e.

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Internal Auditing of the

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Quality Management

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System

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Original Release, (Mo/Yr)

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 e.
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Part 1:

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Introduction

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to ISO 9001

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 Why Standardize?

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 Why Standardize?

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 The Origins of ISO 9001

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MIL-Q-9858 NATO AQAP-1 BS9000 BS5179

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(1959) (1968) (1971) (1974)

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BS5750 ISO ISO

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(1979) 9001:1987 9001:1994

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Virtually identical Minor changes

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ISO ISO
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9001:2000
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9001:2008
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“ISO 9K2K”
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 The ISO 9001 Document Set

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• Published as a set of THREE documents:

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– ISO 9000:2000 “Fundamentals & Vocabulary”

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– ISO 9001:2008 “Quality Management System Requirements”

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– ISO 9004:2000 “Guidelines for Performance Improvement”

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 Process Approach

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• ISO 9001:2008 requires the Company

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adopt the “process approach” to its

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management activities.

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• “The application of a system of processes within an organization,

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together with the identification and interactions of these
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processes, and their management, can be referred to as the
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‘process approach.’” --- ISO 9001:2008 clause 0.2.

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 The ISO 9001: 1987/1994
Method

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• LINEAR

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• Assumes the Company’s operations are

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comprised of a sequential, linear set of

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operations, managed in tandem.
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• Example:
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• Receipt of Customer order  Create traveler  manufacture product  inspection 

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 The ISO 9001:2008 Method

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• Everything has inputs and outputs, making it a “process.”

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• Those inputs may not appear on a linear graph, as they may

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not always come from a previous process.

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• Outputs may then be used by multiple subsequent

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processes.
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PROCESS
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PROCESS
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PROCESS
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INPUTS OUTPUT
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 Nested Processes

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 Example of a Nested
Process

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Production

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MATERIAL

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PRODUCTION SHIPPING

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PROCUREMENT Load
Prep

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& VALIDATION Material QUALITY

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OF MATERIAL DATA REVIEW

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Program
Finishing
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REVIEW OF machine
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CUSTOMER DEFECTIVE
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REQUIREMENTS MATERIAL
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INPUT OUTPUT
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PROCESSES Typical manufacturing process
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 Benefits of the Process
Approach

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• Shows a more accurate picture of a Company’s operations than

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the “life cycle” or linear model.

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• As a result, may reveal built-in problems immediately. Examples:

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– Points out built-in inefficiencies

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– Points out redundancies
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– Enables companies to review areas for growth or cutback and
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predicts areas affected of such changes

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• Each process has its inputs and outputs (internal Customers)

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clearly defined
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• Enables management to set goals and objectives by process,

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 Process ≠ Procedure

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• Not every process needs a procedure.

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For example, “sorting files” may be a process but

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do you need a procedure on how to sort?

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• Where ISO calls for “defining” a process, this

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may not always require a “procedure.”

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• Sometimes “defining” is a simple sentence in the

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Quality Manual or a box on a flowchart, not an

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entire procedure.
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 e.
What is AS9100

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• The AS9100 standard adds some

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additional AEROSPACE-SPECIFIC

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requirements onto the ISO 9001

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standard.

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• AS9100 was created by the Americas
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Aerospace Quality Group (AAQG), and es
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is published by SAE.
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• Through International Aerospace Quality

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Group (IAQG), the it is now recognized

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 AS9100 = ISO 9001 Plus

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• AS9100 simply adds boldface

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requirements to the text of ISO 9001.

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ISO 9001 language

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“quality” changed to conformity

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AS9100 addendum
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 Origins of AS9100

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Not widely adopted

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ISO9001

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AS9000:

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AS9100:1999

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1998

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AS9100 Rev. B

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AS9100 Rev A lti
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ISO 9001:2000 only
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Section 2:
ISO 9001:1994
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Requirements AS9100 Rev. C

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Section 1:
2009
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ISO 9001:2008 Current version

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Requirements ISO 9001:2008

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 OASIS

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• On-line Aerospace Supplier Information System

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– Lists AS9100 companies

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– Includes a score from previous audit(s)

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– Does not divulge nonconformity details es
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– Viewable by registrars, potential buyers

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www.sae.org/oasis
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 All Politics is Local…
Sort of

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ISO ISO develops and publishes standards

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International Accreditation Forum: Governs

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IAF

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standards for accrediting bodies

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ANSI represents US within ISO.

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ANSI

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Registrar Accreditation Board
United States

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RAB es accredits US registrars;
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certifies registrar’s auditors
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Registrar
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Registrar audits companies Registrant

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for compliance, issues

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certificates
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 e.
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Part 2:

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Auditing

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to ISO 9001 & AS9100
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 e.
There is an Auditing

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Standard

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• ISO 19011 provides guidance on auditing

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itself.

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built on these requirements, with some

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added necessities.
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 e.
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The Auditing Process

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• Despite weaknesses in 19011 – which

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treats auditing as a “program” instead of a

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“process” – registrars nonetheless have

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properly interpreted ISO 9001 as requiring
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auditing to be conducted both:

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• AGAINST processes
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 The Basic Audit Process

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• Like all processes, auditing converts

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inputs into outputs

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REQUIREMENTS

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AUDITING

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FINDINGS

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PROCESS
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EVIDENCE
Requirements are
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compared against
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evidence.
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 Typical Audit Inputs

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• Requirements:

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– ISO 9001/AS9100 requirements

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Typically documented,

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but not always
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– Statutory or regulatory requirements

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– Objective evidence only

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 Typical Audit Outputs

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• Audit findings

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– Reports of noncompliances

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– Compliments
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 Structure of the Audit

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• Develop Audit Plan

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• Compare Requirements vs. Documentation

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• Record findings

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• Submit audit report for review
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• Request corrective action
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• Review overall auditing trends (by management)

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 Current Processes

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Currently, there are 16 processes in use.

