Is a complete Internal Audit prior to registration a direct requirement of QS9000?

R

RMontvile

#1
Is a complete Internal Audit prior to registration a direct requirement of QS9000, an indirect requirement, or subject to registrar whim? I ask because a cleint Management Rep. insists that it wasn't required when his parent company was registered in Germany.

Thanks for any help.
 
Elsmar Forum Sponsor
L

Leslie Garon

#2
No it is not a direct requirement, but you must show that your are verifying your quality system effectivness and this is the tool to do it internally.
There are great benefits to doing internal audits as well as prior to registration:
1. They provide evidence that you are reviewing your quality system effectivness.
2. They provide issues for corrective and preventive action as well as improvement opportunities. You must be able to demonstrate that these systems are in place and working properly at the requistration audit. This is the tool.
3. They provide an opportunity to show Associates what the registration audit will be like.
4. They provide practice for both the department management and the associates in how to answer questions and what kind of questions will be asked during the audit.
5. With frequent internal audits, they allow the requistration and subsequent followup audit(s) to be a comfortable event instead of a fearful one. Gets rid of nervousness<sp>.
6. Most importantly, they will hopefully bring out noncompliance areas prior to your registration audit.

A final recommendation is to ask your registrar to perform a pre-assessment<sp> audit about 2 months prior to your registration audit date. This will help catch the large nonconbformities prior to the real thing and give you a chance to fix areas you may be unaware that need fixing.

NOTE: You should have 3-6 months of evidence that your quality system works in a complient manner prior to requistration audit.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
LRQA is one registrar which does require a complete round of internal audits prior to the registration audit. They also expect some of them to have been addressed and closed out.

As far as I know it is not written in QS the point is registrars obviously have different requirements. I highly recommend that you ask your registrar what they require.

This goes along with each registrar having different requirements on how long prior to registration audit they expect the systems to operate. LRQA asks for 3 months minimum. So - if you dream up a new corrective action system, you need 3 months of evidence to show the system does work. What this means is that they want all level 2's up and running well before the registration audit.

With that said, I agree with Leslie. With a client I typically want to get the internal audit system up and running as soon as possible. I try to get 2 complete cycles of audits done prior to registration audit. The first cycle gets the internal auditors started. The second round is 'serious', if you will.

Answer to question: ---> Registrar whim... ;)
 

barb butrym

Quite Involved in Discussions
#4
would't you want to see if the system works...and is effective as part of the prep..i wouldn't call in teh registrar until I had a full round of audits done....
 
Thread starter Similar threads Forum Replies Date
S AS9100C Complete Internal Audit Software Package Recommendations Quality Assurance and Compliance Software Tools and Solutions 13
M Internal audit checksheet for TS 16949 that covers a complete system audit? Document Control Systems, Procedures, Forms and Templates 11
A Is there a better way to do a complete assessment of our QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
A Document Change Notice vs complete System re-write Manufacturing and Related Processes 4
G Best Practices for IT auditing - Is a session-id necessary for a complete audit trail? IEC 27001 - Information Security Management Systems (ISMS) 0
M How to complete structure Analysis and Function analysis sections' columns of AIAG-VDA DFMEA form FMEA and Control Plans 0
S New AIAG FMEA Process - How to complete the new format FMEA and Control Plans 32
D China - Where I can get NMPA complete structure/organogram chart and GB/YY format list China Medical Device Regulations 1
J0anne 90 Day Limit Imposed by NB to complete NCs raised at audit Preventive Action and Continuous Improvement 6
S What is considered the complete software medical device? Medical Information Technology, Medical Software and Health Informatics 6
L A Complete Control Chart Decision Tree Statistical Analysis Tools, Techniques and SPC 5
N Interesting Discussion How to Deal with Suppliers Who Refuse to Complete our ISO Survey? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 51
H FMEA sample for complete CNC machining process FMEA and Control Plans 1
B New to Metrology and told to complete Gage R&R with AIAG compliant software Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 16
P Searching for a complete audit check list based on ISO14001:2004 ISO 14001:2015 Specific Discussions 1
D What is a reasonable consulting fee for preparation of a complete traditional 510k? Consultants and Consulting 11
E Is Design Transfer to Production be complete prior to Release of first production lot 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
K Partial FAI on Semi-Complete Parts question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D When to complete FAA Form 337 (Major Repair and Alteration) Federal Aviation Administration (FAA) Standards and Requirements 4
Q Complete Company Restructuring & Impact on ISO 9001 Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D Steps to Complete Quality Control Plans and Work Instruction Manufacturing and Related Processes 4
E Auto Populate Date and Time in an adjacent cell to one the user will complete..... Excel .xls Spreadsheet Templates and Tools 7
F Process Maps as a complete QMS Manual ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Calibration conducted to 3 steps only of the std instead of complete 5 steps General Measurement Device and Calibration Topics 4
2 Complete Cycle for Complaint Process - Idea Searching Customer Complaints 7
A AS9100 rev C Skill Examiner Audit to complete my RABQSA Auditor certification Career and Occupation Discussions 3
optomist1 Complete list of all Default Conditions for Y14.5M 1994 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
E List of Complete EMC Test Requirements consisting of IEC, EN, Cispr, etc. General Measurement Device and Calibration Topics 2
L ISO 9001 Clause 7.3.2 Design & Development Input - Adequacy, Complete, Unambiguous ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Requirement to complete an MSA when doing Comparative Tests Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
N The Gap Analysis is complete - From which clause do I begin? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
V Issue: Suppliers charge for complete Level III PPAP package - Heat Treated Parts APQP and PPAP 16
Hami812 Minitab and Control Charting Time to Complete each Repair Over Time Using Minitab Software 8
L Records Register is not maintained and is far from complete ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
S Required Complete calibration SOP, calibration Plan and master list template! IATF 16949 - Automotive Quality Systems Standard 3
S AS9102 Form 1 Item 19 FAI Complete / Not Complete Box - Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
F Importance of Complete Inspection Records in Aerospace Manufacturing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
G Help needed to complete a Financial Audit of a Nonprofit Organization Various Other Specifications, Standards, and related Requirements 7
J ISO9001:2008 - What a complete joke! ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 85
L 5S Auditing & Accountibility - Keeping our 5S tool boards complete and accounted for Lean in Manufacturing and Service Industries 13
R Creating Quality System and using it before it is complete ISO 13485:2016 - Medical Device Quality Management Systems 8
P Help Needed to complete audit hours under a Certified Lead Auditor - ISO 9001 General Auditing Discussions 5
N Basic MSA - A simple way to complete an MSA study on Dial Calipers Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
C Complete ISO idiot on a steep learning curve - Quality Manual Review appreciated ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A Complete change of the ISO 9001 Quality Management System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
P Earned Value Calculation when you have moved forward but work is not complete Quality Tools, Improvement and Analysis 1
B Is it Compulsory to complete Management Review before Stage 1 Audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 22
R Requirement to Complete Missing Documentation - Changing Registrars Quality Manager and Management Related Issues 6
T 21 CFR Part 11 Compliance - Generation of Complete Copies of Records Qualification and Validation (including 21 CFR Part 11) 3
SteelMaiden Surveillance Audit Complete ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5

Similar threads

Top Bottom