What is the difference between Process and Compliance Audit?

qusys

Trusted Information Resource
#11
All audits are to review whether we are in compliance with our stated goals. Why should there be a difference between process or compliance? Aren't we supposed to be in compliance with our stated processes as a way of daily business? There are too many supposed differences between audit types, first article, in0process, tooling, gaging, finak, dock etc.... we are continually monitoring ourselves based on what we said we were doing.

Al...
Hi Al,
the question of the Cover is not so clear and without the details necessary to a response , so we are doing some assumptions.
To respond to you, sometimes compliance audit are held to verify the compliance vs statutory or regulatory standards ( I mean SOX , specific country laws vs fraud, etc) and they are usually separate from quality.
In fact sometimes thare are misunderstandings when people speak about audit, that does not quality aspect vs ISO 9001.
To be clearer, people should speak of audit and system audit ( quality, environmental, health and safety according the standards).
Said that, I will still assume that the Cover is speaking about this two kind of audit.
What about??:bigwave:
 
Elsmar Forum Sponsor
K

keres

#12
The main difference is that the process audit must give conclusion about process efficinecy, and compliance audit give conclusion about compliance against definied requirements.
 
B

baby12

#13
I'm not sure I completely understand your question, but I'll give it a try...

In my opinion...

A process audit is a review of a process's inputs, activities, and outputs, verifying conformance to requirements, such as internal standards (e.g., documents) and external standards (e.g., ISO 9001).

A compliance audit is an audit that verifies/validates the organization's systems and process adhere (or comply) to regulatory and legal requirements (e.g., enviromental laws, safety standards, etc.)
i agree with you, you will remember that ISO 9001 5.2 states customer focus but a mere compliance audit can not help us to give excellent customers services only process audit which is the input of customer rendering can do us good. you will remember that for complying to those requirements does not give services that customer want only by auditing services rendering process you will be able to indentify where you shortfall of customer expectation
 
B

baby12

#14
The main difference is that the process audit must give conclusion about process efficinecy, and compliance audit give conclusion about compliance against definied requirements.
so can i then make one checklist that will cover both audits(process&compliance)and what would i call it remember i working for service industry we do acceptance and delivery
 
B

baby12

#15
Hi Al,
the question of the Cover is not so clear and without the details necessary to a response , so we are doing some assumptions.
To respond to you, sometimes compliance audit are held to verify the compliance vs statutory or regulatory standards ( I mean SOX , specific country laws vs fraud, etc) and they are usually separate from quality.
In fact sometimes thare are misunderstandings when people speak about audit, that does not quality aspect vs ISO 9001.
To be clearer, people should speak of audit and system audit ( quality, environmental, health and safety according the standards).
Said that, I will still assume that the Cover is speaking about this two kind of audit.
What about??:bigwave:
this a quality management system about service Iso 9001 where you have to audit your process to see really if they are supporting the requirements of qms 5.2 becuase is through this process audit to check the level of compliance whether you are meeting customer expectation
 
B

baby12

#17
As others have mentioned, the question is not very clear. I'll try a different answer:

You test for compliance by comparing criteria to results.

You test for adequacy by comparing criteria to systems/processes.

It's the same as Verification/Validation. You have to do both.
Are you doing the right thing?
Are you doing the thing right?
i think the question is are we doing the right things as expected becuase you can comply just for fear of regulatory requirements but not meeting customer requirements
 

qusys

Trusted Information Resource
#20
this a quality management system about service Iso 9001 where you have to audit your process to see really if they are supporting the requirements of qms 5.2 becuase is through this process audit to check the level of compliance whether you are meeting customer expectation
Ok, thamks.
Clause 8.2.2 of ISO 9001 does not make any differences in the internal audit type.
The organization shall establish the scope and criteria of the internal audit as per ISO 19001 guidelines.