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• Calibration (7.6)

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• Configuration management (7.3.7)

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• Contract review (7.2.2)

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• Control of nonconforming product (8.3)

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• Control of documents (4.2.3)

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• Control of production and service (7.5.1)

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• Control of records (4.2.4)

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• Corrective and preventive actions (8.5.2, 8.5.3)

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• Purchasing (7.4)
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• Responsibility and authority (5.5)

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• Shipping (7.2.1, 7.5.1, 7.5.5)

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• Training (6.2.2)
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 Each Process Gets
Audited

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Each process...

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• Receiving ... Gets at least one audit

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• • AUDIT OF

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Purchasing

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AUDIT OF
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• AUDIT OF
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 The Internal Audit

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Schedule

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• The Quality Manager will develop and maintain a

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schedule of audits for each year.

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• The audits are scheduled according to

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importance, need, and other factors.

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audited more frequently if necessarylti
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• One audit per process per year is the minimum.

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 (Auditing)2

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• Even “Internal Auditing” is a process that

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must be audited itself.

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• When an auditor does the audit of the

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Internal Audit process itself, they must be

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sure not to audit their own audit reports.
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 Getting Assigned

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• The Quality Manager will assign an Auditor

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for each audit.

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• Each audit covers only one process.

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• If a process is particularly complicated, an

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audit team may be assigned.
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• When a team is assigned, one member is the

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Lead Auditor.
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 Lead Auditor

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• The Lead Auditor has the final say on

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audit findings and makes final

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decisions regarding the audit.

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• They also responsible for making any
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corrections to the final audit report if

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such problems are found by the

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Quality Manager.
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 e.
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Part 3:

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In-Depth Look

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at A9100 Rev. C

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 Clauses

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AS9100 / ISO 9001:2008 is comprised of Nine “Clauses” each of which is

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subdivided into any number of sub-clauses.

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Clauses 0 through 3 are introductory, and not auditable (i.e., they do not

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contain requirements for registration or for implementation.)

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of ISO 9001 and AS9100.
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Thoroughly review changes in ISO 9001:2008 and AS9100C as part of this

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orientation.
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business operation.
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 Introductory Clauses

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• 0.0: Introduction

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•

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some important limitations on its application. For example:

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“It is not the intent of this International Standard to imply

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uniformity in the structure of quality management systems or
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uniformity of documentation.” (Clause 0.1.)
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• The next three are self-explanatory:

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– 2.0: Normative Reference

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– 3.0: Terms & Definitions

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 e.
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Clause 4:

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Quality Management System

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• This first auditable clause sets out the

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basic rules for developing the ISO 9001
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compliant “QMS”
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 4.1 General Requirements

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• Possibly the most important Clause within the entire

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standard, it’s generic name belies its impact. Here it

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requires that the Company to:

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• Determine its processes (Has the Company

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determined it’s processes?)

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• Define their interaction and sequence (Has the

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Company defined the interaction?)
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• Determine criteria and methods for control
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• Ensure resources are available for each process

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• Monitor, analyze and/or measure those processes

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• Employ corrective and preventive action to improve

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the processes
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 e.
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4.2 Documentation Requirements

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• 4.2.1 General

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• Defines the minimum documentation required for ISO

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9001 compliance.

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– Does the company maintain the required procedures?

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– 4.2.3 Document control procedure

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– es
4.2.4 Record control procedure
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– 8.2.2 Internal audit procedure

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– 8.3 Control of nonconforming product procedure

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– 8.5.2 Corrective action procedure

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– 8.5.3 Preventive action procedure, etc.

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– Are Quality objectives and Quality policy defined?

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– Other documents to support QMS.

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• Does the Company maintain the required
records?

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– Management Review Minutes 5.6.1

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– Training records 6.2.2

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– Records needed to provide evidence that the realization processes and

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resulting product meet requirements 7.1.d

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– Contract review records 7.2.2

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– Design inputs records 7.3.2

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– Design review records 7.3.4

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– Design verification records 7.3.5

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– Design validation records 7.3.6

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– Design change records 7.3.7

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– es
Supplier evaluation records 7.4.1
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– Traceability records (if required) 7.5.3

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– Records of loss, damage or nonconforming CSP 7.5.4

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– Calibration records 7.6

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– Records of release authority of inspected product 8.2.4

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– Corrective action records 8.5.2.e

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– Preventive action records 8.5.3.d

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 4.2.2 Quality Manual

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– Defines the requirements of the Quality

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Manual.

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– Has the Company defined scope & exclusions

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– Required procedures or reference to them.

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(Also mentioned in 4.2.1)
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– Description of process interaction.
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(Also mentioned in 4.1)

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 * Required 

4.2.3 Document Control Procedure

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 Sets rules for control of documents.

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• Does the Company have a procedure that

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defines?

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– Are documents approved prior to release?

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– Review and Update; re-approve

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– Are changes identified (example: history table)

C.
LL
– Is the current revision identified?
,
es
lti
– Ensure documents are available, legible and
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identifiable.
F
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– Obsolete documents identified and controlled

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– External documents are identified and

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controlled
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 *  Required 
4.2.4 Record Control Procedure

e.
id
• Sets rules for control of records.

w
ld
or
• Records provide evidence of conformity to

w
ed
requirements.

rv
se
• 16 required records; any other records used within the

re
s
QMS.

