ministry of Health
3. For companies that distribute or market medical products and for companies that provide services related to devices, the UNI EN ISO 13485 certification allows you to participate in tenders published by the public administration.

The advantage of ISO 13485: 2016 derives from the effective and continuous implementation of the system, certification based on sampling may not be a guarantee of absolute implementation; therefore, it is necessary that the organization that intends to be certified guarantees effective implementation and control before planning the evaluation. Auditors choose the sample to verify the effectiveness of the management system, it is possible that the sample taken is deemed correct and certification is issued, but the problem may persist within the organization. Please note that the Certification is issued with the obligation / commitment on the part of the Organization to satisfy the requirement of the standard.

To request a quotation for certification send an email to info@tnv-europe.eu with your details in the application form (downloadable from the site) and send an email or call the number indicated on the website. The quotation is based on the size and complexity of your organization.

The certification process of ISO 13485: 2016 requires an initial audit consisting of two phases, in phase 1 the documentation of your organization is verified while in phase 2 the implementation of the documented management system audit is verified. During the audit, if the audit team identifies any findings, the client will have to deal with them prior to the Certification decision. Subsequently, at least 1 audit per year must be carried out to verify continuous compliance with the requirements of the management system standard.

Costs for Certification may depend on the size, location, complexity of the operation, processes and inter-relevance. TNV produces an indicative price list based on the nature and size of the company.

For a quote, send your request, providing information on your organization, using the application form TNV F 001, which can be downloaded by clicking on the Download link available on the website or by sending the request to info@tnv-europe.eu or by calling us at +39 0289954488.

There are mainly three types of fees applicable for ISO certification services:

1. Audit fees: variable based on man days;
2. Registration fees: variable according to the number of sites and size;
3. Any other expenses: such as travel, hotels and miscellaneous.

Each standard can be integrated with other similar standards:

• ISO 14001: 2015
• ISO 45001; 2018
• ISO 22000: 2005
• ISO 20001: 2005
• ISO 27001: 2013
• HACCP.