SCRUM integration into IEC62304

sagai

Quite Involved in Discussions
#1
Hello,

recently we shall finalize our software lifecycle SOP and I am not confident at all the way I think is the best for integrating SCRUM development method into the 62304 .
There are two candidate approaches to do so according to our ideas, I only would like to know your impression which would be the most acceptable by you, or may be these are the same, or you may have a better idea.

SCRUM is an iterative software development method, BUT 62304 is basically a V modell driven one.

Way I. (in highlights):
Define for 5.2 a scrum plan document, wich defines the scrum cycles, the project team, the wish list and the timing, product backlog, etc.
For scrum iterations, only add for 5.5 the iteration related activities/tasks, the user/system/design documentation will be changed using the Problem management->Configuration management change processes via configuration item change controll.

Way II. (in highlights):
Define for 5.2, 5.3, 5.4 and for 5.5 all the necessary iteration related activities/tasks, saying for all of them that it will be finished when the last iteration completed.

If there is a question or i have not expressed something clearly, please ask for more details, I am very much interested your views.


br
Sz.
 
Elsmar Forum Sponsor

Le Chiffre

Quite Involved in Discussions
#2
There's a lot of papers and websites that discuss this, search for 62304 and the more general term "Agile".

My comment would be that although IEC 62304 may use the "V" model for illustration, it allows for software to be developed with any methodology. e.g. Waterfall, Incremental (agile) and Evolutionary. It's emphasis is that all process outputs be maintained and that all tests and risk assessments are conducted before release.

To be agile in medical device software development means that you have to include the main elements of 62304 in each sprint. This may lengthen the Scrum sprints normal for other software development, but requirements management/traceability, design verification and validation, code reviews, integration testing, risk management and control, and configuration management must all be performed each time.
 

sagai

Quite Involved in Discussions
#3
actually we are planning only to run 5.2-5.5 in each iteration(incl. Process 7-8-9) with a special subset build numbering identification for the software product, and 5.6-5.7 only after (or in) the last iteration.
thank you for you reply and any future ones, br
Sz.
 
Thread starter Similar threads Forum Replies Date
C Change Control in a SCRUM World Misc. Quality Assurance and Business Systems Related Topics 3
0 ISO 13485:2016 Chapter 8 Integration of the subsections ISO 13485:2016 - Medical Device Quality Management Systems 3
P IEC 62304 - evaluation of integration and system testing IEC 62304 - Medical Device Software Life Cycle Processes 4
Sidney Vianna Informational ISO releases second edition of handbook on Integration of Management System Standards Other ISO and International Standards and European Regulations 0
A Integration of Information Security in an existent Integrated Management System IEC 27001 - Information Security Management Systems (ISMS) 4
tony wardle Lean and TS16949 - Integration Lean in Manufacturing and Service Industries 4
S ERP Software and Quality Department Procedures Integration Misc. Quality Assurance and Business Systems Related Topics 4
O Integration of ISO 14001, OHSAS18001 and ISO50001 Management System Other ISO and International Standards and European Regulations 1
A Integration of Management System (Power Station) Misc. Quality Assurance and Business Systems Related Topics 1
x-files Standpoints about integration of Policies & Manuals ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Integration of ISO 9001 and OHSAS 18001 - Management Manual Occupational Health & Safety Management Standards 5
E Owns Customer Property but No Product Integration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Marc Definition IFAT - Integration Factory Acceptance Testing Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
A Forklift Integration into the Quality Manual AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
P Integration of Lean and Six Sigma Six Sigma 3
J RoHS/REACH Compliance Tools and PLM Integration RoHS, REACH, ELV, IMDS and Restricted Substances 14
P ISO 22000 and ISO 9001:2008 Manual and Procedures Integration Food Safety - ISO 22000, HACCP (21 CFR 120) 9
R Quality and Environmental Management System Integration Benchmarking 11
V Process Validation Guidance establishing the Integration with QbD - April 2012 Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
E CMMI (Capability Maturity Model Integration) - questions Software Quality Assurance 5
M Integration of Management Systems in a Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
T Integration of Supplier Quality Assurance within Plant Engineering Supplier Quality Assurance and other Supplier Issues 5
E System Integration - How to integrate ISO 14064 and ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B Integration of ISO 14001 & OHSAS 18001 with ISO 9001:2008 REACH and RoHS Conversations 5
S Integration of HR (Human Resources) and Quality Management Systems ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Organization Chart Control and Quality Manual Integration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
V Integration of Quality Manual and Procedure Manual Quality Management System (QMS) Manuals 13
R CMMI (Capability Maturity Model Integration) - Ever heard CMMI? Software Quality Assurance 5
T Most appropriate ISO Standard for Design & Integration company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
L Vertical vs Horizontal Integration ISO9000 QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T CAPA Software with Oracle integration capabilities ISO 13485:2016 - Medical Device Quality Management Systems 5
F Strategic Planning and Quality Management System Integration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
S help me.......18001/14001 integration documents ISO 14001:2015 Specific Discussions 13
M Integration of ISO 17025 with TS 16949, ISO 14001 and OHSAS 18001 ISO 17025 related Discussions 8
L ISO 9001:2000 and CMMI v1.2 Integration and Org Deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
P Problems with Internal Process Audit integration due to different CSR IATF 16949 - Automotive Quality Systems Standard 3
P Problems with FMEA integration due to different Customer Specific Requirements FMEA and Control Plans 12
T Software Integration Test Software Quality Assurance 3
B How to increase integration between our Quality & Environmental Management Systems Miscellaneous Environmental Standards and EMS Related Discussions 8
A Post Acquisition Integration Stage ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S How do I learn CMMI (Capability Maturity Model Integration)? Software Quality Assurance 4
E Integration of six sigma and environmental management systems Miscellaneous Environmental Standards and EMS Related Discussions 1
R Integration of lean principles in supply chain Lean in Manufacturing and Service Industries 4
A Integration of Six Sigma & TPM - Please tell me how Six Sigma 5
M Integration and test - how to convince boss to change approach Customer and Company Specific Requirements 1
H VDA Qdx V1.0 - An integration standard for quality data exchange VDA Standards - Germany's Automotive Standards 5
Govind Sarbanes-Oxley integration with existing QMS (Quality Management System) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
S OHSAS 18001 Implementation - ISO 14001 Integration - Worker's Comp breaks? Occupational Health & Safety Management Standards 10
L More ISO 14001 and ISO 9001 Integration Questions Miscellaneous Environmental Standards and EMS Related Discussions 11
G Integration of ISO 14001 with ISO 9001 for a 'single' system Miscellaneous Environmental Standards and EMS Related Discussions 24

Similar threads

Top Bottom