Scope of Employee and Function Levels of Internal Audits

Z

zaid_iec

#1
Hello All,

I am preparing an Internal Audit Procedure for my company. In raw words if i say i would be interested in auditing the processes at employee level and functional level.

Employee Level
[FONT=&quot]1. Time Sheet Entry
[/FONT]
[FONT=&quot]2. Drawing Check[/FONT] as per check sheets etc.

Function Level
1. HR Process of recruiting
2. Facility maintenance etc.

Now this is something kind of process audit i think. Can you please help me out in defining the SCOPE & PURPOSE of this audit.

Also please suggest should i call it Internal Audit, Internal Process Audit or Process Audit ?

Regards
Mohammad
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Hello All,

I am preparing an Internal Audit Procedure for my company. In raw words if i say i would be interested in auditing the processes at employee level and functional level.

Employee Level
[FONT=&quot]1. Time Sheet Entry
[/FONT]
[FONT=&quot]2. Drawing Check[/FONT] as per check sheets etc.

Function Level
1. HR Process of recruiting
2. Facility maintenance etc.

Now this is something kind of process audit i think. Can you please help me out in defining the SCOPE & PURPOSE of this audit.

Also please suggest should i call it Internal Audit, Internal Process Audit or Process Audit ?

Regards
Mohammad
I will take it as the ISO9001 that you refer to.
Just call it "Internal Audit"
Your QMS is based on ISO9001 frame, and this asks for process approach. All your people must be aware about this approach.
The scope must be your QMS + ISO9001 standard requirements.
The purpose must be to evaluate effective implementation and maintenance of your QMS and its continual improvement.
 
Z

zaid_iec

#3
We don't have ISO implemented in our organization. Although the case is like hospitals where people know what to do but there is no standard way of doing it. Output or result matters.
 

somashekar

Staff member
Super Moderator
#4
We don't have ISO implemented in our organization. Although the case is like hospitals where people know what to do but there is no standard way of doing it. Output or result matters.
If you have your own management system, and you know all your processes and its interaction, still my response will not change much...
Just call it "Internal Audit"
Your management system, and its process approach must have been understood by all personnel and they must be aware about this approach.
The scope must be your management system. (Your QMS)
The purpose must be to evaluate effective implementation and maintenance of your management system and its continual improvement.
 
Thread starter Similar threads Forum Replies Date
Chennaiite Is Audit of Employee Canteen Food within the scope of OHSAS 18001? Occupational Health & Safety Management Standards 17
M ISO 9001 Audit Concern about Written Job Scope & Responsibility for Employee? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T How to handle out-of-scope activities. ISO 13485:2016 - Medical Device Quality Management Systems 7
E Supply chain main policies ,scope, risk assessments & relavant KPI Supply Chain Security Management Systems 2
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Can outsourced processes be excluded from QMS scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
D IATF 16949 M&TE Laboratory scope IATF 16949 - Automotive Quality Systems Standard 4
J Informal vs formal scope creep... managing non-medical devices through system processes ISO 13485:2016 - Medical Device Quality Management Systems 2
R "Medical devices" required in scope ISO 13485:2016 - Medical Device Quality Management Systems 2
R CB/Auditor Requiring a change in scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
H Implementing ISO22301 on a Limited Scope Business Continuity & Resiliency Planning (BCRP) 2
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
Q The scope of ISO 21534 Other Medical Device Related Standards 0
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
K Medical Device Repairs and ISO 13485 Scope ISO 13485:2016 - Medical Device Quality Management Systems 7
K Software Updates in the Field and ISO scope ISO 13485:2016 - Medical Device Quality Management Systems 2
I IATF Lab Scope Testing Qualification and Competency Documentation IATF 16949 - Automotive Quality Systems Standard 3
Crimpshrine13 Laboratory Scope - Calibration vs. Test Methods - IATF 16949 IATF 16949 - Automotive Quality Systems Standard 3
silentmonkey Are risks in supply chain and development activities within scope of MDD? EU Medical Device Regulations 4
D Limited Scope for second site Question? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Scope of ISO 9001 clause 10.2 in the product life cycle ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A IATF 16949 4.3.1 - Determining the scope of the quality management system - supplemental IATF 16949 - Automotive Quality Systems Standard 9
hockeyhead Existing process never included in AS9100 scope of certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
G APQP Scope and scale tool APQP and PPAP 2
R NRTL - Scope Question - Off-the-Shelf Plug In IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D ISO 9001:2015 4.3 Determining the Scope of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Scope of Combined ISO 9001 and IATF 16949 QMS - Non-automotive customers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
O MDSAP Reduction in Scope Other Medical Device Related Standards 0
D Do non-IATF customers need to be included in audit scope? IATF 16949 - Automotive Quality Systems Standard 23
K Restricted Scope of ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 7
C IATF 16949 - Scope or not? IATF 16949 - Automotive Quality Systems Standard 2
S Similar scope medical products connected by WIFI US Food and Drug Administration (FDA) 2
N IATF 16949:2016 7.1.5.3.2 External Laboratory - How to approve the Testing Laboratory without accreditation scope IATF 16949 - Automotive Quality Systems Standard 2
qualprod To raise a NC beyond the audit scope? Two signatures were missing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D CE Marking Requirements MDD & MDR - new product development covered under same scope EU Medical Device Regulations 1
P Scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M ISO 27001 ISMS scope for companies with subsidiaries IEC 27001 - Information Security Management Systems (ISMS) 0
T AS9100D - Scope of QMS for New Company - Only Choosing a Function Subset Due to Management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
R Scope of ISO 13485 certification ISO 13485:2016 - Medical Device Quality Management Systems 6
D Scope of Facility - Our auditor asked us last week for our "Scope of the Facility" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
L Dying a slow SCOPE death - NEW ISO APG Paper on Scope and Applicability May 2020. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
P Dropping ISO 9001 limits the scope of the ISO 13485 audit? ISO 13485:2016 - Medical Device Quality Management Systems 6
W Scope of MRB (Material Review Board) Responsibilities Misc. Quality Assurance and Business Systems Related Topics 5
P ISO 80369-7 standard - Interpreting which Parts should be in scope Other Medical Device Related Standards 7
I Sales Documents in scope for ISO-9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
V Exclusion of 'Design and Development' from scope of certification ISO 13485:2016 - Medical Device Quality Management Systems 9

Similar threads

Top Bottom