ISO 9001

Awareness
Information
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 We’ve Done This Before...

Why will this be

different?

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 Basic Responsibilities
•  Know your job duties!
•  Know your documentation!
•  Do you job correctly!

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 The Basics
Say What You Do
This means document your systems so you will consistently do the
job the same way every time. We must make sure we have
appropriate documentation.

Do What You Say

This is what the auditors want to see. Objective evidence that what
you say you are doing in your documentation is what you are
doing in practice.

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 Payback
•  Companies minimize
deficiencies in supply and
support of products and
services.
•  Companies identify problem
areas and address them
quicker.
•  Companies identify customer
needs more accurately.
•  Companies become more
consistent in their product and
services.
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 Typical Documentation Tiers
We ensure flow down of
requirements from the top down
Defines Policy,
Quality Objective and
Tier 1 Assurance Approach
Manual (Non-Specific)

Defines Who, What

Tier 2 Policies & Procedures and When

Department Product &

Tier 3 Specific Process
Documents & Answers How
Instructions
Instructions

Tier 4 Forms & Tags Objective Evidence The Results

Records

Ad Hoc, Temporary Documents

Tier 5 E.g.: Data collection sheets made for special investigations and
temporary material identity tags.

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 Documentation Structure

Tier 1
Defines Approach
Applies to the Entire Company Systems Through Policies
(We will... or We do…)
Manual
Tier (Level) 2 Defines Who, What and When Things
Major Systems - Typically Apply to
Policies and General Happen
the Entire Company
Operating Procedures (These describe Tier 3 Sub-Systems)

Tier (Level) 3
Answers How Things Happen - The
Department and/or
Product and Process Documents Individual Steps
Location Specific
Inter-Departmental Procedures (These describe Tier 4 Documents (Records)

Tier (Level) 4 The Results of Tier 3 Systems/

Procedure Specific Procedures - Evidence of
Forms and Tags Occurrence such as Inspection and
Objective Evidence Records Test Results

Tier (Level) 5 These Are Typically

Investigative Documents
Situation Specific Ad Hoc (Temporary) Documents and Records
(including any associated records)

The 'Standard' Document Pyramid

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 Typical Types of Records
•  Contract Review
•  Purchasing
•  Identification and Traceability
•  Process Control
•  Inspection and Test
•  Control of Measurement and Test Equipment
•  Non-conforming Product
•  Corrective and Preventive Action
•  Internal Quality Audits
•  Training
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 Records Management Activities
•  Management of Active records
•  Records creation (forms)
•  Design of records system
Retention schedule
Vital records protection
•  Development of records
procedures
Indexing
Filing
Access
Disposition

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 Preparation
•  To prepare for the audit you should be
reviewing your area for problems.
•  Start at one corner of the room and sweep
through it.
•  Have an way to identify what you have looked
at.
•  Be ready to identify and explain every piece
of paper in your area whether on walls, in
drawers or in open files (including 3 ringed
binders).

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 Preparation 2
•  Review all the questions in this
presentation.
•  If there are any questions you cannot
answer, FIND the answer - ask
someone who knows!
•  If you find what you believe is a
problem, notify the appropriate person.

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 Registration
•  Your company will choose a registrar.
•  Registration lasts for 3 years.
•  Registration is NOT a ‘one-shot’ deal.
•  Your company will be re-audited at
least once a year.

Forever.
And ever.
And ever..... (Not a fairy tale!)

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 Registration Audit
Registration requires regular
audits by your Registrar. These
are called Third Party audits. Just
as has been done in banks for
years, auditing has reached every
industry. Whether twice a year or
once a year, your company quality
system has to audited by the
company which registers your
company. That company is your
Registrar.
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 What Is An Audit?
•  An Audit is a check to
ensure that what a
business says it does is
actually what it is doing.
•  In ISO 9000 and ISO 9001
an audit is meant to
validate that a company
‘Says what it does and
Does what is says’. For the
most part this is a
verification and validation
of written procedures,
policies and related
documentation.
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 What is Documentation?
•  Documentation is much talked about. There are
different types. There is the Systems Manual and
there are "Level 2's" There is process documentation
in the manufacturing areas.
•  Everyone uses documentation outside of work. If you
buy something (like a clock), there are instructions in
the box. That is documentation.
•  Think of documentation as instructions.
Documentation explains how to do things.
•  The auditor’s job is to make sure everyone is
‘Following Instructions’.

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 What is Controlled Documentation?
•  A controlled document is typically one that is Revision
sensitive - BUT - Not always!!
•  If a controlled document is changed, a record of the
change has to be made. This means we must have a
History of All Changes.
•  If a document is changed, people who use it must
know about the change. This means there has to be
a distribution list or other effective way to let everyone
who uses it know the document has changed.
•  Every employee must know how to check to see if
documentation they are using is the most current
version.

