ISO 13485:2016

ISO 13485:2016

QI: implementation of the agreed work stages:

Step 1: Choose the right standard
Help the client correctly determine which qualifiers match
- Customer requirements.
- State requirements (laws and regulations).
- Development and innovation of the company's business system.

Step 2: Make the correct choice for the certification device
Provide advice and support in the selection of the external auditor (third party) which is appropriate to the needs of both
- Customer requirements.
- State requirements (laws and regulations).
- Development and innovation of the company's business system

Step 3: Analyze the gap
Analyzing and evaluating the current situation (for the work system) in accordance with the requirements of ISO 13485: 2016.
Step 4: Training and awareness
Conducting training courses for the team (emergency team and crisis / business continuity team) and awareness of the following:
5 - Requirements of the Medical Facility Management System ISO 13485: 2016
6. Advanced Auditing Principles in accordance with ISO 19011: 2018.
 
Step 5: Authentication
Establishment of the following documents for the work system within the company:
14. Quality policy of the medical establishment.
15- Quality guide for the medical establishment.
16. Establishment of work procedures, including:
- Procedures for the control of documented information.
- Internal audit procedures.
- Management review procedures.
- Human resources and training procedures.
Risk and opportunity assessment procedures.
- Institutional context procedures and analysis and classification of interested / interested parties.
- Infrastructure / work environment procedures.
- Procedures for planning and achieving the product and stages of work.
- Quality control procedures.
- Product design and development procedures.
- Procurement procedures and supplier evaluation.
- Maintenance and calibration procedures.
- Storage and trading procedures.
- Procedures for controlling cases of non-conformity and corrective actions.
- Procedures for improvement and continuous development.
17. Work instructions for vital services.

Step 6: Application
The above procedures are explained to all departments and departments and assist the company in the process of implementation and implementation and provide support in respect of the adjustments to:
- Quality policy of the medical establishment.
- Quality guide for the medical establishment.
- Work procedures of the medical establishment.
- Work instructions.

Step 7: Internal Audit and Management Review
Preparing and preparing for the implementation of the internal audit through:
28. Selection of internal auditors.
29. Composition of the Internal Audit Committee.
30. Preparation of the internal audit plan.
13. Notify the relevant administrations of the timing and timing of the internal audit.
32. Preparation for the implementation of internal audit and preparation of checklists.
33. Implementation of internal audit.
34. Take corrective actions resulting from internal audit.
35. Internal audit report and termination of the audit plan.
36. Preparation for the Management Review Meeting.
37. Inform the concerned of the agenda of the meeting.
38. The meeting was held and the agenda of the meeting was discussed.
39. Decisions on the meeting.
40. Follow-up to the implementation of resolutions.
Step 8: Certificate.
Contact and communicate with the third party (specific) external auditor and implement the following stages:
- Request a quote.
- Study and approve the bid and write the contract of agreement.
- Determination of the implementation dates of the audit.
- Implementation of external audit (third party).
- Action on corrective action and action plan (if any)
Obtain the certificate


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