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THE
QUALITY MANAGEMENT SYSTEM
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Protected by copyright © 2001-2005
QSM
Quality Systems Manual
Uncontrolled Copy
QUALITY MANAGEMENT
SYSTEM
Record Group 4
THE
Record Group 5
Record Groups
Quality Management System
Record Group 6
Management Responsibility
Resource Management
Product Realization
Measurement, Analysis & Improvement
This manual is considered controlled in bound form and may only be issued as a complete
manual. The revision of any document contained in this manual requires the replacement of the
revised document and the update of the revision history block below.
Release
Rev Effective Date
0
5/14/2007
Released By
Description
Documents
Approved By
Approval
of Change
Draft Release
Affected
All QSM Docs
Signature
Date
Record Group 8
Revision History for QSM
Record Group 7
For Internal Distribution Only
Quality
Systems
Manual
Document #
QSM
Index &
Overview
Rev. 0
05/14/07
Page 1 of 4
FULLCO QUAILTY SYSTEMS MANUAL
INDEX & OVERVIEW
QSM – INDEX
Page
Cover
1
2
3
4
Contents
QSM Revision History Page
Index & Overview
Using this Manual
Identifying Documents
Maintaining Documents
RECORD GROUP Section 4.0
RECORD GROUP Section 5.0
RECORD GROUP Section 6.0
The sections contained in this manual
are referred to as Record Groups (RG)
and are color-coded following the QCM
format.
RECORD GROUP Section 7.0
RECORD GROUP Section 8.0
QSM – OVERVIEW
FULLCO QUALITY
CONTROL MANUAL
QCM
FULLCO QUALITY
SYSTEMS MANUAL
QSM
This manual is a companion to the Fullco
Quality Control Manual (QCM), providing
supporting documentation to the policies in the
QCM.
In the absence of a detailed procedure for a task
or process, the QCM will include enough
information to ensure the Quality Management
System is accomplished.
Record Groups include procedures and supporting documentation necessary to
accomplish the policies set forth in the QCM.
Record groups may include one form or many, depending on the requirements of our
quality management system and the process requirements for the activities we perform.
A list of all documents with revision levels may be found on the
Document Master Log L-4.2.3
QSM, Rev. 0
Index & Overview
Quality
Systems
Manual
Document #
QSM
Index &
Overview
Rev. 0
05/14/07
Page 2 of 4
USING THIS MANUAL
Fullco Quality documentation is designed to be used, and understood, by all of our
employees. To assist the reader in understanding and applying this information, we have
incorporated the use of the symbols shown below and simple color-coding.
Our Quality Management System includes five (5) sections, each identified with a
different color. Section colors are used to identify all support documentation, including
procedures, records, forms, etc.
Procedure Exists
This manual includes the procedures referenced in the QCM. In the
event a procedure is supported by the content of another procedure, the
Magnifying glass may be used as a reference.
Record Required
The clipboard tells you a record is required. A record may be a form,
tag, or some other document that must be completed to verify a process.
You will find the form number in the center of the clipboard, and the
reference to the record will be highlighted in the text. A “For
Reference Only” copy of the form is located at the end of the
procedure.
Responsibility
The pointing finger is used to point out responsibilities. Use this symbol
for a quick scan to find out who is responsible and what their
responsibilities are. When you see the pointing finger at the beginning
of a section, it usually indicates that entire section is listing
responsibilities.
QSM, Rev. 0
Index & Overview
Quality
Systems
Manual
Document #
QSM
Index &
Overview
Rev. 0
05/14/07
Page 3 of 4
IDENTIFYING DOCUMENTS
All documents are assigned a unique identifier, including a prefix, document number and
a revision level. This allows us to identify the document and ensure we are using the
latest version.
Every document identifier includes three elements.
1. Prefix Code – The prefix code identifies the type of document.
Prefix Coding
P = Procedure
WI = Work Instruction
S = Schedule
L = Log
F = Form
FC = Flow Chart
2. Document Number – The document TEXT REMOVED FOR SAMPLE
procedure that provides the information
to be collected and/or specific instructions on how to use it.
