Guide 25 Extension, IASG Interpretations

D

Dan Indish

#1
#1
The following was issued by the IASG on 1/22/99 and is at the ASQ
website at:

http://www.asq.org - Link Was: /standcert/qs-9000/sancl.html

This is the interpretation our customers needed and will give us, the providers, time to respond.

"Element 4.11 Control of Inspection, Measuring and Test Equipment

C2 Calibration Laboratory Requirements, (4.11.2.b.1) (1/22/99)

Due to a current lack of suppliers of accredited calibration services
for calibration laboratories, compliance to QS-9000:1998 Third Edition
laboratory requirements, 4.11.2.b.1,
may be satisfied if the supplier
has a documented plan to assure that,
effective January 1, 2001, the supplier is fully in compliance with
QS-9000:1998 Third Edition cl. 4.11.2.b.1 requirements.

More information is available in a QS-9000 Laboratory Requirements Self
Study Guide available from AIAG at (USA) 248-358-3003 and on the AIAG
website: http://www.AIAG.org/quality."

I now have to get back to my A2LA application package.

--
Jack Gale, ASQ-CQE
ESSCO Calibration Lab
(800) 325 - 2201
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M An introductory guide to medical device Clinical Evaluation & Clinical Evaluation Reports (CER) EU Medical Device Regulations 0
S Labeling; User Guide US Food and Drug Administration (FDA) 4
PQ Systems The Complete Guide to GAGEmail Using GAGEpack Software 0
R Reusable Needle Guide Classification EU Medical Device Regulations 0
Sidney Vianna ISO Practical Guide on ISO 31000:2018 - Risk Management Other ISO and International Standards and European Regulations 0
A Mistakes in the CQE Study Guide Misc. Quality Assurance and Business Systems Related Topics 11
M Surgical angle measurement guide device with an application software Medical Device and FDA Regulations and Standards News 4
S Requirements for "Claims Guide" for medical devices Medical Device and FDA Regulations and Standards News 6
H Can a calibration lab still use ISO 6789:2003 as guide for torque calibrations Other ISO and International Standards and European Regulations 1
D MDR 2017/745 Classification Guide EU Medical Device Regulations 8
M Informational MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies – August 2019 Medical Device and FDA Regulations and Standards News 1
D Standard guide for shelf life determination of non sterile component with degradation materials Reliability Analysis - Predictions, Testing and Standards 1
M Informational TGA – Medical device incident reporting (MDIR) guide Medical Device and FDA Regulations and Standards News 0
F EUDAMED UDI Medical Devices User's Guide Medical Device and FDA Regulations and Standards News 7
L I'm looking for Translation Procedure Guide MEDDEV 2.5/5 Rev.2 (NOT Rev.3) CE Marking (Conformité Européene) / CB Scheme 0
M Informational IMDRF final document – Assembly and Technical Guide for IMDRF Table of Contents Submissions Medical Device and FDA Regulations and Standards News 4
M Informational EC – Guide for referencing standards in public procurement in Europe (JIS Action 11) Medical Device and FDA Regulations and Standards News 0
O Guide on EMC for Functional Safety CE Marking (Conformité Européene) / CB Scheme 3
Q Practical guide to scan for Risks in all QMS systems without missing any ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
R Non-Conformity Report from Notified Body - MEDDEV Guide is not Legally Binding EU Medical Device Regulations 16
J ISO 17025 Guide and Ideas for a New Calibration Business ISO 17025 related Discussions 18
A Plastic Injection Molding Process Troubleshooting Guide Manufacturing and Related Processes 1
F Distributors Audit guide Supplier Quality Assurance and other Supplier Issues 4
S Seeking Feedback on ASQ Guide to Failure Mode and Effect Analysis FMEA and Control Plans 2
D Looking for the FDA's Small Entity Compliance Guide 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
N ISO 20000 Implementation Guide and Compliance Checklist wanted IT (Information Technology) Service Management 2
E Where to get a GagePack 2000 User Guide Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
A A Guide to Effective Internal Management System Audits Book, Video, Blog and Web Site Reviews and Recommendations 2
CharlieUK New EU Commission "Blue Guide" to CE Marking - 2014 CE Marking (Conformité Européene) / CB Scheme 2
automoto International Problem Solving Guide Problem Solving, Root Cause Fault and Failure Analysis 2
M A Guide or Standard for Calibration Interval (Frequency) Calibration Frequency (Interval) 2
AnaMariaVR2 The Essential Guide to Combination Products cGMPs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
J Free Improvement Guide provided by USCG Book, Video, Blog and Web Site Reviews and Recommendations 9
A Exploding the Myths Surrounding ISO 9000: A Practical Implementation Guide Book, Video, Blog and Web Site Reviews and Recommendations 28
T The Consultants Guide to Successfully Implementing 5S review Book, Video, Blog and Web Site Reviews and Recommendations 1
J What Standard/s can a tourist guide be certified to? Service Industry Specific Topics 4
Marc Guide To Inspections Of Medical Device Manufacturers - 1997 (06/08/2010) US Food and Drug Administration (FDA) 3
A CATERPILLAR BGPP (Benchmarking Guide for Painting Process) Questionnaire Customer and Company Specific Requirements 4
AnaMariaVR2 Guide to Microsoft Excel for Calculations, Statistics, and Plotting Data Excel .xls Spreadsheet Templates and Tools 11
M Need practical guide on TS 16949 Clause 7.6 Requirement IATF 16949 - Automotive Quality Systems Standard 1
M Shingo Prize Model as an Assessment Guide for Lean Implementation Lean in Manufacturing and Service Industries 1
Q Quick Guide - Processes vs. ISO 9001 Clauses? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J 3-Legged 5 Whys - Help guide for Internal Corrective Action System Nonconformance and Corrective Action 2
Sidney Vianna ISO/IEC Guide 63:2012 - Medical Device Safety Aspects Other Medical Device Related Standards 1
automoto How ISO 9001 could look in the future - ISO 9001 revision (Guide 83) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Sidney Vianna ISO/IEC Guide 63:2012 - Safety Aspects in International Standards for Medical Devices Other Medical Device Related Standards 1
T ASQ Certification Testing Book and Study Guide recommendations wanted Book, Video, Blog and Web Site Reviews and Recommendations 7
Stijloor Simple Navigation Guide for the MSA 4th Edition Manual Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
B FORD CPA (Capacity Planning Analysis) User Guide for Suppliers Customer and Company Specific Requirements 13
S ISO/IEC Guide 51: 1999, Safety Aspects - Guidelines for their inclusion in standards Food Safety - ISO 22000, HACCP (21 CFR 120) 4

Similar threads

Top Bottom