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ISO 9001 QMS

Policies, Procedures & Forms
ABR211M

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This Sample Package contains:

A: Overview of the Sample Package (1 page)

B: Table of Contents (6 pages)
C: Policy, Procedure, and Form Set (5 pages)
Dear Friend:

Thank you for downloading this sample content from the ISO 9001 QMS Policies, Procedures &
Forms. This manual conforms to the ISO 9001:2008 Standard.

Bizmanualz delivers an acclaimed knowledge system of manuals, training and support services to small-
and mid-sized firms seeking more effective management compliance and controls over their key
business functions and processes.

Over the last decade, Bizmanualz has helped thousands of companies, in the United States and abroad,
implement best practices through pre-written policies and procedures manuals. Written by expert
authors and editors, these manuals are general enough to fit most business situations. And, since all
content is provided in Microsoft Word files, you can edit and customize the policies and procedures
to fit your own specific needs.

The following 12 pages of this sample package contain a complete table of contents and a complete
policy, procedure and form(s) set. This policy for Customer Property exemplifies the content, writing
style and format of the full manual. The Customer Property Policy is located in the manual under
Section 400: Quality Procedures.

If you have any questions after reading this sample package, please feel free to contact us. You may call
us at 1-800-466-9953 (toll free, US only) or at 314-863-5079, send an email to sales@bizmanualz.com,
or contact us online from our website (www.bizmanualz.com). Thanks again.

Best regards,

Chris Anderson
Managing Director, Bizmanualz

ISO 9001 QMS TERMS & DEFINITIONS

Policies, Procedures & Forms Manual: A system of approved policy statements
US$ 595.00 and corresponding procedural guidelines and
supporting forms that direct an organization toward
This manual includes: its operational goals.
• 23 pre-written policies & procedures Policy: A stated course of action with a defined
• 48 accompanying forms purpose and scope to guide decision-making under
• Sample Quality Manual a given set of circumstances within the framework
of corporate objectives, goals and management
Each policy/procedure in the manual includes: philosophies.
• Policy
• Purpose Procedure: A series of prescribed steps followed
in a definite regular order which ensure adherence
• Scope
to the guidelines set forth in the Policy to which the
• Responsibilities
Procedure applies
• Definitions
• Procedure Activity: An action, element or decision
• Activities, references & forms where applicable. representing a prescribed step in the Procedure
process.
What’s in the Shipment: Task: A detailed component of an Activity
1. Three-Ring Binder with over 400 pages of printed specifying required behavior to complete the
material, organized by colored tabs. activity.
2. CD-Rom with all content in MS-Word files – fully
editable and customizable. Form: A pre-formatted document containing
instructions and place-holders for data entry to
monitor progress through a particular Procedure
and to ensure proper recordkeeping.

Prices are subject to change without prior notice

ISO 9001 QMS Policies, Procedures & Forms www.Bizmanualz.com

ISO 9001 QMS Policies, Procedures, and Forms

Table of Contents

Section ID Section Name Tab

100 Introduction ..................................................................... 1

200 Manual Preparation ......................................................... 2

1. Introduction
2. Installation Instructions
3. Your Quality Manual
4. Effective Communication
5. Quality Procedures

300 Quality Manual................................................................. 3

1.0 Purpose
2.0 Scope
3.0 Relation to ISO 9001:2008
4.0 Our Company’s Quality Management System
5.0 Management Responsibility
6.0 Resource Management
7.0 Product Realization
8.0 Measurement, Analysis, and Improvement
9.0 Revision History

400 Quality Procedures ......................................................... 4

QP1000 Document Control1
1.0 Procedure Format
2.0 Work Instruction
3.0 Forms
4.0 Document Approval
5.0 Temporary Document Changes
6.0 Document Revisions
7.0 External Documents
8.0 Document Distribution
Forms
QP1000-1 Document Request
QP1000-2 Document Control file/database

