Questions about an Internal Audit Checklist for our QMS

#11
Golfman - I can't agree that such a small company "needs" to get anyone trained up. If there's no money how is that going to happen? What "needs" to be done is to get to the root of why management don't see the benefit to this system and the internal audits. Once that hurdle is overcome, an externally provided auditor - who doesn't need to learn the ropes as new folks do - can demonstrate the benefits as were described to them. New auditors aren't likely to do this, at least not early on.

Going through the motions of having anyone trained as auditors and filling in checklists is completely failing the key point here, IMHO.
 
Last edited:
Elsmar Forum Sponsor
A

ARNAY

#12
You first need to have the manual.The manual explains the requirements.You can get a checklist from every tom dick and harry.You need a checklist so that you can look at the requirements from a basic level first and then improve as you go along.Your company will have to invest into the implementation.You can help to contain the investments by getting enough information as possible on a site like elsmar cove.Quality should not be made difficult becauce it is not.Do not listen to people that want to make it difficult.Stick to the basics first and then improve.
 
T

thira7

#13
No the organization is not certified and probably is not going for certification. Is a small NGO and they want a QMS based on ISO 9001. They are doing it for their own good.
 
T

thira7

#14
I agree with you that we need someone who understands the requirements. I am working on this project with one other employee(not manager), however he is not a quality manager or trained auditor. The management team do not really want to involve in this as they believe that this is all about documenting their processes and nothing else.

I am not a trained auditor i basically studied production engineering, but i believe that QMS is an ongoing project where you can identify your mistakes or any opportunities for improvement(correct me if i am wrong).

As a result me and the other guy we are the only people who we really are into the project. To be honest i used a lot of help from the internet during the design and implementation of the system, but maybe my colleague can convince them so he gets the auditor training.

Finally i was asking about the checklist because my internship ends in 6 weeks so we thought it would be good if we could make an audit.

Thank you very much.
 
H

Hutch2014

#15
If you've been assigned as the internal ISO auditor, you really need to go and get trained. This job is too important in most companies to be left to chance, keeping ISO accreditation is essential to retaining some customers, and winning deals and tenders.
 

John Broomfield

Staff member
Super Moderator
#16
Thira7,

Before you concern yourself with 8.2.2 why not ask the Process Owners to monitor and correct their processes (and procedures) per 8.2.3?

You can use the standard to verify that all the parts of your management system are in place but it is the others who must be monitoring the effectivess of their processes.

From their monitoring, they may need your help to invoke and complete corrective actions for themselves.

By working this way you will have taught them to fish for themselves instead of handing them fish and then leaving them to starve.

John
 
L

lk2012

#17
Agree with Hutch.
Also, the standard requires a person trained specifically to do the QMS and the audits. :2cents:
 

Helmut Jilling

Auditor / Consultant
#18
If you've been assigned as the internal ISO auditor, you really need to go and get trained. This job is too important in most companies to be left to chance, keeping ISO accreditation is essential to retaining some customers, and winning deals and tenders.
There is a FREE white paper on my website that does a good job explaining internal auditing in a process approach.

Free Download on the TOOLS tab at Jilling.com...

http://jilling.com/downloads/Internal Process Audit Toolbox_WHITE PAPER_Helmut_.docx
 
Thread starter Similar threads Forum Replies Date
A Internal Audit Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Purchasing - Internal Audit Questions Internal Auditing 8
F API Spec Q1 9th Edition Surveillance Audit - Questions about internal audits. Oil and Gas Industry Standards and Regulations 22
M ISO 13485 Audit Questions - Internal Auditor Training and other Requirements ISO 13485:2016 - Medical Device Quality Management Systems 10
E TS16949 Internal Audit "What do I Do" questions Internal Auditing 6
K Sample Questions for Auditing Management Rep , Internal Audit and Reg. Compliance Internal Auditing 7
L Written Supervisory Procedures - Internal Audit Checklist Questions Internal Auditing 2
M Internal Audit questions on Technical Resources & Work Environment Internal Auditing 9
L Top Management - Internal Audit Questions to Ask Internal Auditing 17
M Internal Audit for ISO 14001 - Questions for Management Internal Auditing 12
Q APQP Compliance Internal Audit - Ideas, check lists or main questions to prepare APQP and PPAP 9
J Internal Audit Questions - Accounting - ISO 9001 Internal Auditing 24
C New to performing internal audits - Looking for audit questions Internal Auditing 5
T Internal Audit questions for Statistical Process Control and Process Control Internal Auditing 14
T Supplier Control in TS 16949 - How to spice up my Internal Audit questions IATF 16949 - Automotive Quality Systems Standard 13
S Need questions for Internal Audit of Financial departement? Internal Auditing 11
A Internal Quality Audit - Can I follow the Auditors and Ask Questions? Internal Auditing 11
Q Internal Audit Questions - Does anyone have sample questions for Management Internal Auditing 16
C Audit Differences - Process, Product, Internal? (4 questions) - TS 16949 General Auditing Discussions 7
N Simpified ISO 9001 Internal Audit Questions Internal Auditing 19
M Questions about AS9100 Internal Auditor Training AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
Q AS9100 Quiz Questions for Internal Training AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
G New to Internal Auditing - Best questions to ask? Internal Auditing 17
R What questions should I ask during Internal Audits? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
A Internal Audits - Questions for Auditees Internal Auditing 14
C UDI Questions on Control Units Other US Medical Device Regulations 6
M NFPA 70 electrical harness questions Various Other Specifications, Standards, and related Requirements 2
L Project Managers - Questions For You Career and Occupation Discussions 0
B Toyota PPAP Process - Three Questions APQP and PPAP 3
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
D Signature Matrix questions ISO 13485:2016 - Medical Device Quality Management Systems 4
D ECO (Engineering Change Order) process questions ISO 13485:2016 - Medical Device Quality Management Systems 7
C 8.5.1.1 Control of Equipment, Tools, and Software Programs - Questions about the extent of control of NC programs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485) Document Control Systems, Procedures, Forms and Templates 9
D Shipping and recall questions ISO 13485:2016 - Medical Device Quality Management Systems 2
D Questions regarding process validation ISO 13485:2016 - Medical Device Quality Management Systems 6
M Quality Metrics Questions Lean in Manufacturing and Service Industries 2
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 5
A Some questions about voluntary consensus standards in traditional 510(k) submission US Food and Drug Administration (FDA) 6
T AMS2570E certification equipment questions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Mr Roo ISO 9001 - 7.1.3 Infrastructure - questions concerning evidence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
K AS9100 - 7.3 - Are these black and white questions with specific correct answers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M Medical Device Identification & Codes - Article 27 Requirements questions EU Medical Device Regulations 1
Q Asset / Tooling Management - Two Questions Manufacturing and Related Processes 3
Q VDA 6.3 questions vs IATF 16949 clauses VDA Standards - Germany's Automotive Standards 0
I Questions to ask when auditing for Organizational Leadership and Planning for the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A ISO13485:2016 name and ownership changes questions ISO 13485:2016 - Medical Device Quality Management Systems 3
C CQA Test Questions Bank General Auditing Discussions 1
E Three basic questions about ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Informational EU – EMA revised guidance – Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 201 Medical Device and FDA Regulations and Standards News 2

Similar threads

Top Bottom