procedures (general)

  1. A

    Process Control / Control Charting Procedure

    Hi Elsmar Covers, I was wondering if anyone could share either tips or a redacted work instruction for creating and applying control charts. Background: We acquire multiple discrete data sets during our incoming inspection, in-process work, and final inspection. The data acquired is defined in...
  2. S

    Looking for procedure on UDI (Unique Device Identification)

    Looking for a procedure on UDI requirements. Thank you!
  3. M

    Quality System Processes without Documented Procedures

    This thread went on a bit of a tangent discussing procedureless processes. Highly recommend checking it out as BevD's description of Toyota's assembly process without procedural documentation should be fascinating to anyone - like myself - who is ensconced in the...
  4. Marcelo Antunes

    FDA News USFDA Final Rule – Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures

    Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures Continue reading...
  5. K

    Assigning the Correct Procedures Applicable to Job Titles

    I'm the management rep for a small (35 employees) job shop. The previous rep kept a skills matrix and assigned specific procedures for all the different job titles in the shop. We have 17 procedures and 15 different job titles. I find it very confusing as to which specific procedures to assign...
  6. M

    Translate Procedures into Spanish

    About half of our staff are non English speakers and all of our procedures are written in English. Right now I have a Spanish speaking person who works for me go over the procedure with them and explain in Spanish. Is there any regulations or anything that says I can't just have her translate...
  7. J

    Nonconforming product procedures SOP help :)

    Looking for some good Nonconforming product procedures for examples. Thanks
  8. R

    Endless doubts and questions concerning procedure vs process.

    Reading some articles about the differences between Procedures and Processes, I usually find that Processes are "what" and procedures are "how" things are done. This White Paper...
  9. Uriel Alejandro

    Evaluation of the effectiveness of correction actions

    Hello Everybody, I´m making some updates to my corrective actions procedure and during this process I´m having some problems trying to define a correct method for the evaluation of the efectiveness of a implemented action. I the past, I managed to solve the effectiveness requirement...
  10. P

    What is expected in a Medical Device Commercial Release Procedure

    Hi, I have been tasked with generating and implementing a commercial release procedure for class I & II medical devices. This would take place when the device has been manufactured and produced and is ready to be released to the market so needs sign off by various departments. Currently, we...
  11. S

    Document Storage/Archival Procedure

    My question is, is there any specific requirements when storing documents that are being archived by ISO Standards. Where I came from we had strict storage processes and at my current job they store their documents in their on-site warehouse. I need to write a procedure for this and want to...
  12. S

    Document Handling during an Audit

    The last question I asked went so well, that leads me to my next question. I have been asked to create a Deviation and Customer Complaint procedure, which I have in process right now. The hold up for the powers that be is my tracking spreadsheets I have created. They have been asked in previous...
  13. A

    Return information production and post production

    Hello; how can I make a production and production feedback procedure in accordance with ISO 13485 version 2016, to show that every negative feedback will be treated as a complaint; Thank you in advance
  14. S

    How many QMS processes and procedures?

    Hi everyone, Being the only person driving the QMS in my small company right now, and I am not the most experienced person in quality. I have a question about the ISO 13485:2016 standard. Questions are below: 1. How many QMS processes are there? 2. There are over 60 procedures in...
  15. V

    Paint batch approval procedure for automotive industry

    Hi, Can anyone help me to get Paint batch colour approval procedure for automotive industry? Thanks, Vivkrish.
  16. Q

    Nonconforming procedure and ISO 9001-2015

    Hello Quality Pros: My nonconforming procedure is from our ISO 9001-2008 revision. It was required. Do I need to modify/change the 2008 procedure to meet ISO 9001-2015 standard? How are companies that were ISO 9001-2008 out there meeting this requirement to ISO 9001-2015 standard? Thanks
  17. R

    Clinical evaluation Meddev (2.7.1 revision 4) - Example or Template

    Hi I'm a trainee in regulatiuon and quality management system. I'm asked to do the clinical evaluation for a medical device Does any one have an exemple or template of (regarding to the recommendation of the Meddev 2.7/1 révision 4 and new EU regulation) : - a clinical investigation...
  18. A

    Difference between Quality System Procedure and Standard Operating Procedure (SOP)

    Hello Guys, Can someone help me in understanding the difference between Quality System Procedure (QSP) & Standard Operating Procedure (SOP) ?? And what are the contents that must be included in a SOP. Thanks in Advance,:thanks: A1S2H3I4T5H
  19. D

    Job Titles referenced in Procedures

    We are a small business, so many staff members serve in different functions (wear different hats so to speak) We are in the process of updating the system manual for IATF. I am running into a lot of procedures and instructions that reference job titles that simply have never existed at the...
  20. T

    Requirement of signatures anywhere in IATF ?

    Good morning, is there a shall in IATF in regards of certain documents needing signatures? I went thru the book and didn't see anything. We are trying to go paper less as much as possible, and set up electronic signatures for certain documents. I've identified myself what forms that...
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