Pratically, when you plan an internal audit vs a process or activity as per your internal audit programme , you shall take into account the requirements of 8.2.2.
Besides, I suggest to take a look also to your internal audit procedure where all these items should be dealt with.
Hope this helps:bigwave:
 
Thread starter Similar threads Forum Replies Date
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J What is the difference between Process Variation and Tolerance? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
S What is the difference between Process Capability and Machine Capabilty Capability, Accuracy and Stability - Processes, Machines, etc. 13
T What is the difference between Supplier and Outsourced Process? Supplier Quality Assurance and other Supplier Issues 8
T Difference between the terms Function & Process when used in Construction Management Business Continuity & Resiliency Planning (BCRP) 12
J Difference between Outsourced Process and Support Service? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
V What is the difference between a System and a Process? US Food and Drug Administration (FDA) 30
H What is the difference between Process Variation and Product Tolerance for GR&R? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
A What is the difference between Process Objectives & Criteria for Effectiveness? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
R What's the difference between Engineering (ECN) and Process (PCN) Change Notes? FMEA and Control Plans 4
M The Difference between Process Audits and Layered Audits General Auditing Discussions 5
N What is the difference between Process, Procedure and Work Instructions Document Control Systems, Procedures, Forms and Templates 2
D Difference between Process Verification vs. Process Validation in APQP? APQP and PPAP 4
H Clarify the Difference between Activity and Process - What is Data Analysis IATF 16949 - Automotive Quality Systems Standard 9
S Difference between SPC (process control) and SQC (quality control) Statistical Analysis Tools, Techniques and SPC 12
S What is the difference between the quality process and quality procedure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
D TS 16949 - Is there a difference between a process and an activity? IATF 16949 - Automotive Quality Systems Standard 5
M What is the difference between process documents vs. Work Instructions? Document Control Systems, Procedures, Forms and Templates 2
R What's the difference between using PPM or Defect Rate in a process? Quality Tools, Improvement and Analysis 1
W What is the difference between TYPE B and TYPE BF? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T The difference between ISO 14644-3:2005 and ISO 14644:2019 Other Medical Device Related Standards 2
Q Terminal Lugs sizes - Difference between 225/24 vs. 275/24 lugs Manufacturing and Related Processes 2
M Difference between "Production Trial Run" and "Run at Rate" IATF 16949 - Automotive Quality Systems Standard 8
D Difference between Test Method Validation and Gage R&R Qualification and Validation (including 21 CFR Part 11) 18
R What's the major difference between Green Belt and Black Belt in term of training and project Six Sigma 3
T Difference between a subcontractor and a supplier ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
H Difference between Stainless Steel 316 ASTM F899 and ASTM A276 Other Medical Device Related Standards 3
A Exact terms for a plating failure and difference between rejection rate and failure rate Manufacturing and Related Processes 9
M Difference between MSA and MSE? General Measurement Device and Calibration Topics 1
gramps What is the difference between discrete and continuous variables? Problem Solving, Root Cause Fault and Failure Analysis 3
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
S Difference between EU-MDR Annex IX and the Annex-combo X&XI EU Medical Device Regulations 4
T ISO 17025:2017 Clause 4.2.2 - The difference between "be notified" and "be informed" ISO 17025 related Discussions 4
Jimmy123 What is the difference between Error Proofing and Controls? ISO/IATF 16949 - Control Plans FMEA and Control Plans 16
C IEC 60601-1-8, difference between table 4 and annex D IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A What is the difference between Basic UDI-DI and UDI-DI? EU Medical Device Regulations 6
Q What is the difference between AS9100D 9.3.2.f and 9.3.3.a AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Aluminum - What is the difference between 6061-T6 and 6061-T651 (both per ASTM B211)? Manufacturing and Related Processes 4
P What is the exact difference between Risk and Opportunity in context of ISO 27001? IEC 27001 - Information Security Management Systems (ISMS) 7
S Difference between Surface Finish (Ra) and Flatness (GD&T) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
O Air Flow - Which is the operational difference between LAF (vertical and horizontal) and RLAF? Manufacturing and Related Processes 2
S What the difference is between Stub Acme & Acme thread? Oil and Gas Industry Standards and Regulations 1
S DO 178B - What is the difference between review and verification? Federal Aviation Administration (FAA) Standards and Requirements 1
T The difference between SOP and Kaizen Standardization Lean in Manufacturing and Service Industries 2
K Difference between intended purpose and intended use of the device EU Medical Device Regulations 9
Q What is the difference between normal and licensed internal auditor? VDA Standards - Germany's Automotive Standards 9
O Difference Between PFMEA & Control Plan FMEA and Control Plans 3
S Difference between an Advisory Notice (ISO 13485) and a Field Safety Notice? ISO 13485:2016 - Medical Device Quality Management Systems 3
T Difference between "data analysis" and "management review" ISO 13485:2016 - Medical Device Quality Management Systems 4
qualprod What is the difference between 7.4.1 (2008) and 8.4.1 (2015)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6

Similar threads

Top Bottom