Shall the first Internal Audit cover all the processes of the company?

D

Dubai_capi

hi,

for the first internal audit of iso:9001:2008 shall it cover all the processes of the company.. since am performing the audit by myself..and i need some time to cover all of them..

can i go for certification if i only cover say 85%..

thanks
 

somashekar

Leader
Admin
An internal audit program is planned taking into consideration the status and importance of the process and area as well as results of previous audit.
In your case is there any previous audit ?
 
D

Dubai_capi

no this is the first internal audit.. and yes i wud consider the core processes and most important ones when its going to be initiated.. but my question is: shall it cover all the processes of the company for the pre-registration? and also the scope of the QMS cover all the company processes regardless the processes being core or supoorting processes..

so does the external auditor require that we perform all the processes audit included in the scope؟
 

somashekar

Leader
Admin
shall it cover all the processes of the company for the pre-registration?
I will not say shall, cause this is not so said in the standard.
However being a start-up and the first internal assessment, expectation is that you have measured and analyzed all your established processes if it conforms to plan (+ meets the ISO9001 standards requirement) and is implemented and maintained. Also of requirement to you will be to see how your processes are interacting and being effective to meet the company goals and targets. Please do not think and act on the lines of external auditor requirement.
and also the scope of the QMS cover all the company processes regardless the processes being core or supoorting processes..
A BIG YES YES YES

If I were you, I would begin with all and then assess which process / area I can change the frequency
 
Last edited:

AndyN

Moved On
hi,

for the first internal audit of iso:9001:2008 shall it cover all the processes of the company.. since am performing the audit by myself..and i need some time to cover all of them..

can i go for certification if i only cover say 85%..

thanks

Yes, but you will receive a "concern" at the stage 1 for two reasons...
 

Randy

Super Moderator
Nooooooooooooooo

You have to have conducted a complete "System" audit, not a "Company" audit, 2 entirely different animals

Either that or I just did a very bad thing an recommended registration for a companies management "System"
 
J

JRKH

no this is the first internal audit.. and yes i wud consider the core processes and most important ones when its going to be initiated.. but my question is: shall it cover all the processes of the company for the pre-registration? and also the scope of the QMS cover all the company processes regardless the processes being core or supoorting processes..
Help me understand here....Are you trying to get an audit together in preparation for your registrar doing a "pre-registration" audit?

so does the external auditor require that we perform all the processes audit included in the scope؟
An initial registration audit is going to cover everything so it is to your benefit to have already covered as many areas as possible. However if you cannot cover all areas then at least have done a systems audit and:
1) Have an audit schedule / plan to get the more detailed work done and
2) Have any actionable from the audits you HAVE done documented and at least in the process of being addressed.

Just my 2 cents.....

James
 

savantrep

Registered
The answer is no. Even when a registrar performs an audit, they are taking a "snapshot" and not a view of the entire system. Audit your major processes and you will be fine. You will want to try to cover all of your major processes over your subsequent audits. However, it is not required to audit everything all at once.
 
