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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:
      100
      Messages:
      1,042
      Latest: Job titles change so frequently how to handle documented procedures? Golfman25, Oct 17, 2018 at 1:48 PM
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    2. ISO 9001:2015 - Quality Management Systems

      ISO 9001:2015 - Quality Management Systems - Published September 2015
      Discussions:
      480
      Messages:
      4,861
      Latest: A few questions about ISO 9001:2015 8.5.6 and 7.5.3 judegu, Oct 18, 2018 at 1:31 AM
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    3. ISO 14001:2004 - Environmental Management Systems

      ISO 14001:2004 - Environmental Management Systems
      Discussions:
      11
      Messages:
      54
      Latest: Implement Monitoring System for medical facilities Gracy, Jun 12, 2018
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    4. ISO 14001:2015 - Environmental Management Systems

      ISO 14001:2015 - Environmental Management Systems- Published September 2015
      Discussions:
      18
      Messages:
      85
      Latest: Facility Expansion tony s, Aug 22, 2018
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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:
      152
      Messages:
      1,295
      Latest: General Consensus- CQI Audits ? ncwalker, Oct 16, 2018 at 4:25 PM
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    2. APQP and PPAP

      APQP (Advanced Product Quality Planning) and PPAP (Production Part Approval Process)
      Discussions:
      28
      Messages:
      152
      Latest: Not feeling the love for element 9 ncwalker, Aug 7, 2018
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    3. VDA Standards - Verband der Automobilindustrie

      Germany's VDA Standards - Verband der Automobilindustrie
      Discussions:
      5
      Messages:
      13
      Latest: PSB audit checklist Faith Brink, Oct 8, 2018
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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:
      25
      Messages:
      114
      Latest: 10.3 - continual imrovement - should it be recorded? Jennifer Kirley, Oct 9, 2018
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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:
      62
      Messages:
      426
      Latest: Design and Development Plan Karly Chester Etzel, Oct 9, 2018
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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:
      17
      Messages:
      63
      Latest: IEC 60601 Patient Monitor Brightness Requirement SZ5261, Sep 21, 2017
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    4. IEC 62304 - Medical Device Software

      IEC 62304 - Medical Device Software - Software Life Cycle Processes
      Discussions:
      3
      Messages:
      20
      Latest: Certification to BS EN 62304:2006 Andy Nichols, Nov 9, 2017
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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:
      31
      Messages:
      138
      Latest: Article 12 Procedure Pack Labelling Requirements Amy G, Oct 2, 2018
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    9. US Medical Device Regulations

      United States Medical Device Regulations
      Discussions:
      22
      Messages:
      72
      Latest: Would the FDA audit my company? Zara Joyce, May 9, 2017
      RSS

    10. Other Medical Device Regulations World-Wide

      Other Medical Device Regulations World-Wide
      Discussions:
      13
      Messages:
      38
      Latest: Standard, regulation for neurostimulators QualityB, Jul 19, 2018
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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:
      10
      Messages:
      38
      Latest: 8.1.1 Multi-employer workplaces John C. Abnet, May 4, 2018
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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:
      17
      Messages:
      97
      Latest: Quality manual for ISO 17025:2017 Andy Nichols, Oct 17, 2018 at 12:51 PM
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    2. Gage R&R and MSA - Measurement Systems Analysis

      Gage R&R and MSA - Measurement Systems Analysis
      Discussions:
      41
      Messages:
      275
      Latest: Gage R&R Opinions: Are they effective ? ncwalker, Sep 26, 2018
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    3. Gage Calibration and Uncertainty

      Gage Calibration and Uncertainty
      Discussions:
      17
      Messages:
      126
      Latest: Gauge verification ncwalker, Jul 2, 2018
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    4. SPC - Statistical Process Control

      SPC - Statistical Process Control
      Discussions:
      30
      Messages:
      221
      Latest: How can I manage the defective rate in this situation? Bev D, Aug 21, 2018
      RSS

    5. Capability - Process, Machine, Gage …

      Capability - Process, Machine, Gage …
      Discussions:
      24
      Messages:
      120
      Latest: Quantile Cpk Bev D, Oct 9, 2018
      RSS

