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The Quality Forum Online

  1. Quality Management and Environmental Standards

    Quality Management and Environmental Standards

    1. ISO 9001:2008 - Quality Management Systems

      ISO 9001:2008 - Quality Management Systems
      Discussions:
      102
      Messages:
      1,070
      Latest: Is 2008 still current? Andy Nichols, Mar 17, 2025
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    2. ISO 9001:2015 - Quality Management Systems

      ISO 9001:2015 - Quality Management Systems - Published September 2015
      Discussions:
      967
      Messages:
      10,193
      Latest: Physically challenged people_consequences_ for Implementation of ISO 9001-2015 Andy Nichols, Apr 17, 2025
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    3. ISO 14001:2004 - Environmental Management Systems

      ISO 14001:2004 - Environmental Management Systems
      Discussions:
      14
      Messages:
      68
      Latest: 8.2 Emergency Preparedness (d) Carlee Gruizinga, Oct 23, 2024
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    4. ISO 14001:2015 - Environmental Management Systems

      ISO 14001:2015 - Environmental Management Systems- Published September 2015
      Discussions:
      48
      Messages:
      261
      Latest: ISO 14001:2015 Documentation Timothy Wade, Apr 21, 2025
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  2. Automotive Quality Standards

    Automotive Quality Standards

    1. IATF 16949:2016 - Automotive Quality Systems

      IATF 16949:2016 - International Automotive Quality Systems (Formerly: ISO/TS 16949)
      Discussions:
      383
      Messages:
      3,040
      Latest: GM Customer Specific Requirement - Layered Audits qmr1976, Apr 28, 2025 at 9:07 PM
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    2. APQP and PPAP

      APQP (Advanced Product Quality Planning) and PPAP (Production Part Approval Process)
      Discussions:
      44
      Messages:
      238
      Latest: The "New" integrated FMEA - or "Much Ado About Nothing" Andy Nichols, Oct 19, 2024
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    3. VDA Standards - Verband der Automobilindustrie

      Germany's VDA Standards - Verband der Automobilindustrie
      Discussions:
      14
      Messages:
      47
      Latest: product audits Andy Nichols, May 23, 2023
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  3. Aerospace Standards

    Aerospace and Aviation Requirements

    1. AS 91XX - Aerospace Quality Standards

      SAE AS 9100, AS 9110, AS 9120 - Aerospace Quality Standards and Requirements
      Discussions:
      97
      Messages:
      528
      Latest: 8.5.1 and 8.5.4 and FOD interpretation Andy Nichols, Apr 3, 2025
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  4. Medical Device Standards and Regulations

    Medical Device Standards and Regulations

    1. ISO 13485 and ISO 14969 – Medical Devices QMS

      ISO 13485 and ISO 14969 – Medical Devices Quality Management System
      Discussions:
      105
      Messages:
      615
      Latest: ISO13485: Marketing materials and design files felicebehaviour, Sep 25, 2024
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    2. ISO 14971 - Medical Devices Risk Management

      ISO 14971 - Application of Risk Management to Medical Devices
      Discussions:
      7
      Messages:
      52
      Latest: ISO 14971 - Use of detection in FMEA yodon, Jan 31, 2024
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    3. IEC 60601 - Medical Electrical Equipment Safety

      IEC 60601 - Medical Electrical Equipment Safety Standards Series
      Discussions:
      23
      Messages:
      75
      Latest: Battery Powered ECG Holter Dielectric Test Bardia Baraeinejad, Mar 24, 2025
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    4. IEC 62304 - Medical Device Software

      IEC 62304 - Medical Device Software - Software Life Cycle Processes
      Discussions:
      7
      Messages:
      33
      Latest: IEC 62304 for developer tools that are packaged with final product. yodon, Aug 30, 2023
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    5. IEC 62366 - Medical Devices Usability Engineering

      IEC 62366 - Application of Usability Engineering to Medical Devices
      Discussions:
      2
      Messages:
      8
      Latest: Usability procedure yodon, Apr 3, 2018
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    6. Canada Medical Device Regulations

      Canada Medical Device Regulations
      Discussions:
      1
      Messages:
      6
      Latest: CMDCAS addition to ISO 13485 OrangeIsEnergy, Aug 25, 2015
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    7. China Medical Device Regulations

