wi-822-001 internal auditor training
Post on 10-Apr-2018
213 Views
Preview:
TRANSCRIPT
-
8/8/2019 WI-822-001 Internal Auditor Training
1/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Internal Auditor Training
ISO 9001 / AS9100
Quality Management System
-
8/8/2019 WI-822-001 Internal Auditor Training
2/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Internal Auditor
Training Agenda
Todays topics:
How the Audit fits
Quality System Audits vs. Other
Audits
Parts of the Audit System
How to Plan an Audit
-
8/8/2019 WI-822-001 Internal Auditor Training
3/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Internal Auditor
Training Agenda
Todays topics:
How to Conduct an Audit
How to Write the Final Report
How to Follow up the Audit
Review of the ISO Requirements
-
8/8/2019 WI-822-001 Internal Auditor Training
4/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Internal Auditor
Training Agenda
Questions & Answers -
Ask the questions when
they come to mind,
DONT WAIT.
-
8/8/2019 WI-822-001 Internal Auditor Training
5/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How the Audit Fits
What is a Quality System?
Documentation of the System
What is an Audit?Why do we Audit?
Managements Role
-
8/8/2019 WI-822-001 Internal Auditor Training
6/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
What is a Quality System?
Quality Policy
System Requirements
Best Practices
Types of Standards
How the Audit Fits
-
8/8/2019 WI-822-001 Internal Auditor Training
7/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Quality Policy
A documented COMMITMENT to
have a QUALITY SYSTEM that
will provide CUSTOMERS with
PRODUCTS & SERVICES that
MEET ALL REQUIREMENTS &ENSURE CUSTOMER
SATISFACTION.
How the Audit Fits
-
8/8/2019 WI-822-001 Internal Auditor Training
8/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How the Audit Fits
Company
Quality PolicyTechnical
Assistance
Marketing
Design &
Development
Process
Planning
ProductionInspection Storage
Installation
Sales
Disposal
System Requirements
-
8/8/2019 WI-822-001 Internal Auditor Training
9/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
C
ustomers
R
equirements
Management
Responsibility
Measurement,analysis &
improvement
Resource
Management
ProductRealization C
ustomers
Satisfaction
Value added
activityInput Output Product
Continuous improvement of the QMS
P
Plan
D
Do
C
Check
AAct
Information
Flow
Info.
Flow
-
8/8/2019 WI-822-001 Internal Auditor Training
10/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How the Audit Fits
Best Practices
Quality ManualProcedures
Work Instructions
Workers
Auditor
Verification
-
8/8/2019 WI-822-001 Internal Auditor Training
11/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How the Audit Fits
Types of Standards:
Contractual Standards
OSH
A EPA Customer Required Standards
Voluntary Standards
National Particle Board Association NEMA ISO 9001
-
8/8/2019 WI-822-001 Internal Auditor Training
12/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How the Audit Fits
Documentation - Why we have it
Guidance
Consistency
Compliance
Basis for Auditing
-
8/8/2019 WI-822-001 Internal Auditor Training
13/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Typical ISO Documentation Structuring
QualityManual
Procedures
(Implementation ofPolicy)
Work Instructions
(The how to do it documents)
Blank FormsRecords
Completed Forms
FORMS
RECORDS
Company PolicyStatements
Who does What,
Where & WhenThe HOW to do it
instructions
How the Audit Fits
-
8/8/2019 WI-822-001 Internal Auditor Training
14/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How the Audit Fits
What is an Audit? Planned Event
Independent Shows Intent
Shows Implementation
Shows Effectiveness
Management Driven
Required by the Standard
-
8/8/2019 WI-822-001 Internal Auditor Training
15/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How the Audit Fits
Why do we Audit?
