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TOPIC 3, QMS - REQUIREMENTS, MS ISO 9001 CERTIFICATION - Coggle Diagram

- - - - Top management must define measurable quality objectives that align with the quality policy and product requirements.
    - - QMS planning must ensure goals are met and the system remains effective, even during changes.
- - - - ✔ Track customer opinions to measure performance and satisfaction.
    - - ✔ Conduct regular internal audits to check if the QMS is followed and effective.
      - ✔ Use qualified, impartial auditors and fix any problems found.
    - - ✔ Monitor key processes to ensure they perform as expected.
      - ✔ Take corrective action when they don’t.
    - - ✔ Inspect and test products at appropriate stages to make sure they meet requirements.
      - ✔ Keep records and only release products that pass.
  - - - ✔ Find and fix the root cause of problems so they don’t happen again.
      - ✔ Use a documented process to review, act, and track.
    - - ✔ Identify and fix potential issues before they happen.
      - ✔ Follow a process similar to corrective action, but proactive.
    - - ✔ Use audits, feedback, and reviews to keep making the QMS better.
- - - - Any outsourced processes affecting product conformity must be controlled and identified within the QMS.
      - Monitoring, measuring, and analyzing processes are essential for achieving planned results and continuous improvement.
      - Adequate resources and information must be available to support the system.
      - It should establish methods to ensure effective operation and control of these processes.
      - The organization must define the necessary processes for the QMS and how they interact.
  - - - a) A written quality policy and quality goals
      - b) A quality manual
      - c) Required documented procedures as stated by the standard
      - d) Documents needed to plan, run, and control processes effectively
      - e) Records required by the standard
    - - a) The scope of the QMS and reasons for any parts not included
      - b) The documented procedures or references to them
      - c) A description of how the QMS processes work together
    - - a) Approve documents before they are used
      - b) Review and update documents as needed, and re-approve them
      - c) Track document changes and current versions
      - d) Ensure the right documents are available where they are needed
      - e) Keep documents clear and easy to read
      - f) Control documents received from outside sources
      - g) Prevent use of outdated documents and clearly mark them if kept for reference
    - - Records must be kept to show that the QMS meets requirements and works effectively.They must be:
        
        Legible
        
        Easy to identify
        
        Easy to find when needed
- - - - hiring a consultant with a strong background (knowledge and experience) in QMS to train staff/help develop QMS.
  - - - -
        
        develop Quality Manuals & procedures
        
        carry out QMS planning
        
        identify & implement improvement processes
        
        audit compliance with the QMS
  - - - create a timeline for QMS development, draft a quality manual & policy and establish quality objective.
  - - - conduct audits to ensure compliance
      - take corrective actions to address any issues
      - revise the manuals, procedures & objectives (if required)