apply-iso-13485-certification-guide

ISO 13485 is the gold standard for quality management in the medical device industry, ensuring safety, compliance, and operational excellence. The latest revision of the standard places even greater emphasis on risk management—a critical focus, especially as the number of ISO 13485 certifications worldwide surged from 27,229 in 2021 to 32,963 in 2023. 

This growing adoption highlights the increasing commitment of medical device manufacturers to meet stringent regulatory requirements, minimize product risks, and enhance safety, making ISO 13485 not just a certification but a crucial framework for success in the global market. 

Whether you're new to ISO standards or seeking recertification, this guide will outline how to get ISO 13485 certification, covering everything from risk management to employee training.

The Need for ISO 13485 in the Medical Industry

ISO 13485 is an internationally recognized standard for quality management systems (QMS) tailored specifically to the medical device industry. In fact, the number of ISO 13485 certifications grew by 33.1% in 2020 alone, reflecting the medical industry's increasing focus on quality management and compliance.

The medical device industry operates in a global market with varying regulatory requirements. ISO 13485 bridges these gaps by creating a unified framework that aligns with major regulatory systems, such as the EU’s MDR, Canada’s CMDCAS, and the U.S. FDA's QSR.

ISO 13485 provides a framework for organizations involved in the design, production, installation, and servicing of medical devices, helping them consistently meet both regulatory and customer requirements. Based on a risk management approach, it emphasizes strict quality control at every stage of a product’s lifecycle, from development to post-market activities. 

In a highly regulated and sensitive industry, the certification serves as a cornerstone for ensuring trust and confidence among regulators, healthcare providers, and patients.

How ISO 13485 Can Boost Your Business

Implementing ISO 13485 isn’t just about compliance—it’s a game changer for your business. Here’s how this certification can elevate your operations:

• Unlock Global Markets: Gain access to regulated markets like the EU, US, and Canada.
• Simplify Compliance: Align with global standards like FDA QSR and EU MDR, ensuring smoother product approvals.
• Increased Customer Trust: Builds confidence among healthcare providers and patients by showcasing commitment to safety and quality.
• Enhanced Traceability: Improves record-keeping and traceability, ensuring accountability and quick response in case of issues.
• Enhance Operational Efficiency: Streamlines processes reduces waste, and improves overall organizational efficiency.
• Minimize Risks: Prevent product failures and costly recalls with better risk management.

It’s essential to know how to get ISO 13485 certification, so let’s analyze the steps to achieve ISO 13485

Step-by-step Guide on How to Get ISO 13485 Certification

Understanding how to get ISO 13485 certification is essential for medical device manufacturers aiming to meet global quality standards and regulatory requirements. The process involves implementing a compliant QMS, training employees, conducting audits, and preparing for certification. Here's a detailed step-by-step guide:

1. Understand the ISO 13485 Standard

This standard defines the requirements for a quality management system (QMS) in medical device manufacturing. Purchase a copy of the standard from an authorized source to study its clauses and annexes. Begin by studying the document thoroughly, with a particular focus on:

• Clause 4 outlines the general QMS requirements.
• Clause 5, which emphasizes management responsibility. 
• Familiarize yourself with Clause 7, which addresses product realization, including design and development.

Consider training courses or hiring an ISO consultant who can provide deeper insights into compliance requirements.

2. Develop a Quality Management System (QMS)

As per Clause 4.2, organizations must create and document their QMS to meet ISO 13485 requirements. This includes drafting a quality manual, defining processes, and establishing records. Ensure the QMS aligns with your organization’s structure and objectives while fulfilling customer and regulatory requirements. Include specific procedures for document control, monitoring, and process improvement.

Required Documentation:

• Quality Manual
• Quality Policy and Objectives
• Procedures for control, monitoring, and measurement of processes
• Records demonstrating compliance

Easily manage SOPs, quality manuals, and audit reports and simplify QMS development with BPRHub's Document Hub, thus ensuring ISO 13485 compliance with ease.

3. Conduct a Gap Analysis

Conducting a gap analysis helps identify areas where your current processes do not meet ISO 13485 requirements. Review your organization’s processes against the standard, focusing on key clauses such as:

• Clause 6.2 (competence, training, and awareness)
• Clause 7.1 (planning of product realization).

Identify gaps in compliance, such as missing documentation, inadequate processes, or insufficient risk management practices. Prioritize areas needing immediate attention, especially those impacting regulatory compliance. This exercise provides a clear roadmap for bridging deficiencies and ensures that your implementation plan effectively addresses critical compliance areas.

4. Strategically Plan Your QMS

An implementation plan ensures your organization addresses identified gaps systematically. Start by outlining specific actions for each non-conformity found during the gap analysis. As per Clause 5.4, set measurable quality objectives and define timelines for achieving them.

Assign team members responsibilities for each task, ensuring accountability. Include resource allocation, such as budget and training needs, in the plan. Regularly review progress against milestones to ensure the plan stays on track and aligns with ISO 13485’s requirements.

5. Train Employees

Provide ISO 13485 training to employees across all relevant departments to ensure awareness and compliance. As required by Clause 6.2, provide training tailored to roles and responsibilities, ensuring employees understand their part in maintaining compliance.

Conduct general awareness sessions for all staff to highlight the importance of the QMS and targeted training for specific roles, such as internal auditors. Maintain training records as evidence for audits. A well-trained workforce contributes to the overall success of the QMS and certification process.

6. Implement Risk Management Processes

Establish a formal risk management system in line with ISO 14971 (Risk Management for Medical Devices). This includes:

• Identifying potential risks
• Analyzing their impact
• Implementing control measures

Document risk management procedures to ensure consistency and repeatability. Regularly review and update the risk management system to adapt to new challenges and ensure your products meet safety and regulatory requirements throughout their lifecycle.