To Identify Opportunities for
Improvement
To Verify Implementation
To determine Effectiveness
To Meet the Requirements of
ISO
-
8/8/2019 WI-822-001 Internal Auditor Training
16/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Managements Role
Initiate Audit Program
Provide Audit Leadership
Assure Auditor Independence
Provide Resources
Corrective Action Follow Up
How the Audit Fits
-
8/8/2019 WI-822-001 Internal Auditor Training
17/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Questions
-
8/8/2019 WI-822-001 Internal Auditor Training
18/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Quality System Audits
vs. Other Audits
Quality System Audits
Other Audits Types of Audits
-
8/8/2019 WI-822-001 Internal Auditor Training
19/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Quality System Audits
vs. Other Audits
Quality System Audits
Whatever Affects Quality Relates to the ISO Elements
Intent
Implementation
Effectiveness
Supplier Quality
-
8/8/2019 WI-822-001 Internal Auditor Training
20/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Quality System Audits
vs. Other Audits
Other Audits
Product Audits
Process Audits
Problem or Spot Audits
Self Audits
-
8/8/2019 WI-822-001 Internal Auditor Training
21/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Quality System Audits
vs. Other Audits
ISO 9001 - Types of Audits
YOU AUDIT YOURSELF
YOU AUDIT YOUR SUPPLIER OR
YOUR CUSTOMER AUDITS YOU
First Party
Third Party YOUR REGISTRAR AUDITS YOU
Second Party
-
8/8/2019 WI-822-001 Internal Auditor Training
22/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Questions
-
8/8/2019 WI-822-001 Internal Auditor Training
23/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Parts of the Audit System
People
Procedures
Goals
Results
Follow up
-
8/8/2019 WI-822-001 Internal Auditor Training
24/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Parts of the Audit System
People
Top ManagementManagement Rep.
Audit Team
Engineering
Dept. Manufacturing
Dept.
Sales
Dept.
-
8/8/2019 WI-822-001 Internal Auditor Training
25/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Parts of the Audit System
Procedures
Audit Tools
Audit Appeals
Auditor Qualifications
Auditor Behavior
-
8/8/2019 WI-822-001 Internal Auditor Training
26/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Parts of the Audit System
Audit Tools
Audit Procedures
Check List
Record of Non Conformity
Audit Plan
Corrective Action Schedule
-
8/8/2019 WI-822-001 Internal Auditor Training
27/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Parts of the Audit System
Audit Appeals
What is the Avenue?
Concentrate on the Facts.
-
8/8/2019 WI-822-001 Internal Auditor Training
28/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Parts of the Audit System
Auditor Qualifications / Attributes:
Open Minded / Mature
Sound Judgement, Analytical Skills and Tenacity
Realistic Perceptions and
Broad Perspective
-
8/8/2019 WI-822-001 Internal Auditor Training
29/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Parts of the Audit System
Auditor QualificationsAuditor Actions:
Fair Evaluate Effects SensitivityAvoid DistractionsG
ive Full Attention & Support Effective Under StressArrive at Valid Conclusions
-
8/8/2019 WI-822-001 Internal Auditor Training
30/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Parts of the Audit System
Auditor Behavior
Solutions to Stalling & Diversions
Schedule Briefing Prior to Audit
Allocate Specific Time for Tour / Audit
Offer to Meet Again if Conflict is
Apparent
Have Contact / Alternate PhoneNumbers
Deal Only in Facts
Insist on a Knowledgeable Counterpart
-
8/8/2019 WI-822-001 Internal Auditor Training
31/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Parts of the Audit System
Auditor Behavior
Solutions to Stalling & Diversions
Note any Attempts at Intimidation orGratuitous Conduct
Contact the Lead Auditor when
Needed (Thats why they get paid the BIG BUCKS)
-
8/8/2019 WI-822-001 Internal Auditor Training
32/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Parts of the Audit System
Adhere to Auditor Rules
Safety & Smoking
Lunch / Break Times
Control of Proprietary Data
/ InformationManagement Discussions
Off Shift Auditing
Unsolicited Negative Information
Auditor Behavior
-
8/8/2019 WI-822-001 Internal Auditor Training
33/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Parts of the Audit System
Goals of Auditing
Ensure compliance to Quality System
Requirements
Ensure Quality system is Effective
Help Make Our Company Better
-
8/8/2019 WI-822-001 Internal Auditor Training
34/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Parts of the Audit System
Results
Non Conformities
Final Report
-
8/8/2019 WI-822-001 Internal Auditor Training
35/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Parts of the Audit System
Follow Up Results
Corrective Actions
Effective Implementation
-
8/8/2019 WI-822-001 Internal Auditor Training
36/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Questions
-
8/8/2019 WI-822-001 Internal Auditor Training
37/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Plan The Audit
How to Plan the Audit
Pre audit Visit
People Plan
Check List
Methods
-
8/8/2019 WI-822-001 Internal Auditor Training
38/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Plan The Audit
Pre Audit Visit
Scope
Location Departments
Expertise for Processes
Who, What & How Many
-
8/8/2019 WI-822-001 Internal Auditor Training
39/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Plan The Audit
People = Who ?
