Preparing for External Audits - Asking Registrar for their Audit Check List(s)

Helmut Jilling

Auditor / Consultant
#11
Al Rosen said:
I would ask for their checklist. Also, look at what quality requirements are specified on their POs or contracts.

Most CB auditors no longer use a checklist. The TS QSA checklist may still be available somewhere to be used as a gap analysis, but it is not to be used to set up a system anymore. The same comment would apply to ISO, but I don't know who still has a commercial gap analysis checklist for plain ISO.

All the CB's and AB's are supposed to be requiring a process approach, not a checklist approach.

PS: I just realized that the original post dealt with 2nd party audits, not 3rd party. It is possible some companies might be using a checklist of some sort for 2nd party audits.
 
Last edited:
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#12
hjilling said:
PS: I just realized that the original post dealt with 2nd party audits, not 3rd party. It is possible some companies might be using a checklist of some sort for 2nd party audits.
Right. The title of the thread should be changed to Preparing for External Audits - Asking CUSTOMERS for their audit checklists.
 

Antonio Vieira

Involved - Posts
Trusted Information Resource
#13
These “2 very large companies” are they your clients?
I presume they are, that’s why they are going to audit your organization. In this case you can always ask for the check list they are going to use in the audit. If it’s a typical ISO 9001 audit It think they are going to use also the typical registrar check list (the standard, but with requirements transformed in questions).
If they have customers specific requirements, I think they should be glad to tell you before those requirements, than getting you surprised in the audit day. (This is applicable if they really want to keep your organization as their supplier).
In my opinion – ask anything to the auditor but do it before the audit starts! :rolleyes:
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#14
Sidney Vianna said:
Asking CUSTOMERS for their audit checklists.
Customer's internal audit check lists - A good discussion topic in its own right.

I will say that even though they're not supposed to use 'check lists', there is an analogous way to track what has and has not been covered in a audit. Maybe cross reference matrix or something like that would be the appropriate term here.
 

harry

Super Moderator
#15
Hello Everybody

I am in complete agreement with Antonio. I think we have to make a distinction between an audit checklist(as used by auditors if they still do) and an audit preparation/readiness checklist. Generally this is what the registrars/CB's gave you.

I had recently downloaded such a list from 'UL's' website for ISO 14000. Very comprehensive, about 40+ pages. If you had taken care of all the items listed in the checklist - you should breeze through any audit.
 

Helmut Jilling

Auditor / Consultant
#16
harry said:
I had recently downloaded such a list from 'UL's' website for ISO 14000. Very comprehensive, about 40+ pages. If you had taken care of all the items listed in the checklist - you should breeze through any audit.

That's a good comment. And I appreciate that it helps you on breezing through the audits. But, I felt the comment reveals a little bit about your company culture.

I wish clients would first focus on using ISO to help them run good companies better, and not make the focus on breezing through the audits. That is an automatic result of running a good ISO program.

I think your focus would be better if you said that it helped you run a better ISO 14001 program, ... and by the way, made the audit a breeze too.
 
#17
2 Large companies????

Are the companies customers? If not, who are they?:confused:

Why are they auditing you? I agree with the previous post saying that 'preparing' is futile. I'd use the opportunity to see what the auditors find to get some kind of evaluation of the strengths and weaknesses of the organization. As a new person there, you could use the info. So tag along with the auditors, don't try to 'bluff' through the audit. If the company didn't have a 'formal' QMS then don't make it look like it did!:nope:

Andy
 

harry

Super Moderator
#18
Thanks for helping to make it clearer. Thats what I meant - if you had run and maintain a system properly, everything should be there (against the checklist also) and you should have no worries and therefore breeze through any audit. Infact at anytime as you mentioned somewhere.

Sadly, having an ISO is an 'end or achievement' for a handful of companies despite our continual stress that it is only the beginning of a new journey. Several years down the road you will receive 'SOS' calls requesting for audit checklist and what nots because the system is not being maintained and nobody is willing or competent or had the time to prepare the necessary and survelliance audit is maybe two weeks away.

Maybe that's the reason why new companies keep on appearing while the older ones kept disappearing.
 
