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Implementing a management system_

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Guest user Created:   Sep 28, 2018 Last commented:   Sep 28, 2018

Implementing a management system_

"I want to know how and where to start for ISO Certification. and I want to know what are the clauses included and excluded in ISO for general and wholesale trading of medical equipment because that is the nature of our business.”
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ISO 9001 PROCEDURE FOR MANAGEMENT REVIEW

Define how to perform the QMS review by the top management.

ISO 9001 PROCEDURE FOR MANAGEMENT REVIEW

Define how to perform the QMS review by the top management.

Expert
Carlos Pereira da Cruz Sep 28, 2018

Answer:
I believe that there will be no exclusions and all clauses of ISO 9001 are applicable to your organization. Considering that your business is general and wholesale trading of medical equipment, perhaps ISO 13485 is more appropriate (medical devices).

I would start the implementation of a management system by:
Assembling a project team;
Developing a project plan with a timetable;
Basic training on ISO 9001 for project team members;
Define the scope of the management system;
Perform a Gap Analysis;
Determine internal and external context;
Determine interested parties;
Map your processes;
Define quality policy, objectives and plans to meet them;
Determine risks and opportunities and define action plans to act upon the most important;
Document your processes;
Start measuring performance;
Perform internal audits;
Do a management review and decide if you are ready for certification.

The following material will provide you information about implementing a management system:
- ISO 9001 – Checklist of ISO 9001 implementation & certification steps - https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/
- Six Key Benefits of ISO 9001 Implementation - https://advisera.com/9001academy/knowledgebase/six-key-benefits-of-iso-9001-implementation/
- free course ISO 9001:2015 Lead Implementer Course - https://advisera.com/training/iso-9001-lead-implementer-course/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

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Sep 28, 2018

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