ISO 13485 Quality Management System

ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series

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What is ISO 13485?

ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the previous version of ISO 9001, ISO 9000:2008 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance; therefore it is more prescriptive in nature and requires a more thoroughly documented QMS.

ISO 13485 was written to support medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes. It ensures the consistent design, development, production, installation and delivery through to disposal of medical devices that are safe for their intended purpose.

Audit Certification Approach

1. Scouting Framework.
2. Pre-Assessment.
3. Stage 1 Audit.
4. Detailed Stage 2 Audit.
5. Increase visibility & Control risks.
6. Implementing Continuous improvement and Maintaining Certification.

Our Service Offerings

Dedicated Consultants
Internal Audit Schedule Planning
Scoping and Gap Assessments
Developing Policies and Procedures
Awareness trainings
Audits, Treatment Development Plan
Certification Conformance Management
Full documented report on all findings & recommendations

Baseel's Deliverables

  • Scoping and Gap Assessments: Suggest on the optimized scope for the ISO13485 certification and conduct precise gap assessment including high level advice on time and effort estimates for gap remediation. Develop Statement of Applicability. (SOA)
  • Developing Policies and Procedures: To meet the specific needs of the organization and implement an assurance framework to ensure the effective continuation of the implementation.
  • Awareness trainings: Develop and provide awareness training bespoke to the needs of various user groups within the organization.
  • Risk Frameworks and Assessments: Develop and implement risk frameworks and conduct an organization-wide risk assessment. Develop risk treatment plans and oversee risk remediation.
  • Pre-certification audits: Conduct pre-certification audits to ensure guaranteed pass within the first attempt.
  • Certification conformance management: Oversee conformance of the ISO13485 requirements at regular intervals to ensure organization passes annual audits.

  • The importance of ISO 13485

    ISO 13485 is important to designers, manufacturers, and distributors of medical devices. In addition, suppliers and service providers can enhance an organization's marketability as more and more manufacturers require certifi cation in order to do business with a vendor .

    When it comes to medical device manufacturing, patient safety greatly depends on the quality and consistency of medical products, and ensuring effectiveness, control and maintenance of your QMS is critical to customers, stakeholders, patients and users, and regulatory agencies.

    The value of ISO 13485 is not just in the implementation, but also in providing a tool for a thorough audit to test the effectiveness of the system. It provides the manufacturer with a higher level of confidence in the ability to consistently achieve and maintain compliance with regulatory requirements. It can also help to minimize surprises and failures which might adversely affect patient safety and damage a manufacturer's reputation.

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