Thread starter Similar threads Forum Replies Date
A Preparing an ESD workstation Preventive Action and Continuous Improvement 6
M Tips on preparing for IATF 16949 Internal Lead Auditor exam Manufacturing and Related Processes 1
E Preparing for the ASQ CPGP (GMP professional exam), how to revise and remember the vast syllabus? ASQ - American Society for Quality 2
dinakim_zv Preparing for Investigational Device Exemption ISO 13485:2016 - Medical Device Quality Management Systems 11
V Preparing the IFU in compliance with MDR 745, Chapter III EU Medical Device Regulations 2
F BREXIT - What/How are You and Your Business Preparing for It? EU Medical Device Regulations 20
A ISO-13485 7.1 - Preparing for our MDSAP audit ISO 13485:2016 - Medical Device Quality Management Systems 5
F CLASS III - Preparing a registration dossier for a dermal filler Other Medical Device Regulations World-Wide 8
S Preparing a Root Cause Report - Possible Root Causes Document Control Systems, Procedures, Forms and Templates 11
bobdoering Preparing an X hi/lo-R Chart in Datalyzer Imported Legacy Blogs 0
S Preparing a Turtle Diagram for Maintenance Department Misc. Quality Assurance and Business Systems Related Topics 2
D FDA Guidance Document for Preparing Annual Product Reviews US Food and Drug Administration (FDA) 2
N Preparing a supplier readiness report (advanced launch report) IATF 16949 - Automotive Quality Systems Standard 2
Hershal ILAC is preparing to start the possible revision to ISO/IEC 17025 ISO 17025 related Discussions 2
D Preparing for Pre (Fabrication) Inspection Meeting for Telecommunication Systems Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
N Need Help Preparing for Medical Device Quality Engineer Interview Career and Occupation Discussions 2
S Help me with preparing Internal Audit Schedule based on Risk analysis 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Presentation on "Preparing" a Quality Manual wanted - ppt AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
G Preparing for RAC Exam - Need to take online-course at RASP? Professional Certifications and Degrees 2
B Templates for Newbies Preparing for ISO 9001 Certification Document Control Systems, Procedures, Forms and Templates 4
AnaMariaVR2 Preparing for the RAC Examination -- Developing an RAC Study Plan Professional Certifications and Degrees 1
D Preparing for ISO 29001/API Q1- Establishing Control Features Oil and Gas Industry Standards and Regulations 3
Marc Apple preparing to deliver iPad twins with 9.7-inch screens (rumor) After Work and Weekend Discussion Topics 0
A Who is the leader for preparing testing procedure to qualify NEW part? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
A Preparing for CQE Exam - Calculators and Statistical Calculations Professional Certifications and Degrees 4
V Preparing for SSGB - Six Sigma Probability Question Six Sigma 13
J Preparing a Quality Management Review Report Quality Manager and Management Related Issues 4
M Ways to encourage participation of other dept in preparing for the surveillance audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
D Preparing a job description that meets the ISO 9001:2008 standard requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
bobdoering Preparing an X hi/lo-R Chart in Infinity QS ProFicient Imported Legacy Blogs 2
B Green Initiative - Please help me in preparing Go Green Steps.... Sustainability, Green Initiatives and Ecology 6
Y Preparing an audit plan for ISO 13485, MDD and CMDR for medical imaging company Imported Legacy Blogs 8
B Define Fault, Double Fault and Normal Conditions - Preparing a Risk Management File FMEA and Control Plans 1
A Preparing manual for Calibration laboratory! How should it be named? General Measurement Device and Calibration Topics 1
B Preparing myself for certified six sigma black belt Professional Certifications and Degrees 1
Anerol C Stage 1 Audit for ISO 9001 and Notifying/Preparing Employees General Auditing Discussions 27
K Template for preparing Consultant's Proposal for Implementing ISO 9001:2000 Consultants and Consulting 29
C Are CQE refresher courses by local ASQ centers helpful in preparing for the exam? Professional Certifications and Degrees 11
T Preparing Quality Management System Reviews for the Executive Management Group ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q Preparing a Waste Inventory for ISO 14001 ISO 14001:2015 Specific Discussions 3
L Preparing for a Hyundai 5 Star Audit General Auditing Discussions 2
R Preparing the Technical File for a 12 Lead ECG Monitor EU Medical Device Regulations 8
C Preparing a "What is ISO 9001" training presentation for hourly employees Training - Internal, External, Online and Distance Learning 17
L Preparing small company for AS9100 registration - Am I missing any procedure(s)? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D Preparing a Design Package for API 6A Valves for the Monogram audit Oil and Gas Industry Standards and Regulations 13
L Study Materials for Preparing for ASQ Certification Exams Book, Video, Blog and Web Site Reviews and Recommendations 6
C Strategy for preparing CQE exam and can any one suggest some good books? Professional Certifications and Degrees 1
D Single Minute Exchange of Die - Preparing to launch a SMED project Manufacturing and Related Processes 14
P Pre-Audit Tips for Employees - Preparing Employees to be Audited General Auditing Discussions 24
J Preparing for initial FDA inspection - What must I do? ISO 13485:2016 - Medical Device Quality Management Systems 7

Similar threads

Top Bottom