What is ISO 13485 Certification?
ISO 13485 is an internationally recognized standard for quality management systems specific to the medical device industry. It outlines requirements for a quality management system that ensures the safety, effectiveness, and regulatory compliance of medical devices. ISO 13485 certification is a process by which a third-party auditor assesses a medical device manufacturer’s quality management system against the standard’s requirements and issues a certificate of compliance if the company meets the standard’s criteria.
ISO 13485 Certification: Ensuring Quality in Medical Device Manufacturing
ISO 13485 is a globally recognized standard for quality management systems specific to medical devices. It provides a framework for ensuring that medical device manufacturers meet regulatory requirements and consistently produce safe and effective products.
At PQSmitra, we offer ISO 13485 certification services to help medical device manufacturers establish and maintain a quality management system that complies with the standard’s requirements. Our team of experienced auditors works closely with clients to assess their current quality management system, identify areas for improvement, and implement effective solutions to achieve ISO 13485 certification.
Benefits of ISO 13485 Certification:
ISO 13485 certification offers several benefits for medical device manufacturers, including:
- Compliance with regulatory requirements: ISO 13485 certification demonstrates that a company’s quality management system meets regulatory requirements and is in compliance with international standards.
- Increased customer confidence: ISO 13485 certification shows that a company is committed to producing safe and effective medical devices, which can help build trust and confidence among customers and stakeholders.
- Improved efficiency and effectiveness: Implementing an ISO 13485-certified quality management system can help streamline processes, reduce waste, and improve overall efficiency and effectiveness.
- Access to new markets: ISO 13485 certification is often a requirement for companies seeking to enter new markets, especially in countries with strict regulatory requirements.
Why Choose PQSmitra for ISO 13485 Certification?
At PQSmitra, we are committed to helping our clients achieve ISO 13485 certification and improve their overall quality management system. We have a team of highly experienced auditors with extensive knowledge of the medical device industry and regulatory requirements.
Our certification process is designed to be efficient and cost-effective, with a focus on providing practical solutions to help our clients achieve their quality objectives. We also provide ongoing support to help our clients maintain their certification and continually improve their quality management system.
Contact us today to learn more about our ISO 13485 certification services and how we can help your company achieve compliance with this important standard.
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Hassle-free ISO 13485:2016 Certification with PQSmitra
ISO 13485 Certification is a specific standard for the design and manufacture of medical devices, the requirements are very stringent as it is directly associated with human health and safety. The manufacturing and administrative controls expected to be implemented are on the shop floor and office processes as well. In such a scenario, the practical, easy and effective implementation of the system is very essential. PQSmitra is one of the leading ISO 13485 Certification Consultants in Mumbai, India. Our team with the expertise of more than 20 years has supported many clients in implementing ISO 13485 certification and getting successful certification. The ISO 13485:2016 implementation process is described below:
Simple & Practical Methodology
Initial Review
- Review of the existing Quality Management System
- Gap analysis and planning for the documentation
Documentation
- Designing and developing of forms, formats, and procedures
- Training on sector specific requirements and its implementation
- 100% documentation support
Effective Verification
- Internal audit for verification of implemented system
- Management review
Achieve Certification
- Certification audit –
Stage 1 & Stage 2 - Closure of non-conformities support if any
- Rewarding the certificate to the organization
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Take the first step towards ISO 13485 Certification and ensure the safety and quality of your medical devices and products. Contact PQSmitra today to learn more about our services and how we can help you achieve certification.
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Frequently Asked Questions (FAQ)
- Integration of customer requirements specific to design and manufacture of medical devices
- Standardization of the manufacturing processes and other business processes
- Risk management and Contingency planning
- Formulating Quality Policy and Objectives
- Setting up system for documentation and records.
- Management information system
- Business performance and sustainability.
The organization shall demonstrate continual improvement in the field of quality management system for medical devices by maintaining, establishing, implementing and providing documented information.
The documented information required for ISO registration
- The organizations scope for Medical Devices
- The organizations Quality policy and Quality Objectives
- A Quality Manual (Medical Devices)
- Standard operating Procedures
- Records at individual process / department. E.g. Sales, Purchase, Production, Quality Assurance, Maintenance, Customer Service.
- The certification is availed primarily by the companies which are in the design and manufacture of medical devices. This ISO 13485 certification standard can also be used in other industry sectors when a quality management system with additional requirements over an ISO 9001:2015 system is needed.
NOTE : The eligible organizations shall be able to furnish data related to design and manufacture of the medical devices while ISO 13485 certification audit.
- Opportunity to supply ISO 13485 certification for medical devices and/or supply to medical devices OEM.
- Recognition and opportunity to cater to the export market
- Recognition of the certificate and the system by other industry sectors
- Improved product safety and traceability management
- Manufacturing process controls enhancing Quality and Productivity
- Business process streamlining and efficiency improvement
- Better business performance and Enhanced sustainability.
- Year 1996 – ISO 13485 standard was published
- Year 2000 – EN ISO 13485 certification the European Committee for Standardization (CEN) unifies the European version with the International standard and withdraws the previous EN 46001
- Year 2003 – 2nd Revision of the standard (2nd Edition)
- Year 2012 – EN ISO 13485 certification harmonized European version with three European directives associated with the medical sector 93/42/EEC, 98/79/EC, 90/385/EFC
- Year 2016 – 3rd Revision of the standard (3rd Edition)
- ISO 9000:2015 – Quality management system (QMS)
- ISO 10012, Measurement management systems — Requirements for measurement processes and measuring equipment.
- Generally, whenever there is a revision, the previous standard is kept valid for 2 to 3 years. It is also called a transition period. Earlier the organization certified as per previous standards is expected to upgrade and get certified in accordance with the revised new standard.
- This dependence on a number of factors, like the size of your firm, the complexity of your processes, the procedures you already have in place, and so on. Implementation can take 2-3 months for a smaller company (less than 100 people) and 5- 6months for a larger organization (more than 100 employees). The procedure is also influenced by the amount of time and resources your firm has to devote to implementation. That time should be factored into your overall schedule ahead of time, especially if you have a registration deadline to meet.
- The ISO 13485 certification cost is determined by a variety of criteria, including internal resourcing capabilities, pre-existing management system documentation, as well as the size and scope of products and services offered by the organization. The cost of the Certification Body and the cost of the ISO 13485 certification Consultant are two of the most important charges involved.
- It takes 15 to 20 days after the 2nd stage of the ISO Audit.
- An ISO certification will need time, effort, and improvement from a variety of departments inside a company. The steps that must be done, however, are well worth it for any organization. Owners, staff, and customers will all gain from it.
- To identify the authenticity of your accreditation body, one must
- Visit the IAF – International Accreditation Forum website home page
- Go to the IAF – International Accreditation Forum MLA–Multilateral Recognition Arrangement signatory’s category
- Select the recognized AB – Accreditation Body sub category or recognized region sub category
- From there you will select your country or the country your accreditation body belongs to
- After which you can visit the website and look for your certification body.