SBS - The best value in QMS software

Review and approval methodology

P

Paul Morrow

#1
I have always worked in organisations (quite a few) that use a 'form', be it hardcopy or electronic for both the review and approval of a new document and for any subsequent propsed changes following issue.

However, I am currently working with a small organisation that is seeking approval to iso9k, and on examining this standard I note that their is no requirement for such a form, merley that certain criteria be satisfied - to approve prior to use, that changes are identified, etc.

Oh I thought, thats changed from the 94 version. But of course it hasn't. There never was a requirement for such a type of form or request.

OK. So the 'form' may be alright for some organisations but I really dont want to introduce such a thing. We cannot use email or an intranet. What other methods are you people using?
 
Elsmar Forum Sponsor
J

JodiB

#2
We use a form.

But you could use a printed hardcopy of the document, with approval signature right there on it and changes in the margins all initialed. Similar to what you would do for a contract.
 
Thread starter Similar threads Forum Replies Date
D Engineering Drawing Review and Approval Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
W ISO 9001:2015 Clause 7.5.2 - Is Review and Approval applicable to Records? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 30
T Inspection Form Review And Approval - FDA Requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
A Procedure for Labeling Review and Approval and Specifications Matrix US Food and Drug Administration (FDA) 2
J ISO 17665-1 & 2 Review and approval of validation (of moist heat sterilizers) Other ISO and International Standards and European Regulations 3
J Requirements for Review and Approval of QMS Documents Document Control Systems, Procedures, Forms and Templates 14
S Showing Evidence of Review and Approval of Blank Forms and Templates 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
V Supplier?s PPAP - Production Process Control Plan Review, Evaluation and Approval? FMEA and Control Plans 5
V How do you manage the Review Comments post to Approval of a Document Document Control Systems, Procedures, Forms and Templates 3
K Human Factor Assessment for IRB (Institutional Review Board) Approval? EU Medical Device Regulations 7
L ISO 9001 Document Review and Approval Form Requirements Document Control Systems, Procedures, Forms and Templates 6
H Review and Approval in Quality Records? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Requirement for Review and Re-Approval of Documents - ISO 9001 Clause 4.2.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J Supplier Purchase Order Review and Approval Requirements IATF 16949 - Automotive Quality Systems Standard 3
S Review/Revision and Approval sections of SOP's and WI's Document Control Systems, Procedures, Forms and Templates 2
P A SAP DMS Q: Sequantial work flow for DMS review and Approval Document Control Systems, Procedures, Forms and Templates 1
J Quality Manual Review and Approval - For each & every page? Quality Management System (QMS) Manuals 12
G Enquiry and Contract Records - Review and Approval Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
F Delivery before PPAP review and/or approval APQP and PPAP 5
S Defining Document Review and Approval responsibilities - ISO 13485 - Medical Device Document Control Systems, Procedures, Forms and Templates 3
J Using Forum software as review and approval system. Document Control Systems, Procedures, Forms and Templates 9
M TS 16949 - 7.5.2 - Process Validation - Criteria for review and approval of processes IATF 16949 - Automotive Quality Systems Standard 8
T Document Review and Approval Form - Examples Attached Document Control Systems, Procedures, Forms and Templates 11
S Evidence of Review and Approval ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Purchasing Review and Approval Process QS-9000 - American Automotive Manufacturers Standard 6
Marc Do signatures need to appear on procedures to indicate review and approval? Document Control Systems, Procedures, Forms and Templates 2
S Risk Management Review ISO 14971 - Medical Device Risk Management 4
G Management Review (integrated system) Management Review Meetings and related Processes 17
M Management review check-list Management Review Meetings and related Processes 3
A Ethics Committee Review Process for IVD Products EU Medical Device Regulations 2
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
G Control Plan & PFMEA Review Procedure? FMEA and Control Plans 1
B SAP Audit trail Periodic Review EU Medical Device Regulations 1
K AS9100D 8.2.1 Review Requirements for Products and Services AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R MRB (Material Review Board) Process using MS Sharepoint or MS Teams Manufacturing and Related Processes 2
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
R MDR & depth of technical files review by NB's EU Medical Device Regulations 18
D Legacy Device Review CE Marking (Conformité Européene) / CB Scheme 1
Q PPT used as Design Review ISO 13485:2016 - Medical Device Quality Management Systems 3
bryan willemot Contract Review and risk managment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
S ISO 9001 Clause 8.2.3 - Review of the requirements for products and services in a Cafe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A 510(k) review timeline 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
S Management Review (9.3) - Management Review Minutes/Report ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
M Forms review Manufacturing and Related Processes 5
V Quality review Meeting with Customer for complaints we received Customer Complaints 6
C Contract Review with Multiple Line items ISO 13485:2016 - Medical Device Quality Management Systems 7
O ISO 13485 - Is management review required before stage 1? ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom