QMS helps ensure medical devices being manufactured are consistently meeting strict quality standards, thereby ensuring their safety and efficacy. A robust QMS helps medical device manufacturers reduce errors, minimize risks, and ensure product quality. The ISO 13485:2016 provides a framework for establishing an effective QMS in a medical device company. Hence, ISO 13485:2016 guidelines are of paramount importance in medical device companies. Having an ISO 13485:2016 compliant QMS will help medical devices companies maintain their reputation and consumer trust. Moreover, conducting regular internal audits helps ensure compliance with ISO 13485:2016 guidelines. Additionally, these audits help identify and resolve potential nonconformities. An internal audit of ISO 13485:2016 QMS will help understand the effectiveness of the system. Thus, an ISO 13485:2016 QMS internal audit will help medical device companies be prepared prior to external regulatory audits. 

What is ISO 13485:2016 QMS?

QMS or quality management system is a structured system of procedures, processes, and practices that are used to ensure quality, safety, and efficacy of medical devices. The scope of QMS covers raw material quality, manufacturing process, distribution, and post-market surveillance of the device. Moreover, QMS focuses on Good Manufacturing Practices (GMP), documentation, risk management, and Corrective Actions and Preventive Actions (CAPA). Thus, QMS is at the core of dynamic and highly regulated medical devices industry.

ISO 13485:2016 defines the international standard for an effective QMS for medical device companies. This standard provides guidelines for medical device manufacturers to meet regulatory requirements for medical device safety, quality, and efficacy. Additionally, it will help manufacturers consistently meet customer expectations. ISO 13485:2016 QMS provides a framework for consistently manufacturing medical devices that are safe for their intended purpose. By establishing a QMS per ISO 13485:2016 standards, manufacturers can ensure consistency in design, development, and production of medical devices.

5 benefits of having an ISO 13485:2016 compliant QMS

1. Regulatory Compliance
2. Enhanced Product Quality
3. Improved Operational Efficiency
4. Improved Customer Trust 
5. Increased Market Access

What is internal audit of ISO 13485:2016 QMS?

Internal audits are self-conducted inspections of the organization’s quality processes to ensure all operational aspects align with industry standards. Basically, it evaluates the strengths and weakness of the QMS. These audits are instrumental in fostering continuous improvement, ensuring standards are upheld, and preparing for external regulatory inspections. An internal audit of ISO 13485:2016 QMS will help identify shortcomings or deviations in the system. Moreover, the ISO 13485:2016 guidelines recommend setting up an internal audit program. The guidelines require medical device manufacturers to develop an internal audit procedure, solve the problems identified during the audits, and verify that the problems have been actually solved. Hence, to ensure device quality and safety, medical device manufacturers must regularly perform internal audit of ISO 13485:2016 QMS. Furthermore, the internal audits will help medical device manufacturers ensure the compliance of their QMS with the ISO 13485:2016 guidelines.

ISO 13485:2016 internal audit requirements

As per ISO 13485:2016 guidelines, medical device manufacturers are required to perform internal audits at regular intervals.

 During audits, the manufacturers are required to:

• Confirm the quality management system is being implemented effectively and consistently.
• Establish and maintain proper documentation mentioning how the internal audit of ISO 13485:2016 QMS will be planned, executed, and reported.
• Assess whether the QMS meets the guidelines mentioned in ISO 13485:2016 and other applicable regulatory requirements. 

Therefore, ISO 13485:2016 guidelines have emphasized the need for periodic internal audits to evaluate compliance. Furthermore, corrective actions implemented have to be properly documented. Additionally, re-audits have to be conducted to ensure the effectiveness of the corrective measures implemented.

