Using consultants for Internal Audits

D

DRAMMAN

Are there any members who are using external consultants to perform your internal audits?
 
T

Tara Monson

We used one for our first internal audit, simply to have one on record for our ISO certification. We were being forced to meet a certification deadline from Corporate and had to outsource.

It worked well for us, and we got some training in the process.
 

normzone

Trusted Information Resource
I'm not, but I've heard tell of some who are. I can see two sides to that coin.

One, you get a no-punches-pulled audit. The external internal auditor doesn't have any friends to protect, or fears of exposing dirty laundry.

The other side of that coin is, he won't have any inside knowledge of where the bodies are buried.

So whether or not this would be a good idea is dependent on how good your internal audit program is.
 

mihzago

Trusted Information Resource
I've used external consultants for internal audits at few companies.
For many small companies using an external consultant is the only way to perform an internal audit.
 

AndyN

Moved On
I've done them, but they were simply a "clean house" exercise before the CB auditor came in. As a result, they were only done once, were expensive relatively speaking and the motive for doing them was entirely wrong. I wouldn't be doing them like that again...
 
Last edited:

Ninja

Looking for Reality
Trusted Information Resource
My company used to outsource all of our internal audits.
It was an effective way to handle this requirement and, as stated above, gave a "no pulled punches" review of our QMS.

As we grew up (largely through this consultant) over a number of years, we took internal audits inside when the cost of them was no longer yielding as much value.

Note that it was the same auditor each time, and he got to know where the bodies were buried.
When there were fewer and fewer bodies, and he was really reaching to find non-compliance, we thanked him and discontinued the relationship.

We now do our own internal audits, led by one of the people trained by that consultant.
For us, it was a good investment.
 

Eredhel

Quality Manager
We used a consultant as we got our ISO 9001 certification and we used him to do our internal audit prior to the registrar's Stage I audit. It was incredibly valuable and we plan on using him for our internal audits from now on. It will be interesting to see if that value decreases as we grow and our system matures.
 

J0anne

Joanne
Not at present and I would prefer to train staff internally on auditing as that helps them gain a better understanding of the QMS.
 

somashekar

Leader
Admin
Are there any members who are using external consultants to perform your internal audits?
Choose good consultants
Use them for the internal auditing
Involve with them
Learn the techniques
Attempt internal auditing
Get the feel and comfort
Internal audit yourself
Associate with the consultants on continual basis for learning and auditing if needed
.
..
...
The goal has to be that internal auditing must become an integral part of your organization.
We did this way.
 
V

vedika

Yes it is required to identify weak areas and to confIr that all clauses are implemented
 
Thread starter Similar threads Forum Replies Date
Stoic Which medical device companies are using Recombinant Factor C (rFC) instead of Limulus Amebocyte Lysate (LAL) for endotoxin testing? Sustainability, Green Initiatives and Ecology 0
J Using MSA instead of calibration Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
J Using current gauge to verify masters General Measurement Device and Calibration Topics 1
Q Using the N/A for blank fields ISO 13485:2016 - Medical Device Quality Management Systems 8
S Anyone using a GOM ATOS Scanbox 3D Vision System? General Measurement Device and Calibration Topics 0
M Any alternative method instead of using GR&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 26
R Using RPN to Confirm Risk Reduced to an Acceptable Level Risk Management Principles and Generic Guidelines 12
P Comparing Two Test Variables Using Attribute Data Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
J Using real time shelf life study as accelerated ISO 13485:2016 - Medical Device Quality Management Systems 1
C Clinical Trial using Prototype devices (EU MDR & ISO 14155) EU Medical Device Regulations 4
J Using an online software to maintain your QMS Quality Assurance and Compliance Software Tools and Solutions 7
S Process Monitoring using SPC software Quality Assurance and Compliance Software Tools and Solutions 6
R Using Scrapped NC items for training Medical Device and FDA Regulations and Standards News 15
M What is the Risk of Using Obsolete Versions of C=0 & ANSI/ ASQ Z1.4 Sampling Plans? ISO 13485:2016 - Medical Device Quality Management Systems 8
F Using non-randomized clinical study for change in existing 510(k) device? US Food and Drug Administration (FDA) 1
J Using MD on a flight EU Medical Device Regulations 9
K Using Google Drive/Docs ISO 13485:2016 - Medical Device Quality Management Systems 32
J What risk to cover when NOT using ISO 17025 accredited/certified labs for calibration ISO 17025 related Discussions 3
T Poisson regression using Minitab Statistical Analysis Tools, Techniques and SPC 3
T Using NICE for guidance during CER CE Marking (Conformité Européene) / CB Scheme 0
T Using Review articles from Pubmed for CER CE Marking (Conformité Européene) / CB Scheme 8
Tagin Using a meme generator to poke fun at quality Funny Stuff - Jokes and Humour 2
D Finding Optimum Design Parameters using Taguchi method? Using Minitab Software 2
V MSA - Using a R&R study for a Tape Measure Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 19
D Using electronic lab notebooks in the design control process ISO 13485:2016 - Medical Device Quality Management Systems 3
M Using a Non Certified vendor Supplier Quality Assurance and other Supplier Issues 8
H Using/Selling power banks with your product as a "mobile version" CE Marking (Conformité Européene) / CB Scheme 3
cgaro62 Using internal audits as part of document reviews Document Control Systems, Procedures, Forms and Templates 21
R Select the 1 Supplier based on the Parts Durability from 6 Supplier Samples using Minitab Using Minitab Software 11
M MSA angle issue - Nylon parts using Aberlink 3D Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
D Question on using audit checklist ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 20
J Using of CE marking - Two CE markings on the product CE Marking (Conformité Européene) / CB Scheme 5
R Using R package to implement Bayesian phase I/II dose-finding design for three outcomes ISO 13485:2016 - Medical Device Quality Management Systems 6
S Defibrillator Protection applicability When using Multiple applied parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
P Using Zinc Plated Steel in a Cleanroom Other Medical Device Related Standards 4
J Incoming Inspection Records using Excel File ISO 13485:2016 - Medical Device Quality Management Systems 2
J Using ring gauges General Measurement Device and Calibration Topics 2
M Load Cell Calibration using a totalizer on a flow meter General Measurement Device and Calibration Topics 0
P Can Neoprene be Cleaned Using Isopropyl Alcohol (IPA) Manufacturing and Related Processes 4
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
chris1price Sterilization using beta radiation Other Medical Device Related Standards 2
M Using the phrase "herein referred to" Document Control Systems, Procedures, Forms and Templates 8
B Struggling with using the 5.6 version Ford Capacity Analysis Report APQP and PPAP 5
cnbrosa Study Type 1 on a CMM using a measuring support Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
rerusk1 MRB (Material Review Board) Process using MS Sharepoint or MS Teams Manufacturing and Related Processes 2
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
B AS9100D 7.1.5.2 Calibration or Verification Method using outside cal lab AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
D Calibration tolerance question using Pipettes Medical Device and FDA Regulations and Standards News 3
D Risk Analysis using Monte Carlo Simulation instead of Scoring and Heat Map Risk Management Principles and Generic Guidelines 2

Similar threads

Top Bottom