SBS - The best value in QMS software

Now that most of us (?) have made the transition...

What happened to the size of your QMS documentation when you transfered to ISO9K2K?

  • It shrunk

    Votes: 10 83.3%
  • It remained unchanged

    Votes: 1 8.3%
  • It grew

    Votes: 1 8.3%

  • Total voters
    12

RoxaneB

Super Moderator
Super Moderator
#21
RosieA said:
did have to add several new procedures to address 9K2K stuff.
If you don't mind me asking, Rosie, oh Warrior Goddess, what procedures did you need to add that weren't addressed under the 1994 Standard?
 
Elsmar Forum Sponsor
T

tarheel

#22
Quality documentation size

I eliminated over 75 forms, and it was because they did not need to be controlled. We had control numbers on vacation request forms. Apparently when this company first registered, they decided to control every single piece of paper in the plant. :thedeal:



"Make a bet every day, you may be walking around lucky and not know it!
 
G

Greg B

#23
RCBeyette said:
Thank the stars, it shrunk. Our well-over 100 pages and never-read Quality Manual is now 28 pages and I've seen guys on the floor actually reading it! :cool:

We've cut out over 30 work instructions for processes that can be covered under on-the-job training or in other documentation.

And we're looking to streamline the paperwork even more!

First and foremost, though, we're attempting to streamline processes. Continual improvement. Onwards and upwards.
Roxanne,

This sounds like my system, exactly. We are getting rid of old Work instructions,Forms, Improving training and gutting the QM.
I like Richard's One Page theory - DO IT RIGHT. But I may no longer have a job if it was that simple.
I think those people that have nominated training as the number one way to reduce paperwork are on the right track.
Greg B
 
Last edited by a moderator:

RoxaneB

Super Moderator
Super Moderator
#25
tarheel said:
I eliminated over 75 forms, and it was because they did not need to be controlled. We had control numbers on vacation request forms. Apparently when this company first registered, they decided to control every single piece of paper in the plant.
Interesting. So your organization is going to have documentation only necessitated by the Standard's requirements? I'm just asking.

We had vacation request forms, too, once upon a time and they have been rendered obsolete, but only because we now have a vacation request tracking software programme.

Obviously, I advocate maintaining a system that works for your organization's culture. I guess I'm now used to a system that goes above and beyond the requirements of the Standard...and that sometimes means documentation that has no "shall" for it to meet. :)
 

RoxaneB

Super Moderator
Super Moderator
#26
Greg B said:
But I may no longer have a job if it was that simple.
Isn't that the whole point of our job? ;) Aren't we supposed to work in order that we no longer have a job? Shouldn't the BMS be self-sustaining with minimal amounts of baby-sitting required by us?

Okay, I know, reality-check, Roxane...a girl can dream, though. :eek:
 
T

Tom W

#27
RCBeyette said:
Interesting. So your organization is going to have documentation only necessitated by the Standard's requirements? I'm just asking.

We had vacation request forms, too, once upon a time and they have been rendered obsolete, but only because we now have a vacation request tracking software programme.

Obviously, I advocate maintaining a system that works for your organization's culture. I guess I'm now used to a system that goes above and beyond the requirements of the Standard...and that sometimes means documentation that has no "shall" for it to meet. :)
:agree: Doing it throughout the organization must mean something to the organization to be effective. Where I work, we actually use the system for improvements and look for ways to eliminate waste throughout the entire organization. Like I have said before - "A well controlled monster is better than an out-of-control monster!" :D
 
J

Jimmy Olson

#28
RCBeyette said:
Isn't that the whole point of our job? ;) Aren't we supposed to work in order that we no longer have a job? Shouldn't the BMS be self-sustaining with minimal amounts of baby-sitting required by us?

Okay, I know, reality-check, Roxane...a girl can dream, though. :eek:
Just thought I would pass on a little tidbit that I had heard once. Learn to be at peace with reality. :)
 
R

RosieA

#29
RCBeyette said:
If you don't mind me asking, Rosie, oh Warrior Goddess, what procedures did you need to add that weren't addressed under the 1994 Standard?
We didn't have anything written on objectives, or customer sat. The balance of what I had to do was adjustments to current procedures. I think these were the only brand new ones.
 

RoxaneB

Super Moderator
Super Moderator
#30
RosieA said:
We didn't have anything written on objectives, or customer sat. The balance of what I had to do was adjustments to current procedures. I think these were the only brand new ones.
Ah, got it...I think many organizations were probably the same as you.

Thanks to our Brasilian company, we always had Quality Objectives and we could show how our Key Indicators tied into them.

Our Sales Department also had documentation for assessment forms, surveys, and trip reports, so we were okay in that area, too.
 