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ig
lr
• Records must be legible (no white out, changes must

Al
C.
be identified)

LL
,
• Records must be readily identifiable & retrievable
lti
es
(records must be presented during the audit)
ia
ec
Sp

• Is there a documented procedure that defines controls

F
Jn

for:
©
ht

– Identification Storage Protection Retrieval Retention time

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py

– Disposition
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 Clause 5:
Management Responsibility

e.
id
w
ld
or
w
ed
rv
se
re
• This Clause defines the minimum

s
ht
ig
requirements for Management in order to

lr
Al
C.
maintain compliance to ISO 9001.
LL
,
es
lti
ia
ec
Sp
F
Jn
©
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rig
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 5.1 Management Commitment

e.
id
w
ld
or
• Management shall provide evidence of it’s

w
ed
rv
commitment to development,

se
re
s
implementation and continual

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ig
lr
improvement of the quality system

Al
C.
LL
• Not an idle requirement, audits must
,
es
lti
ia
ec

confirm ongoing management

Sp
F

commitment.
Jn
©
ht
rig
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Copyright © JnF Specialties, LLC. All rights reserved worldwide. www.quality-control-plan.com/copyright.htm

 5.1 Management Commitment

e.
id
w
ld
or
w
• Does management communicate the importance

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rv
of meeting Customer, regulatory & statutory

se
re
requirements?

s
ht
ig
• Has management established a quality policy?

lr
Al
C.
• Has management established quality
LL
,
objectives? es
lti
ia
ec

• Has management conducted formal

Sp

management reviews?
F
Jn
©

• Has management ensured the availability of

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rig

resources?
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 5.2 Customer Focus

e.
id
w
ld
or
• Requires a general awareness of

w
ed
rv
Customer requirements throughout the

se
re
s
ht
Company.

ig
lr
Al
• Some companies elect to use this as a

C.
LL
way of promoting the concept of internal
,
es
lti
ia

Customers, which is acceptable.

ec
Sp
F
Jn
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 5.3 Quality Policy

e.
id
w
ld
• Sets forth the requirements for the

or
w
ed
Company Quality Policy, including:

rv
se
re
– Must include a statement of continual

s
ht
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lr
improvement

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C.
– Must act as a “framework” for quality
LL
,
es
objectives.
lti
ia
ec
Sp

– Is communicated and understood within

F
Jn

the Company
©
ht

– Is reviewed for continued suitability

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 5.4 Planning

e.
id
• 5.4.1 Quality objectives

w
ld
or
– Objectives must be established for processes and

w
ed
product.

rv
se
re
– Quality objectives must be measured and consistent

s
ht
with quality policy.

ig
lr
Al
• Example: Quality policy says”…provide products on

C.
LL
time…”
,
es
– Company must show measurement for on time delivery through
lti
ia

a quality objective.
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Sp

• 5.4.2 QMS planning

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Jn
©

– Sets some minimum requirements for overall

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rig

planning of the QMS... but very minimal.

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 5.5 Responsibility, Authority &

e.
id
Communication

w
ld
or
w
• 5.5.1 Responsibility & Authority

ed
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se
– Company must define both

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s
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ig
– “Authority” now emphasized

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C.
• 5.5.2 Management Representative
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,
es
lti
– A member of the Company’s management must
ia
ec

be assigned to spearhead and represent the

Sp
F
Jn

QMS. They must:

©
ht

• Promote awareness
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• Report to management
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 5.5 Responsibility, Authority &
Communication

e.
id
w
ld
or
w
• 5.5.3 Internal Communication

ed
rv
se
– Requires processes be established for

re
s
ht
internal communication, especially for

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Al
communicating the “effectiveness of the

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LL
QMS” throughout the Company.
,
es
lti
ia

– Employees throughout the Company

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Sp

should be aware of the QMS and its current

F
Jn

standing (quality objectives data, status of

©
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rig

registration, etc).
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 5.6 Management Review

e.
id
w
ld
• Sets forth the minimum agenda and other requirements

or
w
for periodic review of the QMS by top management.

ed
rv
– results of audits,

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– Customer feedback,

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s
– process performance and product conformity,

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ig
– status of preventive and corrective actions,

lr
Al
– follow-up actions from previous management reviews,

C.
LL
– changes that could affect the quality management system, and

,
– recommendations for improvement. es
lti
ia
ec

• Management review meeting minutes must be

Sp

maintained.
F
Jn
©

• If quality objectives or other goals are not met, action

ht

should be taken to meet goal.

rig
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 Clause 6:
Resource Management

e.
id
w
ld
or
w
ed
• ISO 9001 requires certain resources,

rv
se
and that management ensure the

re
s
ht
provision and control of those

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lr
Al
resources.

C.
LL
,
es
lti
ia
ec
Sp
F
Jn
©

(Within the Company’s means, of course.)

ht
rig
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 e.
6.1 Provision of Resources

id
w
ld
or
w
ed
rv
• Requires resources:

se
re
s
ht
– to implement and maintain the QMS and

ig
lr
Al
continually improve its effectiveness

C.
LL
– to enhance Customer satisfaction by meeting
,
es
lti
Customer requirements.
ia
ec
Sp
F
Jn
©
ht
rig
py
Co

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 6.2 Human Resources

e.
id
w
ld
or
• Requires management of human

w
ed
resources

rv
se
re
• Includes all the requirements for a

s
ht
ig
Company training program

lr
Al
C.
– competence for personnel

LL
,
– provide training es
lti
ia
ec

– evaluate training effectiveness

Sp

– personnel are aware quality system including quality

F
Jn

objectives
©
ht
rig

– maintain appropriate records of education, training,

py

skills and experience

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 6.3 Infrastructure

e.
id
w
ld
or
w
ed
rv
se
• Requires infrastructure be managed.

re
s
ht
ig
• “Infrastructure” includes:

lr
Al
C.
– buildings, workspace & utilities,
LL
,
es
lti
– process equipment & software
ia
ec
Sp

– supporting services (transportation,

F
Jn

communication, internet, intranet, etc.)

©
ht
rig
py
Co

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 e.
id
w
6.4 Work Environment

ld
or
w
ed
rv
se
re
• Requires management of the work

s
ht
ig
environment so that quality is not impaired

lr
Al
C.
LL
,
es
lti
ia
ec
Sp
F
Jn
©
ht
rig
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Co

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 Clause 7:
Product Realization

e.
id
w
ld
or
w
ed
rv
• Sub-clauses within Clause 7 may be

se
re
s
excluded from the scope of the

ht
ig
lr
Company’s QMS, if not applicable to the

Al
C.
LL
business.
,
es
lti
ia

• This clause presents most of the

ec
Sp
F

“production” related requirements.