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 What is an Auditor?
•  An auditor is a person. Their job is to
validate documentation. This means
they look at documentation
(instructions) and make sure people are
following the documentation.

•  Auditors go from company to company

validating documentation.

•  Auditors are just people who ask

questions about how you do your job.

NOT an Auditor!

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 Auditors Are Not!!!
•  Inquisitors
•  Fault Finders
•  Rock Throwers
•  Avenging Angels
(Biased For or
Against)
•  Dishonest
•  Overactive

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 The Reason For Audits
•  Everyone is familiar with the idea of audits. One place we are all
aware of audits is in the banking industry. For years, the
government has required banks to submit to periodic audits by
government agencies and/or external companies who specialize
in auditing. Few people want to put their money in a bank where
there are no controls such as periodic audits. If there are no
audits, you have no way of knowing if your bank is using your
money well. If the bank is not ‘using your money well’ the bank
could easily fail - then you could lose all of your money.
•  Audits in manufacturing industries are not new. Customer audits
have been going on for years. But only recently has the idea of
third party audits become reality. This is in large part due to the
adoption in Europe of ISO 9000 and other international
standards.

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 Reasons for Audits 2
•  The intent of third party audits is to provide assurance
that a company complies with a standard or
specification.
•  Many people say that third party audits will eliminate
customer audits. This has not been the case up to
now in part because customers still see the need to
ensure compliance to their specific requirements.

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 What Will The Auditors Do?
•  The auditors will look at written procedures and
policies (verification).
•  The auditors will then look at and ask how people in
the company do things. They will look to make sure
each person is following written procedures and
policies (this is called validation).
•  They will look at records to ensure everyone is
properly completing paperwork (examples would be
process related documentation and SPC charts).
•  They will look to make sure everyone is properly
trained to do their job.

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 Who Will Be Audited?
•  Absolutely Everyone whose job affects
quality is subject to the audit.
•  And the farther up the corporate tree you go, the more difficult
the audit is. This is because as you go up the tree (eventually to
the CEO), job duties and responsibilities increase.
Corporate Personnel
Plant Manager
Departmental managers
Supervisors
Engineers
Technical personnel
Associates

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 The Audit Team
•  When you are visited by an auditor, he/she
will NOT be alone. At the very minimum, there
will be:
The Auditor
A Company Escort - This will be someone from within
Gunderlin who knows the area and the specification well. The
escort will try to provide structure to the audit and will try to help out
when he/she can.

The Area Supervisor and/or Manager - The area

supervisor or other person directly responsible for the area will be
present.

•  Remember - YOU ARE NOT ALONE!

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 Types of Audits
•  Internal Audit
An audit of internal systems and/or procedures. An internal audit is
most often performed by people how directly work for the company.
Many companies hire outside firms (see third party below) to
perform the audits.
•  External Audit
Customer Audits
•  Customer audits are those where a customer (or a customer representative)
performs the audit. A customer audit is not ‘objective’ because the customer is
intimately involved with your company (the supplier to the customer). This
involvement can BIAS the audit.
‘Third Party’ Audits
•  Third party audits are like those you think of when you think of bank audits. Banks
(and other financial institutions) must hire a company or person to audit their
books and procedures. The company or person hired to do the audit cannot have
an ‘interest’ in the business it is auditing. This is known as an ‘Independent Audit’.
Your registrar audit is a third party audit.

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 What Will Happen If...
•  If an auditor finds a problem, s/he will let the person being
audited know immediately that a possible problem may exist. In
NO case will the auditor ‘find a problem’ and not discuss it with
the auditee ‘on the spot’. They always tell the auditee the
suspected problem. Many registrars (for example, LRQA does
*NOT* require this) will ask the auditee (or other company
official present) to sign a statement of fact of what was found
(statement of objective evidence). The auditee should know that
signing the statement is NOT an admission of a problem. It is an
agreement of facts found. Whether or not it is a problem is
discussed during end-of-day and final review meetings.
•  If an auditor leaves your area and says nothing about a possible
problem, you can be sure no problem(s) were found. Auditors
do NOT report findings to management without discussing it
with the personnel involved FIRST. There are no tricks. Nothing
is ‘hidden’ until later.