      China Medical Device Regulations
      Discussions:
      6
      Messages:
      32
      Latest: China NMPA Registration Jaken Wang, Aug 6, 2024
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    8. EU Medical Device Regulations

      European Union Medical Device Regulations
      Discussions:
      42
      Messages:
      160
      Latest: Electronic Signatures Wins Letshawn, Mar 20, 2025
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    9. US Medical Device Regulations

      United States Medical Device Regulations
      Discussions:
      27
      Messages:
      92
      Latest: FDA 21 CFR 803 Device Malfunction yodon, Feb 5, 2024
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    10. Other Medical Device Regulations World-Wide

      Other Medical Device Regulations World-Wide
      Discussions:
      16
      Messages:
      44
      Latest: Brazil / Japan: Essential Safety and Effectiveness Requirements MaxiFuer, Sep 15, 2019
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  5. Health & Food Safety

    Health & Food Safety

    1. OHSAS - Occupational Health and Safety

      OHSAS - Occupational Health and Safety Advisory Services
      Discussions:
      17
      Messages:
      79
      Latest: Worthy Incentives for Safety Programs Brian Vandolah, Mar 25, 2025
      RSS

    2. HACCP - Hazard Analysis & Critical Control Points

      HACCP - Hazard Analysis & Critical Control Points
      Discussions:
      2
      Messages:
      4
      Latest: Chocolate Mousse HACCP Plan Andy Nichols, Nov 30, 2017
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  6. Metrology and Statistical Analysis

    Metrology and Statistical Analysis

    1. ISO 17025 - Calibration and Test Laboratories

      ISO 17025 - Calibration and Test Laboratories
      Discussions:
      50
      Messages:
      298
      Latest: CoA conditions of use Andy Nichols, Nov 12, 2024
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    2. Gage R&R and MSA - Measurement Systems Analysis

      Gage R&R and MSA - Measurement Systems Analysis
      Discussions:
      69
      Messages:
      437
      Latest: Family of gages bkirch, Mar 13, 2025
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    3. Gage Calibration and Uncertainty

      Gage Calibration and Uncertainty
      Discussions:
      26
      Messages:
      175
      Latest: Deciding Vernier Caliper verification tolerances MonsterEnergy22, Nov 29, 2023
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    4. SPC - Statistical Process Control

      SPC - Statistical Process Control
      Discussions:
      72
      Messages:
      473
      Latest: Attribute control chart Bev D, Jan 28, 2025
      RSS

    5. Capability - Process, Machine, Gage …

      Capability - Process, Machine, Gage …
      Discussions:
      34
      Messages:
      177
      Latest: Process Capability sixpack on a Profile Bev D, Oct 30, 2024
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    6. Sampling, Standards and Inspection

      Sampling, Standards and Inspection
      Discussions:
      48
      Messages:
      288
      Latest: Ballooning Drawings Miner, Apr 1, 2025
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    7. Reliability Analysis

      Reliability Analysis
      Discussions:
      8
      Messages:
      47
      Latest: Issues with Minitab - Interval-Censored Data Set Miner, Apr 3, 2025
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    8. DOE - Design of Experiments

      DOE - Design of Experiments
      Discussions:
      34
      Messages:
      150
      Latest: Negative value of response in central composite design Miner, Mar 13, 2024
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  7. Geometric Dimensioning & Tolerancing and Design

    Geometric Dimensioning & Tolerancing and Design

    1. GD&T Standards and Practices - ASME & ISO

      GD&T Standards and Practices - ASME & ISO
      Discussions:
      15
      Messages:
      48
      Latest: Profile of surface to base shawnw212, Sep 16, 2024
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  8. Risk Analysis and Mitigation

    Risk Analysis and Mitigation

    1. FMEA - Failure Modes and Effects Analysis

      FMEA - Failure Modes and Effects Analysis
      Discussions:
      50
      Messages:
      334
      Latest: OCC and DET score for "Error Proof" prevention control Bev D, Apr 24, 2025 at 3:06 PM
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    2. HAZOP - Hazard and Operability Analysis

      HAZOP - Hazard and Operability Analysis
      Discussions:
      1
      Messages:
      1
      Latest: Chemical exposure risk assessment FatmaD, Nov 21, 2023
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    3. ISO 31000:2009 - Risk Management

      ISO 31000:2009 - Risk Management
      Discussions:
      3
      Messages:
      17
      Latest: Risk Management Process MCW8888, Jan 7, 2016
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  9. Common Quality Assurance Processes and Tools

    Common Quality Assurance Processes and Tools

    1. 5S, 5Why, 8D, TRIZ, SIPOC, RCA, Shainin Methods...