Jn
©
ht
rig
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Co

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 7.1 Planning of Product

e.
Realization

id
w
ld
or
• Requires that production planning include

w
ed
rv
definition of:

se
re
– quality objectives and requirements

s
ht
ig
– processes, documents, and resources

lr
Al
– required verification, validation, monitoring, inspection and test

C.
activities specific to the product and the criteria for product

LL
,
acceptance;
es
lti
– Records
ia
ec
Sp

• These requirements may not be written in a single

F
Jn

document but may be implemented throughout the

©

Company. An auditor may have to find evidence

ht
rig
py

of each.
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 New and Relocated Requirements

e.
id
w
ld
or
• 7.1.1 Project Management

w
ed
• New requirement for planning and managing product realization in a

rv
structured and controlled way.

se
re
• 7.1.2 Risk Management

s
ht
• New requirement of implementation of a risk management process

ig
lr
applicable to the projects & products; responsibility, criteria,

Al
mitigation & acceptance.

C.
LL
• 7.1.3 Configuration Management
,
es
• Moved from clause 4.3 to clause 7.1 and added details on the
lti
different activities to be covered.
ia
ec

• 7.1.4 Control of Work Transfer

Sp
F

• Moved from clause 7.5 (Production) to clause 7.1 to add emphasis

Jn

on having a process for planning and control of transfer activities.

©
ht
rig
py
Co

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 7.1.3 Configuration Management

e.
id
w
ld
or
• Company must define and implement a

w
ed
rv
configuration management process that is

se
re
s
applicable to the product.

ht
ig
lr
Al
– Method of configuration management must be

C.
LL
defined.
,
es
lti
ia
ec
Sp
F
Jn
©
ht
rig
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 7.2 Customer Related Processes

e.
id
w
ld
– 7.2.1 Determination of requirements

or
w
• Company must determine requirements including delivery and post

ed
delivery activities.

rv
se
• Requirements not stated by Customer, but necessary.

re
s
• Statutory, regulatory or other requirements

ht
ig
lr
– 7.2.2 Review of requirements

Al
• Company must review requirements prior to commitment to supply

C.
LL
product.

,
• Company must ensure that: es
lti
ia
ec

– Product requirements are defined

Sp

– Requirements differing from those previously expressed are

F
Jn

resolved.
©

– The company can meet the defined requirements

ht
rig

• Records of the review and actions arising must be maintained.

py
Co

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7.2.3 Customer Communication

e.
id
w
ld
or
• Customer communication

w
ed
rv
se
– ISO 9001 now requires there be formal

re
s
“arrangements” for handling Customer

ht
ig
lr
communications, including but not limited to

Al
C.
complaints
LL
,
es
lti
– Company must maintain effective
ia
ec
Sp

communication for:
F
Jn

• Product information
©
ht

• Enquiries, contracts order handling

rig
py
Co

• Customer feedback
Copyright © JnF Specialties, LLC. All rights reserved worldwide. www.quality-control-plan.com/copyright.htm
 7.3 Design & Development

e.
id
w
ld
• Defines all the requirements for activities

or
w
ed
related to the design and/or development of

rv
se
product or services.

re
s
ht
ig
• Design planning: plan the steps of design,

lr
Al
manage communication, define responsibility

C.
LL
and authority.
,
es
lti
ia

• Design Input: functional, performance,

ec
Sp

regulatory, statutory and other requirements

F
Jn
©

defined. Records are required.

ht
rig
py
Co

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 Design and Development

e.
id
w
ld
or
w
ed
rv
• Design output: outputs to meet input

se
re
requirements, contain acceptance

s
ht
ig
criteria, and information for purchasing

lr
Al
C.
and servicing.
LL
,
es
• Design review: evaluate design to meet
lti
ia
ec

requirements, identify problems, propose

Sp
F

solutions, and records maintained.

Jn
©
ht
rig
py
Co

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 Design and Development

e.
id
w
ld
or
• Design verification: ensuring the resulting

w
ed
rv
design (drawing, code, etc.) addresses all

se
re
requirements. Records must be maintained.

s
ht
ig
lr
• Design validation: ensuring the resulting

Al
C.
product meets the original requirements.
LL
,
Records must be maintained. es
lti
ia
ec

•
Sp

(“Testing from the user’s standpoint.”)

F
Jn

• Design changes must be controlled.

©
ht
rig
py
Co

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 7.4 Purchasing

e.
id
w
ld
or
• Defines the minimum requirements for:

w
ed
rv
se
– Evaluating suppliers and subcontractors

re
s
ht
– Defining scope of approval

ig
lr
Al
– Purchasing goods and services

C.
LL
,
– Defining information on purchase orders
lti
es
ia
ec

– Defining aerospace specific requirements on

Sp
F

POs
Jn
©

– Verifying received goods or services.

ht
rig
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Co

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 7.5 Production & Service

e.
Provision

id
w
ld
or
w
ed
rv
• Defines a variety of requirements to be carried out

se
re
during typical production or servicing.

s
ht
ig
– 7.5.1: Control of Production & Service Provision:

lr
Al
C.
activities shall be done under controlled conditions

LL
,
• the availability of information that describes the characteristics of the
es
lti
product,
ia
ec

• the availability of work instructions, as necessary,

Sp

• the use of suitable equipment,

F
Jn

• the availability and use of monitoring and measuring devices,

©

• the implementation of monitoring and measurement, and

ht
rig

• the implementation of release, delivery and post-delivery activities.

py
Co

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 Special processes

e.
id
w
ld
or
w
ed
– 7.5.2 Validation of Processes for

rv
se
re
Production and Service Provision:

s
ht
ig
such processes must be validated

lr
Al
before implementation

C.
LL
,
es
lti
ia
ec
Sp
F
Jn
©
ht
rig
py
Co

Copyright © JnF Specialties, LLC. All rights reserved worldwide. www.quality-control-plan.com/copyright.htm

