What are you looking for?

Four areas to choose from:

1. Certification standards advice & support  Link

  • ISO 9001 Quality Management, inc upgrade to ISO 9001:2015
  • ISO 14001 Environmental Management
  • ISO 31000 Risk Management
  • HACCP (Hazard Analysis & Critical Control Points)
  • ISO 22000 Food Safety Systems Management
  • Medical devices safety management systems for regulatory purposes (inc registration) ISO 13485 (2003 & 2016)

Internal and external auditing and auditor training as per ISO 19011

  • But avoiding the conventional “policeman” methods that get you nowhere, so learn how to engage people in doing it properly!

2. Medical devices  regulatory advice & support Link

  • Coming at you like an express train..
    • Medical Devices Single Audit Programme (MDSAP),
      • Taking over from Canadian CMDCAS by end 2018
    • European Medical Devices Regulations (MDRs effective 2020 – CE Marks expire…)
    • Changes in ISO 13485:2016
  • There right now…
    • Canadian SOR-98-282 Medical Device Regulations with  CMDCAS &  ISO 13485:2003
    • CE Marking
      • EU Medical Device Directives (Articles and Annexes)
    • US FDA inc GMP as per 21CFR-820
    • Japan Ord 169
  • Medical devices regulatory surveillance
    • Get a monthly report vs your product codings…

3. Training & facilitation in problem solving (CAPA)  Link

  • Understanding “solutions first syndrome” to work out the problem before wasting money on the wrong solutions!
    • The Seven Management & Planning Tools
    • The Seven Quality Control Tools
    • The Swiss Cheese Model, on the best of them all!

4. Then there’s the Clearline Way…clearing your lines of sight. Link

Clearline Service Ltd offers a full programme of analysis support and  training that enables you  to live the dream of “clear lines of sight” across your business so you know it’s working properly, your way.

  • 4 steps like this...
    • First – we review your current situation, and agree what needs to be improved..
    • Second – we work out what systems and processes you need to deal with the issues…
    • Third – we facilitate what needs to be done, whilst training your people along the way!
    • Fourth – we review your systems periodically over time because keeping it all going is Really Hard!!

The Clearline Way..
The following is a PDF of a Microsoft PowerPoint presentation that shows The Clearline Way to “appreciate you business in so many ways…”

Please note that the animation that works in Microsoft PowerPoint, does not work in this PDF version.

What we offer (PDF)