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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:
      103
      Messages:
      1,078
      Latest: Same KPI in different processes although related? Jennifer Kirley, Sep 19, 2021
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    2. ISO 9001:2015 - Quality Management Systems

      ISO 9001:2015 - Quality Management Systems - Published September 2015
      Discussions:
      839
      Messages:
      8,921
      Latest: Receiving Inspection requirements - need help pls RonR Quality Pro, Nov 30, 2021 at 1:47 PM
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    3. ISO 14001:2004 - Environmental Management Systems

      ISO 14001:2004 - Environmental Management Systems
      Discussions:
      11
      Messages:
      57
      Latest: Calculation of energy use and waste JohnD, May 12, 2019
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    4. ISO 14001:2015 - Environmental Management Systems

      ISO 14001:2015 - Environmental Management Systems- Published September 2015
      Discussions:
      36
      Messages:
      184
      Latest: Guidance Regarding Additional Training for ISO 14001:2015 Jennifer Kirley, May 23, 2021
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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:
      281
      Messages:
      2,273
      Latest: IATF 16949 Standard as pdf? Norbert Rogalski, Dec 2, 2021 at 7:27 PM
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    2. APQP and PPAP

      APQP (Advanced Product Quality Planning) and PPAP (Production Part Approval Process)
      Discussions:
      38
      Messages:
      199
      Latest: Safe Launch Plan! ncwalker, Nov 17, 2021
      RSS

    3. VDA Standards - Verband der Automobilindustrie

      Germany's VDA Standards - Verband der Automobilindustrie
      Discussions:
      9
      Messages:
      29
      Latest: Is it a nonconformity if RoxaneB, Apr 30, 2021
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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:
      51
      Messages:
      262
      Latest: AS9100D CLAUSE 7.5 S Russell, Nov 30, 2021 at 3:21 PM
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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:
      98
      Messages:
      606
      Latest: Medical device Non-conformance based on ISO 14971 ? John C. Abnet, Dec 1, 2021 at 6:58 PM
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    2. ISO 14971 - Medical Devices Risk Management

      ISO 14971 - Application of Risk Management to Medical Devices
      Discussions:
      6
      Messages:
      50
      Latest: Certification to ISO 14971 ? Quality Manager Liz, Dec 8, 2017
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    3. IEC 60601 - Medical Electrical Equipment Safety

      IEC 60601 - Medical Electrical Equipment Safety Standards Series
      Discussions:
      21
      Messages:
      69
      Latest: Defining a lower ESD test limit for 60601 test Alex Mayer, Feb 22, 2021
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    4. IEC 62304 - Medical Device Software

      IEC 62304 - Medical Device Software - Software Life Cycle Processes
      Discussions:
      4
      Messages:
      22
      Latest: Traceability in Medical Software Development Process yodon, Jul 21, 2021
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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:
      5
      Messages:
      23
      Latest: New China RoHS Regulation [Effective on July 2016] QAengineer13, Apr 29, 2016
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    8. EU Medical Device Regulations

      European Union Medical Device Regulations
      Discussions:
      37
      Messages:
      153
      Latest: Article 12 Procedure Pack Labelling Requirements Stephen1985, Jul 26, 2021
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    9. US Medical Device Regulations

      United States Medical Device Regulations
      Discussions:
      24
      Messages:
      81
      Latest: Economic operators in the US Chaïma, Nov 24, 2020
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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:
      16
      Messages:
      75
      Latest: 45001 (5.4) consultation and participation of workers John C. Abnet, Nov 24, 2020
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    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:
      38
      Messages:
      225
      Latest: A2LA consulting? Andy Nichols, Nov 9, 2021
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    2. Gage R&R and MSA - Measurement Systems Analysis

      Gage R&R and MSA - Measurement Systems Analysis
      Discussions:
      62
      Messages:
      404
      Latest: Attribute MSA sample collection Kamlesh Sonar, Sep 23, 2021
      RSS

    3. Gage Calibration and Uncertainty

      Gage Calibration and Uncertainty
      Discussions:
      22
      Messages:
      150
      Latest: All things Calibration and Uncertainty BradM, Nov 5, 2021
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    4. SPC - Statistical Process Control

      SPC - Statistical Process Control
      Discussions:
      57
      Messages:
      349
      Latest: SPC charts suitable for dependent data? E.g numbers on waiting list over time Miner, Jul 23, 2021
      RSS

