Unattached (stand-alone) Forms acceptable for AS9100C?

Elsmar Forum Sponsor

Michael_M

Trusted Information Resource
#2
Re: Unattached forms

I am not sure what your question is regarding so I will answer to the best of my ability hoping I hit your question.

1. Forms (not filled out) are part of document control (4.2.3). In essence, these need to be controlled to prevent unintended use, legible, identifiable, and relevant. We have all forms logged in an excel file (because we are old fashion) with form number, revision, who is responsible, and who it applies to. We ended up 'controlling' some forms that seemed, at the time, to be silly such as vacation requests, person tool purchases, and the like. However, it was pointed out that these fall under 6.2 so we gave them identifications. (Note: I still disagree that things like Vacation requests, and office supply request forms should be on this list but I was the loser in this argument).

2. If you are talking about records (form is filled out) that falls under 4.2.4 and must be maintained for the duration. You and/or your customer define the time. For example, material certifications per our customer must be maintained for 2-10 years (depending on customer) so we just maintain all material certifications for 10+ years. Vacation Requests are stored for 1 year after the vacation is taken (we defined this time).

I hope this helps.
 

wooden nickle

Involved In Discussions
#3
Re: Unattached forms

I am not sure what your question is regarding so I will answer to the best of my ability hoping I hit your question.

1. Forms (not filled out) are part of document control (4.2.3). In essence, these need to be controlled to prevent unintended use, legible, identifiable, and relevant. We have all forms logged in an excel file (because we are old fashion) with form number, revision, who is responsible, and who it applies to. We ended up 'controlling' some forms that seemed, at the time, to be silly such as vacation requests, person tool purchases, and the like. However, it was pointed out that these fall under 6.2 so we gave them identifications. (Note: I still disagree that things like Vacation requests, and office supply request forms should be on this list but I was the loser in this argument).

2. If you are talking about records (form is filled out) that falls under 4.2.4 and must be maintained for the duration. You and/or your customer define the time. For example, material certifications per our customer must be maintained for 2-10 years (depending on customer) so we just maintain all material certifications for 10+ years. Vacation Requests are stored for 1 year after the vacation is taken (we defined this time).

I hope this helps.
Thank you Michael M, what I am refering to is: does a form need to be attached to a procedure or work instruction. I don't know how anyone would know it existed if it did not. I am getting some pushback on this.
 

Michael_M

Trusted Information Resource
#6
I can give an example of a form that is not referenced in a work instruction, procedure or process. The Vacation Request form. We do not have an reference to it but it is still a controlled form since Human Resources uses it.

Personally I think it is the 'best form' we have :notme:
 

howste

Thaumaturge
Super Moderator
#7
Our Document Control Clerk stated today that we have forms that are not attached to anything they are standalone. Is this policy ok in AS9100C
The short story is that AS9100 does not require (blank) forms to be referenced in another document.

I'm sure that there are lots of reasons why you or your coworkers may want them to be referenced in other document(s). If they are being used effectively as intended, then you should be fine as is. If you're not getting information recorded that should be because people don't know the forms exist, then do something about it.
 
K

KN Quality

#8
Most organizations will usually reference the associated forms to the procedure that applies but there is no requirement to attach it to the procedure. With regard to a form for vacation as you have stated in you comment above. A vacation form would not fall under the standards definition of a QMS document in my opinion. The standard is more concerned with forms that support the evidence of your system being effectively implemented. Now with the AS100 this might actually change some with the standard going into areas of the organization that it has never gone before.
 