3. Revision Level – The TEXT REMOVED FOR SAMPLE
and improvements are made the revision level will change.
QSM, Rev. 0
Index & Overview
Quality
Systems
Manual
Document #
QSM
Index &
Overview
Rev. 0
05/14/07
Page 4 of 4
Document Identification
L - 4.2.3 Rev. 0
Prefix Code
Example: L = Log
Document Number
Example: 4 = Record Group 4 (Blue)
4.2.3 = Section in QCM & QSM
Revision Level
Example: 0 = 1st
Revision Level
At a glance this example tells us:
The document is a Log (L)
In Record Group 4
The number 4.2.3 is the same number used to identify the Document & Data
Control Procedure P-4.2.3. This indicates the instructions on how to use and
maintain the Log are found in this procedure.
Understanding how to use our Quality System documentation is everyone’s
responsibility. TEXT REMOVED FOR SAMPLE
MAINTAINING DOCUMENTS
The success of our Quality Program depends on the maintenance of the procedures, forms
and records found in this manual. Each section or Record Group of this manual includes
the latest revision of the applicable procedures and a reference only copy of the form or
record needed to support the quality activities required for that section. The forms in this
manual are not to be reproduced for use without the permission of the quality manager.
Color-Coded Binder
A master or reproducible copy of all supporting forms and records is maintained,
by the quality manager, in the appropriate color-coded section of the QMS binder.
Only the latest revision level is maintained and it is the responsibility of both the
user and the quality manager to ensure the latest revision level is distributed and
in use.
Behind each procedure you will find the forms that are required to support
the activities for that procedure.
QSM, Rev. 0
Index & Overview
Insert Logo Image or Type
Company Name Here
1.
Quality
Systems
Manual
Document #
P-4.2.4
BLUE
Rev. 0
10/02/06
Page 1 of 5
CONTROL OF QUALITY RECORDS PROCEDURE
1.1.
Purpose
To establish and maintain a quality records system that verifies the control
activities set forth in the Quality Control Manual and are easily accessible
by customer or contract.
1.2.
Scope
This procedure applies to all documentation required to verify the
COMPANY NAME Quality Management System. Records include, but
are not limited to, the following:
•
•
•
•
•
•
•
•
•
•
•
•
•
1.3.
Management review input and output,
Education, experience, training and qualifications,
Planning of realization processes,
Review of customer requirements,
Design and development review, verification and validation,
Purchasing control,
Identification and traceability,
Customer property,
Validation of processes,
Control of measuring and monitoring devices,
Internal audits,
Measurement and monitoring of product,
Corrective action & Preventive action.
References and Links
ISO 9001:2000 Section 4.2.4 Control of Quality Records
QCM-4.2.4 Control of Quality Records
Contents of this Procedure
• Generation & Source
• Types of records
• Review & Acceptance
• Indexing & Maintenance
• Retention & Storage
• Record Disposal
• Responsibilities
See Also QCM Section 9.0 for a complete list of
COMPANY NAME Record Requirements.
P-4.2.4, Rev. 0
Control of Quality Records
Insert Logo Image or Type
Company Name Here
1.4.
Quality
Systems
Manual
Document #
P-4.2.4
BLUE
Rev. 0
10/02/06
Page 2 of 5
Procedure
1.4.1. Records Generation & Source
Generation – TEXT REMOVED FOR SAMPLE he success of
our Quality Management System. Quality records are designed to
verify a specific activity and are generated as a result of
accomplishing the activity.
Source – The department or personnel responsible for completing a
quality record is considered the source of the record. Many quality
records require multiple sources to complete the record contents.
1.4.2. Types of Records
TEXT REMOVED FOR SAMPLE
t
activities.
Type 1 – Records generated as a result of activities involved in the
management and maintenance of our Quality Management System.
These records generally fall into:
Section 4 - Blue
Section 5 – Red
Section 6 – Green
Type 2 – TEXT REMOVED FOR SAMPLE
involved in the realization of our products and services. These
records generally fall into:
Section 7 – Yellow
Section 8 – Gray
The classification of the record generated effects how it is indexed
and maintained.
