The Organizational structure, procedures, processes and
resources needed to implement Quality management.
Quality system documentation should be used for several
Provide a mean to understand the system
As an Aid for training
Provide an understanding of the requirements
to act as instruction
As a basis for auditing
To satisfy external regulations
The documentation formalizes the QMS are:
Quality Records (Templates)
Road map of the organization
Quality Evidence of commitment to quality and ability to meet specified
Manual It contains Quality Policies, processes and the interaction between theses
It describes the purpose of the process.
What happens over the time to produce a desired results
Procedure Should answer the five Ws; Who, What, When, Where, Why
Work Specifies the detailed requirements for a single operation; the
tasks involved, how these should be performed and if there is a
Instructions standard to be used.
They are the forms generated by applying the procedures
Quality They demonstrate achievement of the required quality
Records Provide objective evidence on how quality system is functioning
They are simply the “output “ of the process
A process is a group of activities, not just one.
The activities that make up a process are not random or
ad hoc; they are related and organized.
All the activities in a process must work together
toward a common goal.
Processes exist to create results your customers –
whether they’re internal or external.
Activity Activity Activity Activity
1 2 3 4
Processes are how we
have Input Output have
People Methods Materials Tools
Expert Mode Intermediate Mode Beginner Mode
• Expert mode • Uses expert mode • Uses the
documentation is but add some intermediate mode
short and concise guidance documentation, but
• Made for experts adds some details
and does not contain • It needs a formal
any training training
• It is short.
• Its problem that not
every one is expert
1. Purpose Why is the activity performed?
2. Activities What actions are performed?
3. Input(s) What work products are used?
4. Output(s) What work products are produce?
5. Entry Criteria When does the activity begins?
6. Exit Criteria When does the activity ends?
7. Roles Who performs activities?
8. Process Context Where is activity performed?
9. Sub-Activity or
How the task implemented?