ISO 9001 QMS Policies, Procedures & Forms

Writing Quality Procedures is fast and convenient with easily editable quality policies and procedures. You Will Learn What ISO 9001 is all about, how to produce an ISO 9001 Quality Manual, and how to write ISO 9001 Quality Procedures.

Take advantage of this comprehensive ISO 9001 Quality Policies and Procedures Manual. Use this manual to simplify the tasks of producing your Quality Manual and/or writing your Quality Policy and Procedures.

Fast Quality Procedures for ISO 9001 Implementation

ISO 9001 Quality Policies, Procedures & Forms Manual comes with over 400 pages of practical documentation in proper ISO format as required by the latest ISO 9001:2000 changes. You will get prewritten quality policies, 38 quality procedures and 30 forms.

Plus you get a detailed explanation of ISO 9000 and helpful information on producing your own QMS quality manual.

The accompanying CD contains all content including policies, procedures and forms in editable MS Word files.

 

Customer satisfaction, profitability and market leadership are driven in large part by delivering quality products and services to customers. Today, more than ever, there is a worldwide trend towards increasingly stringent customer expectations regarding quality. Accompanying this trend has been a growing realization that continuous quality improvements are often necessary to achieving and sustaining excellent economic performance.

One roadblock to providing quality products and services was the definition of what "quality" meant to different customers. Different countries, industries and governments all had varying quality systems that suppliers had to adopt in order to deliver goods around the world. A single worldwide standard was needed to simplify international standards.The result:

The International Organization for Standardization (ISO)

This gave rise to ISO - the International Organization for Standardization. Located in Switzerland, ISO is the specialized international agency for standardization and the source of ISO 9000. Established in 1947, it is comprised of the national standards bodies of 140 countries, working together to produce more than 13,000 International Standards for business, government and society.

ISO is made up of approximately 180 Technical Committees. Each Technical Committee is responsible for one of many areas of specialization. According to ISO,

"The object of ISO is to promote the development of standardization and related world activities with a view to facilitating international exchange of goods and services and to developing cooperation in the sphere of intellectual, scientific, technological and economic activity."

The results of ISO technical work are published as international standards. Many people think that ISO stands for International Standards Organization. They are close, but actually mistaken. The official name of the organization is French and translates to The International Organization for Standardization. ISO is Greek for equal. Some examples of where ISO is used in language today include weather reports - isobars areas of equal pressure or isotherms areas of equal temperature, and in geometry isosceles triangles have equal sides.

The International Organization for Standardization is an organization made up of member nations that develop standards for everything from electronics to management systems. Representatives from the member nations develop specifications and standards. The acceptance of a new or revised standard is by vote, each country getting one vote. The process itself is much more complex involving committees and subcommittees to develop and write the standards, but to accept a proposed standard, each nation has one vote and no nation outvotes another.

The introductory section of ISO 9001 QMS also contains information on the following:

-ISO 9000 and ISO 14000
-Overview of ISO 9001:2000
-Quality Systems
-Certification, Registration and Accreditation
-ISO Definitions

This prototype ISO 9000:2000 Policies and Procedures Manual has been developed to assist organizations in preparing for ISO 9001:2000 certification, which can be custom tailored to fit one's individual company concerns and operations.

The language style and usage is generally representative of practices in companies in the United States. When you edit and construct a policy it should be easy to read, to the point and convey a message that is clearly understood by both the employee and the management staff.

When you have completed your Quality Manual and Quality Procedures, have a team of managers review them and make appropriate comments. After corrections, you may want your company attorney to review the draft for compliance with federal state and local laws. The corrected and finished product is then ready for distribution. But remember, building a Quality Management System is not an event, it is a continuous process so revisions will be required from time to time.

Considerations in writing your manual

It is now common practice to use pronouns that are applicable to either sex or to use his or her, or the more personal and direct, "you". Social changes influence policies on topics concerning smoking, physical fitness, etc.

Have your manual reviewed by an attorney to ensure that you are in compliance with all applicable federal, state, and local laws.

Define terms used in your manual. Definitions should be placed in each procedure as needed.

Revisions

Every organization is dynamic and in some state of change. This will lead to changes to policies from time to time. Revisions should be completed and sent to all personnel who hold a copy of the manual. The revision should have an effective date and of course should be distributed in advance of the effective date. When making a change to your manual be cognizant that the language might have an indirect impact on other policies. And finally, make sure that there is a clear record of revisions made and that all employees have current information in a timely manner.

The Quality Manual as well as each procedure includes a revision section at the end. It is important to keep this revision section up-to-date. It will be the only way to ensure that distributed copies of your manual are current.

