Iso 9001 audit procedures

1. Iso 9001 audit procedures
Planning for the Internal Audit
The key to an effective, thorough and value added internal audit is in the preparation. If
internal auditors are spending one to two hours preparing for an internal audit, it is not
enough time. To properly prepare for an audit, it should take twice to three times that. If
the actual audit time will take an hour, there should be at between two and three hours
spent in preparation. A good rule of thumb to spend about two and half times as much
time in preparation as the audit will take. Often times, auditors plan for a two hour
internal audit and spend 1 hour preparing which leads to them running out of questions
about 30 minutes into the audit. I can't stress this enough if you want to be a successful
internal auditor or manage a successful internal audit program then make certain you
spend adequate time in preparation for the audit.
This sounds easy, but it is actually very difficult. The major obstacles to allocating
enough time for preparation are time restrictions placed on the internal auditors. Chances
are they have other responsibilities aside from internal auditing that compete for their
precious time. One method to help remove that obstacle is to have as many trained
internal auditors as possible to spread the work load.
Effective planning for an internal audit requires following a few simple steps that are
listed below.
1. Learn the process (turtle diagram)
2. Identify the interfaces with the standard
3. Document review (compliance to standard)
4. Identify process interfaces
5. Identify potential process failure modes (pFMEA)
6. Value stream map process to breakdown activities
7. Review old audits
8. Develop audit questions
9. Develop audit plan.
1. Learn the process
Before you can audit a process you must become familiar with it. You need to learn how
it is supposed to work, what it supposed to do, what are the inputs, outputs, activities,
resources and controls. The first step would be to create a turtle diagram of the process
(This may have already been done by the organization as part of their documentation, or
in previous audits). A turtle diagram looks at the suppliers, inputs, activities, controls,
resources, outputs, and customers. A turtle diagram is laid out such that the process
activity is a box in the middle, the inputs come in from the left and outputs exit from the

2. right of the box. The supplier is listed in the upper left hand corner and the customer is
listed in the upper right hand corner. The controls are above the process activity and the
resources are below the process activity. The feedback loop is an arrow from the output
to the input. Let's do an example of a turtle diagram for a process. For this example, the
process will be one that applies to about every business in some way and that's
purchasing.
Inputs:
This is what the process needs for the activity. It can be in the form of information or a
product. For this example the inputs are: Demand (what is driving the purchase),
Quantity, Type, Specifications and Requirements, Due date and Budget (how much can
be spent).
Supplier:
This is who is supplying the inputs to the process. The supplier can supply information or
a material product. For our example the supplier would be whoever is specifying what to
purchase, when to purchase and how many to purchase.
Process Activity:
This is the process. There are a number of associated tasks contributing to the process.
For our example the process activity is purchasing
Outputs:
This is the result of the process. It can be information, energy or material. In our example
the output of the purchasing process is the desired product or service delivered when
needed. For our example it could be a product like a computer or piece of test equipment.
It could be information such as a failure analysis, training materials, book or manual. It
could also be a service such as mowing the grass, doing the laundry or processing
payroll.
Controls:
These are the items that regulate the rate at which inputs are converted to outputs.
Without controls, the process would operate continuously generating the output. The
controls for our example could be the material requirements planning software, the
purchase requisition approval process and inventory analysis.
Resources:
These are the items used or consumed in the process activity. It could be people's time,
machine time or money. For our example, the resources would be the buyer or purchasing
agent, money, the representative for the company supplying the product or service and

3. possibly other support functions who have input for the purchase. Additional resources
are in the form of computers, material planning software, phones, fax, office space, etc.
Customer:
The customer is the group that takes the output and uses it. It is most likely used as an
input to another process or as a resource.
Feedback Loop:
This is the mechanism used to monitor the process. What metric is used to tell the process
owner how the process is performing and when action needs to be taken to correct it. For
a purchasing process it could be supplier performance, dollars spent, on-time delivery or
receiving inspection information.
2. Identify the Interfaces to the Standard
The interfaces are the points where the process intersects the standard. In simple terms it
is where the requirements of the ISO 9001:2000 standard are applicable to the process
being audited. The easiest way to accomplish this is to use a matrix with the elements of
the standard on one axis and the process name on the other.
To better discern the interfaces of the process to the standard you could break the
elements down into the sub elements. For example, 7.2 Customer Related Processes is
comprised of 7.2.1 Determination of requirements related to the product, 7.2.2 Review of
requirements related to the product and 7.2.3 Customer communication. The left side of
the matrix would become larger, but you would have a more definitive intersection of the
process and standard. This activity provides you with the understanding of what areas of
the standard apply to the process. You will be developing questions to ensure compliance
to the standard and this tells you what areas of the standard to focus on.
3. Document Review
The document review section requires reading and understanding the associated
documentation for the process you are auditing. Start with the level 1 document, the
quality manual. The quality manual should provide an overview of the process and
should describe how the process fits into the overall quality system. The quality manual
will explain what processes feed the process you are auditing and what processes are
supported by it. It will describe the interaction and interrelationship of processes within
the quality system.
The main output from the review of the quality manual will be an understanding of all the
processes that make up the quality system and how they interact. The quality manual
should provide a good description of how the processes work.

