Are corrective actions appropriate to the effects of the nonconformities encountered?

Are there corresponding pre clinical product reviews for the products?

Are validation completed prior to release for use of the product to the customer?

Are your organization and the products registered to the legal authorities?

Does your organization use agents or distributors for the sale of its product?

How will the establishment ensure the effectiveness of the procedure?

Is the workspace where the non conformity occurred conducive to a quality product?

Is your organization responsible for the final package of the product?

What other methods of quality management available for organizations to use?

What should it do to ensure that the procedure works effectively?

This ISO 13485 Quality Management System Guide is unlike books you're used to. If you're looking for a textbook, this might not be for you. This book and its included digital components is for you who understands the importance of asking great questions. This gives you the questions to uncover the ISO 13485 Quality Management System challenges you're facing and generate better solutions to solve those problems.

Defining, designing, creating, and implementing a process to solve a challenge or meet an objective is the most valuable role… In EVERY group, company, organization and department.

Unless you're talking a one-time, single-use project, there should be a process. That process needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?'

This Self-Assessment empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make ISO 13485 Quality Management System investments work better.

This ISO 13485 Quality Management System All-Inclusive Self-Assessment enables You to be that person.

INCLUDES all the tools you need to an in-depth ISO 13485 Quality Management System Self-Assessment. Featuring new and updated case-based questions, organized into seven core levels of ISO 13485 Quality Management System maturity, this Self-Assessment will help you identify areas in which ISO 13485 Quality Management System improvements can be made.

In using the questions you will be better able to:

Diagnose ISO 13485 Quality Management System projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices.

Implement evidence-based best practice strategies aligned with overall goals.

Integrate recent advances in ISO 13485 Quality Management System and process design strategies into practice according to best practice guidelines.

Using the Self-Assessment tool gives you the ISO 13485 Quality Management System Scorecard, enabling you to develop a clear picture of which ISO 13485 Quality Management System areas need attention.

Your purchase includes access to the ISO 13485 Quality Management System self-assessment digital components which gives you your dynamically prioritized projects-ready tool that enables you to define, show and lead your organization exactly with what's important.

© 2020 5STARCooks (E-bog): 9781867497585

Release date

E-bog: 11. december 2020