QP1010 Record Control2

1.0 Identification of Quality Records
2.0 Record Generation
3.0 Record Maintenance

1
Procedures QP1000 – QP1050 are required by ISO 9001:2008
2
Procedures QP1000 – QP1050 are required by ISO 9001:2008

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Section ID Section Name Tab

Forms
QP1010-1 Quality Records List

QP1020 Internal Audits

1.0 Internal Audit Program
2.0 Internal Audit Planning
3.0 Conducting the Internal Audit
4.0 Internal Audit Reporting
5.0 Internal Audit Follow-Up
Forms
QP1020-1 Audit Program
QP1020-2 Audit Plan
QP1020-3 Quality Audit Checklist
QP1020-4 Final Audit Report

QP1030 Control of Nonconforming Product/Material

1.0 Identification and Segregation
2.0 Nonconformance Report
3.0 Returned Goods
4.0 Nonconformance Disposition
5.0 Corrective Action
Forms
QP1030-1 Nonconformance Report
QP1030-2 Nonconforming Material Log
QP1030-3 Return Goods Authorization

QP1040 Corrective Action3

1.0 Determining the Need for Corrective Action
2.0 Initiating Corrective Action
3.0 Investigating the Cause
4.0 Taking Corrective Action
5.0 Verification and Closure
Forms
QP1040-1 Corrective Action Report
QP1040-2 Corrective Action Log

QP1050 Preventive Action

1.0 Preventive Action - Background
2.0 Risk Analysis - Evaluating the Need for Preventive Action
3.0 Determining Actions Required and Implementing Them
4.0 Preventive Action Review
Forms
QP1050-1 Preventive Action Report
QP1050-2 Preventive Action Log

3
Procedures QP1000 – QP1050 are required by ISO 9001:2008

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Section ID Section Name Tab

QP1060 Management Reviews

1.0 Management’s Commitment to the Quality Management
System
2.0 Management Review Meetings
Forms
QP1060-1 Management Review Meeting

QP1070 Competence, Training, and Awareness

1.0 New Employee Selection
2.0 New Employee Orientation
3.0 Employee Development Planning
4.0 Ongoing Training
5.0 Training Effectiveness
6.0 Training Records
7.0 Performance Appraisal
Forms
QP1070-1 Employee Competence Matrix
QP1070-2 Employee Development Plan
QP1070-3 Group Training Record
QP1070-4 Individual Training Record
QP1070-5 Sample Job Descriptions

QP1080 Sales Orders

1.0 Starting the Sales Process
2.0 Customer Service
3.0 Credit
4.0 Internet (Electronic) Orders
5.0 Changes to Orders
Forms
QP1080-1 Customer Order

QP1090 Project Definition

1.0 Product Needs Identification
2.0 Project Definition
3.0 Project Definition Review
4.0 Building the Project Plan
5.0 Reviewing the Project Plan
Forms
QP1090-1 Project Plan

QP1100 Design and Development

1.0 Design Inputs
2.0 Design and Development
3.0 Design and Development Review

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ISO 9001 QMS Policies, Procedures & Forms www.Bizmanualz.com

Section ID Section Name Tab

4.0 Design Verification
5.0 Design Validation and Testing
6.0 Project Assessment
Forms
QP1100-1 Design Review Checklist
QP1100-2 Design Completion Checklist for Electromechanical Devices
QP1100-3 Design Completion Checklist for Non-Electromechanical
Devices
QP1100-4 Sample Verification Checklist
QP1100-5 Product Test

QP1110 Design Change

1.0 Requesting Design Changes
2.0 Engineering Change Notice
3.0 Change Design and Development, Review, Verification,
Validation, and Testing
4.0 Preproduction Planning and Manufacturing
Forms
QP1110-1 Engineering Change Notice

QP1120 Vendor Evaluation

1.0 Vendor Files
2.0 Vendor Screening
3.0 Vendor Evaluation
4.0 Vendor Notice
5.0 Vendor Removal
Forms
QP1120-1 Approved Vendor List
QP1120-2 Vendor Audit Checklist
QP1120-3 Critical Vendor-Contractor Evaluations
QP1120-4 Vendor Performance Log

