hello Friends ,
this is ahmed,I am going make a H&S management system based on iso 45001 Requirements,
I need to start it as soon as possible,
I have a Engineering Construction company with some employee around 50+on 3 different locations including head office.
before going for certification...
Starting our audit system from scratch since we are a growing manufacturing company, was wondering if anyone had any good auditing schedule, check list, audit plan templates to help a fella, or if you have a good resources that would be greatly appreciated
I am looking to create a general form for incoming part inspection that I can add to a quality plan for incoming receiving parts. I am struggling to put a form together that will also allow a field for the measured result for the part inspected. For example, I am checking the size of a screw...
Does anyone have electronic templates for making paper control charts? I am looking to print blank control charts for use on the manufacturing floor. It seems that everyone has migrated to electronic SPC. What good is a control chart in your computer unless you have a computer at every...
Can anyone share a DFMEA template...a cursory search revealed DFMEA matrices, but no DFMEA template....additionally for those Cove software experts, please share any current experience re: validation and vetting of deliverable software, tools, processes etc...Thank You
Hi Guys, can anyone share an NCMR (nonconforming material report) procedure of a medical device company?
I want to see how it is managed.
1. lets say I use contract manufacturer to manufacture my medical device.
2. during incoming inspection inc case there is a problem with the device, then I...
Most of the Risk assessment templates that I have seen are all Asset based. You start with asset register, and look for risks and mitigation plans.
I guess that was a standard approach in ISO 27001:2005. There are a couple of templates on the internet, however they are again asset based...
Hi, I am unable to find the Guidance in English for PMS requirements for Taiwan. Does anyone have this translated or a similar presentation or template procedures for adverse event reporting and field corrections in Taiwan, I would be greatly appreciative. Thanks!
Hi, my name is Johnnie, supervisor at a small but rapidly growing mfg/engineering company. I recently became supervisor in our NPI department to control the flow of the floor. My new manager wanted to run in a lean process or six sigma. New to my company and not much experienced personnel here...
I'm looking for clinical evaluation report (CER) template according to the new medical device regulation (MDR) not Meddev 2.7 rev 4.
I'm also looking for templates for clinical evaluation plan , PMCF (post marketing clinical follow up)
could anyone help me?
For a company that makes SaMD, (software as a medical device), does anyone have a design change control form template? I know in the world of hardware devices, there are engineering change controls and the associated forms where you assess the impact. Does the world of software...
I work at a company that uses a Work Order Form for Material Verification, Label Verification, and the different operations(Lamination, Slitting, etc..) it would take to create a part for other automotive companies. Each work order has a unique number to trace it by, but I am...