Overview of ISO 13485 Certification

Safety and quality are not negotiated in the case of medical devices, and so there is a requirement of ISO 13485, which specifies the requirement of a Quality Management System, where an organisation requires to show its abilities to provide medical devices and related services to meet applicable regulatory requirements. These organisations are indulged in one or more life-cycle stages such as design, storage and distribution, production, development, installation or servicing of a medical device and design and development or provision of any associated activities/ services. This ISO 13485 is also used by suppliers or external parties in providing a product with Quality Management System related services to the organisations.

ISO 13485 aligns with the earlier version of ISO 9001, which is an internationally recognised standard for Quality Management Systems established by ISO. The requirements set by ISO are recognised around the world for implementing a Quality Management System. Although ISO 13485 standard came out after the major update of ISO 9001, it does not align with a new revision of ISO 9001, as it was determined that the most recent changes in ISO 9001 were unnecessary for medical devices.

The ISO 13485 is the medical device organisation that mostly accepts international standards for quality management. The third-party Certification of ISO 13485 is required to prove that the Organisation is complying with the standard's requirements because the International Organisation issues it for Standardisation (ISO), which is an effective solution to meet the comprehensive requirements for Quality Management systems in the medical device organisations.

ISO 13485 is divided into eight sections; the first three are introductory, and the last five are mandatory requirements for the Quality Management System (QMS), which are Quality Management System, Management Responsibility, Resource Management, Product Realisation and Measurement, Analysis and Improvement.

Significant revisions of ISO 13485 standard are as follows:

• ISO 13485:2016 has replaced ISO 13485:2003 and 13485:2012.
  
  
• The revised ISO 13485:2016 got published on 1st March 2016.
  
  
• ISO 13485:2016 is aligned with ISO 9001:2008 and not with ISO 9001:2015.
  
  
• The changes are managed by ISO technical committee 210, ensuring that the Quality Management System (QMS)standard remains fit.
  
  
  

Benefits of Getting ISO 13485 Certified

Obtaining ISO 13485 Certification offers numerous benefits for medical device manufacturers and associated organizations. These advantages not only strengthen internal processes but also enhance global market positioning.

Key Benefits:

• Globally Recognized QMS Certification: Achieve compliance with the internationally accepted EN ISO 13485 Quality Management System.

• Increased Product Opportunities: Certification opens the door to new and larger markets.

• Market Access Approvals: Easier approvals for global market access and regulatory requirements.

• Supplier Leverage: Manufacturers and subcontractors can leverage their certification status for seamless integration into specialized certifications.

• Enhanced System Feedback: Receive valuable insights into the effectiveness of your QMS and areas for improvement.

• Regulatory Confidence: Greater assurance in regulatory compliance and reduced legal risks.

• Risk Identification & Mitigation: Pinpoint areas of non-compliance and address operational risks proactively.

• Supports Expansion: Provides a solid foundation for future growth and business scalability.

• Credible Reporting & Certification: Gain access to trusted and globally recognized audit and certification reports.

• Process Clarity: Improved understanding of processes, product handling, and device specifications.

• Continuous Improvement: Facilitates a culture of ongoing quality enhancements and best practices.
  
  

Pre-Requisites for ISO 13485 Certification

Before applying for ISO 13485 Certification, an organization must fulfill several structural, managerial, and procedural requirements to demonstrate readiness and compliance.

1. General Requirements

• Full adherence to ISO 13485 standards.

• Proper documentation of all QMS-related procedures and policies.

• System effectiveness through proactive risk analysis and mitigation planning.

• Defined processes for product realization and performance tracking.

• Responsibility for compliance even when outsourcing processes.

• Legal and regulatory awareness regarding manufacturing and operations.
  
  

2. Documentation Requirements

• Quality Manual outlining QMS scope, processes, and structure.

• Policy & Objective Statements reflecting commitment to quality.

• Documentation for:

  • Medical device design and intended use

  • Product specifications

  • File maintenance and control of documents

  • Records of procedures and process evaluations
    
    

3. Management Responsibility

• Clear leadership accountability for operations and product quality.

• Commitment to customer focus and legal compliance.

• Structured planning and delegation of roles and responsibilities.

• Regular management reviews for performance assessment and improvement alignment.
  
  

4. Resource Management

• Availability of sufficient personnel, infrastructure, tools, and consumables.

• Compliance with ISO 13485 and regulatory requirements through proper resourcing.

• Planning for succession and operational continuity.
  
  

5. Product Realisation

• Planning the full lifecycle of product development.

• Documented design, development, verification, and validation processes.

• Ensuring all steps comply with QMS guidelines from concept to completion.
  
  

6. Measurement, Analysis, and Improvement

• Systems to collect feedback, handle complaints, and report adverse events.