 7.5 Production & Service
Provision

e.
id
w
ld
or
w
ed
rv
se
• 7.5.3 Identification & Traceability: product

re
s
ht
must be properly identified throughout the

ig
lr
Al
production life cycle

C.
LL
,
• 7.5.4 Customer Property: the use of any lti
es
ia
ec

property belonging to the Customer ---

Sp
F

including materials or equipment and

Jn
©

intellectual property must be controlled.

ht
rig
py
Co

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 7.5 Production & Service
Provision

e.
id
w
ld
or
w
ed
rv
se
– 7.5.5 Preservation of Product: product must

re
s
ht
be preserved during the production life cycle to

ig
lr
Al
prevent damage. This includes controls during:

C.
LL
• Identification
,
es
lti
ia

• Handling
ec
Sp

• Packaging
F
Jn
©

• Storage
ht
rig

• Protection
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Co

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 e.
id
7.6 Control of Monitoring &

w
ld
or
w
Measuring Equipment

ed
rv
se
re
s
• Equipment needed to provide

ht
ig
lr
Al
evidence of conformity of product

C.
LL
to determined requirements must
,
es
lti

be controlled, calibrated or
ia
ec
Sp

verified.
F
Jn
©
ht
rig
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Co

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 Clause 8:

e.
id
Measurement, Analysis &

w
ld
or
w
Improvement

ed
rv
se
re
• Defines the basic requirements for:

s
ht
ig
lr
– Measuring data

Al
C.
LL
– Analyzing data
,
es
lti

– Using data to improve the system

ia
ec
Sp
F
Jn
©
ht
rig
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Co

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 8.1 General Rules

e.
id
w
ld
or
w
ed
• Sets the scope of Clause 8, meaning

rv
se
activities necessary...

re
s
ht
ig
– to demonstrate conformity of the product to

lr
Al
requirements,

C.
LL
– to ensure conformity of the quality
,
es
lti
ia

management system, and

ec
Sp

– to continually improve the effectiveness of

F
Jn

the quality management system.

©
ht
rig
py
Co

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 e.
id
w
8.2 Monitoring & Measurement

ld
or
w
ed
rv
se
• Defines requirements for monitoring and

re
s
ht
measuring:

ig
lr
Al
• Customer Satisfaction

C.
LL
• Internal Auditing
,
es
lti
ia

• Processes
ec
Sp

• Product
F
Jn
©
ht
rig
py
Co

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 8.2.4 Monitoring and

e.
id
w
Measurement of Product

ld
or
w
ed
– Revised: Augment 8.2.4.1 and combine with 8.2.4;

rv
se
delete 8.2.4.2; add,

re
s
"When the organization uses sampling inspection as

ht
ig
a means of product acceptance, the sampling plan

lr
Al
shall be justified on the basis of recognized statistical

C.
LL
principles and appropriateness for use (i.e. matching
,
es
the sampling plan to the criticality of the product and
lti
ia
ec

to the process capability)".

Sp
F
Jn
©

– Validation of recognized statistical principles utilized.

ht
rig

– Process used to determine criticality of product.

py
Co

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 8.2.4.2 Moved First Article

e.
id
w
ld
Inspection

or
w
ed
rv
se
re
s
– First Article Inspection (FAI) moved to clause 7.5.1.1 and

ht
ig
renamed.

lr
Al
– Production process verification "FAI" is the requirement to

C.
validate the production process's documentation and tooling and

LL
,
repeat the process when necessary (i.e. when engineering or
lti
es
manufacturing processes change). The requirement was moved
ia
ec

from 8.2.4.2 (measurement) to 7.5.1.1 (production) because it is

Sp

part of product realization and is not intended to be a follow-on

F
Jn

activity.
©
ht
rig
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Co

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 * Required 
Procedure

8.3 Control of

e.
id
w
ld
Nonconforming Product

or
w
ed
• Defines controls for not only

rv
se
re
nonconforming product but infers that

s
ht
ig
such controls should be exercised

lr
Al
C.
over nonconforming service as well.
LL
,
es
lti
ia
ec
Sp
F
Jn
©
ht
rig
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Co

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 8.4 Data Analysis

e.
id
w
ld
or
w
ed
• Mandates that the Company must

rv
se
analyze:

re
s
ht
ig
– Customer satisfaction data

lr
Al
– Product quality data

C.
LL
,
– Data related to characteristics and trends of
lti
es
ia

processes and products including opportunities

ec
Sp

for preventive action

F
Jn

– Supplier performance
©
ht
rig
py
Co

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 * 2 Required 
Procedures

e.
8.5 Improvement

id
w
ld
or
w
ed
• This clause mandates that the Company improve over

rv
se
time, and includes requirements for:

re
s
ht
– 8.5.1 Continual Improvement

ig
lr
– * 8.5.2 Corrective Action

Al
C.
LL
– * 8.5.3 Preventive Action
,
es
• Evidence of the Company not at least attempting to
lti
ia
ec

improve can be seen as nonconforming to 8.5.1.

Sp
F
Jn
©

* - combine procedures is acceptable

ht
rig
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Co

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 ISO/AS Clause exercise

e.
id
w
ld
or
w
• The current revision of the NCR form is revision 6, the NCR form

ed
found for use in the quality control area was NCR form rev. 4.

rv
se
• The finishing operator did not have access to the work instructions

re
s
for his area. All work instructions were on the computer in the front

ht
ig
office and he didn’t have access to that computer.

lr
Al
• In the front office there were two new work instructions in use; “Job

C.
LL
Order creation Rev 0” and “Filing Job Orders Rev 0”. There was no

,
es
evidence these documents had been reviewed and approved.
lti
ia

• The complete list of procedures at the Company are:

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• Record control
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• Nonconforming product control

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• CAR/PAR
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 ISO/AS Clause Answers

e.
• 4.2.3 Control of documents

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• Documents required by the quality management system shall be controlled.

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Records are a special type of document and shall be controlled according to

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the requirements given in 4.2.4.