Thread starter Similar threads Forum Replies Date
R Shall a new UDI-DI be required when stand-alone software device's version is updated? EU Medical Device Regulations 1
E Stand-by vs. ON/OFF symbol IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Software Release Note - Class A stand alone software medical device IEC 62304 - Medical Device Software Life Cycle Processes 2
M Informational USFDA – Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Stand Medical Device and FDA Regulations and Standards News 0
CCaantley Where to get a good test indicator stand for a granite surface plate General Measurement Device and Calibration Topics 8
S Do we need separate stand alone procedure for Suspect Unapproved Parts? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
M ISO 14971 and Stand-Alone Diagnostic Software ISO 14971 - Medical Device Risk Management 4
D Microsoft Excel database to Stand-alone software Calibration and Metrology Software and Hardware 3
P Is a different 510k is required for each (stand alone) software configurations? Other US Medical Device Regulations 3
S Cloud-Based Stand Alone Software - Software Medical Device (Class II) US Food and Drug Administration (FDA) 2
K ISO 13485:2016 Self Certification for Class I (annex 9) Stand-Alone Software? ISO 13485:2016 - Medical Device Quality Management Systems 3
B Is IEC TR 80002-1:2009 applicable to stand-alone medical device software? ISO 14971 - Medical Device Risk Management 1
S What does SOR and DORS stand for in the Medical Devices Regulations? Canada Medical Device Regulations 2
K UDI "Version or Model" for Stand-Alone Medical Device Software US Food and Drug Administration (FDA) 6
Q IATF 16949 Not a Stand Alone System? IATF 16949 - Automotive Quality Systems Standard 14
K DHR approval requirements for stand-alone software US Food and Drug Administration (FDA) 4
K "Purchasing Controls" for Stand-alone Software US Food and Drug Administration (FDA) 2
A End of Life for Medical Mobile App (Stand Alone Software) Medical Information Technology, Medical Software and Health Informatics 5
K What does MIC, CMI and CLSQ stand for in the measurement software output? Calibration and Metrology Software and Hardware 2
G Definition S.N.D. - What does abbreviation S.N.D. stand for on prints? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
L Device Labeling - Stand Alone Symbols of ISO15223 no longer FDA recognized Other US Medical Device Regulations 2
K Classification of the Reseller of Stand Alone Medical Device Software ISO 13485:2016 - Medical Device Quality Management Systems 3
K ISO 13485 requirements for Stand Alone Medical Device Software (Class II a) ISO 13485:2016 - Medical Device Quality Management Systems 1
kedarg6500 What is the difference between NS & NF3 stand for threads Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
bio_subbu MHRA issues guidance on Medical Device stand-alone software (including apps) EU Medical Device Regulations 1
N Which regulations apply to Medical Stand Alone Software in Europe? ISO 13485:2016 - Medical Device Quality Management Systems 3
K Stand Alone Software definition according to PMDA Japan Medical Device Regulations 3
M CE Marking and use of IEC 80002-1 for Risk Management of Stand Alone Software EU Medical Device Regulations 13
C Direction for Use/ UI for stand alone software Canada Medical Device Regulations 1
C Do they use the same standards: Stand-alone software and embedded software? IEC 62304 - Medical Device Software Life Cycle Processes 13
R Equivalent CE for export to Japan - Stand exibition with LED lights CE Marking (Conformité Européene) / CB Scheme 3
G What does m stand for in Cpm? Capability, Accuracy and Stability - Processes, Machines, etc. 2
A Does EN 60601-1 apply to stand alone software medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
B Seeking help in writing an audit report that can stand on the court Internal Auditing 6
C Stand Alone ISO Certification or Include New Mfg. Line in Current Registration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S K-stand definition and more information about it Manufacturing and Related Processes 1
R Stand-Alone Power Supply with Metal Enclosure IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
N RS485 stand to meet the EFT (Electrical Fast Transients) test according to IEC 60601 ISO 13485:2016 - Medical Device Quality Management Systems 3
W MEDDEV: Qualification and Classification of Stand Alone Software Published EU Medical Device Regulations 4
S IEC 62366 for Stand-Alone Medical Device Software and Usability Engineering IEC 62366 - Medical Device Usability Engineering 16
xfngrs What does the Ford Europe acronym ISRD stand for? APQP and PPAP 6
F Does the SI acronym stand for Syst?me International d'Unit?s? General Measurement Device and Calibration Topics 1
R Quality Manual and Procedure Preferences (Stand Alone Documents?) Quality Management System (QMS) Manuals 21
J Acronym in ASTM E-18 & ASTM E-110 - What do Sr & SR stand for? Quality Tools, Improvement and Analysis 6
I Stand-alone Software as a Medical Device IEC 62304 - Medical Device Software Life Cycle Processes 1
W TV stand or wall bracket? After Work and Weekend Discussion Topics 13
H What does the abbreviation for ?POAG? terminal/stud stand for? Manufacturing and Related Processes 3
K Site with only Manufacturing and stand alone ISO 9001 certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S What does the term "S4/IEE" stand for? Six Sigma 6
Q What does MRP stand for? Manufacturing Resource(s) Planning Misc. Quality Assurance and Business Systems Related Topics 4

Similar threads

Top Bottom