P-4.2.4, Rev. 0
Control of Quality Records
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Company Name Here
Quality
Systems
Manual
Document #
P-4.2.4
BLUE
Rev. 0
10/02/06
Page 3 of 5
1.4.3. Review & Acceptance
Review – All quality records shall be reviewed to ensure the
contents have been completed and to verify the accuracy of the
information recorded. Qualified employees who have the necessary
expertise in the processes involved perform the review of quality
records.
Acceptance – After a successful review, quality records are
accepted as complete before indexing and filing. The acceptance
of any quality record is permanently recorded in a manner that
indicates the name of the reviewer and the date of acceptance.
1.4.4. Indexing & Maintenance
Indexing – A key element of the quality records system is its
ability to access pertinent records when required, in a timely
manner.
Type 1 – Records are indexed and maintained in the appropriate
color-coded QMS Binder. The QMS binders shall be maintained at
all times to provide quick retrieval of supporting records. Records
shall be indexed by date of entry.
L-4.2.4
Type 2 – Records are indexed on the Quality Records Index.
The Quality Records Index is a log maintained to provide a cross
reference to all product realization quality records. Records shall
be indexed in a format that provides sort capabilities by the
following information:
Customer order number or PO,
COMPANY NAME job number,
Date of order,
Date of delivery,
Description of service or product delivered.
The Quality Records Index is designed to quickly locate records
and allows the locations and retrieval of all records to be
performed quickly. Type 2 records shall be maintained with project
or sales documentation.
P-4.2.4, Rev. 0
Control of Quality Records
Insert Logo Image or Type
Company Name Here
Quality
Systems
Manual
Document #
P-4.2.4
BLUE
Rev. 0
10/02/06
Page 5 of 5
1.4.7. Responsibilities
The Quality Manager is responsible for establishing and
maintaining an effective quality records system, in accordance
with this procedure and P-4.2.3 Document and Data Control
Procedure. This responsibility is shared with Department Managers
as appropriate. The quality manager assumes ultimate
responsibility for the review and acceptance, indexing and
maintenance, retention and storage, and disposal processes of all
quality records.
Department Managers are responsible for the accurate completion
and review and acceptance of quality records required to verify
process activities. Additional responsibility includes any required
employee training to accomplish the completion of records.
All employees are responsible for completing source information
as required to verify activities.
1.5.
Reference Documents
L-4.2.4
P-4.2.4, Rev. 0
Quality Records Index
Control of Quality Records
DOCUMENT MASTER LOG
Prefix Coding
P = Procedure
S = Schedule
FC=Flow Chart
WI = Work Instruction
L = Log
F = Form
Note: Documents listed on this log are
considered controlled. Changes must be
approved and this log updated with new
revision levels.