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• A documented procedure shall be established (Question 4) to define the

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controls needed:

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• a) to approve documents for adequacy prior to issue,

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•

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b) to review and update as necessary and re-approve documents,

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(Question 3)

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• c) to ensure that changes and the current revision status of documents are

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identified,

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• es
d) to ensure that relevant versions of applicable documents are
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available at points of use, (Question 2)
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• e) to ensure that documents remain legible and readily identifiable,

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• f) to ensure that documents of external origin are identified and their

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distribution controlled, and

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• g) to prevent the unintended use of obsolete documents, and to apply

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suitable identification to them if they are retained for any purpose.

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(Question 1)
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 ISO/AS Clause Exercise

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id
w
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or
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ed
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• Product was shipped to finishing and then drop shipped directly

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to the Customer. No representative from the Company

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inspected the finished production prior to shipment to the

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Customer.

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• There was no evidence of re-evaluation of vendors. Once

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vendors were approved, they were never reviewed again.
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• The purchasing agent had the authority to approve vendors

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based on price and delivery but no records of how he approved

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F

them was maintained.

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 ISO/AS Clause Answers

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id
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or
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•

ed
7.4.1 Purchasing process

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•

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The organization shall ensure that purchased product

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conforms to specified purchase requirements. (Question 1)

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The type and extent of control applied to the supplier and the

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purchased product shall be dependent upon the effect of the

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purchased product on subsequent product realization or the final

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LL
product.
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• The organization shall evaluate and select suppliers based on

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their ability to supply product in accordance with the

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organization's requirements. Criteria for selection, evaluation and

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re-evaluation shall be established. (Question 2) Records of

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the results of evaluations and any necessary actions arising

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from the evaluation shall be maintained (Question3) (see

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4.2.4).
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 e.
id
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ld
or
Part 4:

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ed
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Performing the

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s
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Audit
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,
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 The Basic Audit Process

e.
id
w
ld
• Recall the model of our audit process:

or
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REQUIREMENTS

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AUDITING

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FINDINGS

PROCESS
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,
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ia

EVIDENCE
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Requirements are
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compared against
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evidence.
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INPUTS OUTPUTS
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 e.
Step One: Coordinate With

id
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or
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Your Lead

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• Usually audits are conducted by a single

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Auditor, but if your audit has been

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C.
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assigned to a team, coordinate your
,
es
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activities with the Lead Auditor.
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ec
Sp
F
Jn
©
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 Step Two: Obtain An Audit
Form

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id
w
ld
or
• Audit forms have been developed for each

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ed
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process. These include instructions and

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re
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guidance on conducting the audit.

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,
• This audit report also helps an auditor in
es
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preparing for the audit itself.

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 Audit Form

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id
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ld
or
• The Quality Manager will provide you

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ed
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with the forms needed to perform the

se
re
s
audits.

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C.
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,
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 Requirements and

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id
Processes

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or
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• Prior to starting the audit, the Auditor

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should review which ISO/AS clauses apply

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to the process being audited.

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,
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 e.
Clauses to Remember

id
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ld
or
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ed
• There are other clauses the auditor should

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se
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always be conscious of regardless of what

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ht
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they are auditing.

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C.
– 4.2 Documentation Requirements
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,
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– 6.2.2 Competence, training and awareness.
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ec
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– 8.3 Control of Nonconforming Product

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Jn
©
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 Other Preparations

e.
id
w
ld
or
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ed
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• Review the previous audits

se
re
s
• Review any findings (NCRs) from the last audit.

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lr
• If there are any open NCRs from the last audit,

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C.
LL
ensure you follow-up during the audit.
,
es
lti
• Notify the area or personnel of the upcoming
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ec
Sp

audit.
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Jn
©
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 Start auditing

e.
id
• Gather all required reference material,

w
ld
or
audit forms, etc.

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ed
rv
• Review the reference material. Keep in

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re
s
mind your objective is to do two things.

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Al
– Compare Company documentation against

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LL
the ISO requirements.
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es
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– Compare Company practice against

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documentation and ISO requirements.

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Jn
©
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 Most important Part

e.
id
w
ld
or
w
ed
• The most important step is the audit

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se
re
itself.

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• During the audit, you are actively:

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C.
LL
• Walking around
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es OBTAINING
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• Interviewing people
ia

EVIDENCE
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• Witnessing processes
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Jn

• Examining product
©
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 OK, Lets Review the Form

e.
id
w
ld
or
• The Internal Audit Form has

w
ed
rv
been designed to guide you

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re
s
through the steps of an audit

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process.

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C.
LL
,
es
lti
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ec
Sp
F
Jn
©
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Co

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 The Audit form

e.
id
w
ld
• Step One is the

or
w
“Audit Plan”:

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se
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s
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lr
Al
C.
Details on the audit and 

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the applicable clauses.

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es
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Sp
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Other documents you 
Jn

plan to audit.
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Include QMS 
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rig

Procedures, WI’s, QC’s, 
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etc.
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 Record or 
Step Two reference your 

e.
evidence here.

id
w
ld
or
Three standard 

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questions included 

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for all processes.

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s
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LL
,
es
lti
ia
ec
Sp
F
Jn
©

Give suggestions for 
ht
rig

improvement on 
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documentation.
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 Step Three

e.
id
w
ld
or
w
ed
rv
se
re
s
ht
ig
lr
Al
C.
LL
,
es
lti
ia
ec
Sp

List the source of the 
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Jn

requirement, whether  Write down 
List the 
©

AS9100, QMS Manual  your 
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questions.
evidence.
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or procedure. Indicate 
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your answer
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 Step Three

e.
id
w
ld
If you have lots of 

or
w
notes to write, indicate 

ed
a Notes Reference #.

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se
Then write your notes, 

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s
with the appropriate 

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ig
reference #, on the last 

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Al
page of the report.