Technical Expertise of Auditors
Auditing Expertise of Auditors
Independence From Departments
Audited Need For Orientation
-
8/8/2019 WI-822-001 Internal Auditor Training
40/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Plan The Audit
The Plan - Do we have one?
The Schedule (Annual Plan)
The Check List (Who, Where, What
to Audit and What you Found)
-
8/8/2019 WI-822-001 Internal Auditor Training
41/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Plan The Audit
Check List
To Stay Focused
To Show Serious Intent
It Reminds You What to Look at & for
Provides a Place to Record Findings
-
8/8/2019 WI-822-001 Internal Auditor Training
42/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Plan The Audit
Making up a Check List
Fill Out Header Information
Review / Understand Documents
pertinent to Area to be Audited
Use Document Paragraph Reference
numbers when Selecting Audit Point
Write Audit Point Clearly on Check List
-
8/8/2019 WI-822-001 Internal Auditor Training
43/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Plan The Audit
Methods of Auditing
Vertical - follow records through departments
Upstream - shipping to sales
Downstream - sales to shipping
Horizontal - departmental interfaces
By ISO Requirement
-
8/8/2019 WI-822-001 Internal Auditor Training
44/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Questions
-
8/8/2019 WI-822-001 Internal Auditor Training
45/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Conduct the Audit
Opening Meeting
Objective Evidence
Audit Techniques Non Conformities
Closing Meeting
-
8/8/2019 WI-822-001 Internal Auditor Training
46/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Conduct the Audit
Opening Meeting
If You Dont Know the Auditee -
introduce Yourself
May Be a Phone Call orHallway Meeting
Deliver / Send a Copy of the Check List
Determine If Confidentially Issues Exist
Special Precautions / Safety
-
8/8/2019 WI-822-001 Internal Auditor Training
47/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Conduct the Audit
Objective Evidence
First
H
and Factual
Based on Direct Observation
Interviews
Records Results of an Activity
-
8/8/2019 WI-822-001 Internal Auditor Training
48/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Conduct the Audit
Objective Evidence
Information Which Can BeProven TRUE, Based on FACTS
Obtained Through OBSERVATION,
MEASUREMENT, TEST or Other
Means.
-
8/8/2019 WI-822-001 Internal Auditor Training
49/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Conduct the Audit
Audit Techniques
Review Documentation Prior to
Audit
Use Your Check List
Use Different Interviewing
Techniques Open Ended Questions
Closed Ended Questions
Silence
-
8/8/2019 WI-822-001 Internal Auditor Training
50/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Questions
Open-ended questions typically begin with wordssuch as "Why" and "How", or phrases such as "Tell
me about...". Often they are not technically a question,
but a statement which implicitly asks for a response.
Closed ended questions encourages a short or single-word answer.
Examples:
Closed-Ended Questions
Do you get along on well with your boss?
Who will you vote for this election?
What color shirt are you wearing?
Open-Ended Questions
Tell me about your relationship with your boss.
What do you think about the candidates in this
election?
Thats an interesting color shirt youre wearing.
-
8/8/2019 WI-822-001 Internal Auditor Training
51/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Conduct the Audit
Uncover / Discover Objective
Evidence
How to Find It
Cross Check Results
Avoid Spring boarding IntoNew Findings
Audit Techniques
-
8/8/2019 WI-822-001 Internal Auditor Training
52/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Conduct the Audit
Non Conformities
Activity Doesnt Follow Procedures
Written
Oral (Training Records)
Procedure Is Not Effective
Procedure is Non Existent
-
8/8/2019 WI-822-001 Internal Auditor Training
53/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Conduct the Audit
Non Conformities
Document Specific Facts
What Department, Line, Activity, Etc;
What Specifically Was Observed
What Was Said / by Whom?
What Does the Activity Not Meet
Procedures / Contract
The requirements of the Standard
Effectiveness Criteria
-
8/8/2019 WI-822-001 Internal Auditor Training
54/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Conduct the Audit
Closing Meeting
Auditees / Auditors
Discuss Findings Found During Audit
If Finding Not Clear, Default to Auditee
No Surprises After Closing Meeting
Collectively Discuss Findings &
Determine Validity Initiate C A Rs With Implementation
Time Limits
-
8/8/2019 WI-822-001 Internal Auditor Training
55/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Conduct the Audit
AuditorsAre Not
Auditors Do Not Have the Knowledge
Base to Become Part of the Solution
But Tend to Become Part of the
Problem When Used As the Problem
Solvers.
