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    • Home
    • our Services
      • ISO 9001 Consulting
      • AS 9100 Consulting
      • ISO 13485 Consulting
      • ISO 14001 Consulting
      • ISO IATF 16949 Consulting
      • ISO 27001 Consulting
      • ISO 50001 Consulting
      • Lean Six Sigma Consulting
      • ASME Sec.VIII Consulting
      • Controlled Goods program
    • Useful QMS ISO Forms
      • Approved supplier list
      • Calibration log Form
      • Control Plan Form
      • Corrective Action Report
      • First Article Inspection
      • Internal Audit Report
      • Management Review Form
      • Non-Conformity Report
      • Part Submission Warrant
      • PFMEA Form
      • Process Flow Form
      • Risks and Opportunities
      • Supplier Questioners Form
      • Training Record form
    • Reviews and Testimonials
    • blogs
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Management System Group

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iso-9001-documneted-information

ISO 9001 documented information:

Additional Information

 

A) MANDATORY DOCUMENTED INFORMATION NEEDED TO BE MAINTAINED

- The scope of the quality management system (clause 4.3).

- Documented information necessary to support the operation of processes (clause 4.4).

- The quality policy (clause 5.).  

- The quality objectives (clause 6.2).  

- This documented information is subject to the requirements of clause 7.5.   


B) MANDATORY DOCUMENTED INFORMATION NEEDED TO BE RETAINED

 - Documented information to The extent necessary to have confidence that The processes are   being carried out as planned (clause 4.4).

- Evidence of fitness for purpose of monitoring and measuring resources (clause 7.1.5.1).

 - Evidence of The basis used for calibration of The monitoring and measurement resources (when no international or national standards exist) (clause 7.1.5.2).  

 - Evidence of competence of person(s) doing Work under The control of The Organization that affects the performance and effectiveness of the QMS (clause 7.2).

 - Results of the review and new requirements for the products and services (clause 8.2.3).

 - Records needed to demonstrate that design and development requirements have been met (clause 8.3.2)

- Records on design and development inputs (clause 8.3.3).

- Records of the activities of design and development controls (clause 8.3.4).

- Records of design and development outputs (clause 8.3.5).

 - design and development changes, including The Results of The review and The authorization of the changes and necessary actions (clause 8.3.6).

 - Records of The evaluation, selection, monitoring of performance and re-evaluation of external providers and any and actions arising from these activities (clause 8.4.1)

 - Evidence of The unique identification of The outputs when traceability is a requirement (clause 8.5.2).

 - Records of property of The customer or external provider that is lost, damaged or otherwise found to be unsuitable for use and of its communication to the owner (clause 8.5.3).

 - Results of The review of changes for Production or service provision, The persons authorizing the change, and necessary actions taken (clause 8.5.6).

 - Records of The authorized release of products and services for delivery to The customer including acceptance criteria and traceability to the authorizing person(s) (clause 8.6).

 - Records of nonconformities, the actions taken, concessions obtained and  the identification of the authority deciding the action in respect of the nonconformity (clause 8.7).

 - Results of the evaluation of the performance and the effectiveness of the QMS (clause 9.11)

 - Evidence of the implementation of the audit programme and the audit results (clause 9.2.2).

 - Evidence of the results of management reviews (clause 9.3.3).

 - Evidence of The nature of The nonconformities and any subsequent actions taken (clause 10.2.2).;

- Results of any corrective action (clause 10.2.2). 


C) NOT-MANDATORY DOCUMENTED INFORMATION MAINTAINED BY THE ORGANIZATION FOR THE PURPOSE OF COMMUNICAT

 - Organization charts

 - Process maps, Process flow charts and/or Process descriptions

 - Procedures  

 - Work and/or test instructions  

 -Specifications  

 - Documents containing internal communications

 - Production schedules

 - Approved supplier lists

 - test and inspection plans

 - quality plans

 - quality manuals

 - Strategic plans

 - Forms

Management System Inc. as a Management Consultancy Services can support you to prepare all your organizational required documents along with ISO 9001 documented information required by this standard. 

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Management System Inc.  located in GTA, Ontario and our services cover all Canada. Please contact us for our free evaluation and competitive quote. 

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