QP1130 Preproduction Planning

1.0 Design Completion
2.0 Design Transfer and Documentation
3.0 Production Plan
4.0 Plan Roll-Out
Forms
QP1130-1 Product Design Release

QP1140 Manufacturing
1.0 Production Control
2.0 Production
3.0 Inspection and Testing
4.0 Packaging and Labeling

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Section ID Section Name Tab

5.0 Final Verification
6.0 Final Release
Forms
QP1140-1 Inspection/Testing Checklist
QP1140-2 Product Release Authorization

QP1150 Identification and Traceability

1.0 Identification and Traceability - General
2.0 Identification and Traceability System Development
3.0 Identifying / Tracing Items
4.0 Identification and Traceability Review
Forms
None

QP1160 Customer Property

1.0 Receipt, Inspection, and Stocking of Customer-Supplied
Items
2.0 Unsuitable or Missing Items
3.0 Intellectual Property
Forms
QP1160-1 Material Return Notice

QP1170 Control of Monitoring and Measuring Equipment

1.0 Monitoring and Measuring - General Requirements
2.0 Storing, Handling, and Maintenance
3.0 Calibration System
4.0 Out-of-Tolerance Conditions
5.0 Control of Subcontractor Calibration
Forms
QP1170-1 Calibration Record
QP1170-2 Calibration Database

QP1180 Process Monitoring and Measurement

1.0 General Monitoring and Measurement Requirements
2.0 Reporting Monitoring/Measurement Data
3.0 Process Nonconformity
4.0 Review of Process Monitoring/Measurement
Forms
None

QP1190 Customer Satisfaction

1.0 Customer Satisfaction - General
2.0 Post-Sale Follow-Up
3.0 Customer Satisfaction Survey
4.0 Customer Satisfaction Review

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Section ID Section Name Tab

Forms
QP1190-1 Post-Sale Satisfaction Report
QP1190-2 Customer Satisfaction Survey
QP1190-3 Customer Service Log (database)

QP1200 Data Analysis and Continual Improvement

1.0 Data Collection
2.0 Data Analysis
3.0 Continual Improvement
Forms
None

QP1210 Receiving and Inspection

1.0 Receiving and Stocking
2.0 Detailed Inspection
3.0 Items Received on Certificate of Conformance or Certificate
of Analysis
4.0 Receiving/Inspection Review
Forms
QP1210-1 Receiving Log
QP1210-2 First Article Inspection Report
QP1210-3 Receiving Inspection Report

QP1220 Purchasing
1.0 Order Determination and Requisition
2.0 Order Placement
3.0 Recordkeeping and Matching
4.0 Purchasing Review
Forms
QP1220-1 Purchase Requisition
QP1220-2 Purchase Order
QP1220-3 Purchase Order Log
QP1220-4 Purchase Order Follow-Up

500 Index................................................................................. 5

600 Notes ................................................................................ 6

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ISO 9001 QMS Policies, Procedures & Forms www.Bizmanualz.com

Document # Title: Print Date:

QP1160 CUSTOMER PROPERTY
Revision # Prepared By: Date Prepared:
0.0
Effective Date: Reviewed By: Date Reviewed:

Standards: Approved By: Date Approved:

