Privilege Management, SMART Objectives and Design Controls
Privilege Management
Summary
This is something notoriously complex in organisations. So it’s nice to make it simple and hopefully this does that for you.
All organisations have systems that have access granted and revoked. Privilege management is how you control that.
It gives you an understanding of all of the access that your employees have in your business so if someone starts, leaves or changes position you know what access needs to be granted or revoked.
➕ Additional Information: Privilege Management Template
Setting Objectives for any standard
Summary
All ISO standards including ISO 9001, 13485 and 27001, call out the need for objectives.
If you’re working to ISO 9001 Quality Management Systems or ISO 13485 Quality Management Systems for Medical Devices then you set Quality Objectives.
If you’re working to ISO 14001 Environmental Management Systems then you set Environmental Objectives.
If you’re working to ISO 27001 Information Security Management Systems then you set Information Security Objectives.
Makes sense doesn’t it?
Make your objectives based upon SMART (Specific, Measurable, Achievable, Relevant, and Time-bound) methodology and you’ll be fine.
Additional Information: Below is a way to set your objectives.
Implement and gain certification to ISO 13485: 2016 Medical Devices - Quality Management Systems.
This is sponsored by the Senior Management Team.
The goal is measured by certification.
Progress on the objective is communicated at management review meetings.
The Managing Director is the overall owner of this goal.
Design Controls
Summary
This is big in the Medical Device industry working and I really learned them when working to Food & Drugs Administration (FDA) 21 CFR Part 820 Quality System Regulation.
But the themes can be taken to any industry that essentially has design as part of its day to day as it essentially just aims to verify that whatever you make is what your ideal client is looking for.
Basically, did you build whatever you’re building to suit whatever your clients want.
To do that you have to capture what your clients want.
Additional Information: Design Traceability Matrix Template
A few simple and easy tools are things like:
Questionnaires
Interviews
Focus groups and workshops
Naturalistic observation
Positive and negative competitor reviews
Any research available