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Risk Management Kit

Description:

This Risk Management Kit is designed to meet AS 9100C Standard, and in part ISO 13485 and related quality standard requirements.
It will aid in the planning and implementation process for Risk Management requirements as outlined and required in the Standard AS 9100C clause 7.1-Planning of Product Realization, clause 7.1.2-Risk Management, clause 7.3-Design and Development and related clauses.

Its key processes and procedure components are: assignment of responsibility, definition of risk criteria, identification, assessment and communication of risks throughout product realization, identification, implementation and management of actions to mitigate risks that exceed the defined risk acceptance criteria, acceptance of risks remaining after implementation of mitigation actions, assessment and auditing of implemented processes.

The policies and procedures are based on a step by step input output process concept and are easy to read. The accompanying control forms will enable you to record carried out activities and measure and analyzed results; the audit checklist will enable you assess standard system compliance.

Risk Management Kit provides the basic documentation, forms and tables needed to meet AS 9100C-aerospace, and in part ISO 13485-medical devices Risk Management requirements.

This Risk Management concept was developed by QCSS, under the auspices of Gunther Gumpp, Senior Consultant and President of QCSS including a team of highly experienced Lead Auditors and Quality Engineers.

Contents:

General instructions on Risk Management requirements and how to meet them.
Policies and Procedures addressing clause 7.1.2-Risk Management -and related standard requirements.
Risk Management Plan, Work Instructions on how to implement the described Risk Management processes, Control Forms, Tables and Charts, Audit Checklist.

List of Tables:

- Interaction of Key Processes in sequence covering Key Standard clauses,
- Functional Organization and Process Chart,
- Process Feasibility and Product Characteristics Risk Analysis Checklist,
- Risk Management Plan and Analysis Chart,
- Audit Checklist

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Risk Management Kit

Fax order form

Order information

Product name

Web Address

Office Code

Report Formats

Contact information

Please fax this form to: (646) 607-1907 or (646) 964-6609 (from USA) +353-1-481-1716 or +353-1-653-1571 (from Rest of World)

Payment information

Please fax this form to: (646) 607-1907 or (646) 964-6609 (from USA) +353-1-481-1716 or +353-1-653-1571 (from Rest of World)

Please fax this form to:
(646) 607-1907 or (646) 964-6609 (from USA)
+353-1-481-1716 or +353-1-653-1571 (from Rest of World)

Please fax this form to:
(646) 607-1907 or (646) 964-6609 (from USA)
+353-1-481-1716 or +353-1-653-1571 (from Rest of World)