ISO 13485


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ISO 13485 Certification

ISO 13485:2016

Accredited medical device management system certification

Medical device – Quality management system – Requirements for regulatory purpose – ISO 13485:2016


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ISO 13485 certification and CE marking?

As the number one worldwide accepted quality management standard in the field of medical devices, ISO 13485 certification makes a basis for CE marking or even other national certification schemes and supporting regulations around the world. Due to its great integration and ability to demonstrate sustainable improvements and compliance with applicable regulations, it has been recognized as harmonized standard EN ISO 13485 with European parliament and council directives 93/42/EEC, 98/79/EC and 90/385/EEC.

Meeting the requirements of the ISO 13485:2016 and achievement of ISO 13485 certification is the foundation for maintaining regulatory compliance and provide presumption of conformity with the essential requirements of the directives related to quality management system of manufacture which seeks for CE marking and EC certification according to applicable conformity assessment route.

Choose bqs. as your certification body for ISO 13485 certification

  • Accredited certification service
  • Pool of qualified QMS auditors and technical experts
  • Years of experience in executionof QMS audits, CE marking assessments and product testing
  • Professional independent approach to each client ensuring credibility and sustainability of bqs. certification body
  • Objective feedback on the effectiveness of the quality management system
  • Confidence in compliance with applicable European regulations
  • Weak areas early identification, detection of noncompliance and areas requiring attention
  • Confirmation that best practice is achieved
  • Detection of areas of non-compliance and possible risk
  • Reporting and certification that is valuable and recognized

ISO 13485 certification benefits

  • ISO 13485 certification opens new markets, business opportunities and improve market accessibility as a worldwide recognized quality management system standard
  • Ensures position within supplier list of your customers and maintain competitive advantage
  • Demonstrates ability of your quality management system to meet requirements of European medical device directives
  • Reduces production costs by regulate third party auditing and identification of weak points in your management system
  • Enhances reputation and credibility of company by accredited ISO 13485 certification in order to be trusted company

It is a internationally recognized standard based on ISO 9000 standard series which is intended to be use by manufacturers, suppliers and other organizations in one or more stages of medical devices life-cycle and production chain.

In order to cover unique specification of medical device manufacturing as an industry sector which is thoroughly regulated and supervised, the ISO 13485 standard has been divided from the ISO 9001 in order to set specific medical device management system requirements on well known process based approach principles Plan, Do, Check and Act.

The quality management standard ISO 13485:2016 was published to support medical device manufacturers, designers, suppliers and other interested organization in building, designing and implementing quality management systems in order to ensure sustainable effectiveness of their processes.

Well established and by bqs supervised quality management system is right way how to ensure the consistence of design, production, delivery, installation through to disposal of medical devices and in vitro medical devices that are safe and meet performance claims for their intended purpose.

How to Achieve ISO 13485 Certification with bqs

Introduction: Achieving ISO 13485 certification demonstrates your organization’s commitment to the quality and safety of medical devices. As an accredited certification body, bqs is dedicated to guiding you through this process. This guide outlines the steps required to achieve ISO 13485 certification with BQS, ensuring your organization meets the highest standards for medical device quality management.

Step 1: Understand ISO 13485 Requirements

  • Familiarize with the Standard: Start by thoroughly understanding the ISO 13485 standard and its requirements. This standard specifies the requirements for a Quality Management System (QMS) specific to the medical device industry.
  • Purchase the Standard: Obtain a copy of the ISO 13485 standard from an authorized source.

Step 2: Obtain Management Support

  • Secure Commitment: Ensure top management is committed to the project. Their support is crucial for providing the necessary resources and fostering a culture of quality within the organization.

Step 3: Define the Scope of the QMS

  • Determine Scope: Define the boundaries and scope of your QMS. This includes identifying the parts of the organization to be covered and the medical devices to be managed.

Step 4: Conduct a Gap Analysis

  • Identify Gaps: Conduct a detailed gap analysis to identify areas where your current processes do not meet ISO 13485 requirements.
  • Develop a Plan: Create a detailed plan to address the gaps and ensure compliance with the standard.

Step 5: Establish a QMS Policy

  • Create Policies: Develop quality management policies and procedures that align with ISO 13485 requirements.
  • Document Policies: Ensure all policies are documented and communicated to relevant stakeholders.

Step 6: Implement the QMS

  • Deploy Procedures: Implement the necessary procedures and controls to meet ISO 13485 requirements.
  • Training and Awareness: Train employees and raise awareness about the importance of quality management and their role in maintaining it.
  • Resource Allocation: Allocate the necessary resources, including technology, personnel, and financial support, to implement the QMS.

Step 7: Monitor and Review the QMS

  • Continuous Monitoring: Regularly monitor and review the QMS to ensure its effectiveness.
  • Internal Audits: Conduct internal audits to identify non-conformities and areas for improvement.
  • Management Reviews: Perform regular management reviews to evaluate the performance of the QMS and make necessary adjustments.

Step 8: Conduct a Pre-Certification Audit

  • Gap Analysis: Conduct a pre-certification audit (gap analysis) to identify any gaps between your QMS and ISO 13485 requirements.
  • Address Gaps: Implement corrective actions to address identified gaps.

Step 9: Apply at bqs Accredited Certification Body

  • Lodge an application with bqs
  • Fill the RFQ forms provided by us with all required information

Step 10: Certification Audit with BQS

  • Stage 1 Audit: bqs will conduct a Stage 1 audit to review your QMS documentation and readiness for the Stage 2 audit.
  • Stage 2 Audit: bqs will conduct a Stage 2 audit to evaluate the implementation and effectiveness of your QMS.
  • Certification Decision: If the audit is successful, bqs will issue the ISO 13485 certification.

Step 11: Maintain and Improve the QMS

  • Surveillance Audits: Undergo regular surveillance audits (usually annually) conducted by bqs to ensure continued compliance with ISO 13485.
  • Continuous Improvement: Continually improve your QMS by addressing new risks, updating policies, and incorporating feedback from audits.

Conclusion: Achieving ISO 13485 certification requires a systematic and disciplined approach to managing the quality of medical devices. By following these steps and partnering with bqs, your organization can establish a robust QMS, enhance product quality and safety, and gain a competitive advantage.

Call to Action: Ready to achieve ISO 13485 certification? Contact bqs today to learn how we can assist you in implementing and certifying your Quality Management System for medical devices.

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