7. Conduct Internal Audits

Perform a thorough internal audit to evaluate your QMS against ISO 13485 requirements. According to Clause 8.2.2, regular audits should be scheduled to review critical areas, such as document control, risk management, and corrective actions. 

Use a structured audit checklist and involve trained internal auditors for an objective evaluation. Document findings, including non-conformities, and implement corrective actions promptly. Internal audits prepare your organization for the certification audit and help in identifying areas for continual improvement within the QMS.

Schedule, track, and execute audits effortlessly with BPRHub's Audit Hub, a centralized platform for managing internal evaluations and regulatory inspections

8. Management Review

Management review ensures top leadership is involved in the QMS’s effectiveness, as outlined in Clause 5.6. Schedule regular review meetings to evaluate key metrics, such as audit results, customer feedback, and process performance.

Conduct a management review meeting to address non-conformities and define strategic actions for improvement. Document the review's outcomes as evidence for audits. This process demonstrates top management’s commitment to ISO 13485 and ensures the QMS aligns with the organization’s goals and regulatory requirements.

9. Select a Certification Body

Research and choose an accredited certification body with expertise in ISO 13485 and the medical device industry. Consider factors such as cost, industry reputation, and support offered during and after certification. Many certification bodies also provide a pre-assessment service, which can help identify potential non-conformities before the official certification audit begins.

10. Certification Audit

The certification audit is the final step in demonstrating compliance with ISO 13485. This process includes two stages:

• Stage 1: Documentation review (Clause 4.2)

The auditor reviews your documentation to ensure it meets ISO 13485 requirements. This includes checking your quality manual, organizational structure, internal auditing process, and corrective action protocols.

• Stage 2: On-site audit (Clause 8.2.2)

The auditor conducts an on-site evaluation of your QMS to verify compliance with ISO 13485 standards. This involves assessing processes, sampling records, and ensuring all regulatory requirements are met.

Address any non-conformities identified during the audits promptly to proceed with certification.

11. Achieve Certification

Once your organization meets all requirements, the certification body will issue an ISO 13485 certificate. This certificate signals to regulators, customers, and stakeholders that your organization prioritizes quality and safety. Display the certification prominently in marketing materials and operations to build trust and credibility in the medical device industry.

12. Continuous Improvement

Once certified, the ISO 13485 certificate is valid for three years, but as emphasized in Clause 8, it is not a one-time achievement but an ongoing process. Continually monitor and improve your QMS by analyzing process data, customer feedback, and audit findings. 

Regular management reviews (Clause 5.6) should be conducted to align with organizational goals. Issues should be proactively addressed to prepare for annual surveillance audits. Promoting a culture of continuous improvement ensures long-term compliance and enhances the quality of your medical devices, strengthening your organization’s reputation and performance.

Simplify compliance and ensure continuous improvement with BPRHub's Standards Hub, which maintains an up-to-date repository and streamlines ISO 13485 management.

Challenges of Obtaining ISO 13485 Certification

Achieving ISO 13485 certification is a rigorous process that requires organizations to meet stringent quality management system (QMS) requirements. The 2016 updates introduced modern regulatory requirements, adding to the complexity. The key challenges of ISO 13485 are:

To overcome these challenges, organizations need a streamlined approach and expert guidance; this is where BPRHub steps in, offering tailored solutions and powerful tools to simplify the ISO 13485 certification process.

Conclusion 

For organizations wondering how to get ISO 13485 certification, BPRHub offers tailored solutions that simplify the journey and address the challenges at every step. From interpreting complex requirements to sustaining long-term compliance, BPRHub provides the expertise and tools needed to streamline the process. 

From interpreting complex regulations to building a customized QMS, BPRHub provides pre-designed templates, risk management support, and real-time compliance analytics. It also offers automated workflows, role-specific employee training, and continuous compliance support, ensuring long-term success. BPRHub makes achieving and maintaining ISO 13485 certification more efficient and less burdensome.

Learn how to get ISO 13485 certification effortlessly with BPRHub's expert guidance on QMS implementation, regulatory alignment, and cost-effective compliance. 

FAQ’s

1. How long is ISO 13485 valid?

Ans: ISO 13485 certification is valid for three years. After that, organizations must undergo a surveillance audit each year to ensure continued compliance, with a full recertification audit required at the end of the three years.

2. What is the ISO 13485 audit checklist?

Ans: An ISO 13485 audit checklist is a tool used to evaluate a company’s compliance with ISO 13485 standards. It includes key areas like document control, risk management, employee training, product realization, and internal audits to ensure adherence to quality management requirements.

3. What are the documents required for ISO 13485 certification?

Ans: Required documents for ISO 13485 certification include a quality manual, quality policy, procedures for process control, monitoring and measurement, risk management documentation, training records, internal audit reports, corrective action records, and compliance records for product realization and traceability.

4. How do BPRHub’s features support ISO 13485 certification?

Ans: BPRHub's Standard Hub ensures up-to-date regulatory compliance, Document Hub simplifies QMS documentation management, and Audit Hub streamlines internal audits and tracking, providing the tools to manage ISO 13485 certification and sustain ongoing compliance efficiently.

5. How to get ISO 13485 certified? 

Ans: To get ISO 13485 certified, implement a compliant Quality Management System (QMS), conduct a gap analysis, provide employee training, integrate risk management, and perform internal audits. Then, select an accredited certification body, undergo a certification audit, and address any non-conformities to receive the certification.