SBS - The best value in QMS software

ISO 9001 Documents for Submission to the Registrar

Big Jim

Super Moderator
#11
DO they understand the purpose of the stage 1 audit, in that case?
They certainly do.

The CB isn't reviewing the documents, just checking to see if they have them.

Can you cite the clause of 17021 that you think is being violated?
 
Last edited:
Elsmar Forum Sponsor
#12
They certainly do.

The CB isn't reviewing the documents, just checking to see if they have them.

Can you cite the clause of 17021 that you think is being violated?
Now Jim, why would you ask that? The point of doing the stage 1 is to ensure readiness. As we know from the common CB process before 17021 came along (an the IATF took the bull by the horns) just looking at documents tells you nothing of any substance.
 

Jim Wynne

Staff member
Admin
#13
Now Jim, why would you ask that? The point of doing the stage 1 is to ensure readiness. As we know from the common CB process before 17021 came along (an the IATF took the bull by the horns) just looking at documents tells you nothing of any substance.
An example of the audit scope for a CB stage-1 TS16949 audit is attached. Poorly worded, which comes as no surprise, but it shows in general what purpose the stage-1 audit is supposed to serve.
 

Attachments

somashekar

Staff member
Super Moderator
#14
Now Jim, why would you ask that? The point of doing the stage 1 is to ensure readiness. As we know from the common CB process before 17021 came along (an the IATF took the bull by the horns) just looking at documents tells you nothing of any substance.
:agree1:
Readiness, yes.
A typical quotation cites the audit mandays for stage 1 and stage 2. None of these are offsite. Any auditor travel costs applies to both stage 1 and stage 2. This can be a desktop review at site + site tour. (Avoids awkward surprises in stage 2)
Anything else is shortcut.
 

Big Jim

Super Moderator
#15
Now Jim, why would you ask that? The point of doing the stage 1 is to ensure readiness. As we know from the common CB process before 17021 came along (an the IATF took the bull by the horns) just looking at documents tells you nothing of any substance.
So I guess that you can't cite what you think has been violated. Is that right?

Do you think that the accreditation bodies would permit something you think is so wrong? After all, the accreditation bodies do come in and audit the certification bodies from time to time and look over audits performed and their system of auditing.

Until you can cite the clause that has been violated you are just voicing an opinion.

Now back to what I said, the certification body I mostly work with does require clients to submit documentation prior to the stage one, not to audit the documents, simply to confirm that they exist. This saves a great deal of grief. Before 17021, when working under Guide 62, there was more than one occassion that I showed up for a registration audit and the auditee was nowhere near ready.

Maybe you prefer to work that way. I don't.
 

Big Jim

Super Moderator
#17
Jim: It's really not a case of "violation" (what an ugly word), it's about what is effective.
Very true, and it appears to be very effective to confirm the documents exist before committing an auditor. Perhaps you have different criteria for effectiveness.

I posted when explaining why a certification body may want to have the documents sent ahead. I explained that is how some do it. I'm not in a position to debate that it is the only way to do it, but I will say from the perspective of an auditor that works within that system that it works.

If other certification bodies have found a different way to effectivly handle it and the accreditation bodies have had no issues with it, then I don't either. It is simply an alternative that works for them.
 

somashekar

Staff member
Super Moderator
#18
Now back to what I said, the certification body I mostly work with does require clients to submit documentation prior to the stage one, not to audit the documents, simply to confirm that they exist.
Jim, does this still say that the stage 1 is an audit at site, to evaluate readiness ?
 

Big Jim

Super Moderator
#19
Jim, does this still say that the stage 1 is an audit at site, to evaluate readiness ?
As Randy aluded to, there are some certification bodies that sometimes perform part of the Stage 1 off site. Stage 1 cannot be completed until an auditor is on site to confirm that the activties there match the documents including the scope statement. Performing part of the Stage 1 off site saves the auditee the expense of transporting an auditor on site, simply to confirm that the documentation matches the site. That can be confirmed prior to Stage 2 after arriving on site for Stage 2 before starting Stage 2. I have done Stage 1 audits both off site and on site. Off site Stage 1 audits are often only a half day.

However, that has no bearing on a CB confirming that the documents exist before committing to a Stage 1 audit. It is a seperate issue.
 

somashekar

Staff member
Super Moderator
#20
As Randy aluded to, there are some certification bodies that sometimes perform part of the Stage 1 off site. Stage 1 cannot be completed until an auditor is on site to confirm that the activties there match the documents including the scope statement. Performing part of the Stage 1 off site saves the auditee the expense of transporting an auditor on site, simply to confirm that the documentation matches the site. That can be confirmed prior to Stage 2 after arriving on site for Stage 2 before starting Stage 2. I have done Stage 1 audits both off site and on site. Off site Stage 1 audits are often only a half day.