• Internal audits to evaluate performance and compliance.

• Methods to detect non-conformities, implement corrective actions, and drive continuous improvement.

• Data analysis to refine processes and enhance product quality.
  
  
  

Documents Required for ISO 13485 Certification

To achieve ISO 13485 Certification, an organisation must maintain a comprehensive set of mandatory documents that demonstrate compliance with the standard’s requirements. These documents ensure the effectiveness, traceability, and integrity of the Quality Management System (QMS) specifically for medical devices.

Below is the detailed list of required documents:

1. Organisational & QMS Structure

• Quality Manual

• Quality Policy

• Quality Objectives

• Responsibilities and Authorities

• Roles undertaken under applicable regulatory requirements

• Procedure and Records for Management Review

• Procedure for Document Control

• Procedure for Record Control
  
  

2. Human Resources & Infrastructure

• Procedure for Training

• Requirements for Infrastructure and Maintenance Activities

• Requirements of the Work Environment

• Arrangements for Control of Contaminated or Potentially Contaminated Products
  
  

3. Customer Focus

• Records of Customer Requirements Review and Actions

• Arrangements for Communication with Customers

• Procedure for Customer Feedback

• Procedure and Records for Complaint Handling

• Records of Reporting to Regulatory Authorities
  
  

4. Product Realisation & Design Control

• Outputs of Product Realisation Planning

• Procedure for Design and Development

• Design and Development Planning

• Design and Development Outputs

• Records of Design and Development Reviews

• Design Verification Plans, Results and Conclusions

• Design Validation Plans, Results and Conclusions

• Process for Risk Management in Product Realisation

• Process of Transfer of Design and Development Outputs to Manufacturing

• Process and Records for Control of Design and Development Changes

• Design and Development File
  
  

5. Procurement & Supplier Management

• Procedure for Purchasing

• Criteria and Records for Evaluation and Selection of Suppliers

• Record of Verification of Purchased Product
  
  

6. Production & Service Provision

• Medical Device File

• Record for Medical Device or Batch Providing Traceability

• Requirements for Cleanliness of the Product

• Requirements for Medical Device Installation and Verification

• Process and Records for Servicing of the Medical Device

• Records of the Sterilisation Procedure

• Procedure and Records for Production and Service Provision Process Validation

• Procedure and Records for Validation of a Process for Sterilisation and Sterile Barrier Systems
  
  

7. Traceability & Identification

• Procedure for Product Identification

• Procedure for Traceability

• Records of Traceability with Name and Address of Shipping Package Consignee

• Report on Changes in Customer Property

• Procedure for Preserving the Conformity of the Product
  
  

8. Monitoring, Measurement & Control

• Process of Monitoring and Measuring

• Record of Calibration

• Procedure and Records for Validation of Application of Computer Software used for Monitoring and Measuring

• Identity of the Person Authorising the Release of the Product

• Procedure and Record of Control of Non-Conforming Product

• Record of Rework
  
  

9. Data Analysis & Improvement

• Procedure and Records for Data Analysis

• Procedure and Records for Corrective Action

• Procedure and Records for Preventive Action
  
  
  

Procedure to Obtain ISO 13485 Certification

Getting ISO 13485 Certification involves a structured process that ensures your organisation’s Quality Management System (QMS) meets global standards for medical devices. Below are the four essential steps to achieve certification:

1. Optional Preliminary Audit

A voluntary site inspection is conducted where quality management documentation is reviewed. This phase helps assess the organisation's readiness for the full-scale Stage I and Stage II audits.

2. Audit: Stage I – Documentation Review & Eligibility Check

An initial on-site assessment is carried out to:

• Review your QMS documentation

• Evaluate your business practices

• Determine the eligibility for certification based on the preparedness of the system and documentation
  
  

3. Audit: Stage II – System Evaluation

This stage involves a comprehensive on-site evaluation of your implemented Quality Management System. The auditor checks for:

• Effectiveness of applied practices

• Compliance with ISO 13485 requirements

• Operational efficiency and control
  
  

4. Certification

Upon successful completion of both audit stages, your organisation is issued the ISO 13485 Certification, officially validating that your QMS meets international standards and is suitable for the manufacturing and servicing of medical devices.

Fastzeal Assistance in Obtaining ISO 13485 Certification

Fastzeal offers end-to-end support to help you achieve certification with ease:

1. Purchase a Plan for expert consultation and full support
   
   

2. Add Queries regarding ISO 13485 to get personalised guidance
   
   

3. Submit Required Documents to the Fastzeal expert team
   
   

4. Fulfil All Admissibility Criteria during the preliminary screening
   
   

5. Complete All Procedural Steps with Fastzeal's expert direction
   
   

6. Get Certified without delays – Fastzeal handles everything efficiently