SBS - The Best Value in QMS software

Non-sector specific requirements: Do I need to write a physical procedure

D

disheppa

#1
Ok this seems a little sophomoric but the non sector specific requirements: do I need to write a physical procedure or can I just back the spec up with an already in place procedure- like 6.2.2.3 training on the job or 7.2.2.2 organization manufacturing feasibility. Or am I just bracketing the whole idea of the certification so I can get it done sooner?
 
Elsmar Forum Sponsor
D

D.Scott

#2
I am not sure I fully understand your question but if you have an existing procedure that addresses the requirements and suits your company, there is no reason to re-invent the wheel. Even the required procedures can be addressed by an existing procedure.

I hope this is on-line with your question.

Dave
 
D

disheppa

#3
Thanks for answering my questions sorry that was poorly worded. Let me give you a little more background, I have a small safety equipment manufacturing company I have maybe 10 big jobs a year (still fairly small jobs≈500 seat belts or widgets) that go out to the big three, 90% of the remaining jobs are custom. Were attempting not to gain certification but compliance in order to smooth out wrinkles in our current method of operations and if anyone should request certification the process could be started with ease. What I meant to say is: many of these things we do naturally with out a written procedure even before we started the ISO/QS project, each individual product is checked before it leaves, we have a shipping and receiving log where we keep tracking numbers. For the info sector specific info that is not in the black boxes: Is it more important that there is paper saying that I have a specific procedure or is a knowledgeable staff that can demonstrate that they understand and can carry out the spec just as acceptable. Or do I need both? I hope that this clears that question up a little.
 
R

ralphsulser

#4
Based on my TS16949 experience i would suggest you should have both procedures, and a "Training matrix" or skill map showing what training and competency levels your employees have achieved. I have posted an example here previously. If you can't find it, let me know and I will send you an example of a typical "Skill Map" we use. (BTW, I will be out form end of day today untill Monday a.m.)
 
Thread starter Similar threads Forum Replies Date
V APQP Implementation In A Non-automotive Sector APQP and PPAP 1
F Non conforming locked? Manufacturing and Related Processes 13
M Changing Investigational Device from Non-Sterile to Sterile - what are the implications? Other Medical Device and Orthopedic Related Topics 3
K Is Calibration Required for Non-Adjustable Commercial Inspection Devices? General Measurement Device and Calibration Topics 11
J Informal vs formal scope creep... managing non-medical devices through system processes ISO 13485:2016 - Medical Device Quality Management Systems 2
G Not accepting a non conformity during an audit General Auditing Discussions 11
J In-house (NHS) manufacture and use (by staff) of non-medical devices.. any regulations apply? UK Medical Device Regulations 6
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
A Brexit Mandate for EU Authorised Representative for non medical devices CE Marking (Conformité Européene) / CB Scheme 7
E Accredited vs. non-accredited labs for 60601 compliance in the US IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Accredited vs. non-accredited labs for 60601 compliance in the US Other Medical Device Related Standards 4
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
L Water requirement for Non-sterile topical OTCs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
B Procedure packs with non-medical devices EU Medical Device Regulations 1
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
S Advice on how to reduce overhead of handling non-conforming material Nonconformance and Corrective Action 7
G Team to analyze a non conformance Customer Complaints 26
J Promoting and marketing of a non approved device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
G 0 non conformities in registrar audits over 4 years Management Review Meetings and related Processes 12
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
S Non parametric test for semi-quantitative data. Statistical Analysis Tools, Techniques and SPC 5
B Free Sales Certificate for Non Medical Devices Other Medical Device Related Standards 2
P Ppk results shown as asterisk after the transformation of Non-normal data Using Minitab Software 4
I When is necessary to have RoHS declaration on non-electrical parts? REACH and RoHS Conversations 1
Johnnymo62 Non Aerospace topics - Anything for military trucks, trailers, Humvee type vehicles? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
G Dealing with non conformity caused by Supplier Components detected in the production line IATF 16949 - Automotive Quality Systems Standard 14
M Who are the go to companies for non-destructive hardness testing? General Measurement Device and Calibration Topics 3
R Non conformance (NC) or Corrective & Preventive action (CAPA) CE Marking (Conformité Européene) / CB Scheme 7
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 7
E Qualification for non gmp service providers Supplier Quality Assurance and other Supplier Issues 1
R MDD x PPE Directive - Statement of Non-Applicability EU Medical Device Regulations 3
B Exclusions or justification for non-applicability of IEC standards Reliability Analysis - Predictions, Testing and Standards 1
C Non-EU Language Requirements Other Medical Device Regulations World-Wide 3
A Non-Conformances Found After 3rd Party Sorting Supplier Quality Assurance and other Supplier Issues 12
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 8
D Using non-conforming components even though the final assembly is conforming? Manufacturing and Related Processes 5
N Competent Authority notification for non-EU manufacturer EU Medical Device Regulations 4
M CE marking for NON-EU EU Medical Device Regulations 0
E Non-GMP examples in Pharmaceutical industry Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
blile Increasing PFMEA occurrence ranking after non-conformance FMEA and Control Plans 4
S Non-Conformance and Deviations ISO 13485:2016 - Medical Device Quality Management Systems 4
B Risk Assessment Checklist for Non product Software IEC 62304 - Medical Device Software Life Cycle Processes 1
T Ideas for developing a Supplier Quality Management System, non automotive ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
N Audit non-compliance - API Spec Q1 9th Ed 5.6.1.2 b Oil and Gas Industry Standards and Regulations 16
R Applicability of new non-harmonized standards (MDD/MDR) EU Medical Device Regulations 14
M Scope of Combined ISO 9001 and IATF 16949 QMS - Non-automotive customers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Guidance on manufacturing non-surgical face masks US Food and Drug Administration (FDA) 3

Similar threads

Top Bottom