-
8/8/2019 WI-822-001 Internal Auditor Training
56/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Questions
-
8/8/2019 WI-822-001 Internal Auditor Training
57/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Write
the Final Report
Report Procedures
Report Content
-
8/8/2019 WI-822-001 Internal Auditor Training
58/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Report Procedures
Everything Remains Proprietary
No Surprises After Closing Meeting
Organize Report Logically
Meet the Promised Date
How to Write
the Final Report
-
8/8/2019 WI-822-001 Internal Auditor Training
59/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Report Procedures
Give All Team Members Responsibilities
Clarify, Dont Argue Over the Results
How to Write
the Final Report
Fl id MEP S l ti f M f t
-
8/8/2019 WI-822-001 Internal Auditor Training
60/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Reference the Audit Basis
Results Findings & Significance
Evaluation
Conclusion
How to Write
the Final Report
Fl id MEP S l ti f M f t
-
8/8/2019 WI-822-001 Internal Auditor Training
61/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Report Content
Agreements on Corrective Actions
Recommendations if requested ??????
Non Conformities & Support
Routing of Report
How to Write
the Final Report
Fl id MEP S l ti f M f t
-
8/8/2019 WI-822-001 Internal Auditor Training
62/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Questions
Fl id MEP S l ti f M f t
-
8/8/2019 WI-822-001 Internal Auditor Training
63/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Follow Up The audit
Auditor Actions for Corrective
Actions
Closure With Management
What the Registrar Will Look for
Elements of Success
Fl id MEP S l ti f M f t
-
8/8/2019 WI-822-001 Internal Auditor Training
64/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Follow Up The audit
Auditor Actions for Corrective Actions
Verify Corrective Action
action taken
action effective
on all findings
Fl id MEP S l ti f M f t
-
8/8/2019 WI-822-001 Internal Auditor Training
65/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Follow Up The audit
Auditor Actions for Corrective Actions
Identify + Address = Reduced Recurrence
Overall Process Addressed ?Any Interim Actions ?
Root Cause Found ?
Not Symptoms
Florida MEP Sol tions for Man fact rers
-
8/8/2019 WI-822-001 Internal Auditor Training
66/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Follow Up The audit
Auditor Actions for Corrective Actions
When Does C/A Take Effect ?
(Effectively) Document Your Acceptance
By Signature / Date
By Letter
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
67/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
How to Follow Up The audit
Closure with Management
Successful Verification of C/A Effective Implementation of C/A
Summarize Results and C/A's
Inform the Auditee
Audit is Now Closed
Thank All That Helped
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
68/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Questions
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
69/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
What Will The
Registrar Look For ?
Audit plan
Final report
Corrective actions
required (open)
Corrective actions
followed up (closed)
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
70/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Schedules of management
reviews
Procedures to conduct
audits
Documented auditor
training
What Will The
Registrar Look For ?
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
71/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
What Will The
Registrar Look For ?
Check lists
Copies of procedures
Work instructions
Training records
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
72/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Audit reports
Non conformity reports
Records of audits
Records of management
reviews
What Will The
Registrar Look For ?
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
73/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
What Will The
Registrar Look For ?
Opening and closing
meeting memos
Quality policy compliance
to the referenced quality
standard
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
74/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
What Will The
Registrar Look For ?
Customer complaint files
Proactive, preventive
action procedures
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
75/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
What Will The
Registrar Look For ?
ANYTHINGAND
EVERY THING THATYOU THOUGHT WASWELL TAKEN CARE
OF AND YOU LEASTEXPECTED TO BEAUDITED FOR
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
76/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Questions
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
77/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Take A Break
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
78/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
ISO 9001
Quality Management
System Requirements
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
79/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
4 Quality Management System
4.1 General
Establish, document and maintain a QMS Identify the processes
Determine their sequence
Available resources Monitor, measure and analyze (continuous
improvement)
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
80/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
4.2.2 uality anual
The uality anual must include: The cope and justi ication or any
exclusions
ocumented procedures or a re erence Interrelationship o the processes
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
81/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
4.2.3 Control o ocuments
ll documents must be controlled.
