How should we document individual Support Processes

#1
Hi all,

I have recently been asked to transition the company from the 2008 to 2015 9001 standard. As a background we are a small manufacturing company, with 4 management and around 26 other personnel. We believe the processes in our 2008 manual are far too great to be owned and measurable with such a small management team, so have reduced these to 4 core processes of Business Development, Purchasing, Production and Shipping. For each of these we have created a process definition document, analysed risks with this and have KPI's set.

We are wondering how we should be documenting the individual support processes, should these be done in the same way. For instance, we have accounting, maintenance, inspection, document and data control etc listed under support processes. Do we have to create a process definition document as per the core processes for each individual support process, including owner, KPIs, risk analysis. The previous manual which had been drawn up by a previous employee, had a flow map for each of the processes and then only had a documented procedure for each. Any help would be greatly appreciated.
 
Last edited:
Elsmar Forum Sponsor
B

bigqman

#2
The standard does require documented information associated with "support" clauses 7.1.5 monitoring and measuring resources, and 7.2 competence. Your process definition document with analysed risks and KPI's are a form - but not the only form - that such documented information could take. Maybe you only need to identify, document, and monitor the support outputs. (We have a training matrix on a spreadsheet that serves that purpose, for example) The degree of helpful documentation of the support processes should be proportionate to the risk/criticality associated with each support process in your business system. Hope this helps - Congrats on the core process work!
 
Thread starter Similar threads Forum Replies Date
G ISO 17025:2017 7.1.2 - Should I produce a document for the customer? ISO 17025 related Discussions 8
A Removing purchase order form from document control - should it be done? Document Control Systems, Procedures, Forms and Templates 9
T Should a supplier self assessment form be a controlled document? Document Control Systems, Procedures, Forms and Templates 9
R Should Internal Audit criteria be a Controlled Document? Internal Auditing 5
A PFMEA a 'Live' Document and should always have Open Actions FMEA and Control Plans 15
J What should be included in the Design Change Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
C When should an expired document be removed from use? Document Control Systems, Procedures, Forms and Templates 10
R Who should document the Design Review Meeting and Design History File? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
T How much information should I keep in my Master Document Register? Document Control Systems, Procedures, Forms and Templates 8
P ISO 14971 - Is it a guidance document or should we fully comply with it? ISO 14971 - Medical Device Risk Management 14
S Should an auditor document potential nonconformities in the audit report? General Auditing Discussions 41
V Should the EMS manual be a controlled document? Miscellaneous Environmental Standards and EMS Related Discussions 7
A Sale of Demonstration Units - How should we document it from GMP standpoint? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
I Quality should own document control - WHY is finance getting involved?? Document Control Systems, Procedures, Forms and Templates 5
P TS16949 - Should specific process notes be considered a controlled document. IATF 16949 - Automotive Quality Systems Standard 4
A The PFMEA is a living document - When should it be reviewed? FMEA and Control Plans 4
S What is a Desk Audit? What should I expect? A Document Review? IATF 16949 - Automotive Quality Systems Standard 4
Y Who should be the Document Controller? Document Control Systems, Procedures, Forms and Templates 12
T 510(k) submission - Which name should I use in the submission? Other US Medical Device Regulations 3
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
G Should I perform Gage R&R only at the beginning of a new project? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Should 510(k) Predicates be Actively Listed Devices? Other US Medical Device Regulations 12
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
J On PFMEA for danger labels - Label always should be assigned severity 10 ? FMEA and Control Plans 3
H Who should be listed as the manufacturer/distributor on the box? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
M MDR, RED and LVD - Should our device comply with them? EU Medical Device Regulations 2
BeaBea How Many Processes should be created for each Department? Process Maps, Process Mapping and Turtle Diagrams 5
M Should volume of sales be factored into risk probability assessments? ISO 14971 - Medical Device Risk Management 33
MrTetris Should potential bugs be considered in software risk analysis? ISO 14971 - Medical Device Risk Management 5
S Should safety checks be included in the Control Plan? IATF 16949 - Automotive Quality Systems Standard 5
M Which incubation condition should be selected to recover both bacteria and fungus effectively Miscellaneous Environmental Standards and EMS Related Discussions 3
D Is there a specific location for PPE such as safety glass holders and glove dispensers should be mounted Occupational Health & Safety Management Standards 10
Robert Stanley Which Registrar Should I Choose for ISO 9001:2015 registration? Registrars and Notified Bodies 10
M Who should receive the bills from suppliers and vendors, account payable or procurement? Consultants and Consulting 4
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
A We are ISO 13485:2016 should we be audited to ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 16
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
J Organization merger. Should we keep two separate ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 6
S Companies that maintain your machine should be in ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Use of "Shall" versus "Should" in Procedures ISO 13485:2016 - Medical Device Quality Management Systems 21
D Class II medical device - When should a complaint be closed? Customer Complaints 6
Sidney Vianna IATF 16949 News Presentations from the latest IATF Stakeholder Event - Expectation that IATF 16949 certification should equate with product quality. Misguided? IATF 16949 - Automotive Quality Systems Standard 7
L Clause 0.4 of ISO 9001 and EHS - Where should I stop the inclusion of EHS in my QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Ed Panek Part 11 Self Certify Memo - What else should it cover? Qualification and Validation (including 21 CFR Part 11) 5
H Should I mention machine/Equipment password In SOP? Qualification and Validation (including 21 CFR Part 11) 4
D How long should we keep the spare parts available for our medical device, after we have stopped the production? ISO 13485:2016 - Medical Device Quality Management Systems 0
H Statistical Techniques Procedure - What should be included Document Control Systems, Procedures, Forms and Templates 4
Q How should I analyze measurement correlation between me and customer? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
Sidney Vianna Interesting Discussion ISO 9001:2024 - What should be changed in the next Edition of ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 82

Similar threads

Top Bottom