Thread starter Similar threads Forum Replies Date
lanley liao How to understand this words that the planning of internal audit shall take into consideration the results of previous audits? Oil and Gas Industry Standards and Regulations 10
S Internal Auditors shall not audit their own work? Internal Auditing 21
Gman2 ISO 9001:2000 Internal Audit: Someone PLEASE find me the "Shall" on "Process Audits" Process Audits and Layered Process Audits 37
L Quality Manager wants Internal Auditor to softgrade the findings - What shall I do? Internal Auditing 23
V The organization shall have internal auditors - 8.2.2.5 - Internal auditors IATF 16949 - Automotive Quality Systems Standard 6
T Internal audits shall also meet contract and/or regulatory requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R TS16949 Clause 7.6.3.1 - Internal laboratory - Facility shall have a defined scope IATF 16949 - Automotive Quality Systems Standard 5
Z Is thermal limits detection and switch to standby mode violate clause11.1.1 "- THERMAL CUT-OUTS shall not operate in NORMAL CONDITION." IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
T § 820.120 Device labeling - "shall be documented in the DHR" 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
K "Shall be" vs "Is" Document Control Systems, Procedures, Forms and Templates 18
R Advice needed: Shall I report my not complying company to NB / competent Authority (Europe) EU Medical Device Regulations 6
B What regulates DICOM Viewer? Wat are the mandatory info that shall be displayed on the screen? Other Medical Device Related Standards 1
John C. Abnet ISO 9001 4.4.1 "...shall determine the processes needed..." ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 72
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 5
K ISO 13485 clause 8.5.2 'Any necessary CA shall be taken without undue delay' ISO 13485:2016 - Medical Device Quality Management Systems 11
R Shall a new UDI-DI be required when stand-alone software device's version is updated? EU Medical Device Regulations 1
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
S Mandatory documents vs shall "something" but without mandatory documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
S Use of "Shall" versus "Should" in Procedures ISO 13485:2016 - Medical Device Quality Management Systems 26
K ISO 17025:2017 clause 7.6.2 - Performing calibration of its own equipment shall evaluate the measurement uncertainty ISO 17025 related Discussions 6
R Deciding if a medical device shall be supplied sterile or not Other Medical Device and Orthopedic Related Topics 5
J AS9104-1 Clause 18.1 (a) (b) - Organizations (contractor) shall be required to allow access to Tier 2 data AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
A DHF File - Shall the document cover all the variants? Design and Development of Products and Processes 2
B IATF 16949 clause 7.1.5.1.1 - Statistical studies shall be conducted IATF 16949 - Automotive Quality Systems Standard 3
J AS9100D Cl. 8.4.3d - The organization shall communicate to external providers... AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
N Who shall manage PPAP process? APQP and PPAP 4
J Japan's Definition of Should and Shall Japan Medical Device Regulations 1
M IATF 16949 Cl. 7.1.5.1.1 - Statistical studies shall be conducted IATF 16949 - Automotive Quality Systems Standard 3
K Measurement system analysis "shall be conducted to analyze the variation..." Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
shimonv 21 CFR 820.20(d) says: Each manufacturer shall establish a Quality Plan 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Do I need to Register with FDA? How shall my structure of processes look like? US Food and Drug Administration (FDA) 4
A Shall I apply for this job position (Quality Manager)? Career and Occupation Discussions 5
M How strictly are "Shall" and "Should" interpreted? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A ISO 17025 sections state "Shall have a Policy and Procedure" ISO 17025 related Discussions 2
x-files Documents required by the quality management system shall be controlled ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
X Shall not exceed 2 working weeks = shall not exceed within 10 working days? IATF 16949 - Automotive Quality Systems Standard 2
B Shall issue CAR when KPI fail? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Shall we raise SCAR/CAR for every defect as per our current procedure? Nonconformance and Corrective Action 4
M Shall Customer Questionnaire (8.2) be Verified according to 7.6? TS 16949 IATF 16949 - Automotive Quality Systems Standard 7
J Safety Special Equipment (e.g. lift, boiler) shall be audited by ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q Outsourced Process also shall be Documented? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Clause 7.6 - "Shall have Identification in order to determine its calibration status" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 34
M AS9100 Clause 4.2.3 requirements - Documents required by the QMS shall be Controlled AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
K How to apply IEC 62366 and what shall be changed in establishing a Technical File ISO 13485:2016 - Medical Device Quality Management Systems 2
sagai Required Documentation for 820.25(b) - What does "Training shall be documented" mean 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
D Calibration Certificate - 'test report shall not be reproduced except in full' General Measurement Device and Calibration Topics 2
C The organisation shall Establish, Implement & Maintain a Procedure(s)? ISO 14001 ISO 14001:2015 Specific Discussions 21
T Quality Manual shall Outline Structure of Documentation - Clause 4.2.2 ISO 13485:2016 - Medical Device Quality Management Systems 10
E AS9100 section 7.6 "D" - Equipment shall be safeguarded from adjustments General Measurement Device and Calibration Topics 17
L ISO 17025 4.12: "...potential sources of nonconformities...shall be identified." ISO 17025 related Discussions 21

Similar threads

Top Bottom