Reviewed and approve by proper people
Changes are identi ied
vailable at point o use
Legible and readily identi iable
Prevent unintended use
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
82/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
4.2.4 Control o Records
vidence o con ormity stablished
aintained
Legible
Readily identi iable
Protection
Retention time isposition
torage
Retrievable
Re erence to para.
4.2.4 means a record
is mandated
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
83/136
Florida MEP: Solutions for Manufacturers
WI-822-001 Rev. Basic CLI
Questions
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
84/136
WI-822-001 Rev. Basic CLI
5 Management Responsibility
5.1 Management Commitment
Must sho commitment to the QMS by: Communicating requirements
Establishing Quality olicy & Ob ectives
Conduct Management Revie s Making resources available
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
85/136
WI-822-001 Rev. Basic CLI
5.2 Customer Focus
Customer requirements are determined andmet with the aim o enhancing customer
satis action.
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
86/136
WI-822-001 Rev. Basic CLI
5.3 uality Policy
Is appropriate to your company
Commitment to comply with requirements and
continuous improvement
Provides ramework or establishing and
reviewing uality bjectives Communicated and understood
Reviewed or continuing suitability
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
87/136
WI-822-001 Rev. Basic CLI
5.4.1 Quality Ob ectives
Established at relevant functions and levels
Measurable and consistent ith the Quality
olicy
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
88/136
WI-822-001 Rev. Basic CLI
5.4.2 Quality Management
System lanning
Is carried out to meet requirements andob ectives
Integrity of the QMS is maintained hen
changes to the QMS are planned andimplemented
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
89/136
WI-822-001 Rev. Basic CLI
5.5.1 Responsibility and
Authority
Ensure responsibilities and authorities are
defined and communicated.
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
90/136
WI-822-001 Rev. Basic CLI
5.5.2 anagementRepresentative
ppoint a member o management who: nsures that processes are
established, implemented and maintained
Reports on the per ormance o the to
top management needs or improvement
Promotes awareness o requirements
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
91/136
WI-822-001 Rev. Basic CLI
5.5.3 Internal Communication
ppropriate communication processes are
established and takes place regarding the
e ectiveness o the .
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
92/136
WI-822-001 Rev. Basic CLI
5.6.1 anagement Review -eneral
Planned review o the to ensure:
Continuing suitability
dequacy and e ectiveness
ssess opportunities or improvement
ssess needs or changes in the
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
93/136
WI-822-001 Rev. Basic CLI
5.6.2 Revie Input
Audit results
Customer eedback
rocess performance
Status of Corrective and reventive Actions
ollo -up from previous revie s
Recommendations for improvement
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
94/136
WI-822-001 Rev. Basic CLI
5.6.3 Review utput
Improvements o the e ectiveness o the
Improvement o product related to customer
requirements
Resource needs
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
95/136
WI-822-001 Rev. Basic CLI
Questions
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
96/136
WI-822-001 Rev. Basic CLI
6 Resource anagement
6.1 Provision o Resources
To implement and maintain the and
continually improve its e ectiveness To enhance customer satis action
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
97/136
WI-822-001 Rev. Basic CLI
6.2 Human Resources
6.2.1 GeneralAll personnel performing ork affecting
product quality must be competent on the
basis of appropriate education, training,
skills and experience
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
98/136
WI-822-001 Rev. Basic CLI
6.2.2 Competence, warenessand Training
etermine competence or necessary work Provide training or take other actions
valuate this training
nsure personnel are aware o theircontributions to product quality
aintain appropriate records
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
99/136
WI-822-001 Rev. Basic CLI
6.3 In rastructure
Provide in rastructure needed to meetrequirements.