      5S, 5Why, 8D, TRIZ, SIPOC, RCA, Shainin Methods…
      Discussions:
      30
      Messages:
      283
      Latest: Human error? Devesh#89, Jul 8, 2024
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    2. Documentation Control, Procedures, Templates,...

      Documentation Control Systems, Procedures, Forms and Templates
      Discussions:
      53
      Messages:
      333
      Latest: Transferring Contracts Peter_G, Jan 30, 2025
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    3. Supplier Quality, Audits & Other Supplier Issues

      Supplier Quality, Supplier Audits and Other Supplier Issues
      Discussions:
      24
      Messages:
      159
      Latest: Risk Assessment - Saline Solution Bev D, May 9, 2024
      RSS

  10. Registrars & National/International Organizations

    Registrars and National/International Organizations

    1. ASQ, IRCA, IATF, Exemplar & Related Organizations

      ASQ, IRCA, IATF, Exemplar Global and Related Organizations
      Discussions:
      10
      Messages:
      67
      Latest: Preparing for the ASQ CQE exam RonR Quality Pro, Oct 3, 2023
      RSS

    2. Registrars (Certification Bodies) & Registration

      Registrars (Certification Bodies) and Registration
      Discussions:
      19
      Messages:
      111
      Latest: Everything you wanted to know about ISO Certification - Part 1 Andy Nichols, Apr 28, 2023
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    3. Managing Your Certification Body Relationship

      Tips, hints and discussions on how to make a success of this unusual customer/supplier relationship...
      Discussions:
      4
      Messages:
      16
      Latest: Preparing for your Virtual Certification Audit Andy Nichols, May 15, 2020
      RSS

  11. Auditing - Internal and External

    Auditing - Internal and External

    1. ISO 19011 - Auditing Management Systems Guidelines

      ISO 19011 - Guidelines for Auditing Management Systems
      Discussions:
      80
      Messages:
      835
      Latest: You CAN audit your own work! Andy Nichols, Mar 10, 2025
      RSS

    2. Process Audits and Layered Process Audits

      Process Audits and Layered Process Audits
      Discussions:
      16
      Messages:
      155
      Latest: How familiar are these? Andy Nichols, Mar 16, 2025
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  12. Professional Development and Training

    Professional Development and Training

    1. Professional Certifications and Degrees

      Professional Certifications and Degrees
      Discussions:
      22
      Messages:
      103
      Latest: looking for any additional Quality Assurance training resources due to Redundancy (UK) Andy Nichols, Feb 25, 2025
      RSS

    2. Training - Internal, External and Web-Based

      Training - Internal, External, Web-Based and Distance Learning
      Discussions:
      21
      Messages:
      155
      Latest: UK Funded courses - any good ones? Dotty101, Oct 27, 2023
      RSS

    3. Job Openings and Employment Opportunities

      Job Openings and Employment Opportunities
      Discussions:
      15
      Messages:
      23
      Latest: CMM Programmer (Zeiss) - Plymouth, IN Sharon Doan, Mar 5, 2024
      RSS

  13. All Other Topics

    All Other QMS Related Topics not covered above

    1. Other Quality and Business Related Topics

      All Other Quality Assurance and Business Systems Related Topics not Covered Above
      Discussions:
      90
      Messages:
      473
      Latest: IGCC samy aly, Jan 21, 2025
      RSS

  14. General Discussion Forums

    General Discussion Forums

    1. New Member Introductions

      New Member Introductions
      Discussions:
      181
      Messages:
      810
      Latest: Hello Andy Nichols, Apr 28, 2025 at 1:06 PM
      RSS

    2. Coffee Break and Community Discussion Forum

      Coffee Break and Community Discussion Forum
      Discussions:
      81
      Messages:
      894
      Latest: Season's Greetings! John C. Abnet, Dec 26, 2024
      RSS

  15. Resources

    Forum containing discussion threads about Resources uploaded.

    1. Resource Forum

      Discussion Forum for Resources Uploaded.
      Discussions:
      58
      Messages:
      157
      Latest: New ISO 9001 Myths Book now available! Andy Nichols, Oct 6, 2022
      RSS