ISO13845:2016 is an internationally recognized standard for regulating Quality Management Systems for Medical Devices. It represents a prerequisite for a comprehensive quality management system for the development, manufacture, distribution, installation and maintenance of medical devices, and demonstrating that the quality system is constructively implemented and maintained as the organisation's responsibility.
Why is ISO 13485 important?
ISO 13485 is considered to be the in-line standard and requirements for medical devices, the universal standard for the design, manufacture, export and distribution of various medical devices. Various safety requirements are defined to ensure the quality and robustness of equipment for the medical industry. ISO 13485 is a process-based regulatory standard.
Complying with the requirements of the ISO 13485 standard means that an organisation can establish a high-quality management system related to the supply of various medical devices and machines.
85% Safety
85% Safety
Quality
Credibility
Why get the ISO 13485 Certification?
A company's ISO 13485 certification is essential for complying with international standards for medical devices, increasing corporate credibility, building trust with customers, and expanding business. ISO 13485 certification has the following benefits:
- International recognition, especially in the global market.
- Legal consent based on local regulations.
- Improved product safety and properties.
- Improved customer satisfaction as a direct result of better products.
- Earning trust and confidence from consumers.
- Improved Corporate decisions based on empirical data.
- Enterprise Risk Minimization and Effective Mitigation
What are the benefits of ISO 13485 certification?
ISO 13485 certification helps improve overall performance, eliminate uncertainty, and improve market opportunities. Organisations with this certification communicate their commitment to quality to both customers and regulators.
- Describe how the process can be reviewed and improved.
- Improve efficiency, reduce costs and control performance.
- Demonstration of safer production of medical devices.
- Meet legal requirements and customer expectations.
Which companies can benefit from ISO 13485?
The ISO 13485 standard is designed to be dynamic and versatile and can be implemented by many companies around the world.
- Health
- Medical Infrastructure
- Hospitals
- Pharmaceutical
- Medical R&D Organizations
- Medical AI Manufacturers
Important tips for effective use of ISO 13485.
Understanding the Standard: Start with a thorough understanding of the ISO 13485 standard. Familiarize yourself with its requirements, goals and specific quality management system "QMS". Contains guidelines for medical device manufacturers. This will help you understand the nature of the standard and its applicability to your organisation.
Create a comprehensive implementation plan: To effectively implement ISO 13485, develop a detailed plan outlining the steps and activities necessary to meet the requirements of the standard. Identify key milestones, allocate required resources, and set timelines for each phase of implementation.
Top management involvement: Get the commitment and support of the company's top management. It is important to involve leaders who can provide the necessary resources, authority and leadership to drive the ISO 13485 implementation process. Their commitment sets the tone for the entire organisation and emphasizes the importance of quality control.
Conduct a thorough gap analysis. Conduct a comprehensive gap analysis to identify areas in which your current quality management system complies with ISO 13485 requirements and areas in need of improvement. This analysis serves as the basis for developing an action plan to fill the identified gaps and ensure compliance with the standards.
Establish effective document management: Implement a robust document management system to manage the creation, review, approval and distribution of all relevant documents across your organisation. This includes policies, procedures, work instructions, forms and records required for ISO 13485 compliance. Make your document management system easily accessible so that it can be reviewed regularly and updated as necessary.
Employee training and education: We provide our employees with comprehensive training and education on the processes defined in ISO 13485, its requirements and quality management system. This promotes a better understanding of standards, promotes adherence to established procedures, and promotes a culture of quality and continuous improvement throughout the organisation.
Why QualityAsia?
QualityAsia has always been at the forefront of testing and managing internationally recognized standard practices. At QualityAsia, our focus is on promoting client success by providing superior outcomes from our trained and professional evaluators. Our service provider content complies with international accreditation rules set by accreditation bodies. We support our clients throughout the audit process using best-guarded audit practices such as:
Initial Certification - Level 1 (Preliminary)
- Thoroughly documented information review.
- Exchange information with employees online or in the field.
- Identification of key deliverables, processes and goals according to standard requirements.
- Analysis of facilities, infrastructure, systems and processes to the extent necessary for certification, with a review of resource allocation.
Initial Certification - Level 2 (Onsite Audit)
- Measure, report and review performance against key performance objectives.
- Verification of system suitability to meet legal, regulatory and contractual requirements.
- Gain operational control over processes, internal audits, and management reviews while understanding policy responsibilities.
- Conclusions based on prescribed requirements, policies, performance targets, staff skills, practices, procedures, internal audits, etc.
Surveillance & Certification Renewal
Drawing out the scrutiny on various aspects of the previously done audits on effectiveness while reviewing the various processes and control of the operations in the QMS and finally going for the recertification.