Buildings, workspace and utilities
Process equipment (hardware so tware) upport services
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
100/136
WI-822-001 Rev. Basic CLI
6.4 Work nvironment
ust determine the needs o the workenvironment and properly manage these.
i.e., temperature, cleanliness, sa ety, acilities,heat, light, ergonomics sa ety equipment
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
101/136
WI-822-001 Rev. Basic CLI
Questions
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
102/136
WI-822-001 Rev. Basic CLI
7 Product Realization
7.1 Planning and Product Realization
ust plan and develop the processes neededto manu acture product
et quality objectives
Inspection activity criteria Inspection records
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
103/136
WI-822-001 Rev. Basic CLI
7.2.1 etermination o
Requirements related
to the product
ust determine: Customers requirements or manu acture,
delivery and post delivery
Unspeci ied requirements but necessary
Regulatory requirements
dditional requirements speci ied by theorganization
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
104/136
WI-822-001 Rev. Basic CLI
7.2.2 Review o Requirements
Related to the ProductPrior to acceptance o an order:
nsure product requirements are de ined i erences are resolved
rganization has the ability to meet
the de ined requirements mendments must be communicated to
the appropriate personnel
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
105/136
WI-822-001 Rev. Basic CLI
7.2.3 Customer Communication
ust have established processes or
communicating with customersin relation to:
Product in ormation
Inquiries, contracts, order handling,
amendments, etc.
Customer eedback, including complaints
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
106/136
WI-822-001 Rev. Basic CLI
7.3.1 esign and evelopmentPlanningThe organization must determine:
esign and development stages Reviews, veri ications and validations at the
appropriate stages
The responsibilities o those involved andtheir inter aces
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
107/136
WI-822-001 Rev. Basic CLI
7.3.2 esign and evelopmentInputs
Inputs relating to product requirements must be
determined and records must be maintained.This includes:
Functional, per ormance and regulatory
requirements
Knowledge rom previous designs
ust be reviewed and must not be in con lict
with other requirements
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
108/136
WI-822-001 Rev. Basic CLI
7.3.3 esign and evelopmentutputs
utput must be veri iable against and must meetinput requirements
utput must provide the appropriate in ormation
or purchasing, production and service
ust contain or re erence acceptance criteria ust speci y the characteristics o the product that
are essential or its sa e and proper use
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
109/136
WI-822-001 Rev. Basic CLI
7.3.4 esign and evelopment
Review esigns must be per ormed at appropriate stages
in accordance with the design plan
ust determine i the output meets the input
requirements
ust identi y problems and propose solutions
ppropriate personnel must be involved Records must be maintained
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
110/136
WI-822-001 Rev. Basic CLI
7.3.5 esign and evelopmentVeri ication
ust be per ormed in accordance with thedesign plan to ensure the design outputs
have met the design inputs
Records must be maintained
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
111/136
WI-822-001 Rev. Basic CLI
7.3.6 esign and evelopment
Validation
ust be per ormed in accordance with thedesign plan to ensure the design outputs
have met the design inputs
hould be per ormed prior to delivery or
implementation
Records must be maintained
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
112/136
WI-822-001 Rev. Basic CLI
7.3.7 Control o esign andevelopment Changes
ust be identi ied
ust be veri ied, validated andapproved prior to implementation,
when appropriate
Changes must evaluate the e ect onparts already delivered
Records must be maintained
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
113/136
WI-822-001 Rev. Basic CLI
Questions
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
114/136
WI-822-001 Rev. Basic CLI
7.4.1 Purchasing Process ust ensure that purchased product con orms to
speci ied purchase requirements.
Control taken must be dependent upon its e ect
on the inished product
ust select suppliers based upon their ability
uppliers must be evaluated and recordsmaintained
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
115/136
WI-822-001 Rev. Basic CLI
7.4.2 Purchasing In ormationPurchasing in ormation must describe theProduct to be purchased including,
where appropriate: Requirements or approving product,
procedures, processes and equipment
Requirements or quali ication o personnel requirements
P. .s must be reviewed prior to release
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
116/136
WI-822-001 Rev. Basic CLI
7.4.3 Veri ication o Purchased
Product rganizations must have inspection
activities to insure that purchased product
meets requirements
I the organization or its customer intends
to per orm an inspection at the suppliers
acility, the the arrangements must be
included in the purchasing documents
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
117/136
WI-822-001 Rev. Basic CLI
7.5.1 Control o Production
ervice Provision
ust control production and servicing under
controlled conditions, including, as
applicable:
vailable instructions and requirements
Use o suitable equipment and inspection
equipment
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
118/136
WI-822-001 Rev. Basic CLI
7.5.2 Validation o Processes or
Production and ervice (1 o 2)
Processes must be validated when theresulting output cannot be veri ied by
subsequent testing
Validation must demonstrate that processes
are able to achieve planned results
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
119/136
WI-822-001 Rev. Basic CLI
7.5.2 Validation o Processes or
Production and ervice (2 o 2)Planned arrangements or these processes
must include:
Criteria or approval o processes
pproval o equipment and personnel
Using speci ic methods and procedures ocumentation is required
Revalidation
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
120/136
WI-822-001 Rev. Basic CLI
7.5.3 Identi ication and
Traceability
Product must be identi ied throughout themanu acturing process
Inspection status must be identi ied
Product must be uniquely identi ied whentraceability is a requirement
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
121/136
WI-822-001 Rev. Basic CLI
7.5.4 Customer Property Identi y, veri y, protect and sa eguard
Customer supplied property that is lost,damaged or ound unsuitable, must be
reported to the customer
Includes material, components,
equipment, ixtures and intellectual
materials
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
122/136
WI-822-001 Rev. Basic CLI
7.5.5 Preservation o Product
Product, raw material, components, etc. must
be protected rom damage throughout all
stages o receipt, manu acturing, handling,
packaging, storage and delivery.
