SBS - The Best Value in QMS software

First external audit coming up, do I need to have performed Internal Audits already?

E

ed99999

#1
Hi,

Quick overview of myself:

I'm a 21 year old Uni student having a year out before returning to do my final year at Uni. I have been given the role I suppose of QA manager in writing the Quality Manual, paperwork and procedures to gain the company ISO status. We have been working on this for about 6 months (with small interruptions for other projects) and finally have our audit date booked for 3 weeks time. All the paperwork is done (i think) and just need to tie a couple of bits up.

My question:

Do we need to have conducted internal audits yet or can I set the audit dates for after the main audit so I don't have to worry about these. Or will my auditor want to see they have been carried out prior to the first audit? I understand I would have to be qualified to perform internal audits (which I am not) but we have other people within our group of companies capable of doing this so wouldn't be a problem.

Regards, Ed
 
Last edited by a moderator:
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: First external audit coming up, do i need to have perfomed Internal Audits alread

Welcome to The Cove, Ed! :bigwave:

When you say first external audit, do you mean for registration to a standard? If so, yes indeed you will need to have done internal audits. It's generally expected to have at least one complete audit cycle (all processes covered) completed, as well as corrective actions and most, if not all, of their closure.

Please also see related threads listed at the bottom of this page for more insight.
 
T

TamTom

#3
Re: First external audit coming up, do i need to have perfomed Internal Audits alread

Hi Ed,

as Jennifer told you it is normally expected and also a logical thing to do an internal audit first, because:

1. Why let the external auditor find issues you can find yourself (Normally a system is not perfect the first trial.)

2. You risk a confirmation of non-conformities with an on site visit from your auditor, this means more costs.

3. All you find the external Auditor find not, so he will praise the system, what is not bad for the Quality Department :rolleyes:

Regards,

TamTom
 

Phil Huber

Inactive Registered Visitor
#4
Re: First external audit coming up, do I need to have performed Internal Audits alrea

Good morning, Ed :bigwave:
I would assume you did some type of Gap analysis to determine what procedures, etc., were required? Did you not do audits at each point of implementation to confirm the actions taken were effective?

If so, be sure these audits are documented. It would also benefit you management team to put a summary of these activities together and develop additional action plans (for continual improvement). That way you will have achieved:
a) internal auditing
b) verification of effective corrective action
c) management review

If you have not completed these actions, do so prior to the "external" audit. You may find that you will want to move this audit out to a later date.

You will find the Cove to be a valueable resource, I know I have!
 
S

SpongeMouse

#5
Re: First external audit coming up, do I need to have performed Internal Audits alrea

time is short for the external audit and internal audit.:(

usually, in our case, internal audit comes 1st then after 3 months comes the external audit.

as Phil said, better to move that external audit
 

SteelMaiden

Super Moderator
Super Moderator
#6
Re: First external audit coming up, do I need to have performed Internal Audits alrea

Any of the registrars that I have ever worked with require a complete round of internal audits (and at least one management review, which you wouldn't be 100% compliant on because you cannot report on your internal audits) be completed.
 
#7
Re: First external audit coming up, do I need to have performed Internal Audits alrea

Ed, from one Brit to another.......

Gotta get your internal audits done, if you expect to be certified to ISO 9001!

It will be a major finding if you don't! You will not be looking good, as a result!

So, you'll have to cover, typically, the whole system at least once - what's often called a 'full cycle'. Also, I believe it would be expected that you'd at least done some to follow up on any actions taken as a result. Apart from anything else, you don't want your CB finding big holes in the system and, you have to demonstrate the internal audit system works too. You can't wait until after the CB audit, now can you.....ISO 9001 says you have to do them....

So, I'd suggest you crank up the audits and do a lot of them. One big system wide one (like the CB auditor(s) will do, and some smaller more focused ones on things your company didn't do 'before ISO', type of thing. They shouldn't take more than a day each to do.

BTW - have you had any training on audits? I would hate for you to also come under scrutiny for 'competency'.......

BTW - 'ow's 'Uddersfield?
 
Last edited:

Phil Huber

Inactive Registered Visitor
#8
Re: First external audit coming up, do I need to have performed Internal Audits alrea

Ed,
Looks like we've started to pile on the work for you, sorry! :(

So,
While we're at it, perhaps a check list of activities to complete prior to the "external" audit:
a) complete your (and others as appropriate) internal auditor training
b) identify the "processes" of the quality system (sequence and interactions-process mapping)
c) audit those processes
d) report out findings and actions to be taken to management
e) implement those actions
f) verify that actions taken are effective

This is the typical "Plan, Do, Check, Act" cycle, continue to perform this cycle. As your quality system becomes more mature, you will find less nonconformances and a greater number of opportunities to improve. Thus the "continual improvement of the quality management system" requirement of ISO 9001.
 
E

ed99999

#9
Re: First external audit coming up, do I need to have performed Internal Audits alrea

Thanks for all your replies, they're a great help. I think general consensus is the audits are going to have to be carried out. This is fine, i can get them organised before out main audit date. Our company is only a fairly small (15 employees) manufacturing facility so there isn't masses of people and processes to audit. All our material is free issue from our customers and i have commented and excluded the design stage as we have nothing to do with the design of the components we manufacture. I have all the paperwork in place for the audit, might just take a few long evenings getting it all written up!

