ISO 9001 2015 procedures require these documents to be in place. They are mandatory.
needed to be maintained by the organization for the purposes of establishing a
QMS (high level documents) including:
The scope of the quality
management system (clause 4.3).
necessary to support the operation of processes (clause 4.4).
The quality policy
The quality objectives
information is subject to the requirements of clause 7.5 for documented information and records control.
maintained by the organization for the purpose of communicating the information
necessary for the
organization to operate (low level, specific documents). See 4.4.
Although ISO 9001:2015 does
not specifically requires any of them, examples of documents that can add value
to a QMS may include:
Process maps, process
flow charts and/or process descriptions
Work and/or test
Approved supplier lists
Test and inspection plans
Does this sound simple? Write the above and then you can apply for ISO 9001 certification. Sorry, no it is not that easy. Why not? because there is a catch:
The standard also requires procedures to ensure effective planning, operation and control of all QMS processes.
Your companies processes determine the additional necessary documents. For small companies, you may only need a few more procedures. For large companies with many departments, many products and many processes will require numerous procedures.
Why do you need procedures? Because
They prevent loss of specific details.
They control sequence of steps.
They provide consistency of results.
They promote uniformity and reduce variation between employees.
They are a necessary training tool.
They are your internal standards.
They are audit references.
Changes can be easily tracked as improvements are made.
They describe who is responsible and accountable.
Cover the 6 Ws in your procedures
Why must the procedure be followed?
How is the activity performed?
What is covered within the procedure?
When is the procedure applicable?
Where does the activity take place ?
Who is responsible for following the procedure?
Make the procedure readable. Make it easy to find the information. Make it logical. Keep is simple.
How do you know which details to include and which details not to include in a procedure? Ask this question about the details. If I leave a specific detail out of the procedure does it affect product quality? If it doesn’t affect product quality then you can leave those details out.
The three tier approach to ISO 9001 2015 procedures
Tier one is the Quality Assurance Manual.
Tier two is the quality assurance management system procedures. This would include the other procedures listed above and any other procedure that specify systems within the Quality Management System.
Tier three is the working documents that detail the specific activity for controlling the product and processes.