Group 4 Documents
Cross Reference Notes
Rev
Release Date
P-4.2.3
Document Control Procedure
0
05/14/07
P-4.2.4
Control of Quality Records
0
05/14/07
F-4.2.3
Document Transmission & Review Form
0
05/14/07
Manual Distribution Log
0
05/14/07
L-4.2.3
Document Master Log
0
05/14/07
L-4.2.4
Quality Record Index
0
05/14/07
Group 5 Documents
Rev
Release Date
Quality System Management Review Form
0
05/14/07
Management Review Meeting Notes
0
05/14/07
Rev
Release Date
0
05/14/07
Rev
Release Date
L-4.2.3 A
Record Group 4 Blue
Cross Reference Notes
F-5.6.1
F-5.6.1A
Record Group 5 Red
Cross Reference Notes
Group 6 Documents
F-6.2
Employee Competence & Training Form
Record Group 6 Green
Cross Reference Notes
Group 7 Documents
P-7.4
Purchasing Procedure
0
05/14/07
F-7.1
Planning of Product Realization
0
05/14/07
F-7.2.1
Product Requirements Review
0
05/14/07
L-7.2.3
Customer Communication Log
0
05/14/07
Purchase Order Form
0
05/14/07
F-7.4.3
Vendor Evaluation Survey
0
05/14/07
L-7.4.1
Approved Supplier Master List
0
05/14/07
F-7.5
Project Order Notice / Travel Report
0
Sample
L-7.6
Calibration Log
0
05/14/07
L-7.8
Maintenance Log
0
05/14/07
Rev
0
Release Date
05/14/07
F-7.4
Record Group 7 Yellow
Cross Reference Notes
P-8.2.2
P-8.3
Control of Nonconforming Product Procedure
0
05/14/07
P-8.5
Improvement Procedures
0
05/14/07
F-8.2.2
Audit Worksheet
0
05/14/07
S-8.2.2
Audit Schedule
0
05/14/07
Nonconformance Report NCR
0
05/14/07
NCR Status Log
0
05/14/07
F-8.3
L-8.3.1
L-4.2.3 Rev. 0
Group 8 Documents
Internal Quality Audits Procedure
Record Group 8 Gray
MANAGEMENT REVIEW
MEETING NOTES
Insert Logo Image or Type Company Name Here
Purpose of the Management Review Meeting: To objectively analyze the effectiveness of the Quality Management System and develop
Quality Management System Planning according to QCM 5.4.2 and accomplish ongoing improvements.
RECORD GROUP 5
RED
A copy of meeting notes and necessary supporting documentation shall be issued to the attendance list above.
Meeting Agenda
Meeting Date:
Review
action items SAMPLE
from previous
Attendance
List:
FORMmeeting.
/ RECORD
Considerations for this review include:
A
B
1 Is our quality policy accurate?
2
7 TEXT REMOVED FOR SAMPLE
8
Reference management review meeting considerations help notes.
9 Have we allocated the
resources necessary to meet our quality goals/objectives?
Review Input Items
C
1 Internal audits
2
3
4 TEXT REMOVED FOR SAMPLE
6
7
8
Attach all reports and/or records used for review input to this form.
Review Output Action Items - Improvements to:
D
1 The Quality Management System and its processes
2
3
4
6 The allocation of resources
Use form F-5.6.1 to document review output action items.
F-5.6.1A, Rev. 0
THE
QUALITY MANAGEMENT
SYSTEM
COMPANY NAME
Record Groups
Record Group 6
Resource Management
Insert Logo Image or Type Company
Name Here
Quality
Systems
Manual
Document #
QSM
Section 7.0
Rev. 0
10/02/06
Page 1 of 2
RECORD REQUIREMENTS FOR SECTION 7
Note: Your program may not require all of the records listed.
If it is required, a form number will be assigned on the Document master Log
L-4.2.3.
Reference your Implementation Helps Manual for additional information.
QCM-7.1 Planning of Product Realization
Form Number Assigned
F-7.1 Product Planning Overview
Description: Worksheet/form to be used for documenting required planning of product realization
activity.
Also reference your QCM Section 5.4.1 Quality Objectives Planning. This section may be satisfied
with this activity.
QCM-7.2.1 Determination of Product Requirements
QCM-7.2.2 Review of Product Requirements
Form Number Assigned
F-7.2.1 Product Requirements Review
Description: A record to verify product requirements are identified for sales proposals, contracts
prior to accepting and verification of review activity for same.
QCM-7.2.3 Customer Communication
Form Number Assigned
L-7.2.3 Customer Communication Log
Description: Log to be used for documenting customer communication activity.
QCM-7.3.1 Design and Development Planning
QCM-7.3.2 Design and Development Inputs
QCM-7.3.3 Design and Development Outputs
QCM-7.3.4 Design and Development Review
QCM-7.3.5 Design and Development Verification
QCM-7.3.6 Design and Development Validation
QCM-7.3.7 Control of Design and Development Changes
Form Number Assigned
F-7.3 Design & Development Worksheet
Description: Worksheet/record to be used to document all design and development activity as
required in the sections above.
