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Medical Electronics


We are there when reliability is of top priority.


Our innovative sensor solutions make medical devices even safer and more eff icient.


13485:2003, in which only product design controls and product realisation processes were subject to risk management requirements. In addition to this important change, processes that are outsourced must also apply a risk-based thinking approach. This section of the standard also states that any


software used as part of the quality system must be validated and documented. In addition, the revised standard requires the maintenance of a comprehensive technical file for each manufactured device that includes a description of the device along with all relevant specifications and records.


Management responsibility (Clause 5) Changes to this section of ISO 13485 primarily involve clarifications of existing requirements regarding quality management system planning, responsibility and authority, management representation and management review.


Resource management (Clause 6) The standard will now oblige device manufacturers to define the specific skills and experience required for personnel involved in the maintenance of the quality management system. Further, ISO 13485 certified organisations will have to maintain systems for ensuring that personnel maintain the requisite knowledge through ongoing training, as well as a mechanism for assessing the effectiveness of such training.


A new clause in this section also addresses contamination control issues for sterile medical devices, and includes requirements related to the validation of processes intended to ensure the integrity and effectiveness of sterile device manufacturing.


Product realisation (Clause 7) Clause 7 addresses specific requirements within each of the areas defined within this enlarged scope of product realisation. Further, as previously noted, medical device manufacturers will be expected to incorporate risk management principles in determining the application of these requirements. New sub-clauses have been added in design and development for transfer of design and development outputs to manufacturing and maintaining a design and development file.


Measurement, analysis and improvement (Clause 8)


Under this section of the revised standard, device manufacturers will be expected to formalise their


www.cieonline.co.uk


How can you prepare? There are important structural differences between ISO 13485:2016 and ISO 9001:2015. These are likely to complicate the compliance and auditing process for medical device manufacturers which are currently certified to both ISO 13485 and ISO 9001. Given the extent of the changes, as well as the structural differences between ISO 13485:2016 and ISO 9001:2015, transitioning to the new requirements is likely to take a considerable investment of time and resources. Therefore, medical device manufacturers and other ISO 13485 certified organisations are advised to promptly begin the process of evaluating the application of the standard’s updates against their existing quality management system, in order to determine the scope of required changes and the time that will be needed to implement them.


www.tuv-sud.co.uk Components in Electronics December 2017/January 2018 29 www.first-sensor.com


processes for obtaining feedback from both production and post-production activities, and to develop sound methods for incorporating that feedback into its risk management programme. The revised standard also strengthens requirements regarding the investigation and control of nonconforming products, as well as those related to corrective and preventative actions. New sub-clauses have been created in monitoring and measurement for complaint handling and reporting to regulatory authorities.


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