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
123/136
WI-822-001 Rev. Basic CLI
7.6 Control o onitoring and
easuring evices etermine instruments to be calibrated
etermine calibration requency stablish processes
Calibrated at speci ied intervals
Identi ied with the calibration status a eguarded rom unintended adjustments
Protected rom damage
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
124/136
WI-822-001 Rev. Basic CLI
Questions
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
125/136
WI-822-001 Rev. Basic CLI
8 easurement, nalysis and
Improvement8.1 eneral
rganizations must plan or inspection andtesting to:
emonstrate con ormity o the product
nsure con ormity to the Continually improve the
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
126/136
WI-822-001 Rev. Basic CLI
8.2.1 Customer atis action
rganizations must monitor their customers
perceptions as to whether they have met
their customers requirements
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
127/136
WI-822-001 Rev. Basic CLI
8.2.2 Internal udit ust conduct audits at planned intervals to
determine con ormance to the , I
9000:2000 and other requirements udits must be scheduled on the basis o
importance, problems, # o processes, etc.
uditor must be independent
Records must be maintained
hould be conducted annually (unwritten)
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
128/136
WI-822-001 Rev. Basic CLI
8.2.3 onitoring and
easurement o Processes
onitor the measurement o the processes and apply Corrective ction
when the results do not con orm with
planned results
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
129/136
WI-822-001 Rev. Basic CLI
8.2.4 onitoring and
easurement o Product onitor the measurement o the product
characteristics to ensure product
requirements are met
ust be carried out at appropriate stages
Records must be maintained
Product may not be released until it has
passed inspection by authorized personnel
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
130/136
WI-822-001 Rev. Basic CLI
8.3 Control o Noncon orming
Product ust ensure that product which does not con orm
to requirements is identi ied and controlled to
prevent unintended use or delivery NC product may be handled by reworking, release
through concession, scrapping or regrading
Records must be maintained
Reworked product must be reinspected
Noti y customer o suspect product
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
131/136
WI-822-001 Rev. Basic CLI
8.4 Analysis of Data Determine, collect and analyze data to
demonstrate the suitability of the QMS and to
evaluate here continual improvement can bemade
Data analyzed ill relate to:
Customer satisfaction
Conformity to requirements Trends of processes and products
Suppliers
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
132/136
WI-822-001 Rev. Basic CLI
8.5.1 Continual Improvement
Continually improve the e ectiveness o the
through use o the:
uality Policy and bjectives
udit results
nalysis o data
Corrective and Preventive ctions
anagement Reviews
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
133/136
WI-822-001 Rev. Basic CLI
8.5.2 Corrective ction
ust be appropriate to the
severity o the problem
etermine the cause o the noncon ormity
etermine the solution
Take action to eliminate the cause o
noncon ormity in order to prevent recurrence
aintain records
Review the Corrective ctions taken
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
134/136
WI-822-001 Rev. Basic CLI
8.5.3 Preventive ction ust be appropriate to the severity o the problem
etermine the cause o the potential
noncon ormity
etermine the solution
Take action to eliminate the cause
aintain records Review the Preventive ctions taken
-
8/8/2019 WI-822-001 Internal Auditor Training
135/136
Florida MEP: Solutions for Manufacturers
-
8/8/2019 WI-822-001 Internal Auditor Training
136/136
ITS OVER
top related