C.
LL
,
es
lti
ia
ec
Sp
F
Jn
©
ht
rig
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 Step Three

e.
id
w
Review previous audit 

ld
or
findings and ensure issues 

w
ed
were resolved.

rv
se
re
s
ht
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lr
Al
C.
LL
,
es
lti
ia
ec
Sp
F
Jn
©
ht
rig
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Co

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 Step Four

e.
id
w
ld
or
w
ed
rv
se
re
s
ht
ig
lr
Al
C.
LL
,
es
lti
ia
ec
Sp
F

The next set of questions 
Jn
©

asks you about the 
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effectiveness of the 
rig
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process as a whole.
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 Step Four

e.
id
w
ld
or
w
ed
rv
se
re
s
ht
ig
lr
Al
C.
LL
,
es
lti
ia
ec
Sp
F
Jn
©
ht
rig
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Co

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 Put new 
MR # here,  Step Five

e.
id
if known.  

w
ld
or
Record your 

w
finding.

ed
rv
se
re
s
ht
ig
lr
Al
C.
LL
,
es
lti
ia
ec
Sp
F
Jn
©
ht
rig

Check a finding detail.
py
Co

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 Step Six

e.
id
w
ld
or
w
ed
rv
se
re
s
ht
ig
lr
Al
C.
LL
,
es
lti
Lead auditor reviews internal 
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ec

audit record to ensure it is 
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complete.  Lead auditor signs and 
F
Jn

dates. 
©
ht
rig

Submits the report to the Quality 
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Manager
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 Step Seven

e.
id
w
ld
or
w
ed
rv
se
re
s
ht
ig
lr
Al
C.
LL
,
es
lti
ia
ec
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F
Jn
©

Quality Manager checks off who is 
ht
rig

sent copies of completed audit 
py

report.
Co

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 Finishing Up

e.
id
w
ld
or
w
• Once the audit is done and approved as

ed
rv
complete, the Quality Manager will update the

se
re
audit schedule and file the reports.

s
ht
ig
lr
• As needed, these reports may be uploaded to

Al
C.
LL
the Company server for general publication
,
es
and/or sent to specific managers.
lti
ia
ec
Sp

• The Quality Manager will verify that all clauses

F
Jn

of the standard have been audited.

©
ht
rig
py
Co

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 Remember the Process

e.
id
w
ld
or
• Remember to audit the effectiveness of

w
ed
rv
the process, not the people

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re
s
ht
– Use the Process Map as a guide

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lr
Al
– Ask Operators open-ended questions:

C.
LL
How do you know how to do this job?
,
es
lti
What is the first thing you do?
ia
ec
Sp

– Request records to verify

F
Jn
©

– Record evidence
ht
rig
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Co

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 Remember the Process

e.
id
w
ld
or
• Interviews should be relaxed and

w
ed
rv
conversational.

se
re
s
ht
– Take time for introductions

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lr
Al
– Ask about position and duties

C.
LL
– Focus on understanding the process and the
,
es
lti
ia

Operator’s role in the process

ec
Sp

– Do not ask leading questions that expect a

F
Jn
©

specific answer
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rig
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Co

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 Remember the Process

e.
id
w
ld
or
• Avoid interviewing a Group unless there is

w
ed
rv
a good reason.

se
re
s
ht
– Such as a project team to understand team

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lr
dynamics

Al
C.
LL
– Or a group of sales representatives before
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es
lti
they leave on assignment
ia
ec
Sp

– When necessary, two Auditors should be

F
Jn
©

present and the Group should be less than

ht
rig

five people
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Co

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 Remember the Process

e.
id
w
ld
or
• Corroborate facts stated and other data

w
ed
rv
collected during an audit interview

se
re
s
ht
– Ask for information in a different way

ig
lr
– Ask for evidence demonstrating an activity is

Al
C.
performed as described

LL
,
– Ask several people the same question es
lti
ia
ec

– Observer the activity in question being performed

Sp
F
Jn

– Review the evidence of other Audit team members

©
ht

– Review other evidence such as procedures,

rig
py

instructions and records

Co

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 Remember the Process

e.
id
w
ld
or
• Overcome communication problems

w
ed
rv
– Rely on the Escort to correct misunderstandings

se
re
s
– Corroborate all information

ht
ig
lr
– Revisit an area or raise the issue for necessary action

Al
C.
at the daily meeting

LL
,
es
– End the interview by asking whether the Operator is
lti
ia

responsible for any other activities or ask for their

ec
Sp

opinion about how well the process is performing

F
Jn
©

– Recognize and control delay tactics

ht
rig

• Personnel unavailable; Escort always late; waiting for

py
Co

supplies and records; constant distractions; didn’t know…!

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 Remember the Process

e.
id
w
ld
or
• Steering, intimidation, too busy, rambling

w
ed
rv
– Randomly select Operators without being steered to

se
re
interview certain people

s
ht
ig
lr
– Sit or stand between the Escort and Operator while

Al
C.
facing the Operator, maintain eye contact with the

LL
Operator – the Escort fixes communication problems
,
es
lti
ia

– Try to sense when an Operator is too busy for

ec
Sp

questions then find other ways to keep the audit

F
Jn

moving
©
ht

– Avoid irrelevant information by focusing on the topic

rig
py

of interest without alienating the Operator

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 Document all evidence

e.
id
w
ld
or
• Auditors must record ALL evidence.

w
ed
rv
Regardless if there was a

se
re
s
nonconformance.

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ig
lr
Al
• If a nonconformance is discovered, it is

C.
LL
important to record all details of the
,
es
lti
ia

finding, why it is a finding and the original

ec
Sp

requirement.
F
Jn
©
ht
rig
py
Co

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 NCR system

e.
id
w
ld
or
• All findings must be entered into the NCR

w
ed
rv
system.

se
re
s
ht
• The form requires the NCR number be

ig
lr
Al
documented.

