In simple terms, an ISO 13485 audit is a review of your business to determine whether it complies with contemporary standards for medical device quality management. A quality management system (QMS) is the method your business uses to plan, coordinate, and monitor all of the actions that are necessary to realise the operational goals you set for yourself. It consists of your organization's structure as well as the planning, processes, tools, materials, and records you use to meet your quality goals.
Medical device quality management follows the industry standard ISO 13485. You can work towards conformity with ISO 13485 as a recorded collection of interconnected processes, including any forms or templates, that establish, implement, and maintain the requirements of the international standard if you want your medical device QMS to bear an internationally recognized seal of approval.
ISO 13485 Audit Requirements
Finding out whether your business has implemented all applicable requirements of ISO 13485:2016 is the goal of ISO 13485 audits.
The audit aims to explicitly assess:
- The success of your quality management system in implementing the relevant regulatory requirements
- Technology relating to goods or processes
- A product's technical paperwork that complies with all applicable regulations
- Your capacity to adhere to these conditions
To fulfil these ISO 13485 audit goals, the auditor will confirm that your organization has enough trustworthy objective evidence to show that your devices adhere to fundamental safety, performance, and effectiveness standards.
The auditor will anticipate that you will keep ISO 13485 documents and records that show ongoing adherence to legal requirements throughout the device lifecycle's post-market phase. Additionally, you'll have to demonstrate that a successful risk-based strategy is in place.
The quality management system of a medical device company must include the implementation of a dependent-on-risk strategy, and senior management must invest the necessary time and money in this task.
The risk-based approach is typically effectively implemented in conjunction with the design and development process, then continues through product realisation (including supplier selection), takes into account input received during post-market monitoring, and continues until your device is decommissioned.
To ensure that their medical devices meet requirements for safety, performance, and regulatory requirements, each medical device organization must implement the risk-based approach as well as risk management in product realisation and determine how much residual risk is acceptable.
Things to do to be Prepared for an ISO 13485 Audit
Your medical device organization must prove its capacity to consistently supply medical devices that fulfil customer and regulatory standards in an external third-party ISO 13485 audit.
Failure to meet even a small percentage of the requirements outlined in the audit activities and tasks will result in audit failure, a delay or revocation of your ISO 13485 accreditation, and a substantial setback in your medical device company's operating goals.
So, an ISO 13485 audit is a review of your company's quality management system procedures to determine how well you conform to the ISO 13485:2016 standard. The goal of this is to help companies who work in the medical device sector comply with legal and customer standards. Senior management has directed that these procedures and how they interact be improved to meet quality goals.
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