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 Things to Know
•  Know what documentation affects YOU!
You must know what documentation applies to your job. This
should have been told to you when you were trained to do the job.
If you are not sure what documentation applies to you, ASK YOUR
SUPERVISOR or TRAINER before the audit.
•  You must follow all documentation that applies to
you. If it says you do something a certain way, you
must do it that way.
•  You must complete all forms. If you are supposed to
initial and date when you do something, the auditors
will check to ensure you complete the form the way
you are supposed to.
•  Know what training you have had. If you do not know,
ASK YOUR MANAGER NOW! Don’t wait until the
audit!
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 Things to Do
•  Listen closely before answering any question(s). If you are not
sure you understand the question, ask the auditor to repeat it. If
you still do not understand the question, tell the auditor you do
not understand it. The auditor will try to better explain him/
herself. Never answer a question you do not understand!
•  Never say “Sometimes I....”. When you do something differently
because of different circumstances, explain that “When ------
happens, I...., and when +++++ happens, I ....”. Be specific.
•  Always tell the Truth. Don’t ever try to hide something. You may
think you are helping someone - you are not. One lie can
destroy confidence. Just like in a marriage, if one spouse lies to
the other and the other finds out, the relationship may be in real
danger. One lie could ruin the entire audit.
•  Be patient. Wait for the audit to ask a question.

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 Things NOT to Do
•  If you do not know the answer to a question, tell the auditor that
you do not know the answer. Don’t attempt to ‘fake it’. If the auditor
tries to explain again and you still do not understand the question, tell
him/her again that you do not understand the question. The Escort will
attempt to help if this happens.
•  Do NOT try to answer a question for another person. (Some
auditors will *test* people for this) If the question is not about the job
you are doing and you know who does that job, tell the auditor who
they should ask if you know.
•  Do NOT try to answer a question about another job. The only
question an auditor is supposed to ask is about YOUR job. If the
auditor asks you a question about someone else’s job, you should
answer “That is not my job.” The escort with the auditor must take the
lead from this point.
•  Do NOT try to hide from the auditor. All the auditor wants is to ask
you about your job and how to do it. You know your job. You can tell
the auditor about as easily as you can tell anyone else.

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 General Things To Know and Do
•  Auditors are NOT trying to test your memory. If you have to
look something up in your documentation, tell the auditor. The
auditor will then tell you whether to look up the information or
not.
•  Only answer the auditor’s question. Do NOT volunteer
information. Do NOT try to ‘help’ the auditor with additional
information.
•  Answer with the shortest, simplest answer you can think of. If
you can answer with a Yes or No, that’s all you should do.
•  Don’t try to explain things beyond the question asked. The
auditor will ask questions to help him/her understand. Your job
is to only answer questions asked.
•  Do not tell stories or speculate what ‘may’ happen.
•  Right NOW!!! If there is any documentation which you are using
that you think or know is not correct, contact your supervisor
immediately!
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 Some Questions to Expect
•  What is ISO 9001?
•  What is the quality policy?
•  What does the quality policy mean to you?
•  What documentation do you follow? Where is it?
•  How do you know you are using the most recent documentation?
•  Who is the Management Representative?
•  How do you know what to do? Tell me about your job and your duties.
•  Do you ever have problems come up? How do you handle them?
•  When you find nonconforming product, what do you do?
•  What are your quality responsibilities?
•  What are controlled documents?
•  If your documentation says you should do something a specific way and
someone else tells you to do it differently, what do you do?
•  What do you do if your machine jams or malfunctions?
If you do not know the answer to any of these questions, talk to your
supervisor SOON! DO NOT WAIT!
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Supervisors Should Think About...
•  Work Instructions
Does Every Job Have Relevant Work Instructions?
Are Work Instructions Controlled?
Is Each Signed & Dated?
Who is the Keeper of a Master List & Where is it Kept?
•  Hand Revisions
Have Any Work Instructions, Visual Aids, or Other Process Documentation
Been Updated By Hand?
If So, Are They Signed and Dated?
•  Equipment PMs
Are All Equipment PMs Up To Date and to a Schedule?
•  Measurement & Test Equipment
Is All Measurement and Test Equipment Calibrated and properly Labeled?
•  Defective Material
Is Defective Material Identified and Segregated?
Is A Defective Material HOLD Area Identified?
Is DMR Material Dispositioned in a Timely Manner?
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 Last Things to Think About
•  Employee Training
Do You Know the Training Requirements Of Your Job Position?
Is Each Employee Trained?
Where Are Training Records Kept?
Are Training Records Up To Date?
•  SPC
Are People Keeping SPC Charts Trained in SPC?
Are SPC Charts Current and Being Utilized?
Are Trends Identified and is Corrective Action Taken?
•  Work Areas
Are Work Areas Clean and Orderly?
•  Baskets, Boxes, Racks, Shelves & Other Containers
Is Each Properly Labeled (Identified)?
Are They Where They Are Supposed To Be?

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 ISO 9001 Reminders
•  Does NOT define quality
•  Is NOT a one-time process
•  Is NOT easy
•  Requires commitment
•  Requires resources

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 Do You Have Questions?
•  If any of this presentation confuses you, talk
to your manager and ask him/her your
question(s).
•  The ISO 9001 Team is another resource for
you to ask if you have any questions.
•  Don’t hesitate to ask if you have a question.
Better ask it now than to forget it only to
remember it when the auditors come!

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