The Iso 13485:2016 takes the integration of risk management in the realization activities one step forwards by demanding the definition, documentation and implementation of risk management system in the quality management system. In this article I will review what may be the critical elements of the new relation between quality management system based on the requirements of the ISO 13485 and a risk managements system.
Risk management documentation
Risk management documentation requirements are presenting a new set of documentation like procedures, diagrams, plans, forms, analysis reports. The documentation shall
- be Relevant to all stages of the life cycle of the medical device
- be actual to the risk management activities that are being performed in the organization
- be applicable to applicable international or local regulatory requirements
- cover all activities of the risks management system.
Risk management Records
Risk management activities will generate a new set of records to be included in the QMS. You will have to define a central place where all those records will be identified, managed and accessible; a dossier or file which will include all relevant records. If you are implementing the ISO 14971, you will have to define and manage a risk management file, for example. The Design History File (DHF) may also be used for that matter.
Design Validation
The Design Validation must clearly and effectively address risk analysis. In other words, the validation activities must include risk management activities; risk analysis, risk evaluation, risk control, and the gathering and analysis of production and post-production information to identify and analyze known risks or seize new risks. One critical point regarding the integration of risk management in the validation activities is the linking between the identified risks, the risk control and the verification of the controls. Read the following resource about how to integrate risk management system in your design validation.
Applicable Risk Management System
The Risk Management System must be friendly and implementable in the organization. It should support the users of the quality management system by delivering them an effective risk management system; defined and well documented which will encircle all stages in the risk management process. It should deliver easy tools for performing the risks management activities and not put obstacles in the way of the employees when they realize the medical device.
Risks Management Team
The risk management is not the business of the quality manager. Forget this old concept that will bring you only rejections in an audit and complaints from users of the medical device. The organization is required to establish a management team that will act as process owner of the risk management processes and activities. In this team representatives of all areas of the organization and the product realization will be involved. The team must be trained in the risk management system and activities and each member of the system must be qualified to perform its related tasks effectively; identify, manage and control risks related to his or her area. Help them be risk management specialist with allowing them access to knowledge and information about the risks management issue.
Systemized post production
Post-production refers to the stage of the life-cycle of the product after the design has been completed and the medical device has been manufactured, and delivered for use. In this stage the manufacturer is expected to collect and review information about the medical device or similar devices in the production and the post-production phases. Unfortunately and often are these requirements being neglected or not implemented. Where are you expected to address this issue?
- In the risk management process shall refer to post-production information
- In the risk management plan where the activities related to collection and review of relevant production and post-production information are defined
- Risk management report where appropriate methods shall be defined and implement in order obtain relevant post-production information
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