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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:
      1,086
      Latest: Quality ISO 9001:2008 in IT Service Delivery and Support Organization astutecertification, Jan 27, 2021
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    2. ISO 9001:2015 - Quality Management Systems

      ISO 9001:2015 - Quality Management Systems - Published September 2015
      Discussions:
      791
      Messages:
      8,482
      Latest: Error caused to produce bad product, once in 5 years, Root cause? Andy Nichols, Mar 4, 2021 at 11:47 AM
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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:
      34
      Messages:
      174
      Latest: Criteria for assessing Environmental aspects NISHITH NEEMA, Feb 6, 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:
      257
      Messages:
      2,119
      Latest: IATF Calibration Question calibration or verification Andy Nichols, Mar 3, 2021 at 12:55 PM
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    2. APQP and PPAP

      APQP (Advanced Product Quality Planning) and PPAP (Production Part Approval Process)
      Discussions:
      35
      Messages:
      191
      Latest: Safe Launch Plan! Steven Severt, Nov 14, 2020
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    3. VDA Standards - Verband der Automobilindustrie

      Germany's VDA Standards - Verband der Automobilindustrie
      Discussions:
      8
      Messages:
      24
      Latest: VDA requirements for a lessons learned process Andy Nichols, Oct 29, 2020
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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:
      43
      Messages:
      227
      Latest: AS 9100 Design Validation Andy Nichols, Feb 7, 2021
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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:
      89
      Messages:
      552
      Latest: Looking for test people JakobA, Mar 2, 2021 at 3:52 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:
      21
      Latest: Traceability in Medical Software Development Process MrTetris, Oct 29, 2018
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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:
      150
      Latest: Procedure for EU MDR Clinical Investigation yodon, Aug 27, 2020
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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:
      33
      Messages:
      207
      Latest: Section 7.2.2.2., changes to validated methods question. Andy Nichols, Mar 3, 2021 at 12:57 PM
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    2. Gage R&R and MSA - Measurement Systems Analysis

      Gage R&R and MSA - Measurement Systems Analysis
      Discussions:
      61
      Messages:
      403
      Latest: Calculating K1, K2, and K3 for 30 part sample Bev D, Jan 25, 2021
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    3. Gage Calibration and Uncertainty

      Gage Calibration and Uncertainty
      Discussions:
      21
      Messages:
      143
      Latest: Linear scales... Mikegrow, Oct 13, 2020
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    4. SPC - Statistical Process Control

      SPC - Statistical Process Control
      Discussions:
      55
      Messages:
      342
      Latest: My data is attribute but the distribution is normal Miner, Jan 20, 2021
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    5. Capability - Process, Machine, Gage …

      Capability - Process, Machine, Gage …
      Discussions:
      32
      Messages:
      153
      Latest: Process capabilities study mechanical properties Miner, Jan 14, 2021
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    6. Sampling, Standards and Inspection

      Sampling, Standards and Inspection
      Discussions:
      43
      Messages:
      262
      Latest: Indi-Ron Minimal Contact inspection fixturing Justin Hasting, Feb 24, 2021
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    7. Reliability Analysis

      Reliability Analysis
      Discussions:
      4
      Messages:
      21
      Latest: MIL-217 Quality Factor sherlockbob, Oct 9, 2020
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    8. DOE - Design of Experiments

      DOE - Design of Experiments
      Discussions:
      19
      Messages:
      98
      Latest: Optimizing Factor Levels when Results are Qualitative JAWChemist, Sep 26, 2020
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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:
      10
      Messages:
      39
      Latest: Parallelism callout - best method? _Zeno_, Mar 12, 2020
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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:
      42
      Messages:
      268
      Latest: Using MIL HDBK 217E alan1000, Feb 14, 2021
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    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
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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:
      22
      Messages:
      200
      Latest: Paint peel off issue Jennifer Kirley, Jan 3, 2021
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    2. Documentation Control, Procedures, Templates,...

      Documentation Control Systems, Procedures, Forms and Templates
      Discussions:
      38
      Messages:
      242
      Latest: Documentation Statement after being Acquired by new company Eric Twiname, Nov 6, 2020
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    3. Supplier Quality, Audits & Other Supplier Issues

      Supplier Quality, Supplier Audits and Other Supplier Issues
      Discussions:
      19
      Messages:
      128
      Latest: What are your strategies on the procurement of new suppliers? jw2198, Jan 12, 2021
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  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:
      8
      Messages:
      51
      Latest: Preparing for the ASQ CQE exam Satyananda Kumar Ch, Oct 2, 2019
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    2. Registrars (Certification Bodies) & Registration

      Registrars (Certification Bodies) and Registration
      Discussions:
      16
      Messages:
      103
      Latest: Warning! Eric Twiname, Dec 10, 2020
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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
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  11. Auditing - Internal and External

    Auditing - Internal and External

    1. ISO 19011 - Auditing Management Systems Guidelines

      ISO 19011 - Guidelines for Auditing Management Systems
      Discussions:
      43
      Messages:
      592
      Latest: Enough! tony s, Feb 2, 2021
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    2. Process Audits and Layered Process Audits

      Process Audits and Layered Process Audits
      Discussions:
      13
      Messages:
      143
      Latest: 4.4.1 ..."...shall determine the processes needed..." leyladonmez, Jan 5, 2021
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  12. Professional Development and Training

    Professional Development and Training

    1. Professional Certifications and Degrees

      Professional Certifications and Degrees
      Discussions:
      15
      Messages:
      77
      Latest: Joining a CQI? Andy Nichols, Nov 15, 2020
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    2. Training - Internal, External and Web-Based

      Training - Internal, External, Web-Based and Distance Learning
      Discussions:
      17
      Messages:
      133
      Latest: Individual Certificate Transfer Smoothy Squish, Jan 18, 2020
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    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
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  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:
      59
      Messages:
      327
      Latest: Opinion needed with regards to sample size and scoring Andy Nichols, Aug 10, 2020
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  14. General Discussion Forums

    General Discussion Forums

    1. New Member Introductions

      New Member Introductions
      Discussions:
      160
      Messages:
      745
      Latest: Hello! Looking for knowledge Andy Nichols, Feb 26, 2021
      RSS

    2. Coffee Break and Community Discussion Forum

      Coffee Break and Community Discussion Forum
      Discussions:
      68
      Messages:
      836
      Latest: FINALLY- a new year. Eric Twiname, Dec 24, 2020
      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
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