ISO 13485:2016 is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations. The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain. ISO 13485:2016 is a standard that focuses on the importance of the lifecycle of a medical device, including its design, development, production, storage. Certifikat ISO 13485 je veljaven, dokler z vsakoletnimi presojami dokazujete, da e vedno izpolnjujete zahteve standarda ISO 13485. Why was ISO 13485 revised and what are the main improvements?Īll ISO standards are reviewed every five years to establish if a revision is required in order to keep it current and relevant for the marketplace. Read more about certification to ISO’s management system standards. However, third-party certification can demonstrate to regulators that you have met the requirements of the standard. Like other ISO management system standards, certification to ISO 13485 is not a requirement of the standard, and organizations can reap many benefits from implementing the standard without undergoing the certification process. EN ISO 13485 is a parallel standard that is issued in the European Union for the purpose of creating a QMS in the medical device industry for use in the.
It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
#Iso 13485 verification
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. The Electrotechnical Testing Institute has a long tradition and experience in the certification of medical devices and verification of the. BSI, together with its Group Companies, also offers a broad portfolio of business solutions other than NSB activity that help businesses worldwide to improve results through Standards-based best practice (such as certification, self-assessment tool, software, product testing, information products and training).A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions. The British Standards Institution (BSI, a company incorporated by Royal Charter), performs the National Standards Body (NSB) activity in the UK.
Likewise, we do not offer consultancy to clients when they also seek certification to the same management system.
The standard directs the companies to identify which regulatory requirements are applicable to its Quality Management System (QMS) and their impact on the QMS.
#Iso 13485 free
It means decisions are made free from any engagements of influences which could affect the objectivity of decision making.Īs an accredited certification body, BSI Assurance cannot offer certification to clients where they have also received consultancy from another part of the BSI Group for the same management system. ISO 13485 standard treats regulatory requirements in the same essence as the customer requirements, because to reach the customer in a medical device industry, regulations are imperative. Impartiality means acting fairly and equitably in its dealings with people and in all business operations. Impartiality is the governing principle of how BSI provides its services.
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