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ISO 13485

Medical Devices

ISO 13485 is a globally recognised quality standard that outlines the requirements for a quality management system in the design, manufacture and installation of medical devices worldwide. With almost 30,000 certificates issued worldwide, this international standard supports compliance with medical product and service regulations, demonstrating an organisation’s commitment to quality and customer satisfaction.

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What is ISO 13485?

ISO 13485 is designed for organisations involved in the design, production, installation and servicing of medical devices. It provides a framework for implementing a QMS, to help businesses deliver medical devices which meet regulatory requirements and maintain consistent quality across all organisations.

ISO 13485 certification for quality management of medical devices manufacturing provides a framework to help:

  • Demonstrate compliance with medical regulatory requirements.
  • Expand into new markets and participate in tenders requiring ISO 13485 certification.
  • Enhance customer satisfaction and retention.
  • Benefit all sizes of organisations involved in medical device development, production and installation.

What are the benefits?

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Product quality assurance

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Adherence to regulatory standards

Boosted customer confidence

Optimised processes and documentation

Effective risk management

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Global market access

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Culture of continuous improvement

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Enhanced supplier relationships

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Efficient post-market surveillance

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Competitive edge

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Greater business opportunities

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Industry recognition

Key Requirements of ISO 13485

The ISO 13485 standard outlines a number of requirements that organisations must meet to demonstrate their commitment to quality management system in the design, manufacture and installation of medical devices. These include

Organisational Context: Understanding the organisation’s external and internal context.

Leadership: Leadership commitment to quality management and continuous improvement, aligning policies with the organisation’s strategic objectives.

Process Control: Implementing controls and procedures to ensure the quality of medical device production and installation.

Risk Management: Identifying and mitigating risks associated with medical device manufacturing.

Performance Evaluation: Regularly assessing and improving the performance of the quality management system.

Customer Focus: Ensuring customer needs and expectations are determined and fulfilled.

Regulatory Compliance Readiness: Preparing the organisation to effectively respond to and comply with medical product and service regulations.

Regulatory Compliance Readiness: Preparing the organisation to effectively respond to and comply with health and safety regulations and requirements.

Implementing ISO 13485

Ensuring your Quality Management System is ready for ISO 13485 certification involves commitment from the entire organisation. Prior to Certification Assessments, you may want to consider a Gap Analysis assessment, a valuable tool to review the readiness of your management system before certification assessments. This analysis provides insights into areas that need improvement, ensuring a smoother certification process.

To start your journey to ISO 13485 certification, get in touch with our team via this form.

Becoming Certified to ISO 13485

Stage One

The initial assessment determines if the mandatory requirements of the standard are being met and if the management system is capable of proceeding to Stage 2.

1

Stage Two

The second assessment determines the effectiveness of the system, and seeks to confirm that the management system is implemented and operational.

2

Recommendation for Certification

At this point in the process we review any corrective actions taken to address findings raised at Stage 1 & 2. Certification may be recommended.

3

Certification Review & Decision

The organisations files are reviewed by an independent and impartial panel and the certification decision is made.

4

Certification Achived

Successful certification is communicated to the client. Certificates are issued.

5

Becoming Certified to ISO 13485

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ISO 13485 FAQs

If an organisation is ISO 13485 certified, it has implemented a quality management system in line with ISO 13485 medical device requirements. This means its processes for ensuring the quality, safety and efficiency of medical devices have been assessed and recognised as reaching the ISO 13485 standard.

ISO 13485:2016 is the most up-to-date version of the standard.

The current standard has significant changes from the previous version ISO 13485: 2003 and reflects the evolution of the medical device regulatory environment and the greater need for risk management and risk-based decision-making processes within the medical devices industry.

Requirements of ISO 13485 apply to organisations regardless of their size and type except where explicitly stated. Wherever requirements are specified as applying to medical devices, they apply equally to associated services supplied by the organisation. The requirements may vary based upon the class of medical device, from a wheelchair to a pacemaker.

The processes required by the ISO 13485 standard that applies to the organisation, but are not performed by the organisation, are the organisation’s responsibility and are accounted for in the organisation’s quality management system by monitoring, maintaining, and controlling the processes.

If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches to be addressed in the quality management system. It is the organisation’s responsibility to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.

Certification to ISO 13485 lasts for three years and is subject to mandatory audits to ensure compliance.

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