Normative reference. Has it changed?

Stuart Andrews

Stuart Andrews

Involved - Posts
#1
#1
I haven't seen a copy of the new standard and would simply like to know if any of the wording has changed for this clause of ISO9000:2000. It's for my IQA project!
 
Download Free White Paper
Elsmar Forum Sponsor
J

Jon Shaver

#2
#2
The only real change is the reference doc.

1994 refers to "ISO-8402:1994 quality management and quality assurance - vocabulary"
2000 refers to "ISO 9000:2000, quality management systems - fundamentals and vocabulary"
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
T Definition What does the term "Normative reference" mean? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
P Normative reference and Terms & conditions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Normative References for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 5
L Particular, Normative and Collateral - IEC EN 60601 Definitions of IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
T Should I include Normative References in our Systems Manual ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M ISO 14971 becomes mandatory in Brazil - ANVISA Normative Instruction 13/2009 ISO 14971 - Medical Device Risk Management 23
S Normative References and 4.3.2 Legal Requirements ISO 14001:2015 Specific Discussions 7
W Cross reference between APQP and VDA MLA? APQP and PPAP 0
J Selecting reference standards for calibration General Measurement Device and Calibration Topics 3
V Is it required to recalibrate reference- standard instruments after equipment qualification General Measurement Device and Calibration Topics 0
I Hold Time studies for Primary Reference standards Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
E 510k reference devices US Food and Drug Administration (FDA) 4
G Seeking reference guides/ documentation /tips on verification best practices Other Medical Device Related Standards 6
B Qualifying a reference analyzer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
E MSA Reference Manual 2nd Edition Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
M Reference to an archived template in multiple SOPs ISO 13485:2016 - Medical Device Quality Management Systems 2
R Statistical Methods for comparing test and reference product equivalence for quality attributes US Food and Drug Administration (FDA) 3
K COPLANARITY: Composite profile tolerance on multiple surfaces- what does" lower dimensional reference frame tolerance" control? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
C KAPPA index Reference Value for Visual inspection IATF 16949 - Automotive Quality Systems Standard 1
G GD&T applied to reference dimension. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
C IVD Metrological traceability without a reference measurement procedure General Measurement Device and Calibration Topics 11
M Reference part calibration or verification General Measurement Device and Calibration Topics 12
G Need journal and reference of abnormal bar chart SPC Statistical Analysis Tools, Techniques and SPC 4
W Do Reference materials for IATF need to be 17025? IATF 16949 - Automotive Quality Systems Standard 15
W What is okay to use as a reference material for ISO 17025? ISO 17025 related Discussions 4
M SOPs - Reference Documents Section Document Control Systems, Procedures, Forms and Templates 4
B Reference to IEC 60950-1 in Amendment 2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Question on equipment - when to use reference only or research only stickers ISO 13485:2016 - Medical Device Quality Management Systems 5
J Marking "Distributed By" to product with distributors' reference-code EU Medical Device Regulations 3
Dazza 9001, 14001 and 45001 mandatory documents and records cross reference matrix Process Maps, Process Mapping and Turtle Diagrams 2
T CSE 5.01 reference on drawing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
N IEC 60601-1-1 - Stress test, reference voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
CycleMike GD&T - Hole pattern - Print (attached) has a single Datum Reference Frame Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
J Sample size for creating a data base as a reference to a tested variable Other Medical Device and Orthopedic Related Topics 6
R ASQ reference material clarification - Spiral bound materials allowed in ASQ Exam? Professional Certifications and Degrees 1
D Good Acceptance Activity/Inspection flowchart for reference - Wanted Please Process Maps, Process Mapping and Turtle Diagrams 2
G Customer complaint over a Reference Dimension Manufacturing and Related Processes 9
G Measure 3 times, for calibration report? Customer Owned Reference Standard General Measurement Device and Calibration Topics 4
I Data Backup Plan - Document Reference ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q How to efficiently and compliantly reference external standards/regulations Other Medical Device Related Standards 2
S Lot assignment for secondary reference standard - Pharmaceuticals Manufacturing and Related Processes 0
V Inspection with 3D Scanning - Reference Data Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
E Ethylene Oxide Sterilization Validation-Reference Load Other Medical Device Related Standards 8
C Must your reference standard provider be ISO17034 certified to meet your testing lab's ISO 17025 certification requirements? Other ISO and International Standards and European Regulations 2
C Do Calibration Reference Standards require an MSA study? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
J Purpose of Reference Section in SOPs Document Control Systems, Procedures, Forms and Templates 6
M Quality Policy - Standards and reference numbers ISO 13485:2016 - Medical Device Quality Management Systems 14
M Reference to IATF 16949 clause 8.4.3 in clause 8.3.4.4, Is it right? IATF 16949 - Automotive Quality Systems Standard 1
S Reference calibration tools (traceable to NIST) that are not used in production ISO 13485:2016 - Medical Device Quality Management Systems 4
S Contract Manufacturer Question - Whether or not the reference to the ex-CMO ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom