SBS - The best value in QMS software

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

Hunkered Down for the Duration with a Mask on...
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 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) 3
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
M Change in Constitution / Ownership of firm -------ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
P ISO 9001 certification with zero customers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M ISO 14971 Determination of Competent Persons ISO 14971 - Medical Device Risk Management 4
R Clinical accuracy and repeatability of IR(infrared) thermometer, no maximum error criteria is recommended in ISO Other Medical Device Related Standards 10
Q The scope of ISO 21534 Other Medical Device Related Standards 0
A What must be recorded? (ISO 9001:2015, subclause 10.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M ISO 14971:2019: Criteria for overall residual risk ISO 14971 - Medical Device Risk Management 4
B Updated IATF 16949 - Will IATF 16949 get revised when ISO 9001:202X is released? IATF 16949 - Automotive Quality Systems Standard 4
S ISO 9001:2015 vs 21 CFR Part 211 matrix Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
N Quality Compliance Officer - ISO 13485, London Job Openings, Consulting and Employment Opportunities 1
T ISO 17025: Lockout/Tagout Requirement ISO 17025 related Discussions 1
N ISO 9001 implementation in a Gold exporting business ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
A Environmental Compliance obligations and risks (ISO 14001:2015 6.1.3) ISO 14001:2015 Specific Discussions 3
R ISO 17025 vertical audit checklist wanted Document Control Systems, Procedures, Forms and Templates 2
A Tips and Tricks to understand ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom