ISO 13485:2016 - Quality Management System
Medical Device Certification
What is ISO 13485:2016 - QMS Certification?
ISO 13485:2016 is an internationally recognized standard that specifies requirements for a quality management system (QMS) specifically tailored for organizations involved in the design, development, production, installation, and servicing of medical devices and related services. The primary goal of ISO 13485:2016 is to facilitate compliance with regulatory requirements in the medical device industry by ensuring the consistent design, production, and distribution of safe and effective medical devices.
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Benefits of ISO 13485 Certification
Enhanced Quality Management
ISO 13485 provides a framework for implementing and maintaining a robust quality management system (QMS), which helps organizations consistently meet customer and regulatory requirements. This leads to improved product quality and reliability.
Compliance with Regulatory Requirements
ISO 13485 is harmonized with regulatory requirements in various countries, including the European Union's Medical Device Regulation (MDR) and the United States' Food and Drug Administration (FDA) regulations. Certification demonstrates compliance with these regulations, facilitating market access for medical devices.
Increased Market Access
ISO 13485 certification is often a prerequisite for doing business in the medical device industry. It enhances credibility and confidence among stakeholders, including customers, regulatory authorities, and business partners, thereby expanding market opportunities domestically and internationally.
Risk Management
The standard emphasizes risk-based approaches throughout the product lifecycle, from design and development to production and post-market activities. Implementing risk management processes helps identify, mitigate, and manage risks associated with medical devices, leading to improved safety and efficacy.
Efficiency and Cost Savings
ISO 13485 promotes efficiency through the systematic identification and elimination of non-conformities and process inefficiencies. By streamlining processes and optimizing resource allocation, organizations can reduce waste, lower production costs, and enhance overall operational performance.
Continuous Improvement
ISO 13485 fosters a culture of continuous improvement by requiring organizations to monitor and measure their QMS processes and performance metrics. This data-driven approach enables organizations to identify areas for improvement and implement corrective and preventive actions, driving ongoing enhancements to product quality and organizational effectiveness.
Who can get ISO 13485 Certification?
ISO 13485 certification is primarily designed for organizations involved in the design, development, production, installation, and servicing of medical devices and related services. This includes a wide range of entities across the medical device supply chain, such as:
Medical Device Manufacturers
Companies that design, develop, and manufacture medical devices, including equipment, instruments, implants, and consumables.
Contract Manufacturers
Organizations that provide manufacturing services on behalf of medical device companies, including contract manufacturing organizations (CMOs) and original equipment manufacturers (OEMs).
Component Suppliers
Suppliers of raw materials, components, and sub-assemblies used in the production of medical devices, such as electronic components, plastics, metals, and packaging materials.
Distributors and Importers
Companies involved in the distribution, sale, and importation of medical devices, ensuring compliance with regulatory requirements and maintaining product quality throughout the supply chain.
Service Providers
Entities that offer services related to medical devices, such as sterilization, calibration, maintenance, repair, and technical support.
Design and Development Organizations
Companies engaged in the design and development of medical devices, including product design firms, engineering firms, and research institutions.
Quality Management Consultants
Consulting firms that provide expertise in implementing and maintaining ISO 13485-compliant quality management systems.
Validity of ISO 13485 Certification
ISO 13485 certification is typically valid for a period of 3 Years. This means that once an organization successfully achieves ISO 13485 certification, the certification is valid for three years from the date it was issued.
Documents Required for ISO 13485 Certification
- System Manual
- System Procedure
- Policy
- Objectives
- Mission & Vision
- Standard Operating Procedure (SOP)
- Checklist
- Forms
- Formats
- Records
The extent of Documented Information differs as per:
- Organization’s size
- Activities performed by the organization
- Processes undertaken by the Organization
- Products and services offered by the organization
- The complexity of processes undertaken
- Competence of persons involved
Role of Shamkris and Process of ISO 13485 Certification
Shamkris adopts a results-oriented approach to effective system implementation in the organization. A simple and practical method of system implementation helps organizations increase business efficiency and sustainability. Shamkris supports 100% documentation to obtain an accreditation body of success in addition to enhanced performance.
The implementation process is described below:
Time Frame
Task
Process
Day 1
GAP Analysis
Certification Body
Selection
Cost Estimates
- Finding the GAP between existing system related to ISO requirements
- Selecting the appropriate certification Body
- Based on the scope of your business & certification Body you choose
Week 1
Developing Documents
- Management System Manual, Management System Procedures, Policy, Objectives, Forms etc.
- Review of Standard Operating Procedures (SOP)
Week 4
Implementing Management System
- ISO Awareness training for the top management and staff
- Implementing a well-documented management system throughout the organization
Week 8
Internal Audit
MRM
CAPA
- Internal audits identifying nonconformities related to ISO requirements
- Management Review Meetings
- Corrective and Preventive Action plan for nonconformities
Week 10
Self Certification/NoBo
Audit
N-C Closing
- Shamkris acts on your behalf and assists you in the third-party audit
- Closing of any nonconformities identified by the certification Body
Week 12
Self Certification/NoBo
- ISO certificates issued for 3 years
- Surveillance Audits yearly
Year on Year
Yearly Compliance
- Support of Yearly documentation for audit
Who can issue the ISO 13485 Certification?
FAQ
ISO 13485 certification signifies that an organization has implemented a quality management system (QMS) that meets the requirements of the ISO 13485 standard. This standard is specifically designed for organizations involved in the design, development, production, installation, and servicing of medical devices and related services.
ISO 13485 certification is important for organizations in the medical device industry as it demonstrates compliance with regulatory requirements and commitment to quality management. It enhances credibility, facilitates market access, and promotes continuous improvement.
ISO 13485 certification is applicable to various entities across the medical device supply chain, including manufacturers, contract manufacturers, component suppliers, distributors, service providers, design and development organizations, and quality management consultants.
ISO 13485 certification is typically valid for a period of three years. To maintain certification validity, organizations must undergo regular surveillance audits conducted by an accredited certification body, with a recertification audit required at the end of each three-year certification cycle.
To achieve ISO 13485 certification, an organization must implement a quality management system that complies with the requirements of the standard. This involves conducting a gap analysis, developing documentation, implementing processes, conducting internal audits, and undergoing a certification audit by an accredited certification body.
ISO 13485 certification offers several benefits, including enhanced quality management, compliance with regulatory requirements, increased market access, risk management, efficiency and cost savings, continuous improvement, and competitive advantage in the medical device industry.
If an organization fails to maintain ISO 13485 certification due to non-compliance with the standard’s requirements or failure to address non-conformities identified during audits, it may lose its certification status. This could impact the organization’s ability to conduct business in the medical device industry and may require corrective actions to regain certification.