What is involved in ISO 10993-12
Find out what the related areas are that ISO 10993-12 connects with, associates with, correlates with or affects, and which require thought, deliberation, analysis, review and discussion. This unique checklist stands out in a sense that it is not per-se designed to give answers, but to engage the reader and lay out a ISO 10993-12 thinking-frame.
How far is your company on its ISO 10993-12 journey?
Take this short survey to gauge your organization’s progress toward ISO 10993-12 leadership. Learn your strongest and weakest areas, and what you can do now to create a strategy that delivers results.
To address the criteria in this checklist for your organization, extensive selected resources are provided for sources of further research and information.
Start the Checklist
Below you will find a quick checklist designed to help you think about which ISO 10993-12 related domains to cover and 12 essential critical questions to check off in that domain.
The following domains are covered:
ISO 10993-12, ISO 10993, Biocompatibility, Medical devices:
ISO 10993-12 Critical Criteria:
Check ISO 10993-12 results and probe ISO 10993-12 strategic alliances.
– How can you negotiate ISO 10993-12 successfully with a stubborn boss, an irate client, or a deceitful coworker?
– Will ISO 10993-12 deliverables need to be tested and, if so, by whom?
– What is our ISO 10993-12 Strategy?
ISO 10993 Critical Criteria:
Study ISO 10993 risks and get out your magnifying glass.
– In what ways are ISO 10993-12 vendors and us interacting to ensure safe and effective use?
– Is Supporting ISO 10993-12 documentation required?
– Are there ISO 10993-12 problems defined?
Biocompatibility Critical Criteria:
Nurse Biocompatibility results and summarize a clear Biocompatibility focus.
– What is the total cost related to deploying ISO 10993-12, including any consulting or professional services?
– In a project to restructure ISO 10993-12 outcomes, which stakeholders would you involve?
– What threat is ISO 10993-12 addressing?
Medical devices Critical Criteria:
Detail Medical devices governance and assess what counts with Medical devices that we are not counting.
– How do your measurements capture actionable ISO 10993-12 information for use in exceeding your customers expectations and securing your customers engagement?
– Does ISO 10993-12 create potential expectations in other areas that need to be recognized and considered?
– To what extent does management recognize ISO 10993-12 as a tool to increase the results?
This quick readiness checklist is a selected resource to help you move forward. Learn more about how to achieve comprehensive insights with the ISO 10993-12 Self Assessment:
Author: Gerard Blokdijk
CEO at The Art of Service | http://theartofservice.com
Gerard is the CEO at The Art of Service. He has been providing information technology insights, talks, tools and products to organizations in a wide range of industries for over 25 years. Gerard is a widely recognized and respected information expert. Gerard founded The Art of Service consulting business in 2000. Gerard has authored numerous published books to date.
To address the criteria in this checklist, these selected resources are provided for sources of further research and information:
ISO 10993 External links:
A Practical Guide to ISO 10993-5: Cytotoxicity | MDDI Online
Medical Duraglide ISO 10993 – MicroCare
ISO 10993 Certified Biocompatible Resins | Entec Polymers
Biocompatibility External links:
Biocompatibility Testing for Medical Devices | Nelson Labs
Biocompatibility Testing Services | NAMSA
Medical devices External links:
Altair Instruments | Medical Devices | Aesthetic Machines