QCM-7.4 Purchasing
Procedure Provided:
P-7.4 Purchasing Procedure
Form Numbers Assigned
F-7.4 Purchase Order Form
F-7.4.3 Vendor Evaluation Survey
L-7.4.1 Approved Supplier Master List
Description: Documents satisfying record requirements of QCM 7.4
QSM, Rev. 0
Section 7.0
PROJECT NOTICE
TRAVEL REPORT
Replace or modify with what you are
currently using.
RECORD GROUP 7
YELLOW
DISTRIBUTE TO:
JOB NO:
CUSTOMER:
DESCRIPTION:
Qty:
SALES CONTACT:
AWARD DATE:
DATE OF NOTICE:
P.O. NUMBER:
AVAILABILITY:
DESTINATION:
INSPECTION & TEST PLAN
Required
Department
YES / NO
Project Management
Autocad
Enclosure Fab
Assembly
Wiring
Instrumentation
Testing
Documentation
Engraving
Crate
Customer Final Inspection
PROCESS REQUIREMENTS
Budgeted
Budgeted Material Cost
Hours
Steel
$0.00
Paint
$0.00
Instrumentation
$0.00
Electrical
$0.00
Pipe & Tubing
$0.00
Documentation
$0.00
Engraving
$0.00
Crate
$0.00
Hardware
$0.00
Ship
$0.00
QA USE ONLY
Place a check beside each Process
Requirement to verify Workscope
completion.
SAMPLE ONLY
DISTRIBUTION LIST
F-7.5A
F-7.5B
F-7.5C
F-7.5D
PROJECT NOTICE / TRAVEL REPORT
PRODUCTION PACKAGE / JOB FOLDER
FINAL INSPECTION & TESTING REPORT
Description
Meets Spec.
Yes
Inspected By:
Date:
No
Additional Inspection & Testing Requirements - List Special Instructions Below
F-7.5 Rev. 0
Project Notice Inspection
SAMPLE LOG
Maintenance Log
Equipment on this list requires regular Manitenance.
Equipment ID
L-7.8 Rev. 0
Serial/Model No.
RECORD GROUP 7
Performed By:
Date
Performed By:
YELLOW
Date
Performed By:
Date
Insert Logo Image or Type
Company Name Here
1.
Quality
Systems
Manual
Document #
P-8.2.2
Gray
Rev. 0
10/02/06
Page 1 of 9
INTERNAL QUALITY AUDITS PROCEDURE
1.1.
Purpose
SAMPLE PROCEDURE TEXT REMOVED FOR SAMPLE
1.2.
Scope
This procedure applies to all quality management system (QMS) audit
activities. The QMS audit is used to assess the degree of implementation
and verify required activities.
1.3.
Upper Level References and Links
ISO 9001:2000 Section 8.2.2 Internal Audits
QCM Section 8.2.2
Internal Audits
1.4.
Phases of the Audit: (PERC)
COMPANY NAME internal quality audits have four basic phases:
•
•
•
•
Planning
Execution
Reporting
Corrective Action
Poor planning, inadequate execution, confused reporting or corrective
action records significantly affect the perception of the audit. A
professional approach in performing internal audits is very important.
P-8.2.2, Rev. 0
Internal Quality Audits
Insert Logo Image or Type
Company Name Here
Quality
Systems
Manual
Document #
P-8.2.2
Gray
Rev. 0
10/02/06
Page 4 of 9
4. Develop the Audit Program – The audit program serves as your road
map during the audit. It should be designed to keep you on track and
on schedule. As a minimum it should identify the duration of the audit,
the areas of the organization that will be subject to assessment, and the
people who should be available to answer the auditors questions.
Key issues in developing the program include:
•
Is it well planned? – Have you thought through the process? Have
you identified a beginning and an end? Can you take a sample
from the system that will enable you to follow the process in a
logical way?
•
Have you set achievable objectives? – Can you verify that
something is actually happening? Can you find evidence of an
effective system? Can you verify that the system or process you
are examining is working? If so, how?
5. Confirm the Program with the Auditee – Review the entire audit
program with the department managers or supervisors of the processes
to be audited. Confirm the dates and time for the audit, and review the
source information identified.
