Procedure and QMS around SAP

N

naghee

#1
Hello All,

I am about to kickstart a ISO9001:2008 implementation process.
The company is currently implementing SAP, and is in the training stage.

I wanted to wait till SAP is up and running, but as usual, management want it now.

I want to know how I should stucture the Quality manuals and procedures needed by ISO9001 around SAP.
And, do the number of procedures requirement reduce with SAP in place?

(SAP version has Quality module, but not yet setup. will take another 6 months to even start working on the quality module)
 
Elsmar Forum Sponsor
A

arios

#2
Good day Naghee,

You can have a documentation system in place while your SAP system is being fully implemented. Options could include a manual system like in the old days (well! not that old :eek: ), but manual does not mean necesssarily complex and burdersome, you can keep it simple and effective. As an alternate option you could make your QMS procedures available on a network drive as pdf documents to prevent unintended changes. In your document control procedure you can specify how it will be maintained.

The amount of procedures needed does not depend on whether you have SAP or not. The standard requires 6 miminum documented procedures (and in some cases they can be merged like Corrective and Preventive Action). Further procedures can be necessary if your organization so determines as needed, e.g. a Purchasing procedure, Calibration procedure, etc.

Hope this helps
 

somashekar

Staff member
Super Moderator
#3
Hello All,

I am about to kickstart a ISO9001:2008 implementation process.
The company is currently implementing SAP, and is in the training stage.

I wanted to wait till SAP is up and running, but as usual, management want it now.

I want to know how I should stucture the Quality manuals and procedures needed by ISO9001 around SAP.
And, do the number of procedures requirement reduce with SAP in place?

(SAP version has Quality module, but not yet setup. will take another 6 months to even start working on the quality module)
Descriptions of the interactions between various processes can be nicely addressed by the SAP within the quality manual to the extent it is mapping now and by the time the SAP fully matures with all its module up and running, you could easily amend the manual to update the same.
 
D

ddunn

#4
SAP is a tool. The tool does not dictate a process it supports a process. Some processes may need tweaking in order to take full advantage of SAP or SAP may need tweaking to help automate a good process. A good process is a good process no matter what tool is used.

Focus on the process. :2cents:
 
S

samsung

#5
I want to know how I should stucture the Quality manuals and procedures needed by ISO9001 around SAP.
And, do the number of procedures requirement reduce with SAP in place?
ddunn has rightly said that SAP is only a tool. You need to structure your manual & procedures in the same way as you would do without SAP. The most important advantage that you can have while integrating SAP ERP with your QMS is its ability to provide real time status of material stock, product availability, real time view of pending orders, faster data transaction etc. All these features can be utilized to conduct frequent, faster & accurate data analysis. Depending on the installed modules, SAP can add to improve process efficiency, delivery of products, inventory optimization, payment settlements, order processing, information management and many more.

As to your second question, Arios has already given a satisfactory reply and you may wish to stick to his advice.

Hope this helps. Ofcourse, you will have plenty of other responses from the subject experts.
 
N

naghee

#7
I will probably be using "policyIQ" as the doc management system

This is the first time I am using this.

Thanks for all the replies.

The question that is coming to mind is:
Do I have to write:
Purchasing Procedure
Incoming Goods Procedure
Despatch procedures
Stocktaking procedures...and such when the process is well defined is SAP, and is automated.
 
S

samsung

#8
I will probably be using "policyIQ" as the doc management system

This is the first time I am using this.

Thanks for all the replies.

The question that is coming to mind is:
Do I have to write:
Purchasing Procedure
Incoming Goods Procedure
Despatch procedures
Stocktaking procedures...and such when the process is well defined is SAP, and is automated.
No, the standard doesn't absolutely require that you 'have to write' the procedures you mentioned above. You can write them if it's an organizational requirement e.g.; for the sake of maintaining consistency in operations, avoiding ambiguity, delegation of responsibility for approvals or for training or other purposes.
 
