Change the way we need to document our work - Copies of requirements?

K

Keith

#1
Hello all,
Please forgive my complete ignorance of this subject as I've never had to think about this before now.

I work in a small industrial repair shop & the increasly stringent quality concerns (NOT that we didn't provide quality services in the past!!!) are beginning to change the way we need to document our work.

What I need to find out is--Where can I get a copy of the "rulebook". It would help us greatly to know what type of documentation is required if any or are our customers just doing a little CYA?

Thanks in advance.

Keith
 
Elsmar Forum Sponsor
D

David Guffey

#2
Keith,

You might want to start with those very customers who may be "CYA"'ing you. What are THEIR expectations? What are THEIR requirements? This may or may not lead you to the ISO 9000 series, the QS-9000 (if you are automotive), or any number of other "standards" you might be expected to comply with.

I have always had the most success in satisfying customers when I ask them what their expectations are.
 
K

Keith

#3
David,
Excellent advice! That was to be my second step. I was hoping to do a little homework first to disguise some of my clueless-ness. I hate to approach someone on any subject and sound completely uninformed (although that still happens every day!) The anonymity of the net makes me a little less shy about displaying my ignorance.

Thank you,

Keith
 
Thread starter Similar threads Forum Replies Date
J Need Change Control Yes/No Decision Tree Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
R Do we need issue ECN (Engineering Change Notice) towards updated Material Specification? Design and Development of Products and Processes 2
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
G Need to change KPI we called NC parts (maximum 3%.) to FTQ (first time quality) IATF 16949 - Automotive Quality Systems Standard 4
T Need help developing an ECO (Engineering Change order) procedure Document Control Systems, Procedures, Forms and Templates 3
V Do I need dimensionals performed for PPAP for every revision change? APQP and PPAP 2
V Note Change to Print - Do I need dimensions results? APQP and PPAP 1
K Need help with AS9100 Scope Change to include Manufacturing Process Maps, Process Mapping and Turtle Diagrams 1
V Do we need to enclose Draft version of Proposed Changes in Change Control US Food and Drug Administration (FDA) 8
E Change in the Expiration Date (from 24-36 months) - Need 510(k) changes? Other US Medical Device Regulations 10
G Change of procedure for handling new projects - do the ongoing ones need to follow? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
W Need to reconduct MSA when there is a change in operators? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
L I need help with containment practices - First off/coil change containment Manufacturing and Related Processes 4
M Need advice to implement CAPP (Computer Aided Process Planning) change. Manufacturing and Related Processes 4
J Change Management System - Does ISO 9001 specify you need a process flow? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
K Culture Shock and Things Need to Change - Implementing ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
S Need to change multi-site TS 16949 certification to add another company Registrars and Notified Bodies 4
S Need assistance on how to generate Change Notices for Vendors and tracking APQP and PPAP 0
C Controlled EC's - Need some advice on my current Engineering Change process IATF 16949 - Automotive Quality Systems Standard 2
J If you change the Control Plan do you need to resubmit PPAP APQP and PPAP 13
D Need to get ISO recertified for a site change, but just near to the original site? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Do I need to change my SOPs? Transitioning to ISO 9001:2000 from the 1994 version ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
G Change History: What Documents Need a History? Document Control Systems, Procedures, Forms and Templates 34
E Procedure Numbering Change? Still the need for maintaining Level 1, 2, 3, documents? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B PPAP and the need to re-submit - Engineering change to a single component part QS-9000 - American Automotive Manufacturers Standard 1
M Change control on Tracking Sheet ISO 13485:2016 - Medical Device Quality Management Systems 11
D EU MDR - Change of device name (legacy device) EU Medical Device Regulations 4
L Change Log in (controlled) Forms? (ISO 9001:2015) Document Control Systems, Procedures, Forms and Templates 6
H Control of Change i.e. process and WI IATF 16949 - Automotive Quality Systems Standard 9
dgrainger Informational MHRA's Software and AI as a Medical Device Change Programme UK Medical Device Regulations 0
K Is implementing Electronic Signatures a Significant Change to the QMS? ISO 13485:2016 - Medical Device Quality Management Systems 10
A Management of change procedure for ISO 45001 Occupational Health & Safety Management Standards 5
N Cleanroom Classification Change Other Medical Device Related Standards 7
D Engineering Change order vs. Change Control ISO 13485:2016 - Medical Device Quality Management Systems 3
Watchcat Change Request Documents - What's Typical These Days? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 14
NDesouza Management of Change (MOC) Manufacturing and Related Processes 11
H Customer Specific Change in a SaaS SAMD IEC 62304 - Medical Device Software Life Cycle Processes 1
D GAMP CAT 5 Change Control Qualification and Validation (including 21 CFR Part 11) 9
lanley liao Questions regarding the change of critical suppliers and key personnel Oil and Gas Industry Standards and Regulations 5
I What revalidation is necessary if we change parts in a WFI loop ? Qualification and Validation (including 21 CFR Part 11) 1
Y Exporting data to the cloud is a "Significant Change"? EU Medical Device Regulations 5
A Design Change/ECO Related Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Reseller Request to Change UPC on Medical Device via Re-labeling Medical Device and FDA Regulations and Standards News 5
S Change management with FAA Federal Aviation Administration (FAA) Standards and Requirements 0
R Revalidation under VDmax25 following material change ISO 13485:2016 - Medical Device Quality Management Systems 2
D Change to labelling - does it require a new 510(k)? US Food and Drug Administration (FDA) 5
A How can we change a device trade name in 510(k) summary? US Food and Drug Administration (FDA) 0
L Change Notification Requirements for class 1 devices Medical Device and FDA Regulations and Standards News 1
R CB/Auditor Requiring a change in scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Ed Panek Notified Body Substantial Change MDD EU Medical Device Regulations 1

Similar threads

Top Bottom