Reference​:

Company Name or
Logo Procedure Title Version​:
Date of approval​:

All text in Blue Color is here to give you guidance. You should remove it and add your own text.

Approval
Function Name Date Signature

Creator

Reviewer

Approver

TABLE OF CONTENT
1. History of changes 2

2. Goals and Objectives 2

3. Scope 2

4. Process Owner 2

5. Key Performance Indicator 2

6. Definitions and Abbreviations 2

7. Standards 2

8. Related documents 3

9. Process 3

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 Reference​:
Company Name or
Logo Procedure Title Version​:
Date of approval​:

1. History of changes

Version Description of changes Date of release

1 First Version April 20th, 2018

2 Inclusion on chapter X, the new process for XXX May 3rd, 2018

3 …... …….

2. Goals and Objectives

Explain to us what is the objective of this procedure. Why do you write it? Which problem this
will solve?

3. Scope
This procedure can maybe be applicable for many places or departments… List them.

4. Process Owner
To help the person who read this procedure, indicate who is responsible for its implementation.
If you have some comments or need some changes of it, this should be the owner you’ll need to
contact. You should not list a name but a function of your organization. E.g. Quality Manager or
Manufacturing engineer.

5. Key Performance Indicator

To measure if this procedure or the process that it describes is performing well you’ll need to
identify a Key Performance Indicator that you should track. In the case there is no need to track
the performance of this process, you can mention that this is not applicable and justify.

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 Reference​:
Company Name or
Logo Procedure Title Version​:
Date of approval​:

6. Definitions and Abbreviations

This section is key to understand the different words and abbreviations that you’ll mention on
this procedure.

7. Standards
To execute this procedure, you’ll maybe need to follow a standard. For example for the Risk
Management Procedure I would list ISO 14971 and mention the title of the standard.

8. Related documents
If this procedure needs some records or other documents, you need to list them here. This
helps to keep track of the document structure. Remember that all the documents should link to
the Quality Manual.

9. Process
Describe the process to execute this procedure. You can do that by writing step by step the
process or by describing it on a process flow or with pictures… This is really up to you. The
objective will be that anyone reading this procedure understand how to perform the action.
You can also list for each step the function that should execute an action.

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