C.
LL
,
es
lti
ia
ec
Sp
F
Jn
©
ht
rig
py
Co

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 Management Review

e.
id
• Over the course of the year, the trends

w
ld
or
in findings of audits will be gathered by

w
ed
rv
the Quality Manager.

se
re
s
• During Management Review, these

ht
ig
lr
Al
trends will be reviewed by top

C.
LL
management.
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es
lti
ia

• Trends may reveal weak/strong

ec
Sp
F

processes, resource needs or other

Jn
©

important revelations.
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rig
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Co

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 e.
id
w
ld
or
Part 5:

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ed
rv
se
Findings &

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s
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Evidence
C.
LL
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es
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ia
ec
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F
Jn
©
ht
rig
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Co

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 What is Evidence?

e.
id
• As you audit, you are gathering

w
ld
or
evidence to record whether or not

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ed
rv
practice matches documentation and

se
re
requirements.

s
ht
ig
lr
Al
• Evidence can take many forms:

C.
LL
• Physical records (electronic or paper)
,
es
lti
ia

• Interview results (comments by employees)

ec
Sp

• Witnessed actions
F
Jn
©

• Physical samples
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rig
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Co

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 Acceptable Evidence

e.
id
w
ld
or
• This is important:

w
ed
rv
se
re
s
ht
• ONLY OBJECTIVE EVIDENCE IS

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C.
ALLOWABLE AS AN AUDIT FINDING!
LL
,
es
lti
ia
ec
Sp
F
Jn
©
ht
rig
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Co

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 Objective Evidence is...

e.
id
w
ld
or
w
• ... "Information which can be proven true,

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rv
based on facts obtained through observation,

se
re
measurement, test or other means."

s
ht
ig
lr
• In other words, objective evidence must have

Al
C.
a component that can be verified.
LL
,
es
• Think: “will someone else be able to verify my
lti
ia
ec

evidence at a later date?”

Sp
F
Jn
©
ht
rig
py
Co

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 Types of Evidence

e.
id
w
ld
or
w
BEST

ed
rv
STRONG OBJECTIVE EVIDENCE

se
re
s
ht
MODERATE OBJECTIVE EVIDENCE ADMISSABLE ON

ig
AUDIT REPORT

lr
Al
C.
WEAK OBJECTIVE EVIDENCE

LL
,
es
lti
ia
ec

SUBJECTIVE EVIDENCE INADMISSABLE!

Sp
F

WORST
Jn
©
ht
rig
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Co

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 Strong Objective
Evidence

e.
id
w
ld
or
w
• Physical records with all data intact and

ed
rv
se
signatures, etc.

re
s
ht
ig
• Verified electronic records

lr
Al
C.
• Physical samples, objects, parts, able
LL
,
es
to be measured, observed, inspected.
lti
ia
ec
Sp

• Direct observation of practice by

F
Jn
©

multiple parties
ht
rig
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Co

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 Moderate Objective
Evidence

e.
id
w
ld
or
w
ed
• Physical records lacking some data but with

rv
se
enough information to satisfy audit or to track

re
s
ht
back to originators for verification

ig
lr
Al
• Verbal statements with some form of

C.
LL
,
supporting proof (documentation, otherlti
es
ia

witnesses, etc.)
ec
Sp

• Direct observation of practice by one

F
Jn
©

qualified individual
ht
rig
py
Co

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 Weak Objective Evidence

e.
id
w
ld
or
w
• Informed opinions: verbal statements

ed
rv
se
without supporting proof but made by

re
s
ht
authorized personnel and/or multiple

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lr
Al
people.

C.
LL
,
• Records with suspect validity but es
lti
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lacking any evidence of outright

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 Subjective Evidence

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INADMISSABLE!

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or statement
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 Recording Your Evidence

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and requirement, indicate BOTH.

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TITLE and REVISION LEVEL.

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 Record All evidence

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timely manner.”
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 Anatomy of a finding

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1. The clause or requirement that has

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not been met.

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situation did not meet the

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requirement.
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 Example

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“A document procedure shall be

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established…” Currently the Company

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does not have a procedure for Corrective

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Action. The ISO 9001 standard requires a
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documented procedure for Corrective

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Action.
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 Some Bad Examples

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told to.”

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identification.”
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 Still Bad, but Better

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• “Product was found without

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identification in the receiving

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area, this is against procedure.”

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 A Very Bad Example

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• “Everything’s cool.”

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 Never Assume

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question or assume evidence exists where

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it doesn’t.

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 e.
No Baggage

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bring to an audit that sometimes get in our

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way of objectivity.

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audit based on his or her own experience,

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which may or may not be relevant.

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 Distinguishing Facts from

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Assumptions

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FOR YOUR ANSWERS.
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question:
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• TRUE FALSE UNCLEAR

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• Jones and Smith work for ABC Iron Manufacturing, Inc. Smith works the 4
to 12 shift and Jones works 12 to 8 shift. Both workers began work on
January 1st. New employees for ABC Iron must undergo one month
training on first shift before being assigned to their permanent shift. Smith

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earns $10.00 per hour and Jones earns $11.00 per hour; in most cases,

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workers earn more per hour due to seniority.

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days of work. Returning from work, Smith pokes out an eye while

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sharpening a pencil and is hospitalized for another month. Returning from

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this injury, Smith's eye is patched and he cannot see his equipment

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properly. As a result, Smith sets his automatic cutting machine for 0.5

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instead of 1.0 and parts begin to eject from the machine 1/2" too short.

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Smith is called into the office by his Supervisor, Lee, and is reprimanded for

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poor work performance; during the conversation, Smith gets agitated and

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causes Lee's temper to flare. Lee yells, causing Smith to have a psychotic

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episode. Smith picks up a welding torch and tries to attack Lee but Teddy

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Jones interrupts and breaks up the fight before any injuries occur. Smith is
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fired from the Company.
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• At midnight, Smith tells his wife of the incident and she announces her
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intention to divorce him as a result. Smith has a nervous breakdown and is

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put into an asylum for the next six years. Smith's chief therapist, Dr. Jekyll,
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teaches Smith a way to properly vent his anger. Upon his release, Smith
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begins work again as an ISO 9000 Auditor and is hugely successful.

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 e.
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 e.
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DISCUSSION

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