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ISO 13485 Certification

Understanding ISO 13485:2016 Certification

ISO 13485:2016 is the internationally recognized standard outlining the requirements for a Quality Management System (QMS) in the design and manufacture of medical devices.

Organizations involved in the production and handling of medical devices are expected to comply with the ISO 13485 standard. This set of guidelines facilitates the implementation of a Medical Devices Quality Management System (MD-QMS), showcasing an organization’s ability to deliver safe, high-quality medical devices and services. It also ensures compliance with regulatory requirements while meeting customer expectations.

Published in 2016, ISO 13485:2016 is the most recent version of the standard. Achieving certification requires establishing a robust quality management system that identifies and addresses potential risks, such as contamination or handling errors. ISO 13485 emphasizes analyzing these risks and implementing preventive measures to mitigate them effectively.

With a global network of experienced auditors, we ensure a smooth, efficient certification process, helping your organization meet ISO 13485 requirements without unnecessary delays.

Principles of ISO 13485 Certification

Customer Focus – The primary goal is to continually improve and meet the needs of customers and other stakeholders. By monitoring and understanding their expectations, organizations can sustain existing customers, expand their customer base, and ensure effective communication throughout the organization.

Leadership – To achieve quality objectives, leaders must align the organization’s strategy, policies, procedures, and resources, fostering coordination and unity of purpose. Cultivating a culture of trust and integrity is essential, and providing employees with the necessary resources, training, authority, and accountability ensures the organization operates effectively.

Engagement of People – Efficiency is achieved when all levels of employees are involved. This can be accomplished by sharing organizational knowledge and experience, recognizing contributions, and encouraging ongoing learning and improvement.

Process Approach – Understanding and executing activities efficiently increases the output’s effectiveness. By identifying organizational capabilities and resource constraints, organizations can plan and execute processes more effectively.

Improvement – Continuous improvement is essential to maintaining and enhancing performance. This involves providing proper training, reviewing processes, planning audits, implementing improvements, and acknowledging achievements, which leads to better risk anticipation and enhanced performance.

Evidence-Based Decision Making – Decisions should be based on data analysis and evaluation, ensuring more efficient and effective solutions. While intuition can play a role, it should never replace data-driven decisions.

Relationship Management – Effective management of relationships with relevant stakeholders, such as suppliers, is vital. A well-managed supply chain ensures a steady flow of products and services, contributing to the organization’s overall success. Recognizing and managing these relationships is key to maintaining stability and growth.

Benefits of ISO 13485 Certification

ISO 13485 provides significant advantages for organizations across all stages of the product life cycle, from design and development to manufacturing, storage, and distribution of medical devices. Its scope also extends to related services, including both remote and on-site technical support.

As an internationally recognized standard, aligning your Medical Device Quality Management System (MDQMS) with ISO 13485 brings numerous benefits to your organization. The standard improves processes, resulting in reduced costs by streamlining operations and eliminating inefficiencies. This leads to better management, which in turn fosters stronger relationships with stakeholders. Additionally, obtaining ISO 13485 certification enhances your organization’s reputation and boosts customer trust in your products.

By adhering strictly to the ISO 13485 requirements, your organization ensures consistent quality and reliability in the medical devices you produce. The certification’s global acceptability also helps expand your business by providing access to a wider market. ISO 13485 is recognized by the Global Harmonization Task Force (GHTF) as the standard for establishing model MDQMS in the medical industry, ensuring that your practices align with both legal and contractual requirements.

Furthermore, ISO 13485 certification also meets the regulatory standards set by the U.S. Food and Drug Administration (FDA), enhancing your product’s credibility and facilitating broader acceptance in international markets.

ISO 13485 Requirements

The first step in achieving ISO 13485 certification is to define the scope of your Quality Management System (QMS). It is essential to understand the purpose and target market of your medical device and to take into account any relevant regional regulations related to the product.

Next, perform an ISO 13485 audit to assess the conformity of your management system with the required standards. This audit helps identify any gaps, which should be thoroughly examined and analyzed for improvement.

Following the audit, a project plan should be developed based on the gap analysis. The corrective action plan will address non-conformities and ensure compliance with both ISO 13485 and other regional regulatory requirements.

Maintaining proper documentation is crucial for a smooth certification process. This includes keeping the mandatory documents such as the Quality Manual, procedures, work instructions, and evidence of implementation, which will be essential during the audit.

Training your workforce is another key requirement. All employees involved in the production of medical devices must be educated on the legal and procedural requirements of ISO 13485 certification to ensure that they are fully equipped to meet the standards.

Once your quality management system is established, it should be implemented and run for at least three months while documenting your processes. This will provide a clear record of your system’s functioning.

An internal audit should be conducted during this period to check for any deviations from ISO 13485 requirements. This audit can be done by a qualified internal employee or by a third-party auditor.

A management review is also necessary to evaluate the effectiveness of your QMS. This review ensures that your system is meeting the required standards and is operating as intended.