Thread starter Similar threads Forum Replies Date
E Configurable/Custom made or accessories? EU Medical Device Regulations 0
K Usability for custom made medical devices IEC 62366 - Medical Device Usability Engineering 5
qualprod Assign a name to a home-made ERP system? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
classical_quality Reflecting: Improvements Made 2019 & 2020? Coffee Break and Water Cooler Discussions 2
J Iterative design and production for custom made products ISO 13485:2016 - Medical Device Quality Management Systems 3
J Validity / outcomes measure for custom made medical device ISO 13485:2016 - Medical Device Quality Management Systems 2
D Are Eye drops made in China classified as medical device in China? ISO 13485:2016 - Medical Device Quality Management Systems 0
DuncanGibbons How are part cut out specimens made and tested? Manufacturing and Related Processes 1
MDD_QNA Country of origin - Made in EU or Made in Finland? EU Medical Device Regulations 1
J Custom made medical devices - Wheelchairs EU Medical Device Regulations 6
T Custom made medical device MDD vs MDR definition CE Marking (Conformité Européene) / CB Scheme 12
M Search for predicates to see what claims are being made for those predicates 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Are medical device companies required to document every change made to their website? Document Control Systems, Procedures, Forms and Templates 2
M Informational US FDA – Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health – Final Rule Medical Device and FDA Regulations and Standards News 0
atitheya Notified bodies operating in India for medical devices made in India CE Marking (Conformité Européene) / CB Scheme 1
J Custom-made implants (Class IIb) and pre-commercialization clinical trials in Spain EU Medical Device Regulations 4
C If it's not a custom-made medical device... What is it? Clinician requests EU Medical Device Regulations 11
P Material selection - How do we select a raw material? Bolt made of SAE J994 grade 2 Customer and Company Specific Requirements 3
R REACH and ROHS compliance for hundreds of parts made over 25 years REACH and RoHS Conversations 3
D US Made class I CE Mark product for export only to EU Other US Medical Device Regulations 4
M Is "Made in (Country)" a labelling requirement? Other Medical Device Regulations World-Wide 8
T IMDS - Creating an MDS out of material and a made item? RoHS, REACH, ELV, IMDS and Restricted Substances 4
L CQE Quiz - Something I made up to make aspiring CQE's head hurt Training - Internal, External, Online and Distance Learning 1
J How to document Corrections made to a Medical Device History File ISO 13485:2016 - Medical Device Quality Management Systems 1
JoCam Labeling Requirements for Medical Devices Made in China EU Medical Device Regulations 6
F Country of Origin or Made In Tags - Where a country is a principality EU Medical Device Regulations 11
V Ultrasonic NDT on CNC Product made of Stainless Steel General Measurement Device and Calibration Topics 2
I Catch up 510(k) - Non-significant changes were made Other US Medical Device Regulations 1
K DoC (Declaration of Conformity) for Custom Made Medical Devices EU Medical Device Regulations 1
A Supplier Audit Request - Made be laugh ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Biocompatibility testing for nasal prongs made of medical grade silicone 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
J Supplier made a Change without Notifying Us APQP and PPAP 11
B Odd First Article Question - Part made by a sister company APQP and PPAP 7
F Registration Process Guidance for Custom-Made Medical Devices in South/Latin America Other Medical Device Regulations World-Wide 11
A Has anyone made an ISO9001:2015 vs. ISO9001:2008 Matrix ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
M Portugal Class I Medical Device Registration of device made in Italy EU Medical Device Regulations 1
W Process Validation Training - Custom made Medical Device Design and Development of Products and Processes 4
Ajit Basrur The man who made a forest ! Coffee Break and Water Cooler Discussions 0
A Generating Purchase Orders - Orders made over the Internet or a Phone ISO 13485:2016 - Medical Device Quality Management Systems 8
AnaMariaVR2 Warning ? Don?t Confuse ?Made In USA? And ?Inspected By FDA? With Patriotism US Food and Drug Administration (FDA) 3
D Are implant rods (made of Titanium) passivated? Other Medical Device and Orthopedic Related Topics 7
T Made up terms and words! Coffee Break and Water Cooler Discussions 14
AnaMariaVR2 Ancient statue discovered by Nazis is made from meteorite Coffee Break and Water Cooler Discussions 1
J Does anyone have a summary of changes made to ISO 11137-2? Other Medical Device Related Standards 3
S Use of Made in XXX Country on Medical Device Labels Other Medical Device Regulations World-Wide 3
J Gage R&R on a Length Gage Made In-House Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
M Custom-Made Medical Device Regulations and Registration in Argentina Other Medical Device Regulations World-Wide 5
W Made in China - Requirement for it to be Printed on the Label? Other US Medical Device Regulations 2
I About the 510(k) Submission US Company but Products are made in China US Food and Drug Administration (FDA) 5
S Changes made in Rev 4 of FMEA Reference Manual FMEA and Control Plans 1

Similar threads

Top Bottom