6. Develop a Checklist – The audit checklist is the backbone of the
actual audit. Thought must be given to structuring the checklist so it
will flow with the process being audited. Details of the samples you
will need and where they will be taken from are included on the
checklist. Checklist questions need to be open-ended ones that will
enable the auditee to explain the process and show how that process is
documented.
P-8.2.2, Rev. 0
Internal Quality Audits
Insert Logo Image or Type
Company Name Here
Quality
Systems
Manual
Document #
P-8.2.2
Gray
Rev. 0
10/02/06
Page 6 of 9
Verifying Information – Auditors have to examine samples of
documents, equipment, products, and so on to verify the information
collected and their observations. The auditor determines the size or
quantity of the samples examined. While one sample is typically not
enough it is not practical to select tens or hundreds of samples. If one
sample is incorrect, it would be wise to select another sample to determine
whether it is an isolated occurrence or a larger problem.
The auditor has the authority to select the sample.
Recording Discrepancies – When nonconformity is identified the auditor
is required to document the findings. The audit is very much a “show me”
exercise that looks for factual evidence. In this respect, a nonconformance
report is a concise record of the facts relating to the nonconformance.
When recording the nonconformance the following information should be
included:
• Where the nonconformance was found,
• An exact observation of the facts surrounding the discrepancy,
• The reason why the facts constitute a nonconformity,
• Sufficient references to allow traceability.
1.9.
Audit Reporting (R)
At the completion of the audit the audit team meets to evaluate the
information collected and all nonconformities identified during the audit.
An audit report is created to document the findings of the audit activity.
(The completed checklist(s) become the basis of the audit report).
What the Report needs to accomplish – The audit report should do the
following:
• Assure a customer or third party inspector that the Quality
Management System is periodically checked for effectiveness.
• Evaluate the adequacy of the Quality Management System as
compared to past performance.
• Identify areas that need improvement.
• Assign responsibilities and timetables to monitor progress of
corrective action.
P-8.2.2, Rev. 0
Internal Quality Audits
Insert Logo Image or Type
Company Name Here
1.11.
Quality
Systems
Manual
Document #
P-8.2.2
Gray
Rev. 0
10/02/06
Page 8 of 9
Responsibilities
Lead Auditor
• To ensure this procedure is followed by all audit staff.
• To ensure the entire audit findings are promptly reported to the
manager in the area audited.
• To ensure any adverse findings are followed up and closed out as
quickly as possible.
• To prepare audit reports for review at the Management Review
meetings.
Audit Team Members
• To take direction from the Lead Auditor.
• To assist in the creation of the audit plan and checklists as directed.
• To maintain a professional, objective attitude.
• Perform the actual audit, including the completion of all required
forms.
Department Manager
• To cooperate in scheduling and attending internal audits.
• To respond promptly to audit findings.
• To take steps to resolve any deficiencies reported in an effective and
prompt fashion.
Quality Manager
• For ensuring the full cooperation of management and supervision
within the activity under audit.
• The Quality Manager has overall responsibility for implementing and
maintaining the internal audit system.
• Selecting and qualifying auditors.
• Ensure complete reports are issued to executive management.
• To establish and verify record keeping.
Executive Management
• To review audit reports and findings as required.
• To ensure actions are taken, without undue delay, to eliminate
nonconformities and their causes.
• Verify corrective action with appropriate follow up.
All COMPANY NAME Employees
Other personnel involved in the processes or areas being audited are
responsible for cooperating fully in the internal audit process and enable it
to be a driver for continuous improvement.
P-8.2.2, Rev. 0
Internal Quality Audits
Insert Logo Image or Type Company Name Here
INTERNAL QUALITY AUDIT
SCHEDULE
RECORD GROUP 8
GRAY
SAMPLE :
Date:
Planned
Date
S-8.2.2 Rev. 0
Submitted By:
Activity / Area to be Audited
Submitted To:
Applicable
Documents
Lead
Auditor
Completion
Date
Internal Audit Schedule