4. Next, review the level 2 documentation or procedures. Procedures should describe the
process in more detail than the quality manual. There could be many procedures outlining
the quality system, or there could be the minimum required by the ISO 9001:2000
standard, six. The six required procedures are:
Control of documents
Control of records
Internal Audits
Control of nonconforming product
Corrective action
Preventive action
Since the ISO 9001:2000 standard requires less documentation than previous versions of
ISO 9000, there may not be as many procedures to evaluate. In this case the document
review portion will be reduced. During the document review of the manual and
procedures your are trying to understand the process and the system and ensure the
requirements of the standard are met.
4. Identify Process Interfaces
Process interfaces are the "hand off" points from one process to another. This is where
the previous process in providing an input to the audited process and the audited process
is providing input to another process. How are process interfaces different from inputs
and outputs? An input is the deliverable the process uses and the process interface
describes how and when the deliverable is achieved. For example, an input into the
purchasing process is the requirements of the purchased item. Looking at the process
interface we want to understand how are the requirements delivered to the purchasing
process, when are they delivered and by whom? In essence we are not looking at do the
requirements exist, but are they clearly defined and understood by the process using
them. We want to investigate are the requirements delivered on time and are they
accurate?
On the output side, we will look at those things the purchasing process provides to other
processes. Clearly one output is the purchased item on time, to specification and in the
correct quantity. Another consideration is how is it moved from purchasing to receiving
and inventory. There are other outputs of the purchasing process used by other processes.
One could be supplier selection for the item purchased. Engineering or Quality may need
to interface with the supplier and if the selection process is delayed, it could affect the
design, or ability to qualify the product.
Understanding the process interfaces can lead to some audit questions concerning how
smooth the hand off is between processes.
5. Identify Potential Process Failure Modes

5. Another tool we want to utilize is the pFMEA, which stands for "process failure modes
and effects analysis. You may have some background in FMEA's and you may not.
Either way is alright because we are not going in depth in the FMEA process. An
pFMEA is a method to identify potential problems with a process before the process is
implemented. It is a preventive measure that aims to resolve problems before they occur.
For our purposes we will be concerned with the process function, the failure mode and
the cause of the failure mode. Below is an example of an pFMEA for the purchasing
process:
Process Function Failure Mode Potential Cause
get good product bad product requirements not understood
supplier is not capable
not inspected enough
product on time product is late lack of capacity
ordered late
supplier out of product
low total cost too costly excessive rework
excessive freight
excessive testing
pFMEA's are an exhaustive approach that generates a large quantity of potential audit
directions. By evaluating the prospective problems associated with a process, you can
develop audit questions and an audit approach to ensure the potential problems are
addressed. This can lead to some findings that can have positive impact on the quality
management system.
6. Value Stream Map the Process
If you really want to energize the efficiency factor of your internal audits, then conduct a
value stream map. Value stream mapping is a lean manufacturing tool that aids in finding
the activities in the process that are non value added. Similar to the pFMEA example we
will approach this tool in an overview so it can be used but we won't go into great detail
and explicit flowcharting that a lean project might require. Lean initiatives would include
take time, inventory, etc, we will not include those for this use of the tool. For this
purpose you will flowchart the process activities and look for steps that could be
eliminated or reduced.

6. 7. Review Old Audits
A key source of information to develop your audit strategy is to review old audits.
Review both internal and external audits if available. Look for areas of weakness or
where findings were noted and see if action has been taken and if it's still effective. In
reviewing an old audit of purchasing you find that there was a nonconformity written for
the buyer not conveying to the supplier all of the requirements of the product. Based on
this you may want to gear some of the audit to see how effective the process is now at
conveying the requirements to the supplier.
8. Develop Audit Questions
What we want to do now in the planning process is develop some questions based on the
exercises listed above.
Turtle Diagram generated questions:
How are the requirements for the purchased item documented and communicated?
Who specifies a budget and who monitors it to ensure it is not exceeded?
What training has the purchasing agent received and what is scheduled?
How is inventory monitored to ensure correct purchases at the right time?
What is the measure of the process?
Who monitors it?
What are the planned results and what happens when they are not achieved?
Interface with the Standard generated questions:
Is there a procedure or work instructions describing the process?
Is the purchasing process covered in the quality manual?
Does the current process reflect what is documented?
How does the purchasing agent know what their responsibilities and authorities are?
Do they know and understand the quality policy and quality objectives? What does it
mean to them?
How are suppliers selected and rated? Is it effective?
How are purchased items evaluated when received?
What happens when a purchased item is received and does not meet requirements?
Who reviews the data from the purchasing process? Does the data get delivered to
management?
How has the purchasing process been improved? Has it shown improvement and what is
currently being done to improve it?
9. Develop Audit Plan
Up to now you have developed an understanding of the business process you will audit,
you have also used various tools to identify some audit questions or paths. Now we will
take this one step further and develop the audit plan. The audit plan is your playbook for

7. the audit. If you fail to plan, then you plan to fail. This statement couldn't be any more
true than in the auditing functions. You develop the audit plan based on the questions and
who you will audit.
Based on our previous work, we will develop our audit plan as follows:
Auditee: Purchasing agent
1. Explain to me how the purchasing process works?
Verify that it is consistent with whatever is documented.
Document what is said, does it match what you had perceived? If not make adjustments
in your audit plan.
2. How are the requirements for the purchased item documented and communicated to
you? Pick a critical purchased part and look for evidence of requirements being specified.
Are they clear and do they communicate the quantity, time frame and budget?
3. How are the requirements communicated to the supplier? Look for records that the
supplier has acknowledged the requirements or was sent them. You can also later review
the incoming inspection or records relating to problems with this part, quality, delivery,
quantity or price, this can be a reflection of how well they understand the requirements.
4. How are the suppliers selected? Look for evidence they followed their process and
verify the effectiveness based on complaints or issues with the product.
5. How is it verified the suppliers are capable? Look for evidence that someone evaluated
them for ability to meet the requirements. Can they produce to the specifications? Was
capability studies done? Do they have the capacity?
You can continue this process to develop a larger audit plan. You can even develop
questions and expected responses for other people such as engineering, quality,
manufacturing, material control, etc. It depends upon the scope of the purchasing process
and who is involved.
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