However, that has no bearing on a CB confirming that the documents exist before committing to a Stage 1 audit. It is a seperate issue.
:confused:
Document review offsite prior to stage 1 - Understand
stage 1 offsite - I do not understand still
You say this:
Stage 1 cannot be completed until an auditor is on site to confirm that the activties there match the documents including the scope statement.
and this:
I have done Stage 1 audits both off site and on site
What exactly is this:
That can be confirmed prior to Stage 2 after arriving on site for Stage 2 before starting Stage 2.
??
CB's before were doing a Prep audit (onsite) to check readiness at a cost before Cert audit (onsite). This was optional for customers.
Customers avoided Prep audit for saving money and Cert audit threw up surprises, awkward surprises.
The Cert audit has been then split to Stage 1 + Stage 2. (both onsite)
So prior to stage 1, CB asking for documents and customer providing the same is CB and company convenience, and a small part of the stage 1. Not the stage 1 itself.
I have done Stage 1 audits both off site and on site. Off site Stage 1 audits are often only a half day.
Offsite How... ? By document review and then back and forth with customer.
What if docs say validation is excluded and they have processes requiring validation, which the other docs do not expose?
What if they say the headcount is 15 and the site has 50. People on work effecting quality are contract labor and the company say they do not count them. How is the readiness assessed offsite ?
There are many more readiness issues when I mention awkward surprises ~~~
 
Last edited:
Thread starter Similar threads Forum Replies Date
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
qualprod To set frequency to review documents in ISO 9001 7.5? Document Control Systems, Procedures, Forms and Templates 13
I Sales Documents in scope for ISO-9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
V ISO 9001 Detailed documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T Customer Specific Documents and Records - ISO 9001 Control Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C ISO 9001:2008 4.2.3(f) - Controlling Documents of External Origin Quality Manager and Management Related Issues 9
K ISO 9001:2008 Logo on objects/documents/brochures/logos where we advertise ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
H Is "Master Documents and Records list" required per ISO 9001 ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
drgnrider Informational Required Documents/Records in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 65
F ISO 9001:2008 Fundamentals: Basic Questions - Controlled Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
O Documents & Records as per ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N What Documents are Required for each ISO 9001 Requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
G Rookie to the ISO 9001:2008 World - Required Procedures and Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
P Where do training documents fit into the ISO 9001 categories? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
F Paperless Procedures - Does ISO 9001 Require Paper Documents? Quality Manager and Management Related Issues 37
L Does ISO 9001 require that hard copies of documents be archived? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
T Control of Safety Documents Required? ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
P Lean ISO 9001 - Lean Documents, use of Gemba, Inspection Methods, etc. Lean in Manufacturing and Service Industries 9
E Control of Documents - ISO 9001 Requirements Document Control Systems, Procedures, Forms and Templates 3
L ISO 9001:2008 - Control of Documents of External Origin Document Control Systems, Procedures, Forms and Templates 13
J ISO 9001:2008 Clause 4.2.3 - What are the required documents? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
K If an individual requests my ISO 9001 QMS Documents, do I have to supply it? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B Requirement for Review and Re-Approval of Documents - ISO 9001 Clause 4.2.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Before the ISO-9001 certification audit can we submit the documents to our customer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K How can I revise my QMS documents to meet requirements of ISO 9001: 2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q How to name ISO 9001 Checklist, Documents and/or Technical Documents? Document Control Systems, Procedures, Forms and Templates 2
S Revisions in ISO 9001 QMS Documents - Where to keep the record of revisions? Document Control Systems, Procedures, Forms and Templates 7
N ISO 9001: 2000 to ISO 9001: 2008 - How to change the documents & procedures? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Control of Documents - ISO 9001:2008 Drowning in Processes! Document Control Systems, Procedures, Forms and Templates 6
D To change or not to change? Our documents reference ISO 9001:2000 Document Control Systems, Procedures, Forms and Templates 31
M Revision Frequency of Documents (in ISO 9001, cGMP, GMP or others)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A Documents required for ISO 17020 vs. ISO 9001? General Measurement Device and Calibration Topics 10
P Required Documents and Document Control in Human Resources for ISO 9001:2000 Document Control Systems, Procedures, Forms and Templates 5
P Documents of external origin not identified? ISO9001 Clause ISO 9001:2000 5.4.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 55
K Can ISO 9001 4.2.3 and 4.2.4 Documents and records be one procedure? Document Control Systems, Procedures, Forms and Templates 8
P Form Number for Master List of Controlled Documents - ISO 9001:2000 Document Control Systems, Procedures, Forms and Templates 8
L Document Hierarchy Structure for Documents Compliant in ISO 9001 and CMMI Document Control Systems, Procedures, Forms and Templates 23
D Controlled Documents - ISO 9001 4.2.3 - What documents must be controlled? Document Control Systems, Procedures, Forms and Templates 9
R Addressing Training in ISO 9001:2000 Process Documents Training - Internal, External, Online and Distance Learning 21
J ISO 9001:2000 - 4.2.3 Control of Documents - Used to be document and data control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A ISO 9001:2000 - Documents Requiring Control - Documents of External Origin Document Control Systems, Procedures, Forms and Templates 27
Q Audit report template ISO 9001/14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Q Process matrix examples of ISO 9001 & 14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
chris1price Archiving of paper records - ISO 9001 7.5.3.1b Records and Data - Quality, Legal and Other Evidence 4
D Common practices in ISO 9001 deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9

Similar threads

Top Bottom