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
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
S Special 510(K) - Labeling change from Rx to OTC Other US Medical Device Regulations 11
A Document Change Notice vs complete System re-write Manufacturing and Related Processes 4
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 1
R Change Notification - Registrar vs Notified body ISO 13485:2016 - Medical Device Quality Management Systems 1
Marc Insects and Climate Change - 2020 World News 0
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q Company Ownership Change ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I Is highlighting on a printed document considered a change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N China - Start manufacturing before change approval? China Medical Device Regulations 1
L 510K - Trade Name Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
D Change Control - Product Name Change and its associated labeling EU Medical Device Regulations 7
K Is a change that fixes a recalled device significant? Medical Device and FDA Regulations and Standards News 2
L Significant change notice for outsourced warehouse Medical Device and FDA Regulations and Standards News 2
U Change Management vs Change Control? Design and Development of Products and Processes 4
H New 510K VS Documents about design change. Other US Medical Device Regulations 1
P Change on Medical Device Classifications - Dental Crowns Other Medical Device Regulations World-Wide 2
D Are medical device companies required to document every change made to their website? Document Control Systems, Procedures, Forms and Templates 2
Ed Panek Relevant questions on Substantial Change Form CE Marking (Conformité Européene) / CB Scheme 3
K Reporting a Change of Contract Manufacturer for a 510(k) cleared device Other US Medical Device Regulations 5
R Software change control process and defect tracking ISO 13485:2016 - Medical Device Quality Management Systems 1
S Device name change and label color change EU requirement? Other Medical Device Regulations World-Wide 6
M CBE (Change Being Effected) 510(k) Submission Other US Medical Device Regulations 2
D Customer and Company Specific Requirements for notification of Customers of a change in Management or Key Personnel Customer and Company Specific Requirements 3
R Explain what "design change" is to people new to the industry ISO 13485:2016 - Medical Device Quality Management Systems 9
S Change value of target during a batch Capability, Accuracy and Stability - Processes, Machines, etc. 0
T Change in BRH (Brazilian Registration Holder) Technical Manager Other Medical Device Regulations World-Wide 2
G Saline solution change for soft contact lens potting CE Marking (Conformité Européene) / CB Scheme 0
Similar threads


















































Top Bottom