ISO 9001:2008, clause
7.5.4

Policy: The Company shall exercise due care in the storage, use, and
disposition of customer-supplied property.
Purpose: To define the methods to be used to identify, verify, protect, and
safeguard customer property while it is in the Company's control.
Scope: This procedure applies to any items supplied by customers,
including components and materials supplied for inclusion in
products, tooling and fixtures used in manufacturing and
inspection processes, and intellectual property.
Responsibilities: Customer Service is responsible for notifying Production and
Purchasing of the customer’s intent to supply materials during the
quotation and contract review processes and coordinating
delivery of customer supplied materials.
Inventory Control is responsible for identifying items as coming
from or belonging to the customer, keeping those items
segregated from other production materials/tools, and maintaining
control of customer inventory.
Production or Engineering is responsible for managing customer
supplied tooling and fixtures.
Engineering is responsible for managing and safeguarding
customer’s intellectual property.
Definitions: Intellectual property – Creation(s) of intellect having commercial
value, including copyrighted (e.g., literary or artistic) and
ideational property (e.g., patents, appellations of origin, business
methods/processes).
Procedure:
1.0 RECEIPT, INSPECTION, AND STOCKING OF CUSTOMER SUPPLIED
ITEMS
1.1 Components and/or materials provided by the customer for use in the production of their
finished products will be received and inspected in accordance with QP1210 –
RECEIVING AND INSPECTION.
1.2 After customer-supplied items have satisfactorily passed the appropriate inspection
criteria, Inventory Control shall identify (mark) those items as “passed inspection” and

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ISO 9001 QMS Policies, Procedures & Forms www.Bizmanualz.com

segregate them in storage until they are required by Production, in accordance with
QP1150 – IDENTIFICATION AND TRACEABILITY.
2.0 INTELLECTUAL PROPERTY
2.1 Engineering shall maintain, safeguard, and coordinate transmission (dissemination) of
customer intellectual property (e.g., blueprints, schematics, flow diagrams, narratives).
Note that the customer’s intellectual property may be in electronic (digital) or in printed
form.
2.2 Engineering shall control customer proprietary information in accordance with QP1000 –
DOCUMENT CONTROL and dispose of such information after its use (e.g., return to
customer, destroy) in accordance with customer requirements.
3.0 UNSUITABLE OR MISSING ITEMS
3.1 In the event a customer-supplied item is found damaged, deteriorated, or otherwise
unsuitable for use during inspection, Receiving shall process that item in accordance with
QP1030 – CONTROL OF NONCONFORMING PRODUCT-MATERIAL and report the
discovery to the customer using form QP1160-1 – MATERIAL PROBLEM REPORT (in
accordance with clause 7.5.4 of ISO 9001). Receiving shall place a copy of QP1160-1 in
the Customer file.
3.2 If, for any reason, a shortage or loss of items is discovered after the original Receiving
and Inspection report is prepared, the Inventory Control manager shall report the
discrepancy to the customer, using form QP1160-1. Inventory Control shall place a copy
of the QP1160-1 in the Customer file.
4.0 ONGOING CONTROL
4.1 Inventory Control and Production shall manage the ongoing awareness, discovery, and
control of customer-supplied materials, using such methods as:
• Periodic physical inventories;
• Using (and reviewing) Customer Property Log; and/or
• Customer property audits (periodically or as needed).

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Effectiveness Criteria:
• Customer property stored, tracked, and used appropriately
References:
A. ISO 9001:2008, “Quality Management Systems - References”, International Organization
for Standardization (ISO), Nov., 2008.
B. Quality Procedures
• QP1000 – DOCUMENT CONTROL
• QP1030 – CONTROL OF NONCONFORMING PRODUCT-MATERIAL
• QP1150 – IDENTIFICATION AND TRACEABILITY
• QP1210 – RECEIVING AND INSPECTION

Forms/Records:
Satisfies ISO
Form # Record/Form/Activity Name
9001 Clause
Required by ISO 9001:2008
QP1160-1 Material problem report 7.5.4
Other Forms/Records
Customer file (database)
Customer tooling & fixture file (database)
Customer property log

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Revision History:
Revision Date Description of changes Requested By
0.0 June 20, 2009 Initial Release

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QP1160-1 – MATERIAL PROBLEM REPORT

REPORT TO: DATE AUTHORIZED BY

PO/CONTRACT NO. INVOICE NO.

_________________________________
REPORTED BY:

4
QTY PART ID ITEM DESCRIPTION NATURE OF PROBLEM

4
Describe what is wrong with the part (e.g., “pkg. read ‘20 pcs.’ but only 19 in box”, “component defective
when received”, “incorrect color of part”).

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