SBS - The best value in QMS software

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!
 
Standard Work Instruction Software by Dozuki
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
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
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 2
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 2
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
B Need to convert Reference Only M&TE to a calibration schedule General Measurement Device and Calibration Topics 3
M Looking for Cross reference of AS9100:2016 to ISO13485 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
E Print only has Reference Dimensions Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
V QMS / QSR - Reference to Framework - Templates - Procedures for Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
R How to Cross-Reference Controlled Documents Document Control Systems, Procedures, Forms and Templates 3
E IEC 60601-2-25 Reference to 60601-1 2nd Edition IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Visual Inspection with No Visual Reference General Measurement Device and Calibration Topics 2
M AS9100 Rev. D - Can anyone recommend a good reference book? Book, Video, Blog and Web Site Reviews and Recommendations 7
B When to use "For Reference Use Only" on documentation Document Control Systems, Procedures, Forms and Templates 4
G BCARs/EASA to ISO9001/AS9100 cross reference matrix/table wanted EASA and JAA Aviation Standards and Requirements 1
J In the ISO 9001:2008 company, can give reference to sister company also. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
E Use of Certified Reference Materials for Quality Assurance General Measurement Device and Calibration Topics 6
A Reference Source for Polarity Symbol Other ISO and International Standards and European Regulations 1
Q Multiple Quality Standards - AS9100 and ISO13485/9001 Cross Reference Matrix Quality Manager and Management Related Issues 3
E Reference Only on Gage or Visual Aid Calibration Frequency (Interval) 4
F Quality Objective Reference Chart Customer Complaints 4
V Good Documentation Practices - FDA Reference US Food and Drug Administration (FDA) 9
M Good reference sites or material to help me brush up quickly on Gage R&R Reliability Analysis - Predictions, Testing and Standards 7
J How does Layout Inspection determine Reference Value? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
W Do "Reference Only" documents have to be physically marked/labeled? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15

Similar threads

Top Bottom