Complete audit before assessment?



Could someone tell me if it is necessary to complete an audit of your entire system before a pre-assessment. We are having our first ever pre-assessment very soon and I'm not sure if we can complete the entire system before it happens.

ISO Confused!:frust:
Elsmar Forum Sponsor



We are very comfortable with many areas of our system and feel it might be o.k. to not audit these ourselves this time.

What do you think?



If you are as comfortable with your system as you say, go for the pre-assessment. It should result in findings that you can correct in a relatively short time. Some Registrars give you a break on the price of the actual audit if you correct deficiencies within a time frame. Like 30 days. After that, you pay full fare. Good Luck.:ko: :smokin:


Thanks for the advice.......I'm pretty green at the process for registration.

Also, the way I read the standard.....You only need to audit the areas you feel necessary as long as you define the criteria, scope, frequency and methods.

Any thoughts????
Registrar requirements

I know several registrars that require a 'complete cycle of audits' prior to the registration audit. They seem to be less clear as to whether 'complete cycle of audits' means the entire system is audited, or if it means performing an audit, making corrective actions and reporting the results in management review. My advice is to check with your registrar to see what their requirements are.


Thanks for the feedback. It's nice to have seasoned veterans that can guide the way for the lost! :confused:

I have found it acceptable to have a schedule (I use an annual audit schedule) showing that all remaining areas are scheduled. Together with the results of audits performed this has always flown for initial registration audits.

Aaron Lupo

I think it is pretty much standard with most registrars that you complete a full cycle of audits- which means your whole system is audited, for a Certification audit. I don't think they require it for a pre-assessment, however, best thing to do is call your registrar.


Our registrar required a full audit cycle and a management review prior to registration. We didn't have a pre-assessment so I don't know if it was needed before that as well.




Clause 8.2.2 states:

"The organization shall conduct internal audits at planned intervals to determine whether the quality management system

a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and
b) is effectively implemented and maintained"

I think the safest way to prove that you have determined that your QMS meets ALL the requirements of ISO 9001:2000 is to have audited all the elements.

If I were auditing a QMS & found that a part was not "effectively implemented and maintained" I would cite it as a nonconformity against the particular clause. My impression of the standard now is nonconformities found in clauses 4, 5 & 6 are normally more serious (system-wide) than those in 7 & 8 (usually more department-specific).

For the pre-assessment, don't worry too much if the auditors find that not all elements are implemented, that's part of what the pre-assessment is all about (though by now over 90% of the requirements should be met).

Incidentally, is the Registrar doing the pre-assessment or is it some other party?

Good Luck,

Thread starter Similar threads Forum Replies Date
B Is it Compulsory to complete Management Review before Stage 1 Audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 22
V What % complete work instructions before audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
G Best Practices for IT auditing - Is a session-id necessary for a complete audit trail? IEC 27001 - Information Security Management Systems (ISMS) 0
J0anne 90 Day Limit Imposed by NB to complete NCs raised at audit Preventive Action and Continuous Improvement 6
P Searching for a complete audit check list based on ISO14001:2004 ISO 14001:2015 Specific Discussions 1
A AS9100 rev C Skill Examiner Audit to complete my RABQSA Auditor certification Career and Occupation Discussions 3
S AS9100C Complete Internal Audit Software Package Recommendations Quality Assurance and Compliance Software Tools and Solutions 14
G Help needed to complete a Financial Audit of a Nonprofit Organization Various Other Specifications, Standards, and related Requirements 7
P Help Needed to complete audit hours under a Certified Lead Auditor - ISO 9001 General Auditing Discussions 5
SteelMaiden Surveillance Audit Complete ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Internal audit checksheet for TS 16949 that covers a complete system audit? Document Control Systems, Procedures, Forms and Templates 11
Marc ISO 9001 Three Year Recertification Audit Requirement(s) - Complete Reaudit Registrars and Notified Bodies 6
Marc Registrar Asking Customer to complete QMS Audit Matrix Registrars and Notified Bodies 16
I TS 16949 Registration Audit Complete!!!!! IATF 16949 - Automotive Quality Systems Standard 14
O ISO 9001:2000 Registration Audit Complete !!!! ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
O What is a complete system audit - ISO9001:2000 General Auditing Discussions 4
P TS16949 Registration audit complete - Zero Nonconformances!!! IATF 16949 - Automotive Quality Systems Standard 4
R Is a complete Internal Audit prior to registration a direct requirement of QS9000? Internal Auditing 3
PQ Systems The Complete Guide to GAGEmail Using GAGEpack Software 0
M Is complete testing required as per ISO 10993 for materials used in orthopedic implants or is literature review route possible Other Medical Device Related Standards 3
B Is 14971 Annex C checklist now in ISO/TR 24971 required to complete prior to 510k filing? ISO 14971 - Medical Device Risk Management 3
L En 62368 How to complete with incomplete parts details CE Marking (Conformité Européene) / CB Scheme 4
S Is it required to complete Internal Audits within one year? ISO 13485:2016 - Medical Device Quality Management Systems 29
N Actor registration EUDAMED restricted: got no Email to complete the registration EU Medical Device Regulations 9
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
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
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
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
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
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

Similar threads

Top Bottom