SAP and ISO 9000 - Azerbagampt

L

lea johnson

#1
SAP and ISO 9000


We are currently working on SAP implementation and converting our ISO 9000 documentation to match SAP. Has anyone else been through this. Do you have any tips suggestions and sources for this project?
 
Elsmar Forum Sponsor

Marc

Fully vaccinated are you?
Staff member
Admin
#2
I haven't actually gone through the process with SAP specifically, but if you tell me what problems you're having I might be able to help. Typically SAP and other manufacturing control programs have a significant amount of documentation you can cite as reference for those systems, but for the most part your master systems, such as nonconformance, shouldn't change - depends upon which modules you install.
 
Thread starter Similar threads Forum Replies Date
S What is the clause in ISO 13485 for SAP Software Validation? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Implementation of SAP and compliance to ISO 9001: 2008 Document Control Systems, Procedures, Forms and Templates 7
A What is the relation between SAP and ISO 9001:2000 documentation requirements? Quality Assurance and Compliance Software Tools and Solutions 3
R SAP B1 Computer System Validation Qualification and Validation (including 21 CFR Part 11) 0
B SAP Audit trail Periodic Review EU Medical Device Regulations 2
R Role of quality compliance in SAP Software Quality Assurance 2
M Medical Device News Health Canada - Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) - Record of Proceedings – January 26, 2018 Canada Medical Device Regulations 0
chris1price Error in data recording - Recording measurements in SAP Capability, Accuracy and Stability - Processes, Machines, etc. 2
R Wet Signature Document Attachments in SAP - Risk on Data Integrity issue? Records and Data - Quality, Legal and Other Evidence 6
R Regulatory Expectations and SAP US Food and Drug Administration (FDA) 2
Z SAP Validation for Part 11 Compliance - Examples (executed protocols) Qualification and Validation (including 21 CFR Part 11) 6
S AS9100 Control of Documents and SAP Implementation Document Control Systems, Procedures, Forms and Templates 1
E Computer System Validation - Migrating to SAP Document Control Systems, Procedures, Forms and Templates 5
A Can the BOM in SAP be used in lieu of process flow diagram? APQP and PPAP 7
A Supplier Rating from SAP QM Module Data Supplier Quality Assurance and other Supplier Issues 2
C Using SAP for SCAR (Supplier Corrective Action Reports) Quality Assurance and Compliance Software Tools and Solutions 2
E Validation of SAP Purchase Order and Sales Order modules Software Quality Assurance 7
A Changes required to procedures after introduction of SAP Document Control Systems, Procedures, Forms and Templates 3
W SAP QM Module - Honest assessment wanted Quality Assurance and Compliance Software Tools and Solutions 11
ScottK Validation of SAP - Secondary Packaging Manufacturer Qualification and Validation (including 21 CFR Part 11) 8
M Is ERP (Enterprise Resource Plannning) software like SAP in scope of AS9100 7.5.1.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
N Procedure and QMS around SAP Document Control Systems, Procedures, Forms and Templates 7
W Validation of SAP for ERP - Inventory, shipping, and monitoring expiration dates Qualification and Validation (including 21 CFR Part 11) 18
P A SAP DMS Q: Sequantial work flow for DMS review and Approval Document Control Systems, Procedures, Forms and Templates 1
K Part Naming Convention for SAP ERP Application Document Control Systems, Procedures, Forms and Templates 4
S Item Part Code change - New SAP System Document Control Systems, Procedures, Forms and Templates 2
R SAP / EtQ Documentation Systems Document Control Systems, Procedures, Forms and Templates 3
R Vantage/SAP Part Number Nomenclature help Document Control Systems, Procedures, Forms and Templates 1
M Commercial Quality Assurance Software (ie: SAP) vs. Custom Databases Quality Assurance and Compliance Software Tools and Solutions 12
J Relationship Between SAP and ISO9001:2000 Quality Assurance and Compliance Software Tools and Solutions 1
M Lean Manufacturing, SAP and 8.2.4 - No records indicating release of product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q SAP ERP Software - do you know anything about it? Quality Assurance and Compliance Software Tools and Solutions 15
Marc SAP AG Lawsuit World News 0
E ISO 13485 software validation ISO 13485:2016 - Medical Device Quality Management Systems 3
B ISO 11197, Venting of Medical Supply Units - cl. 201.11.2.2.101 Other Medical Device Related Standards 2
D Management reviews ISO 17025 ISO 17025 related Discussions 3
L Change Log in (controlled) Forms? (ISO 9001:2015) Document Control Systems, Procedures, Forms and Templates 6
K ISO 9001 Clause 8.3 & 8.6 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
I ISO 17025:2017 / ANAB 3125 - Articulating / Communicating Risks vis-a-vis Audit Findings ISO 17025 related Discussions 2
A Management of change procedure for ISO 45001 Occupational Health & Safety Management Standards 3
S Transition training for Internal Auditor from ISO 9001: 2008 to the ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D Notified Bodies - ISO 13485 & MDR Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 3
E Comparison of Personal Protective Equipment Standards EN 14605 vs GB24539 and ISO 13982 vs GB 24539 Occupational Health & Safety Management Standards 0
H R&D Lab ISO 9001 certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
C Biologic Evaluation based on ISO 10993-1 EU Medical Device Regulations 2
D Deviations - Where in ISO 13485 deviations are covered? ISO 13485:2016 - Medical Device Quality Management Systems 7
B ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 2
J ISO 9001:2015 Clause 8.5.1 Control of Production and service provision - Help with Work Instruction Access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Y ISO 13485:2015 Software Validation IQ/OQ/PQ ISO 13485:2016 - Medical Device Quality Management Systems 12
Ajit Basrur Any ISO standard or guidance documents on barcode and scanning? Other Medical Device Related Standards 1

Similar threads

Top Bottom