In this blog, we have curated a detailed step-by-step guide to help you avoid the common ISO 13485 audit mistakes. Additionally, we have highlighted why should you bother with ISO 13485 certification and how to secure it.

What is ISO 13485?

ISO 13485 provides guidelines for medical device quality management system. The aim of this standard is to help medical device companies consistently meet both customer needs and regulatory requirements.

Why should medical device companies focus on ISO 13485 certification?

We have highlighted 6 reasons why you should opt for ISO 13485 certification.

1. Increased international market access: ISO 13485 certification might be a prerequisite for doing business in certain countries. Thus, having an ISO 13485 certification will increase international market access.
2. Improved product quality: ISO 13485 provides guidelines for medical device QMS. The guidelines have been formulated to help medical device manufacturers consistently produce high-quality medical devices.
3. Risk management: ISO 13485 guidelines focus on risk management throughout the product lifecycle. Hence, by complying with the guidelines, manufacturers can produce safe medical devices and have reduced liability.
4. Operational efficiency: Implementing the guidelines can streamline operations and reduce errors, thereby lead to cost savings.
5. Customer trust and loyalty: ISO 13485 certification will boost the reputation of the medical device company among customers. Customers usually prefer medical device companies with ISO 13485 certification.
6. Regulatory compliance: Many countries mandatorily require medical device manufacturers to be ISO 13485 certified. On the other hand, certain countries use the ISO 13485 standard as a basis for their medical device QMS regulations. Thus, having the ISO 13485 certification will streamline the regulatory journey for medical device manufacturers.

How to get ISO 13485 certification?

1. Thorough gap analysis: Analyse the current processes and systems against the ISO 13485 guidelines to identify gaps or focus areas for improvement to ensure compliance.
2. Proper documentation of processes: Properly document the quality management system policies, procedures, and work instructions.
3. Implementation of processes: Effectively implement the processes and systems outlined in the documentation across the organization.
4. ISO 13485 internal audit: Conduct an ISO 13485 internal audit to verify the effectiveness of your QMS and ensure compliance. It is important to avoid common ISO 13485 audit mistakes.
5. Review the QMS process: Senior management should review the QMS to ensure its adequacy and effectiveness.
6. ISO 13485 audits: The regulatory officials will conduct the ISO 13485 audits to verify compliance. Additionally, the certification body will review the QMS documentation. 
7. Obtain certification: Upon clearing the audit and correction of non-conformities, the ISO 13485 certificate will be issued.
8. Conduct periodic internal reviews to ensure compliance: Conduct regular ISO 13485 internal audits and management reviews to ensure consistent compliance. Moreover, focus on addressing any non-conformities. Additionally, try to avoid the common ISO 13485 audit mistakes that will lead to inadvertent non-compliance.

We have been helping medical device manufacturers secure the ISO 13485 certification since 2007. Our team will help you avoid the common ISO 13485 audit mistakes and secure the certification in a hassle-free manner. Simply get in touch with us to seamlessly secure the ISO 13485 certification.

Common ISO 13485 audit mistakes to avoid

Preparing for an ISO 13485 audit can be overwhelming. Ensuring compliance, successfully passing the audits, and obtaining the certification can be a cumbersome task. Moreover, it is vital to avoid common ISO 13485 audit mistakes to avoid certification rejection. ISO 13485 certification will open global medical device markets, maintain credibility, and uphold patient safety.

ISO 13485 audits are conducted by officials to verify the compliance of medical device manufacturers with the guidelines. A successful audit completion will lead to successful ISO 13485 certification. However, if non-conformities are identified during audits, it will lead to delays, increased expenses, and missed opportunities. Hence, we have highlighted some of the common ISO 13485 audit mistakes and how to overcome them.

How to avoid common ISO 13485 audit mistakes?

1. Emphasize on root-cause analysis in CAPA: Corrective and Preventive Actions (CAPA) forms the basis of ISO 13485 guidelines. Identification of root causes should be prioritised while addressing issues. Invest time and resource in conducting a thorough root-cause analysis for every CAPA case flagged. Moreover, properly document findings and implement the solutions to prevent recurrence of the issues. 
2. Do not focus solely on product risks: Focusing solely on products risks will lead to common ISO 13485 audit mistakes. ISO 13485 guidelines require manufacturers to focus on process risks as well as product-related risks. A thorough review of the medical device QMS will be required to ensure it covers risk assessments for processes as well as products. Moreover, document and implement process risk management activities to demonstrate compliance with guidelines. 
3. Do not skip MDR Article 10 Section 9 requirements: The MDR has provided QMS provisions in addition to ISO 13485 requirements. These should not be overlooked. Thoroughly compare the current QMS and the specific requirements of MDR Article 10, Section 9 to identify any gaps. Then, ensure all additional MDR requirements are integrated and implemented within the current QMS system.
4. Incorporate all industry requirements in the risk management process: Most medical device manufacturers fail to align their risk management process with industry standards. They do not incorporate all industry requirements. Hence, thoroughly review and align your risk management process with industry requirements. Moreover, ensure your documentation properly evidences this alignment to satisfy audit expectations. 
5. Focus on trend reporting: Manufacturers are required to monitor significant increases in trends. Moreover, auditors expect clearly defined procedures and thresholds. Develop specific and measurable criteria for trend reporting. A simple mathematical formula or a clear description should suffice. Furthermore, define action thresholds to systematically address significant increases.

How can Pharmadocx Consultants help you easily secure the ISO 13485 certification?

We are one of India’s premier ISO 13485 certification consultants. Our team has extensive knowledge and expertise in this domain. We will help you comply with all the clauses of the ISO 13485 guidelines.

1. Expert guidance and support: Our team will break down the ISO 13485 requirements and clauses to help you understand every detail.
2. Gap analysis: Our team will assess your current system to identify lapses and areas of improvement. We will find parameters that need enhancement to meet ISO 13485 standards.
3. ISO 13485 audit preparation: With our guidance and support, you will be well prepared for ISO 13485 audits. Our mock audit service will prepare you for the regulatory audit.
4. Training and workshops: We conduct hands-on training sessions and workshops. Our team will equip all the personnel involved with the knowledge and skills needed to comply with ISO 13485 standards. 
5. Successful grant of ISO 13485: With our support, you can easily comply with all the clauses of ISO 13485. Securing the certification will be a breeze for you. Moreover, even after successful certification, we provide support for maintenance, renewals, and compliance with the updated standard.
6. Client-centric approach: We understand every medical device business has unique requirements. Hence, we tailor our services accordingly. Thus, we customize our strategies for ISO 13485 compliance to cater to your specific needs.

We will help you avoid the common ISO 13485 audit mistakes so that you can secure the ISO 13485 certificate in a hassle-free manner. Drop an email at [email protected] or call/Whatsapp on 9996859227 and we will be more than happy to help.