Andy, I haven't had any auditor training but two of the other lads at our place have previous training and experience of internal audits so they can do them. Also Huddersfield's actually got a bit of sun today which makes a pleasant change! Haha
 
T

tsmith7858

#10
Re: First external audit coming up, do I need to have performed Internal Audits alrea

Having just gone through an ISO registration audit in April, I can tell you that everyone is giving you good advice.

We pushed forward a little to quick and had not completed a full cycle of audits. The auditors were okay with what we had to show but they also found a lot of things that we should have found ourselves which made our findings list a little longer than it should have been.

Make sure you don't rush the audits to get them done. It is your last chance to make sure everything is in order.
 
Thread starter Similar threads Forum Replies Date
L IATF external audit virtual (remote) IATF 16949 - Automotive Quality Systems Standard 13
R External Audit and Certificate prorogation due to the pandemic General Auditing Discussions 10
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 8
I What kind of wine best complements the Friday that you close out your external audit findings? Opinions are welcome. Coffee Break and Water Cooler Discussions 12
B Using external FDA and ISO 13485 audit as internal audit Internal Auditing 6
qualprod The Perfect audit? External Audit causes a significant negative impact in a company General Auditing Discussions 9
B How to reply NCR on ineffectiveness of corrective action during IATF external audit? This is repeated issue whereby some mistake was done. IATF 16949 - Automotive Quality Systems Standard 7
B IATF 16949 7.1.5.3.2 FAQ #7 Audit Finding - External Calibration Laboratory IATF 16949 - Automotive Quality Systems Standard 7
P IATF checklist for External Supplier Audit IATF 16949 - Automotive Quality Systems Standard 9
J Ignoring a Failed Gage R&R and upcoming external audit IATF 16949 - Automotive Quality Systems Standard 22
B Integrating ISO 9001/27001 External Audits - Audit Time Reduced? Discounts? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Corrective Action for External Audit NCMR (Procedure Not Followed) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Effectiveness Plan for CAPA initiated from External Audit US Food and Drug Administration (FDA) 3
P Is Internal and external audit of Account Department applicable to any ISO standard Internal Auditing 5
R Can a external auditor raise a finding that is already identified in Internal Audit ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
R Root Cause for "Simple" External Audit Findings ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Internal Audit finding versus External Audit finding General Auditing Discussions 2
drgnrider Control of External Audit Notes and Documents Document Control Systems, Procedures, Forms and Templates 8
L Mock Audit by External Consultant (ISO 13485) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
R External Audit Attendees - Surveillance Audit Quality Manager and Management Related Issues 27
Q External ISO 14001 Audit in a Distribution Center ISO 14001:2015 Specific Discussions 3
R QMS changes before Annual External Audit Quality Manager and Management Related Issues 8
M External Audit Findings - TS 16949 IATF 16949 - Automotive Quality Systems Standard 3
B Audit of equipment after certified external calibration... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M What to do during a Stage 1 External Audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
D Having trouble with corrective action on external audit nonconformance Nonconformance and Corrective Action 8
V Most Common Internal/External Audit Observations on Risk Management ISO 14971 - Medical Device Risk Management 4
S Internal and External Audit Programme Implementation Internal Auditing 6
C No findings from External Audit - Should I be worried? General Auditing Discussions 7
K External Auditor asking for other Audit Findings ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
S Dreading an Ineffective External Audit and the impact it will have on staff General Auditing Discussions 1
Chennaiite External Audit re-defined Imported Legacy Blogs 4
A Need to Audit an External Calibration Laboratory? - Customer Audit Finding Other Medical Device Regulations World-Wide 5
J Withdraw NCR Request - External QMS Audit is In Progress General Auditing Discussions 23
S Customer Audit needs to see External Supplier Management Procedure Supplier Quality Assurance and other Supplier Issues 7
B Critical Action Limits (CAL) for All Internal and External Audit Findings General Auditing Discussions 17
S External Audit Non-Conformance - Control Plan and Inspection Issues IATF 16949 - Automotive Quality Systems Standard 1
S External Auditor Findings when an Internal Audit found a Nonconformance Yesterday Document Control Systems, Procedures, Forms and Templates 11
Chennaiite Questions on the Scope of Remote Locations for the ISO/TS External Audit IATF 16949 - Automotive Quality Systems Standard 7
R ISO 9001 Internal Quality Audit by Consultants (External agency) Internal Auditing 5
A What happens if an External Audit NC (Nonconformance) is not closed in 90 days? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Escalation of an External Audit Nonconformance Nonconformance and Corrective Action 13
M Giving copy of external audit report to customer General Auditing Discussions 20
S External Audit - Nonconformance Root causes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
L Human Resources Officer is absent during an ISO 9001 External Audit General Auditing Discussions 17
P ISO 13485 Audit - EN 62366:2008 not in External Document File IEC 62366 - Medical Device Usability Engineering 1
L How to check for validity of registration scope during ISO9001:2008 external audit Quality Manager and Management Related Issues 3
L Preparation for the second year external audit. General Auditing Discussions 8
A External Audit CAR on Record Control? General Measurement Device and Calibration Topics 6
P External Contract Auditor for Internal Quality Audit Internal Auditing 18

Similar threads

Top Bottom