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  • Make a reservation: 1-800-123-4567
  • ISO 13485:2016 Medical Devices ~ Quality Management Systems ~ Requirements for Regulatory Purposes

    ByRichard Litts

    ISO 13485:2016 Medical Devices ~ Quality Management Systems ~ Requirements for Regulatory Purposes

    Are you a current supplier or trying to become a supplier to the medical device industry? If so, you may be required to implement this standard.

    We will help you understand the requirements of the ISO 13485:2016 QMS, how to interpret the requirements, and provide you with consulting support to develop and implement the system within your organization. We will also assist you in upgrading your current ISO 13485:2003 system to the 2016 requirements.

    This international standard provides the framework for implementing a QMS. It defines requirements in the clauses of the standard. The standard is based upon the “Process Approach”. Whether your “product” is software, hardware, service or processed materials, this QMS can provide structure and aid in bringing discipline within your organization.

    We will help you understand the requirements, how to interpret the requirements and provide you with consulting support to develop and implement the system within your organization.

    The ISO 13485:2016 implementation process would consist of the development of the required ISO 13485:2016 QMS documentation. The applicability of any current site documentation would be reviewed and updated during this process.

    A kickoff meeting would be held with the ISO 13485:2016 QMS implementation management team before the process begins. At this meeting, each clause of the standard will be reviewed and the team selects employees who will be the process owners. The process owner is responsible for soliciting employees who are internal customers and suppliers for that process to help develop the related procedure. These employees will then attend the procedure development meetings. Once the documents are developed, this team is responsible for training the employees.

    Litts Quality Technologies, provides quality consulting and internal system auditors training in the ISO 13485:2016 Quality Management System standard and system auditing techniques.

    implementation management team before the process begins. At this meeting, each clause of the standard will be reviewed and the team selects employees who will be the process owners. The process owner is responsible for soliciting employees who are internal customers and suppliers for that process to help develop the related procedure. These employees will then attend the procedure development meetings. Once the documents are developed, this team is responsible for training the employees.

    Internal System Auditors will be trained in the requirements of the ISO 13485:2016 QMS standard and system auditing techniques. Once the training is completed, they will perform audits of the system to determine compliance and effectiveness of the implementation of the system.

    All employees would attend an ISO 13485:2016 QMS awareness session to become knowledgeable of the standard requirements, their responsibilities and what to expect when the registrar conducts the registration / certification audit.

    We are involved from initial inquiry stage to becoming registered / certified to the standard. This includes but is not limited to;

    • Facilitating each procedure / process draft development session.
    • Facilitating each procedure / process final review session.
    • Coordinating the selection and development of work instructions as necessary.
    • Providing training assistance to employees who will conduct the training of their procedures / processes.
    • Conducting Internal System Auditor ISO 13485:2016 QMS Training.
    • Participating in the initial Internal System Audit.
    • Providing employee Awareness Training Sessions.
    • Providing input to assure compliance with the ISO 13485:2016 QMS standard and,
    • Assisting in the selection of the registration / certification body.

     

    If you are not sure how your current formal or informal system complies with the standard, we can provide you with a gap analysis audit. This audit can be used as a planning guide to implementing the necessary improvements required to be in conformance to this standard.