Internal audit of ISO 13485:2016 QMS: Key guidelines

• Establish a well-structured internal audit procedure with documentation and implementation components
• Properly plan a formal internal audit program
• Perform internal audit of ISO 13485:2016 QMS at planned intervals (annually, semi-annually, or as per the organisation’s needs)
• Maintain proper documentation of the audit plan and performance
• CAPA is a crucial aspect of ISO 13485:2016 QMS internal audit protocol. Implement correction of nonconformances and their root causes to prevent future recurrence.
• Evaluate the effectiveness of the corrective actions taken to address the non-conformance to prevent similar future quality issues.

Regular internal audit of ISO 13485:2016 QMS will help ensure compliance with ISO 13485:2016 guidelines. Furthermore, it will help identify areas of improvement and check the effectiveness of QMS. Hence, medical device companies need to have a formal internal audit program in place. Additionally, they should meticulously document all protocols and data obtained during internal audits. However, conducting an internal audit of ISO 13485:2016 QMS can be challenging. Hence, creating an ISO 13485 internal audit checklist can be helpful.

How to effectively conduct internal audit of ISO 13485:2016 QMS?

We have provided a simple guide to help you effectively conduct an internal audit of ISO 13485:2016 QMS.

1. Audit Planning:  A well-structured audit plan will go a long way in ensuring successful internal audit. The audit plan should be prepared depending on the importance of the processes being audited. For example, for start-ups, conducting frequent audits will help identify gaps early on. On the other hand, for established companies, an annual master audit plan might be beneficial. 
2. Have a team of experts for conducting the audit: Experts trained in ISO 13485:2016 guidelines and having a thorough understanding of the company’s QMS should be recruited in the audit team. The audit team will be responsible for conducting the internal audit of ISO 13485:2016 QMS of the medical device company.
3. Executing the Internal Audit Process: The audit team should conduct the audit systematically. First, advance notice of the audit should be provided. Second, the objectives and scope of the audit should be reviewed during the opening meeting. Third, evaluate key documents and records of raw material supplier approvals, process validations, and device quality control. Finally, during the closing meeting, the insights and findings of the audit should be presented. Additionally, clear actions should be defined for addressing any nonconformances.
4. Implementing corrective measures for addressing non-conformities: Identifying nonconformities is the first step of QMS internal audit process. The next and important step is addressing the non-conformities through corrective actions. Furthermore, the effectiveness of the actions should also be evaluated. This is vital for maintaining regulatory and ISO 13485:2016 compliance. Moreover, regular reviews of the internal audit findings should be conducted. It helps ensure accountability and prepares the QMS of the medical device company for external regulatory audits.  

How can Pharmadocx Consultants help?

We have extensive expertise in the ISO 13485:2016 requirements and CDSCO guidelines for medical devices. As one of India’s premier ISO 13485 certification consultants, the Pharmadocx Consultants will help you secure the ISO 13485 certification in a seamless manner. We have been helping medical devices companies secure the ISO 13485 certification since 2007. ISO 13485 certification is our forte. Our team of experts will ensure your medical device company will comply with all the clauses of ISO 13485. ISO 13485:2016 QMS certification services we provide:

1. Expert Guidance: Our team will help break down the ISO 13485 requirements and simplify the guidelines for you.
2. Gap Analysis: We will evaluate your current QMS and identify areas that need improvement to meet ISO 13485 standards.
3. Training and Workshops: We provide hands-on staff training sessions to equip the team members with the ISO 13485 guidelines.
4. Audit Preparation: Our team will provide guidance for ISO 13485:2016 QMS internal audit. Additionally, we will prepare you for the external regulatory audits.
5. Successful Grant of ISO 13485: We will help you successfully secure the ISO 13485 certification. In our post-certification service, we offer support for maintenance, renewals, and compliance with latest standards.
6. Tailored Solutions: We understand every medical device company is unique. Hence, we provide tailored solutions as per client needs.

Conducting internal audit of ISO 13485:2016 QMS is of vital importance in the medical device industry. Having an ISO 13485 certification will simplify your regulatory journey and provide an edge over your competitors. Drop an email at [email protected] or call/Whatsapp on 9996859227 for a hassle-free ISO 13485 certification journey.