Thread starter Similar threads Forum Replies Date
W Using tailoring guidelines to tailor a QMS procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C QMS Procedure for Obsoleting a Product Document Control Systems, Procedures, Forms and Templates 2
somashekar Electronic data Back-up procedure, for Medical device QMS and regulatory purpose. ISO 13485:2016 - Medical Device Quality Management Systems 4
S Sample QMS Procedure for Adaptation of New Product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Customer Provide Control Procedure & Changes of Products and QMS Control Procedure ISO 13485:2016 - Medical Device Quality Management Systems 5
S QMS (Quality Management System) and Calibration Procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
S Customer Complaint Procedure - Notice for Customers - Place in QMS? Customer Complaints 4
K Marketing Procedure in line with ISO 9001:2000 QMS standard needed Document Control Systems, Procedures, Forms and Templates 2
B Quality Manager wants a Cost of quality (COQ) procedure in our QMS Document Control Systems, Procedures, Forms and Templates 8
B Procedure packs with non-medical devices EU Medical Device Regulations 1
K Need procedure for D&D inputs? ISO 13485:2016 - Medical Device Quality Management Systems 4
J Example of a defined procedure for carrying out Material Review Board (MRB) Manufacturing and Related Processes 0
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
S What should i choose for "testing procedure" characteristics? (N95) General Information Resources 0
S Critical characteristic on manufacturing operations test procedure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
A SPC procedure / flow chart Statistical Analysis Tools, Techniques and SPC 2
J Action Not defined in procedure - NC - Incoming inspection AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
E Procedure ( SOP) for Device Master Record ( DMR ) and for Device History Record (DHR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 3
U Procedure pack components EU Medical Device Regulations 3
G Control Plan & PFMEA Review Procedure? FMEA and Control Plans 1
J Strategy for MDR Regulatory Compliance Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
A IVD in MDR procedure pack EU Medical Device Regulations 2
G RoHS Procedure REACH and RoHS Conversations 2
John Predmore Configuration Management as a process instead of a procedure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
A Design and development procedure for API Spec Q2 Oil and Gas Industry Standards and Regulations 6
M Change management procedure when 7.3 is not applicable ISO 13485:2016 - Medical Device Quality Management Systems 5
L Sample Procedure from Contract Manufacturer Prospective ISO 14971 - Medical Device Risk Management 1
T Internal Nonconformance procedure thoughts (AS9100) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
Anonymous16-2 SOP (Standard Operating Procedure) Numbering Document Control Systems, Procedures, Forms and Templates 7
M UDI procedure/ report 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
DuncanGibbons Resources for aiding in procedure, work instruction and manufacturing plan development and management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
S Article 22 Procedure Pack Labelling EU Medical Device Regulations 4
N EU MDR - Applicability Article 22 Systems and Procedure Packs CE Marking (Conformité Européene) / CB Scheme 4
M Example of statement for procedure pack MDR Article 22? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
R Procedure, Frequency and Acceptance Criteria for Replicate, Recalibration, Before-After and Intermediate Checks ISO 17025 related Discussions 8
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
M MDR - Is a formal GSPR Procedure required? EU Medical Device Regulations 20
Moncia Production Planning procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q Tracking Procedure Revisions (Document Control) Document Control Systems, Procedures, Forms and Templates 9
L Purchasing procedure and workload ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Roles and accountabilities procedure? ISO 13485:2016 - Medical Device Quality Management Systems 9
K Procedure equals a process? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 25
M EU MDR - RA procedure for EU EU Medical Device Regulations 5
F Procedure for Device End of Life/Obsolescence Other Medical Device and Orthopedic Related Topics 3
A MAH license transfer (medical device registrant) procedure in Indonesia Other US Medical Device Regulations 0
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
J Manufacturing procedure / work instruction depth ISO 13485:2016 - Medical Device Quality Management Systems 12
F Hi friends, can anyone show me an example of a procedure for ISO 13485 6.4.1 Work Environment? ISO 13485:2016 - Medical Device Quality Management Systems 2

Similar threads

Top Bottom