What is ISO 13485?

ISO 13485 is an international standard that defines quality management system standards for medical devices. This standard specifies the quality management system requirements for the design, development, production, installation, and servicing of medical devices.

ISO 13485 is a comprehensive standard that covers all processes necessary for medical device manufacturers to ensure the quality, safety, and effectiveness of their products. These requirements aim to enhance patient safety and customer satisfaction by ensuring that medical devices are regularly monitored and continuously improved throughout their lifecycle.

ISO 13485 certification provides medical device manufacturers with a competitive advantage in the international market. It offers assurance of product safety and effectiveness, ensures regulatory compliance, and enhances customer satisfaction.

How to Obtain ISO 13485 Certification?

To obtain ISO 13485 certification, an organization must align its quality management system with the requirements of the standard and then undergo an audit by an accredited certification body.

The steps for ISO 13485 certification are as follows:

A. Stage 1 Audit

On this stage, the organization's quality management system documents are reviewed to assess compliance with the essential requirements of ISO 13485. The quality management system documentation is examined for conformity with ISO 13485 requirements. This stage helps to identify potential deficiencies in the system and to determine whether the organization is ready for the Stage 2 audit. If deficiencies are found, the organization is given time to correct them.

B. Stage 2 Audit

The audit begins with an opening meeting with the organization's management and relevant personnel. The audit plan is reviewed, and information about the audit process is provided. The audit team examines the organization's processes and activities on-site. On this stage, areas such as processes, production lines, supplier management, product traceability, and management of customer complaints are audited. The audit team reviews the quality management system records and evidence, interviews personnel from various departments, and gathers information about the operation of processes. Any nonconformities identified during the audit are recorded and reported. Nonconformities include situations that do not comply with the standard requirements and the organization's internal procedures. The audit team prepares a report including the identified nonconformities and corrective action recommendations, and shares it with the organization in the closing meeting.

C. Certification

The organization carries out the necessary activities to correct the identified nonconformities. This includes the preparation and implementation of corrective action plans. The audit team reviews the evidence of corrective actions and evaluates their effectiveness. After all nonconformities are closed, the file is submitted to the committee for decision along with the audit report, and the certificate is issued based on the committee's positive decision.

D. Surveillance Audits

The ISO 13485 certificate is typically valid for three years. During this period, annual surveillance audits are conducted to verify the effectiveness and compliance of the organization's quality management system. Annual surveillance audits are single-stage and are conducted similarly to Stage 2 audits.

What Are the Essential Requirements of ISO 13485 Standard?

ISO 13485 standard provides a comprehensive framework that defines quality management system standards for medical devices. Here are the basic requirements of ISO 13485:

  1. Quality Management System (QMS)

Documentation: Creation and use of documents such as quality policies, procedures, work instructions, and records.

Quality Manual: Preparation of a quality manual that defines the scope and details of the organization's quality management system.

Control of Records: Ensuring that all quality records are properly maintained and accessible when needed.

  1. Management Responsibility

Top Management Commitment: Demonstration of top management's commitment to the quality management system and continuous improvement.

Customer Focus: Determination and fulfillment of customer requirements.

Quality Policy and Objectives: Establishment of appropriate quality policies and setting of quality objectives.

  1. Resource Management

Human Resources: Ensuring the competence, training, skills, and experience of personnel.

Infrastructure: Ensuring the adequacy of buildings, workspace, process equipment, and support services.

Work Environment: Control of environmental conditions affecting product quality.

  1. Product Realization

Planning: Planning and control of product realization processes.

Customer Relations: Determining and meeting customer requirements.

Design and Development: Planning, implementation, and verification of product design and development processes.

Purchasing: Evaluation and selection of suppliers and control of purchasing processes.

Production and Service Provision: Planning, implementation, and control of production and service processes.

Traceability: Ensuring product traceability and recording batch and serial numbers.

Customer Property: Protection of products and information provided by the customer.

Product Preservation: Protection of products during transportation, storage, and delivery.

  1. Measurement, Analysis, and Improvement

Monitoring and Measurement: Monitoring and measuring product and process performance.

Internal Audit: Conducting regular internal audits to evaluate the effectiveness of the quality management system.

Control of Nonconformities: Identification and control of nonconforming products, and implementation of corrective and preventive actions.

Continuous Improvement: Data analysis and improvement activities to continuously improve the quality management system.

  1. Risk Management

Risk Management Processes: Identification, assessment, control, and continuous monitoring of risks throughout the entire lifecycle of medical devices.

Risk Analysis and Assessment: Conducting risk analyses and taking necessary precautions during the product design and development stages.

  1. Regulatory Requirements Compliance

Monitoring and Implementation of Regulations: Tracking and implementing national and international regulatory requirements related to medical devices.

Product Certification and Approvals: Documenting compliance with regulatory requirements and obtaining necessary approvals.

How can Sertifike assist you?

  1. Gap Analysis

Current Situation Assessment: Examine the organization's existing quality management system and evaluate its compliance with ISO 13485 requirements.

Identification of Deficiencies: Identify gaps and deficiencies between the standard and the current system.

Reporting: Prepare a detailed report based on the results of the gap analysis and offer improvement recommendations.

  1. Documentation Development and Revision

Preparation of Quality Manual: Prepare a quality manual suitable for the organization's activities.

Procedures and Instructions: Prepare necessary procedures, work instructions, and other documents, and revise existing ones.

Management of Records: Establish and improve record-keeping systems.

  1. Training and Awareness

ISO 13485 Training: Provide training for employees and managers on the requirements of the ISO 13485 standard.

Practical Training: Offer practical training on the implementation and management of the quality management system.

  1. Process Improvement

Process Mapping: Map all processes of the organization and aligns them with ISO 13485 requirements.

Risk Management: Support the creation and implementation of risk management procedures.

  1. Internal Audit and Management Review

Internal Audit Implementation: Conduct internal audits with the audit team and report the results.

Audit Findings and Improvement: Supports the identification and implementation of corrective and preventive actions based on audit findings.

Management Review: Guide the planning and execution of management review meetings.

  1. Management of Nonconformities and Corrective Actions

Nonconformity Management: Develop procedures for the management and resolution of identified nonconformities.

Corrective and Preventive Actions: Support the creation and implementation of corrective and preventive action plans.

  1. Certification Process Support

Certification Preparation: Coordinate all activities necessary to prepare the organization for the certification audit.

Post-Audit Follow-up: Follow up on corrective actions after the certification audit.

  1. Compliance with Regulations

Regulatory Monitoring: Track national and international regulatory requirements related to medical devices and help the organization comply with these requirements.

Product Certification: Support the documentation of compliance with relevant regulations and approval processes.

Sertifike team provides the necessary expertise and guidance for medical device manufacturers to establish, improve, and maintain their quality management systems. By ensuring organizations' compliance with the ISO 13485 standard, we help to enhance the safety and effectiveness of your products and facilitate regulatory compliance.