Finally, you can apply for ISO certification by inviting a certification body to perform an audit of your management system. Upon successful completion of the audit, you will be awarded ISO 13485 certification, confirming your organization’s adherence to the standards.

PDCA Cycle

  • Plan: Identify the goals and objectives that need to be achieved within the organization.
  • Do: Implement the planned actions that will help accomplish the identified objectives.
  • Check: Monitor progress and compare the outcomes against the established standards, policies, and requirements.
  • Act: Take corrective actions based on the evaluation to ensure continuous improvement.

3 Steps to Certification

With the assistance of CyberClad Global, the certification process can be completed in as little as 40 days.

Gap Analysis

  • Assess your management system's compliance with the requirements of the applicable standard.
  • Discuss what needs to be included in the project plan and agree on any remedial actions.
  • Identify any non-conforming areas.
  • Set the groundwork for a project plan.

Implementation

  • ISO certification is a comprehensive process that requires expertise and experience.
  • CyberClad Global is not involved in the implementation or preparation of documents to obtain ISO Certification.
  • To maintain integrity and impartiality as a certifying authority, CyberClad Global does not participate in the implementation phase.
  • Organizations must allocate appropriate resources, time, and effort to implement management systems and procedures effectively.

Certification Process

  • Application Form : Clients provide essential organizational details by completing the application form.
  • Contract Review : The quality team evaluates the client’s specific requirements.
  • Audit : Conducted in two stages (Stage 1 and Stage 2) to assess compliance.
  • Decision Making : The Decision-Making team evaluates the audit results and approves the certification.

If you’re a business, this guide will assist you in obtaining ISO 37001 certification for your organization. After developing your Anti-Bribery Management System (ABMS), you should operate it for a period of time, documenting the processes before inviting a certification body for ISO 37001 certification. You will need to complete an application form with your organization’s details. The chosen ISO certification body will review your form and provide a quotation, after which you can schedule your certification audit.

There are six key procedures that form the basis for determining the overall scope of the certification process, as well as the organization’s level of implementation:

  • Proportionate Procedures: The bribery prevention practices must be appropriate for the risks faced and the scope of the organization’s operations. These procedures should be clear, accessible, and effectively enforced.
  • Top Level Commitment: The commitment of senior management, including the board of directors or equivalent, to prevent bribery and foster a culture where bribery is unacceptable.
  • Risk Assessment: A process for determining the organization’s exposure to potential internal and external bribery risks, reviewed periodically.
  • Due Diligence: Procedures to assess individuals performing services for the organization, based on a proportionate, risk-based approach to reduce bribery risks.
  • Communication: Ensuring that bribery prevention policies and procedures are communicated and understood across the organization, including through training.

There are mandatory processes for obtaining ISO certifications. After completing the necessary documentation, follow these steps:

Stage One (Documentation Review): Auditors from the certification body will assess if your documentation meets ISO 37001 requirements.

Stage Two (Main Audit): The auditors will evaluate whether your actual processes align with the documentation and comply with ISO 37001 standards.

ISO 13485 Frequently Asked Questions about Quality Management System for Medical Devices (MD-QMS)

ISO 13485 certification is globally recognized for its emphasis on the efficiency and effectiveness of quality management systems for medical devices, based on the ISO 13485 standard. Its goal is to deliver superior medical devices that meet and exceed customer requirements, fostering stronger relationships with clients.

ISO 13485:2016, the latest version of ISO 13485 certification, was published in March 2016. It is designed to ensure the delivery of superior medical devices and related products that consistently meet customer expectations.

Your certification body uses specific procedures and checklists to verify that you have implemented all the required standards.

Achieving ISO 13485 certification is relatively straightforward with today’s improved systems. The process involves several key steps. First, you must organize all relevant information about your company in a systematic way (it is advisable to consult a legal expert for added assurance). Next, document all necessary details about your business. Afterward, implement the documented processes within your organization. Prepare for internal audits, which are conducted initially during the certification process and then periodically thereafter. Finally, if the certifying body approves your management system, you will be granted the ISO 13485 certification.

The cost of ISO 13485 certification varies depending on the organization. When you approach an internationally accredited certifying body for certification, they will review your management systems and processes. Once approved, they will provide a quotation for the certification. The overall cost is primarily influenced by factors such as the number of employees in your organization, the number of branches, and other relevant considerations.

An ISO certificate is generally valid for three years. Throughout this period, an annual surveillance audit is conducted to ensure that the organization continues to maintain ISO quality standards.

Receiving ISO 13485 certification is just the beginning. To ensure the ongoing effectiveness of your management system, you must maintain the certification. This requires your company to undergo an annual surveillance audit for the duration of the three-year certification period. Once the validity period ends, recertification is necessary.

Obtaining ISO 13485 certification is crucial for any organization as it helps reduce costs and enhance profitability. Implementing a quality management system also enables you to attract new customers and build long-lasting relationships with them.