Tips to Help You Meet ISO 13485 Standards

For companies producing medical devices, adherence to ISO 13485 standards is essential for various reasons. This standard is designed to assist medical device manufacturers in creating a Quality Management System that ensures the efficiency of their processes. Focused on safety and quality, complying with ISO 13485 helps prevent regulatory fines, enhances operational efficiency, boosts customer satisfaction, and elevates product quality. In this article, we will demystify ISO 13485 and its advantages, while also providing tips to help you meet ISO 13485 standards.

What does ISO 13485 Mean?

ISO 13485 is a globally recognized set of standards outlining the requirements for managing quality within a company. It applies to businesses engaged in designing, producing, installing, servicing, and manufacturing medical devices.

Originally released in 1996, ISO 13485 has been updated in 2003 and 2016. The most recent version, ISO 13485:2016, became effective in March 2016. The purpose of these standards is to guarantee that both medical devices and services consistently meet customer expectations and comply with relevant regulatory requirements.

ISO 13485 Courses

• ISO 13485 Fundamental Training Course
• ISO 13485:2016 Internal Auditor Training Course
• ISO 13485:2016 Lead Auditor Training Course

Tips to Meet ISO 13485 Standards

Here are the tips that would help you to meet the ISO 13485 standards

Ensure Comprehensive Audit Trails

To facilitate an ISO 13485 audit, it is beneficial to maintain detailed audit trails. This involves automatically recording every creation, modification, or deletion of any record in an audit history file. Retain this documentation for a specified period and make it accessible for ISO auditors to review and copy as needed. Pay particular attention to records related to Corrective and Preventive Actions (CAPA), risk management, and supplier documentation, as these are specifically highlighted in ISO 13485 regulatory requirements.

Comprehensive Internal Audit

Conduct a thorough internal audit to closely assess your processes and pinpoint areas for improvement prior to engaging an accredited auditor. In the context of ISO 13485, this internal audit enables your company to identify gaps in quality procedures and address high-risk aspects of your processes, saving time by focusing on areas that may not be fully compliant. After completing the internal audit, ensure prompt follow-up to address potential issues that could compromise compliance.

Ensure your Team is well-versed in ISO 13485 Guidelines. 

To stay compliant with ISO regulations, it's crucial for everyone to be aligned. Familiarize yourself with the guidelines, comprehend the certification requirements, and communicate this information to your team. It's essential for the entire team to be informed and aware of how ISO certification could impact business processes, ensuring everyone is working together toward adherence to these guidelines.

Meeting CAPA Standards

Compliance with Corrective and Preventive Action (CAPA) standards is crucial for maintaining high standards in the medical device industry. Failing to meet these standards is a primary reason for receiving citations under the ISO framework. Thus, it is essential to give priority to the CAPA process.

To guarantee that your company aligns with CAPA standards, consult ISO 13485 sections 8.5.3 (prevention) and 8.5.2 (correction). Construct your CAPA standards based on the recommendations outlined in these sections for a robust and compliant approach.

Establish Comprehensive Procedures for Medical Device Reporting (MDR)

Medical Device Reporting (MDR) serves as a post-market surveillance tool employed by the FDA to oversee the performance of medical devices, identify possible safety concerns associated with devices, and contribute to assessing the benefits and risks of these products. In accordance with ISO 13485:2016, medical device companies are obligated to adhere to MDR guidelines, which involve submitting events and annual reports. Therefore, it is crucial to prioritize the development of comprehensive MDR procedures to proactively prevent potential compliance issues.

Why is ISO 13485 Certification Important?

The International Organization for Standardization (ISO) is a global non-governmental organization comprising industry experts collaborating to address worldwide challenges through shared knowledge and expertise.

ISO 13485 comprehensively includes ISO 9001 requirements with some additional criteria. Consumers and participants in the life science supply chain place confidence in ISO, often choosing not to buy medical device products from companies without ISO 13485 certification.

FAQs

Q1: What is ISO 13485?

A1: ISO 13485 is an international standard that defines the requirements for a quality management system in the medical devices industry.

Q2: How does ISO 13485 differ from other ISO standards?

A2: ISO 13485 specifically focuses on the requirements for a quality management system in the design, development, production, and servicing of medical devices, distinguishing it from other ISO standards.

Q3: What are the key benefits of complying with ISO 13485 standards?

A3: Complying with ISO 13485 helps organizations enhance product quality, ensure regulatory compliance, and demonstrate commitment to producing safe and effective medical devices.

Q4: How can a company obtain ISO 13485 certification?

A4: To obtain ISO 13485 certification, a company needs to implement a quality management system meeting the standard's requirements and undergo an assessment by a certification body.

Q5: Are there specific documentation requirements outlined in ISO 13485?

A5: Yes, ISO 13485 mandates documentation of various processes, including quality policy, objectives, and records of design and development activities, as part of the quality management system.