What Are The Most Crucial Requirements Of ISO 13485?
Summary
The article provides a description of the most critical ISO 13485 requirements. It also discusses its clauses to help readers prepare their management system accordingly.
Have you been struggling to grasp the ISO 13485 requirements? Spending countless hours, but still finding it confusing! Then this article is for you!
ISO 13485 is the quality management system standard for the medical device manufacturing industry. Certification to this standard indicates your company complies with global quality standards and takes a proactive approach to mitigate flaws in the process.
Needless to say, obtaining this certification makes you much more attractive to consumers and suppliers.
However, the requirements of ISO 13485 can be a bit complex. But luckily, with expert help, you should not have any problem achieving it.
To help you get started, the following section lists all the crucial requirements of the medical device management system.
So, continue reading!
All The Must-Know Requirements Of ISO 13485
ISO 13485 bases its requirements on the policies of ISO 9001 with a few modifications. So, if you already have ISO 9001 in place, obtaining ISO 13485 certification should not be too complicated.
Below are the 5 primary requirements of the medical device management standard.
1. Establishing your Quality Management System
ISO 13485 requires companies to have a quality management system that meets the standard’s clauses. This section of the standard gives a general idea about how the system should be and the necessity of implementing and documenting the system. According to the standard,
• You shall determine the procedures of the QMS, its process requirements, resources, roles and responsibilities,
• You should take a risk-based approach to control the processes of the system,
• And determine how the processes will interact and form a sequence.
2. Management Responsibility
This section of the ISO 13485 requirements is about management roles and responsibilities. It makes it mandatory
• For management to provide evidence regarding its commitment to QMS maintenance, development and effectiveness,
• To communicate the importance of satisfying the regulatory requirements,
• To establish a quality policy,
• To ensure the establishment of quality objectives,
• To conduct management reviews,
• To ensure the availability of resources.
3. Resource Management
ISO 13485 clauses for resource management focus on outlining the provisions you will need to meet the customer and regulatory requirements. It talks about
• Human resources,
• The provision of resources,
• Infrastructure,
• Contamination control,
• Work environment.
4. Product Realisation
To ensure you don’t rush the product development process and commit mishaps, section 7.1 of ISO 13485 recommends carefully planning your design, production and distribution efforts. It suggests
• Establishing quality standards for the products,
• Defining the required processes and supporting documentation,
• Outlining standards for work environment and company infrastructure,
• Defining employee training and qualification requirements,
• Establishing validation, verification, handling, monitoring, measurement, inspection, traceability, distribution and storage processes,
• Making all the information easily accessible.
5. Measure, Analysis, Improvement
The standard also requires companies to plan how they will monitor, analyse, measure and improve their processes related to the QMS. You may need to
• Data capture and analysis,
• Confirm product conformity,
• Ensure management system conformity,
• Maintain the effectiveness of the system.
The ISO 13485 Clauses
The ISO 13485 clauses are divided into 8 sections, including
• Scope,
• Normative references,
• General requirements,
• Terms and definitions,
• Resource management,
• Management responsibility,
• Product realisation,
• Measurement, evaluation and improvement.
Besides the above requirements, these clauses also discuss a few other requirements. These requirements focus on
• Feedback and review systems,
• Product quality control,
• Setting requirements before releasing a product,
• Advisory notices and non-confirmations,
• Documentation procedures,
• Installation and verification of devices and more.
Bottom Line
ISO 13485 requirements can be lengthy and challenging to understand. So, if your management does not have much experience with ISO standards, it’s best to take guidance from professionals and auditors.
Who are we? Blue Wolf Certifications are a customer friendly auditor representing ISO accredited certification bodies in Australia and the US.