    5. Capability - Process, Machine, Gage …

      Capability - Process, Machine, Gage …
      Discussions:
      33
      Messages:
      160
      Latest: Process capability study in Chemical industry Bev D, Mar 13, 2021
      RSS

    6. Sampling, Standards and Inspection

      Sampling, Standards and Inspection
      Discussions:
      46
      Messages:
      277
      Latest: Ballooning Drawings István Varró, Sep 16, 2021
      RSS

    7. Reliability Analysis

      Reliability Analysis
      Discussions:
      5
      Messages:
      22
      Latest: Why PCB FIT rate is not considered as per ISO26262 Irbaz, Nov 21, 2021
      RSS

    8. DOE - Design of Experiments

      DOE - Design of Experiments
      Discussions:
      24
      Messages:
      112
      Latest: Experiments without replications Jawad, Oct 12, 2021
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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:
      12
      Messages:
      41
      Latest: Are the datums correct for these two drawings? Technology, May 7, 2021
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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:
      43
      Messages:
      280
      Latest: FMEA for non-product processes BradM, Jun 28, 2021
      RSS

    2. HAZOP - Hazard and Operability Analysis

      HAZOP - Hazard and Operability Analysis
      Discussions:
      0
      Messages:
      0
      (Contains no messages)
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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
      RSS

  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:
      22
      Messages:
      202
      Latest: Human error? RonR Quality Pro, Oct 21, 2021
      RSS

    2. Documentation Control, Procedures, Templates,...

      Documentation Control Systems, Procedures, Forms and Templates
      Discussions:
      43
      Messages:
      268
      Latest: Please help me in creating a Corporate Quality Manual Andy Nichols, Nov 19, 2021
      RSS

    3. Supplier Quality, Audits & Other Supplier Issues

      Supplier Quality, Supplier Audits and Other Supplier Issues
      Discussions:
      19
      Messages:
      130
      Latest: Remote Supplier Audit Andy Nichols, Jun 21, 2021
      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:
      9
      Messages:
      57
      Latest: Grading/Not Grading? Andy Nichols, Oct 7, 2021
      RSS

    2. Registrars (Certification Bodies) & Registration

      Registrars (Certification Bodies) and Registration
      Discussions:
      18
      Messages:
      110
      Latest: CB Reducing Audit Durations Andy Nichols, Oct 27, 2021
      RSS

    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:
      49
      Messages:
      649
      Latest: Remote Audits Andy Nichols, Nov 23, 2021
      RSS

    2. Process Audits and Layered Process Audits

      Process Audits and Layered Process Audits
      Discussions:
      14
      Messages:
      145
      Latest: LPAs the Latest Automotive CoolAid? Jennifer Kirley, Oct 9, 2021
      RSS

  12. Professional Development and Training

    Professional Development and Training

    1. Professional Certifications and Degrees

      Professional Certifications and Degrees
      Discussions:
      19
      Messages:
      88
      Latest: Certified Medical Devices Quality Auditor yodon, Nov 30, 2021 at 11:01 PM
      RSS

    2. Training - Internal, External and Web-Based

      Training - Internal, External, Web-Based and Distance Learning
      Discussions:
      18
      Messages:
      136
      Latest: Statistical Process Control Demonstration Miner, Sep 2, 2021
      RSS

    3. Job Openings and Employment Opportunities

      Job Openings and Employment Opportunities
      Discussions:
      14
      Messages:
      22
      Latest: Hardware/Software Engineer, Systems Engineer E-Automotives DariaBreitkreuz, Dec 1, 2020
      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:
      72
      Messages:
      399
      Latest: Dead Horses S Russell, Nov 19, 2021
      RSS

  14. General Discussion Forums

    General Discussion Forums

    1. New Member Introductions

      New Member Introductions
      Discussions:
      168
      Messages:
      769
      Latest: Hello from Texas BradM, Nov 22, 2021
      RSS

    2. Coffee Break and Community Discussion Forum

      Coffee Break and Community Discussion Forum
      Discussions:
      69
      Messages:
      842
      Latest: Happy birthday Atul! Jennifer Kirley, Sep 18, 2021
      RSS

  15. Resources

    Forum containing discussion threads about Resources uploaded.

    1. Resource Forum

      Discussion Forum for Resources Uploaded.
      Discussions:
      57
      Messages:
      156
      Latest: Total Variance Equation Bev D, Aug 14, 2020
      RSS