SBS - the best value in QMS software

Stage 2 audit - Requirement for 3 months of records

L

luismx

Registered
#1
#1
I have heard that an ISO9001 auditor have to request at least 3 months of records during a stage 2 audit.
Is that a requirement? or just a good practice? or "was" a requirement?
If a requirement, where can I find it?
 
QMS for Medical Device Companies
Elsmar Forum Sponsor
Marc

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
#3
It's usually about 3 months. The idea is that it's one thing to have a system in place, it's quite another to have evidence that the system is working. I don't remember if/where it is written, though. Like John says, discuss this with your registrar.
 
Randy

Randy

Super Moderator
#4
#4
1st - the requirement stems from this within the 9001:2015 Standard.......... "4.4.1 The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard." You can't prove that you've "maintained" unless there is evidence present to verify it against and 90 days has been the norm almost forever, it's been disputed and I don't think ever won.

2nd - The requirement will be in the conditions of contract for the initial certification process with the CB as previously stated and anyone that doesn't agree doesn't have to enter into the contract relationship.

3rd - how does one prove effective management/control of documented information (records) without having documented information (records) to control (it's a time based process)
 
Sidney Vianna

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
#5
luismx said:
I have heard that an ISO9001 auditor have to request at least 3 months of records during a stage 2 audit.
Is that a requirement? or just a good practice? or "was" a requirement?
If a requirement, where can I find it?
Click to expand...
Nope, it is not a requirement. At least, not in ISO 17021-1 which would be the primary document defining such expectation. Just another one of those tribal pieces of "wisdom" that permeates the management system certification sector. During the stage 1 audit, one of the PRIMARY objectives is to ascertain the likely readiness of the organization/system to undergo a stage 2 audit with verifiable evidence to be presented to the audit team. You see, auditors are expected to reach audit conclusions based on audit evidence.

Further, you have to realize that records documented information comes in all sizes and shapes, frequency and formats. Some records can be collected hundreds of time a day. Others might take many years to be completed. Instead of getting concerned with these "artificial, unwritten rules", discuss the issue with the auditor at the Stage 1 audit.
 
Last edited:
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
D What is the TS 16949 Stage 1 Audit Requirement on Internal Audit? Internal Auditing 16
Dean Bell Implementation of Controls as per SOA for Stage 2 Audit IEC 27001 - Information Security Management Systems (ISMS) 0
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
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
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
K AS9100 - No NCR's or CA's during Stage 2 Audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
S We had our Stage 2 Audit on 2/19 & 2/20.... AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
J Major Nonconformance on Stage 2 Audit causes to start over Stage 1? IATF 16949 - Automotive Quality Systems Standard 2
N AS9110 Audit Stage 2 - What procedures are required? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 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
S Is a Stage 1 Audit required for ISO 50001 Certification? Sustainability, Green Initiatives and Ecology 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
K Stage 1 Audit Advice for a new Lead Auditor General Auditing Discussions 5
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
J AS9100 Rev.B Registrar Audit Plan for Stage 2 Audits AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A Questions that auditor may ask during the certification or 2nd stage audit. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
P Peer Review prior to Stage 2 Audit - Acceptable or Not? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
P NC from TS16949 stage 2 audit - Internal Auditing - Auditor did not record evidence General Auditing Discussions 15
T ISO 22000 Stage 1 Audit Completed Successfully Other ISO and International Standards and European Regulations 4
J What to expect during Stage 1 and Stage 2 audits - Certification Audit ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B Is it Compulsory to complete Management Review before Stage 1 Audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 22
Anerol C Stage 1 Audit for ISO 9001 and Notifying/Preparing Employees General Auditing Discussions 27
D At what stage should we proceed with manufacturing process audit? General Auditing Discussions 6
W TS 16949 Audit - Examples of Major & Minor NC's and Observations for Stage 1&2 audit. IATF 16949 - Automotive Quality Systems Standard 11
M ISO/TS 16949 Stage 2 Audit Tips General Auditing Discussions 4
M Readiness Review Failed - Stage one audit for TS16949 IATF 16949 - Automotive Quality Systems Standard 7
L We succeeded in our stage 1 audit this afternoon! IATF 16949 - Automotive Quality Systems Standard 2
S TS 16949 Stage 2 Audit Preparedness - Need Advice General Auditing Discussions 5
A Non-conformance logged following a TS16949 Stage 2 audit - APQP Control Plan IATF 16949 - Automotive Quality Systems Standard 15
L Stage One Audit vs. Document Review - TS16949 - Need clarification IATF 16949 - Automotive Quality Systems Standard 5
P TS 16949 Audit - Stage 1 passed! IATF 16949 - Automotive Quality Systems Standard 29
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
S We just Passed our ISO 14001 Stage 2 Audit! Miscellaneous Environmental Standards and EMS Related Discussions 17
O ISO 13485 - Is management review required before stage 1? ISO 13485:2016 - Medical Device Quality Management Systems 6
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 Determining the Scope of the QMS during Stage 1? Registrars and Notified Bodies 11
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
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

Similar threads

Top Bottom