ISO 13485:2016 is an internationally Recognised standard for quality management systems (QMS) in the medical device industry.
It outlines requirements for a comprehensive management system for the design, manufacture, installation, and servicing of medical devices. The standard is based on ISO 9001 but includes additional requirements specific to medical devices to ensure consistent quality, regulatory compliance, and patient safety.
Key Components of ISO 13485:2016
- Risk Management: A critical component of ISO 13485 is risk management throughout the product life cycle, ensuring that potential risks related to medical devices are identified, assessed, and managed appropriately.
- Design and Development: The standard emphasises robust design and development processes, including validation and verification, to ensure that the final medical device meets specified requirements.
- Supplier Management: organisations must have systems in place to evaluate and monitor suppliers to ensure that purchased products or services meet quality and regulatory standards.
- Product Lifecycle Traceability: ISO 13485 requires traceability of medical devices from design to production and distribution, allowing for a comprehensive tracking system in the event of issues or recalls.
- Regulatory Compliance: The standard aligns with many global regulatory requirements, making it easier for companies to comply with country-specific regulations, such as those from the FDA, European Union (CE marking), and other international regulators.
TotalCert Consulting’s Services forISO 13485:2016:
Gap Assessment
- Initial Evaluation: Assess your current management system against ISO 13485 requirements to identify areas for improvement and compliance gaps.
Documentation Development
- QMS Documentation: Assist in developing a comprehensive quality management system, including policies, procedures, work instructions, and records tailored to ISO 13485 requirements.
- Product File Creation: Create and maintain documentation specific to each medical device, including technical files, design history, and risk assessments.
Implementation Support
- System Implementation: Guide your organisation through the implementation of ISO 13485, ensuring that processes meet quality and regulatory requirements.
- Risk Management: Help develop and implement risk management processes in line with ISO 13485 to ensure patient safety and product quality.
Training
- Employee Awareness Training: Provide training to employees involved in the medical device lifecycle to ensure understanding of ISO 13485 requirements and their role in maintaining compliance.
- Lead Auditor and Internal Auditor Training: Train your internal team to conduct audits effectively, identifying non-conformities and opportunities for improvement.
Internal Audits
- Pre-Certification Audits: Conduct internal audits to verify compliance with ISO 13485 before the official certification audit, helping to identify and address any non-conformities.
Certification Support
- Audit Facilitation: Facilitate the certification process with a globally Recognised certification body accredited under the International Accreditation Forum (IAF).
- Certification Preparation: Guide your team through the entire certification process, providing support for external audits and assisting with corrective actions if required.
Project Timeline
The typical timeline for implementing ISO 13485:2016 ranges from four to five months, depending on the size and complexity of the organisation. This includes the initial gap assessment, documentation development, system implementation, employee training, internal audits, and certification audit facilitation.
Why Choose TotalCert Consulting?
Medical Device Industry Expertise
Our consultants have deep experience in the medical device sector, helping organisations navigate the complex regulatory landscape.
End-to-End Support
We offer comprehensive support from initial assessment through certification, ensuring that you meet ISO 13485 requirements and achieve certification efficiently.
Globally Recognised Certification
We only work with IAF-accredited certification bodies, providing assurance that your ISO 13485 certification is accepted worldwide.
Customised Solutions
We tailor our consulting services to meet the specific needs of your organisation, ensuring that the ISO 13485 QMS is aligned with your business processes and goals.