Audit Preparation Tips

Audit Preparation Tips

How to use the Audit Preparation Tips

Ideally, these tips are presented by the ISO 9001 Management Representative or a department
manager to their employees one or a few days before the certification audit; a classroom-type session
would be ideal. For even better results, consider presenting the video training program “How to Deal
with External Auditors - A Basic Guide for Employees” (available at www.iso9001courses.com) as
introduction before discussing these Audit Preparation Tips.

As a less preferable alternative, you may simply use these Audit Preparation Tips in a staff newsletter
or email before the certification audit. However, given the importance of the certification audit (and the
cost involved in flunking it), we suggest you organize classroom-type sessions.

These Audit Preparation Tips should help prepare your employees for an audit; please note, however,
that this is not an exhaustive list so please don't limit the audit preparation to this list.

Tip: The Audit Preparation Tips can also be used to help an internal ISO 9001 auditor prepare for
audits.

Tips for your Audit Preparation

All audits may cover any or all sections of your quality management system. As a general rule, all
audits cover Goals & Objectives, Customer Feedback, Management Reviews, Audits (especially if NCs
from prior audits have been properly corrected), and Corrective Action.  Be sure you know where you
find the records.

General tips:

 Answer all auditor questions honestly; if you don't understand a question, clarify before you answer!
 Don't volunteer information!  Limit your answers to what was asked. 
 Remember, the auditor's job is to establish compliance.  He tries to find what you do right.
 Our company can get certified and maintain certification even with several minor noncompliances
("category II").  Only major NCs ("category I") are a problem.  Major NCs are given for a total
breakdown of the quality system in one area, or for a large number of minor NCs, or for a minor NC
that lead to a significant problem for the company.
 Be able to find your work instructions, as well as procedures that affect your work in the quality
manual.  The Table of Contents in the quality manual, or the cross reference in the back may help.

Goals/Objectives and Metrics:

 Objectives need to be SMART (Specific, Measurable, Achievable, Relevant, Time-bound).

 Top management is expected to show a complete list of goals and objectives (usually part of
business plan).  The goals and objectives should address financial performance, as well as quality
related issues (e.g., percentage damage free, on-time delivery etc).  All objectives need to be
measured (e.g., scorecard), and the results need to be evaluated (management reviews).

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 Department management is expected to have (in writing) clear and measurable objectives that are
in line with the objectives set by top management.  The objectives should be measured (metrics)
typically on a monthly basis.
 Individual staff is expected to have an understanding of the objectives for their departments.

Suppliers:

 You must be able to show how ALL suppliers are qualified.  Those that have been qualified prior to
ISO 9000 implementation at your company (and for which you don't have qualification records)
must be clearly identified as "grand-fathered-in" (i.e., qualified based on their performance history).

Responsibilities, Authorities & Qualifications:

 You must be able to show how ALL employees are qualified to do their job and how they meet the
job requirements described in the job description.  If you have employees that do not meet the
requirements in the job description but that have proven to be able to do the job during their many
years with the company, you need to identify them in their personnel file as "grand-fathered-in" (i.e.,
qualified based on their performance history).

Management Review Meeting:

 Be sure that all the requirements in the quality manual are adhered to and addressed, and that the
minutes reflect this.

Contract Review:

 Be sure that the process of transforming customer instructions/manuals/contracts into (controlled)

work instructions can be explained.
 Be sure to have records of the reviews that show dates and the names of the reviewers.

Document Control: 

 Be sure to have all instructions required by the quality manual.

 Ensure that work instructions show the current situation - not some ideal, future situation.
 Ensure that electronic files are saved to only one location (use shortcuts / links for all users but
never copy a file).
 There must be no uncontrolled or obsolete documents (e.g., be sure that there is not an old quality
policy or quality manual around; also remove HR manuals!)
 The quality manual must be available.  Be sure to have a distribution list etc if your area uses
hardcopies.
 Never use uncontrolled documents (e.g., don't pull up electronic files if they are not controlled).
 Ensure that all records that need to be kept can be located.
 Make sure that the retention period for all records is followed.
 Ensure that all employees understand the disposal methods for records.
 Ensure that records are stored in a safe and secure place.

Corrective and Preventive Action:

 Be able to find your CAPs (Corrective Action Plans).

 The root cause analysis is crucial - be sure it is filled in.

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 Ensure that there is a CAP for each nonconformance found in an audit.  Be sure to close the CAPs
from past audits.
 Documentation on preventive action (i.e., correction of a potential problem) is a plus.
 Be sure to be able to locate documentation on customer complaints.

Internal Audits:

 Do you know where the Audit Schedule is published?

 Comprehensive audit reports must be available for all audits listed in the audit schedule; reports
must cover all areas and elements listed in the audit schedule. 
 

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Typical Auditor Questions

Objectives & Metrics:

 What is your company’s quality policy?  How does it affect your work?  
 What are the company’s quality objectives?
 What are the quality objectives for your department/for you?  How do they reflect your company’s
quality objectives?
 What are the objectives for your department/for you?  How do they reflect corporate strategic
objectives?
 How do you communicate the objectives, and how do you encourage people to meet them?
 What metrics do you use to measure/monitor how you meet all these objectives?
 What metrics do you use to monitor your processes (i.e., how well and how efficient are the various
processes working)?

Customer Feedback:

 How do you know if you meet customer expectations?

 How do you gain customer feedback?  
 How do you select the customers for your surveys?
 What customer feedback have you received?  What is the target (see metrics)?
 How do you follow up on customer feedback?

Management Review:

 How do you review the quality management system?

 Do management review meetings result in actions that are designed to improve the effectiveness of
the quality management system?

Improvement:

 How do people communicate issues or concerns in your company?

 If you have a problem with your work, or a suggestion for ways your company could improve, how
do you tell someone about it?

Corrective & Preventive Action:

 Who is responsible for corrective and preventive action?

 Do you keep records on corrective and preventive action?
 How do you perform the root cause analysis?

Responsibilities, Authorities & Qualification:

 How do you ensure that employees are qualified to do their job?

 Are there any procedures or work instructions that you follow when doing your job?

NOTE: Everybody must be able to find those sections in the quality manual that pertain to them (it's
okay to look up sections in the quality manual).
NOTE: Everybody must be able to locate those work instructions that pertain to them.

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Document Control:

 How do you know you have the most current instructions, forms, specifications, etc?
 If you see an uncontrolled document, what should be done with it? 

Customer Requirements:

 How do you know customer requirements and how does the work you do matter to the customer?
 How does the organization communicate customer requirements?

General ISO 9000:

 What are the reasons for having implemented ISO 9000?

 What does the quality management system mean to you and what does it do to your company?
 Do you have seen benefits since you started ISO 9000?
 Who is your management representative? 
 What is the structure of the Quality Management System?
ANSWER:  Quality Manual (incl. quality policy and procedures), work instructions, records

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