Stage 1 Assessment mandatory for ISO 9001?

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P Just passed TS 16949 Stage 1 Assessment yesterday IATF 16949 - Automotive Quality Systems Standard 6
R What exactly would a Stage I Assessment consist of for ISO9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
B Stage 1 - Adequacy Audit (pre-assessment) - University - What do they look for? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Dean Bell Implementation of Controls as per SOA for Stage 2 Audit IEC 27001 - Information Security Management Systems (ISMS) 0
L Stage 2 audit - Requirement for 3 months of records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
O ISO 13485 - Is management review required before stage 1? ISO 13485:2016 - Medical Device Quality Management Systems 6
O ISO13485 implementation - Are internal audits expected before stage 1 audit? Design and Development of Products and Processes 3
Jacquie Collins Stage 2 Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R What happens during a Stage 1 MDSAP audit? ISO 13485:2016 - Medical Device Quality Management Systems 4
I QMS documents required at each stage of Software development IEC 62304 - Medical Device Software Life Cycle Processes 5
A Doubt on multiple inspection carrying out for same balloon number during Stage Inspection and Final Inspection? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
A A purpose of a Stage 1 audit - Off site document review Registrars and Notified Bodies 3
W Closing of Stage 2 Audit Nonconformances AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A Determining the Scope of the QMS during Stage 1? Registrars and Notified Bodies 11
E Interesting Discussion Was this the fastest ever stage 2 ISO9001:2015 audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 76
Q Stage 1 audit observations - documented report? General Auditing Discussions 5
Y Application of IEC/EN 62304 at an advanced stage of software development IEC 62304 - Medical Device Software Life Cycle Processes 4
K MDSAP Stage 1 Guidance Documents ISO 13485:2016 - Medical Device Quality Management Systems 1
K AS9100 - No NCR's or CA's during Stage 2 Audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
N Non-conformances whilst in the Design and Development stage of a project ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S We had our Stage 2 Audit on 2/19 & 2/20.... AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
B Supplier Certificate Suspended in OASIS - Do we need stage 1 and 2 to reinstate cert? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Risk Management at the Quote Stage AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A Stuck at 'Analyse' stage of DMAIC Improvement Cycle on Cosmetic Specification Manufacturing and Related Processes 10
J Major Nonconformance on Stage 2 Audit causes to start over Stage 1? IATF 16949 - Automotive Quality Systems Standard 2
G Best X-Y Microscope Stage for Submicron Accuracy Capability, Accuracy and Stability - Processes, Machines, etc. 2
V How long can a development stage incident be open? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
R PFMEA (process FMEA) for Incoming Material stage FMEA and Control Plans 7
N AS9110 Audit Stage 2 - What procedures are required? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Crusader What are the CB's inputs and deliverables at Stage 1? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
C ISO 22000 Stage 1 NC's - PRPs not approved and Objectives not inline with Policy Food Safety - ISO 22000, HACCP (21 CFR 120) 3
S Root Cause - Left 5.6.2 paragraph (f) out of Quality Manual during Stage 1 Audit Nonconformance and Corrective Action 21
M What to do during a Stage 1 External Audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
N What is involved in a Stage 1 Review? General Auditing Discussions 7
S Is a Stage 1 Audit required for ISO 50001 Certification? Sustainability, Green Initiatives and Ecology 1
E Risk Management - Planning Stage (AS9100C Section 7.1.2(d)) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Certification Body insist on evidence of Preventive Action during Stage 2 audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M Implementing an AS9100 Quality System - Stage 1 Audit for AS9100 is Oct 2012 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 22
D ISO/TS 16949 Stage 2 Audit Nonconformance Against 7.6.3.1 Laboratory Scope IATF 16949 - Automotive Quality Systems Standard 8
K Internal Audits - Necessary before Stage 1 Audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 42
J Waiting for an Auditor after our AS9100 Stage Two Audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 19
C Contract Manufacturer and Stage 2 Audit for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 5
C At what stage does Design Control play a role in Medical Device Development ISO 13485:2016 - Medical Device Quality Management Systems 2
P MEP Method Statement during Tendering Stage of Railway Station Benchmarking 1
A Magnification for One Stage Dial Gauge Mechanism General Measurement Device and Calibration Topics 1
X Fanuc Injection Moulding Machine - Variable stage speed/pressure injection profiles Manufacturing and Related Processes 1
K Stage 1 Audit Advice for a new Lead Auditor General Auditing Discussions 5
V At what Stage of Equipment Qualification (IQ-OQ-PQ), must we sign-off the SOP? US Food and Drug Administration (FDA) 4
V 18001 2nd stage 3rd party Top Management Questions (Training Assignment) General Auditing Discussions 8
L Is a Gauge R&R Study needed for ISO 9001 Stage 1 Audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9

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