    6. Sampling, Standards and Inspection

      Sampling, Standards and Inspection
      Discussions:
      24
      Messages:
      152
      Latest: Sampling Plan for AQL less than 0.01% Bev D, Sep 13, 2018
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    7. Reliability Analysis

      Reliability Analysis
      Discussions:
      2
      Messages:
      19
      Latest: Reliability Prediction by knowing component counts and processes involved Mike wizowski, Sep 22, 2017
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    8. DOE - Design of Experiments

      DOE - Design of Experiments
      Discussions:
      10
      Messages:
      66
      Latest: Central Composite Design (CCD) Extan, Sep 27, 2018
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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:
      5
      Messages:
      27
      Latest: Smooth Ring Gauge - ease of fit Golfman25, Nov 23, 2016
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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:
      22
      Messages:
      129
      Latest: What is difference between Review & Reverse PFMEA? Serious Man, Sep 19, 2018
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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:
      19
      Messages:
      164
      Latest: 5S audit checklist Kiran Walimbe, Mar 12, 2018
      RSS

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

      Documentation Control Systems, Procedures, Forms and Templates
      Discussions:
      28
      Messages:
      189
      Latest: Document Record Numbers Karly Chester Etzel, Sep 14, 2018
      RSS

    3. Supplier Quality, Audits & Other Supplier Issues

      Supplier Quality, Supplier Audits and Other Supplier Issues
      Discussions:
      13
      Messages:
      96
      Latest: Independence of QA / QC Personnel normzone, Dec 14, 2016
      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:
      7
      Messages:
      42
      Latest: Stuck on ASQ CQE Questions Guilherme Eisinger, Sep 25, 2018
      RSS

    2. Registrars (Certification Bodies) & Registration

      Registrars (Certification Bodies) and Registration
      Discussions:
      13
      Messages:
      86
      Latest: Experiences with TUV, DQS, and/or BSI? GStough, Sep 27, 2018
      RSS

    3. Managing Your Certification Body Relationship

      Tips, hints and discussions on how to make a success of this unusual customer/supplier relationship...
      Discussions:
      2
      Messages:
      4
      Latest: Requesting a new auditor Miner, May 2, 2016
      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:
      23
      Messages:
      346
      Latest: Revision of ISO 19011: Major Changes Raffy, Oct 10, 2018
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    2. Process Audits and Layered Process Audits

      Process Audits and Layered Process Audits
      Discussions:
      10
      Messages:
      132
      Latest: Carte Blanche for an Audit Programme RoxaneB, Jul 30, 2017
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  12. Professional Development and Training

    Professional Development and Training

    1. Professional Certifications and Degrees

      Professional Certifications and Degrees
      Discussions:
      9
      Messages:
      45
      Latest: Supplier quality certifications required Mustafa Kamal Pasha, Aug 7, 2018
      RSS

    2. Training - Internal, External and Web-Based

      Training - Internal, External, Web-Based and Distance Learning
      Discussions:
      15
      Messages:
      125
      Latest: Project Management Training-Recommendations required Ardaqr, Aug 15, 2016
      RSS

    3. Job Openings and Employment Opportunities

      Job Openings and Employment Opportunities
      Discussions:
      10
      Messages:
      18
      Latest: Qualitätsmanager (m/w) Job Ambition, Sep 18, 2018
      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:
      45
      Messages:
      250
      Latest: Authority tight-fisted sldnfl without pharmaceutical Sazuelwet, Oct 18, 2018 at 1:33 AM
      RSS

  14. General Discussion Forums

    General Discussion Forums

    1. New Member Introductions

      New Member Introductions
      Discussions:
      122
      Messages:
      622
      Latest: Hello all! Atul Khandekar, Aug 10, 2018
      RSS

    2. Coffee Break and Community Discussion Forum

      Coffee Break and Community Discussion Forum
      Discussions:
      59
      Messages:
      811
      Latest: Grace Periods in Calibration and Maintenance Intervals Melissa237, Aug 1, 2018
      RSS

  15. Resources

    Forum containing discussion threads about Resources uploaded.

    1. Resource Forum

      Discussion Forum for Resources Uploaded.
      Discussions:
      56
      Messages:
      139
      Latest: Risk-based Nonconformance Tracking Log Atul Khandekar, Oct 8, 2018
      RSS