change management

  1. R

    Linking the Processes of Continual Improvement, Change Management, Risk Management, Action Planning, etc?

    I am trying to create a workflow from one to another. It will be important to have this workflow, as we will have it on a BPMS system. Having a Improvement Opportunity process "separated" from the others, doesn´t make sense. It has Ins and Outs of course. I have seen some Quality software where...
  2. E

    Changes to medical device submitted through a variation?

    Is it a requirement to provide a new EU certificate of conformity/notified body opinion if there are changes to the device submitted through a variation?
  3. S

    Non-significant notice of change to notified body

    Hi Fellows, I'd like to hear what is your experience with none-significant notice of changes to notified bodies. In principle, the manufactures are not obligated to report non-significant changes but with the frequent technology changes often the manufacturers chose to notify the NBs just to...
  4. K

    Change of Existing Medical Devices and 510(k)

    Hi We are manufacturer of Medical X-Ray equipment and already approved by FDA for our one of product. We want to know about the changes for which 510(K) re-submission is required. for example , If we are adding any alternate model of X-Ray tube and Flat panel detector (Image capturing device)...
  5. T

    Change to the FDA cleared device (ours) - Submission or Letter to file?

    Hello, fellow Elsmar members! I don't know how to solve my problem, so I thought maybe another pair of eyes would help me. Basically, my company has made a change to the FDA cleared device (ours) and we wanted to submit a Special 510(k). However, my colleagues are suggesting to letter to file...
  6. R

    SaMD - Software as a Medical Device - Software change control form

    Hello everyone, 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...
  7. A

    Is a Manufacturing Process Sheet required for each Component?

    Hi, We are a manufacturing industry with expertise in Medical equipment Machines. All the manufacturing of the components required are manufactured inhouse through VMC, Lathe, Boring machine etc. Also some processes are outsourced. Ex: Plating, HT, Painting etc. BOM of 1 machine comprises of...
  8. W

    Part Change Request - Standard (OTS) electronic parts (resistors, capacitors etc.)

    Hello everybody, I have a question... the company I work for (Tier 1) is producing infotainment systems (IS) to cars. My question is...... For IS we are using a tons of standard electronic parts (resistors, capacitors etc.) We are buying these parts for suppliers. We call these parts standard...
  9. R

    8.1.3 Management of change - Evidence of HIRA and related things

    In 8.1.3 Management of change the standard says - The objective of a management of change process is to enhance occupational health and safety at work, by minimizing the introduction of new hazards and OH&S risks into the work environment as changes occur (e.g. with technology, equipment...
  10. R

    ISO 20000 requirement about the Change Management Policy

    ISO 20000 has this requirement about the Change management policy that must include the "criteria to determine changes with the potential to have a major impact on customers or services." I know how changes can be assessed and evaluated but I have not been able to find anything about criteria...
  11. J

    South Korea, MFDS - Medical Device Change Management

    Hi, I have had some guidance translated for medical device change management in South Korea. The document is not very clear in places, so I was hoping to seek some clarification on the following questions; 1. Who is responsible for reporting minor changes? Is it the manufacturer or the local...
  12. JoshuaFroud

    Change Control - Minimum Requirements and Unhappy Staff

    Good Morning I'm currently in the middle of a very difficult situation I would greatly appreciate some guidance on. I work for a small but growing Medical Device company, we hold both 9001 and 13485 certifications. I started here December last year and have been updating their quality...
  13. Y

    Change Management in a very complex Research Organization

    Morning, I am currently contracting in a very complex but exciting business model. It is research that is trying to operate commercially and has a mixture of scientists and engineers. The business operates roughly 9 different versions of change management through IT and software, hardware...
  14. J

    Design Verification - Managing Changes

    Hello Folks, Wanted to know your opinion on the following scenario I am in the middle of a design verification and found our that there are two different issues 1. A test failed because the requirement was written wrongly, instead of raising an alarm at 10 seconds, it raised at 20 seconds -...
  15. P

    Change Management & New Hires

    We complete a change management form for any team member moving from one department to another, or if a job title is changed...etc. Is it recommended to complete a change management form for a new hire? Our new hire process is standardized as far as training goes. This includes...
  16. P

    Are we an outlier for so many variations of Change Management?

    While conducting a desk audit of our change management procedure, I realized we do not have a MOC form for quality system changes...I.E. If I were to revise a procedure. We have separate MOC forms for Machinery Moves/Purchases, Process Deviation Requests for our machining processes, Personnel...
  17. M

    Creating change / Forcing change within a Company

    Hello all, I am consulting for a company which drastically needs to implement change. They have acknowledged that change is needed but there is resistance which is quite confusing at first. The overall cost per hour to the business is ?50 per hour in this example. The scenario...
  18. M

    Making a change to an approved Medical Device

    Hey Every one, i have a question regarding a approved medical device (class 1) in US which we will change the Hardware and Software? what must we bear in mind? must apply for a new Registration? or Report the FDA about the Modification? which documents must we give later? Thanks in Advance...
  19. S

    Software Application for Management of Change (API 5.11)

    We have had some re-org going on at my facility and the oversight of the MOC process has tentatively fallen to me. Currently we have a 4 page form that is a manual process of review. I despise paper processes. I'm curious if anyone has had interactions with any software based MOC that...
  20. G

    Management of Change Procedure

    HI All, I'm an internal auditor incompany, but lead quality supervisor left us without any handover, so I am in touble now. After external audit organized by our new clients it has been found out that we don't have "Management Change Procedure". Could you please be so kind to help me with it?....
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