How to Audit Procurement and Maintenance Scheduling Activities

L

Limmeng

#1
Hi.

It's been a long time.

I need to perform ISO 9001 audit, in a company which scope is only involving procurement. Procurement activities are common for each department - i.e each section has its own procurement department - the only differences are the materials they purchase. One more department is coordinating maintenance activities of the consumable units they purchase.

Please give some idea on this audit trailing. Or any reference(s). The company does not even have quality manual that I can refer to.

Thanks for the help.

Lim
 
Last edited by a moderator:
Elsmar Forum Sponsor

Stijloor

Leader
Super Moderator
#2
Hi.

It's been a long time.

I need to perform ISO 9001 audit, in a company which scope is only involving procurement. Procurement activities are common for each department - i.e each section has its own procurement department - the only differences are the materials they purchase. One more department is coordinating maintenance activities of the consumable units they purchase.

Please give some idea on this audit trailing. Or any reference(s). The company does not even have quality manual that I can refer to.

Thanks for the help.

Lim
ISO 9001:2008 Clause 7.4 spells out the requirements for the purchasing process.

When you say "maintenance activities", do you mean that those are related to equipment or purchased product? Purchased product is normally not subject to maintenance activities. If you mean inspection and perhaps rework on that product, that's a different story because then "control of nonconforming product" comes into play.

Stijloor.
 

Jim Wynne

Leader
Admin
#3
Hi.

It's been a long time.

I need to perform ISO 9001 audit, in a company which scope is only involving procurement. Procurement activities are common for each department - i.e each section has its own procurement department - the only differences are the materials they purchase. One more department is coordinating maintenance activities of the consumable units they purchase.

Please give some idea on this audit trailing. Or any reference(s). The company does not even have quality manual that I can refer to.

Thanks for the help.

Lim
When you say that the company "...does not even have quality manual..." I assume that there are no documented requirements at all. If this is correct, you have no basis for an audit, so I don't see how a meaningful audit could be done. If there are documented requirements, they should be the basis of your audit.
 
T

trainerbob

#4
I agree with Jim. It sounds like the "company" has bigger issues than purchasing. One of the first things we all look when auditing is the quality manual. the quality manual needs to show or describe the processes of the organization and the linkages between them. Without the quality manual, there would be no reason to even think about auditing. We audit by processes. We have to know what the processes are.

How did you get put in a situation where you need to do this particular audit?
 

Stijloor

Leader
Super Moderator
#5
When you say that the company "...does not even have quality manual..." I assume that there are no documented requirements at all. If this is correct, you have no basis for an audit, so I don't see how a meaningful audit could be done. If there are documented requirements, they should be the basis of your audit.
The OP only stated that:
I need to perform ISO 9001 audit, in a company which scope is only involving procurement.
ISO 9001 spells out the purchasing requirements. So, if the organization does not meet the ISO 9001:2008 requiremens for purchasing then there will be a number of nonconformities.:mg:

Stijloor.
 
L

Limmeng

#6
The company indeed has no quality manual ... but the reason my boss was asking to see if they are ready ,for us to enforce them in acqquiring ISO. This may sound like "gap analysis".... but i guess my boss wants us to do "process audit" or something similar..

Being trained in IRCA 5 day auditor course - my boss puts me into this.

Maybe the purchasing process audit trailing will do. I believe it's more than just clause 7.4 requirements.... How about plaanning of maintenance activities (maybe clause 7.1, 7.2?)

Thanks for the input...
 
Thread starter Similar threads Forum Replies Date
S Audit Duration Calculation - ISO9001 + EN9100 with different scope General Auditing Discussions 2
T Audit Objective Evidence Photos AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
L How to prepare Top Management for IMS Surveillance Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Response time from API for review of responses to audit findings Oil and Gas Industry Standards and Regulations 7
T External Audit Notification List AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
T External Audit Plan Email Template AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
R Do I need to get calibration certificate from ISO 17025 for IATF Audit IATF 16949 - Automotive Quality Systems Standard 8
kys123 Implications of failing an Anvisa Audit for ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
T Operator Acceptance Audit Standard AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
T New Quality Manager Audit Preparation Quality Manager and Management Related Issues 10
rivariva MDSAP audit QMS preparation Other Medical Device Regulations World-Wide 10
L Evaluation of Readiness of Organization for 3rd Party Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
L ISO 9001, 14001, 45001 Audit Questions for a Security & Corporate Affairs Department ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Moncia Full system pre certification audit ISO 50001 Other ISO and International Standards and European Regulations 8
M External audit non conformity related to applicable regulations ISO 13485:2016 - Medical Device Quality Management Systems 7
D Preparing for IATF 16949 Letter of Conformance Stage 1 audit IATF 16949 - Automotive Quality Systems Standard 4
A Establishing an initial audit schedule for Pharma Suppliers General Auditing Discussions 2
B AS9100 Certification Audit Accounting for Additional Customer QMS Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
B Surveillance audit nonconformity ISO 13485:2016 - Medical Device Quality Management Systems 5
R Live Audit disasters AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
R Audit Closure - Assigned actions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
T Company AS9100D External Audit Preparation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 17
T AS9100D Risk-Based Internal Audit Schedule AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
Crusader Missed Annual Audit… Registrars and Notified Bodies 8
S Minimum Retention Time for Records of internal audit results as per AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
B Establishing topics for IATF internal audit processes Internal Auditing 9
I API Q1 5.7.1.5.a and API 6A10.4.2.12.2 AAR in API audit Oil and Gas Industry Standards and Regulations 0
D Unannounced Audit - Remote ISO 13485:2016 - Medical Device Quality Management Systems 6
L 3rd party audit issues - No audit agenda received a week before the audit Registrars and Notified Bodies 7
T Calculate FPY for Audit Results AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
D Critical Supplier will not allow us to audit Plant floor US Food and Drug Administration (FDA) 12
E Calibration Records during AS9100 Audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
Q Three year audit program template excel Internal Auditing 1
Q Evaluate a process audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
N Audit work documents Internal Auditing 3
S AS9100 Supplier Audit Checklist example AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
Kevin Walters IAQG Required Audit Days Needed (Please help) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Initial Audit FDA US Medical Device Regulations 3
F Surveillance Audit for AS9100D and new ERP system incorporated Document Control Systems, Procedures, Forms and Templates 4
bryan willemot Looking for NADCAP audit Excel spreadsheets template for vendors, specifically heat treat (Vacuum Furnace) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
D Dock audit IATF 16949 - Automotive Quality Systems Standard 9
S Is MDSAP Audit Required? ISO 13485:2016 - Medical Device Quality Management Systems 3
T Robust internal audit program AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
J Average number of Nonconformances during internal quality audit for Medical Device Manufacturers Internal Auditing 3
Q AS9100:D Counterfeit internal audit questions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D ISO 9001:2015 Internal Audit Check Sheet ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Audit checklist for Sterilization Vendors ISO 13485:2016 - Medical Device Quality Management Systems 1
Ed Panek MDR Audit Comment EU Medical Device Regulations 9
R Simple tool to establish an audit schedule? General Auditing Discussions 12
P 9.2.2.2 & 9.2.2.3 Audit Cycle alignment required? IATF 16949 - Automotive Quality Systems Standard 1

Similar threads

Top Bottom