Style and Format

1.  Use a cover or title page.
2.  Include a table of contents.
3.  Put policy statements on a 8 1/2" x 11 " page and print only on one side to make revisions easier.
4.  Organize material by major headings for easy reference.
5.  Include an alphabetized index if your manual is lengthy.
6.  Avoid a detailed paragraph identification systems of numbers and letters as this will detract from its' readability and the message will be lost.
7.  Write in simple easy to understand statements to avoid confusion. Some companies include sample administrative forms with their procedures along with instructions for their completion. This product includes a forms section for use at your discretion in the tabbed section in the back of publication.

This first step in building a Quality Management System is the creation of a "Quality Manual". This is a separate and distinct step from developing quality procedures. The purpose is to state in a concise and brief format, the policies and objectives of the company required to achieve a desired level of quality for the organization or division.

More than likely the input for the Quality Manual will come from your customers. It is the customer that drives the Quality Process. There requirements, needs, and future desires are the basis for implementing an ISO 9000 quality system in the first place.

At a minimum, the Quality Manual is required to address each one of the paragraphs of the applicable ISO Series that the company plans to become registered against. ISO 9001:2000 is the focus of this manual. But, you may need to expand the scope to include EMS 14001, QS-9000, AS-9000, or other industry specific quality requirements.

Each area that is written should include, at a minimum, three parts: Scope, Policy and Responsibilities.

-The Scope portion should simply state the purpose of the covered area.
-The Policy portion should state the company policy regarding the applicable ISO clause.
-The Responsibility portion should state who, in generic titles or positions, is responsible for the policy.

ISO 9000 does not require a specific format for the Quality Manual. A sample manual is provided in this guide for your use as a template to create your own Quality Manual. The Quality Manual Table of Contents is based on the ISO 9000 standard itself. This ensures that each required element is addressed and provides an excellent starting point for building your Quality System.

Table of Contents

QP1000 - DOCUMENT CONTROL

1.0 Document Distribution
2.0 Document Revision
3.0 Procedure and Work Instruction Format
4.0 Temporary Changes
QP1000-1 Request For Document Change (RDC)
QP1000-2 Document Change Control

QP1010 - QUALITY RECORDS

1.0 Identification of Quality Records
2.0 Record Generation
3.0 Record Maintenance
QP1010-1 Quality Records

QP1020 - MANAGEMENT RESPONSIBILITY

1.0 Planning
2.0 Management Representative
3.0 Responsibilities and Authorities
4.0 Management Review

QP1030 - JOB DESCRIPTIONS

1.0 Preparation
2.0 Format and Content
QP1030-1 Job Description Format

QP1040 - COMPETENCE, AWARENESS AND TRAINING

1.0 New employee selection
2.0 New Employee Orientation

QP1050 - QUOTATION PROCESS

1.0 Standard Products
2.0 Custom or modified products and services

QP1060 - SALES ORDERS

1.0 Sales Representatives
2.0 Customer Service
3.0 Credit Department
4.0 Internet Orders
5.0 Changes to orders

QP1070 - CUSTOMER COMPLAINTS

1.0 General
2.0 Receiving a Contact/ customer Complaint
3.0 Trouble Shooting/Problem Diagnosis
4.0 Repairs and/or Replacements:
5.0 Trend Analysis
QP1070-1 Customer Service Log
QP1070-2 Customer Service Contact Form

QP1080 - RETURNED GOODS AUTHORIZATION

1.0 Origination
2.0 Receiving Goods and Processing
QP1080-1 Returned Goods Authorization

QP1090 - WARRANTY AND SERVICE POLICIES

1.0 Warranty Coverage
2.0 Service Programs
3.0 Parts Pricing
QP1090-1 Limited Warranty

QP1100 - DESIGN AND DEVELOPMENT

1.0 New Product Initiation
2.0 Design and Development Inputs
3.0 Design Planning
4.0 Product Development
5.0 Design and Development Output
6.0 Design Review and Verification
7.0 Design Validation
QP1100-1 Design Completion Checklist For Electromechanical Devices
QP1100-2 Design Completion Checklist For Non-Electromechanical Devices
QP1100-3 Request For Engineering Action (REA)

QP1110 - DESIGN CHANGE

1.0 Request for Design and/or Process Changes
2.0 Engineering Change Notice
QP1110-1 Engineering Change Notice (ECN)

QP1120 - PRE-PRODUCTION QUALITY AND PLANNING

1.0 Design Completion
2.0 Design Transfer and Documentation
3.0 Production Plan
QP1120-1 Product Design Release Form

QP1130 - SUPPLIER EVALUATION

1.0 Vendor classification
2.0 Vendor evaluation
4.0 Vendor Files
QP1130-1 New Vendor Notification
QP1130-2 Vendor Survey Form

QP1140 - PURCHASING

1.0 Order Determination and Requisition
2.0 Order Placement
4.0 Record keeping and Matching
QP1140-1 Purchase Requisition
QP1140-2 Purchase Order
QP1140-3 Purchase Order Log
QP1140-4 Purchase Order Follow-Up

QP1150 - RECEIVING AND INSPECTION

1.0 Receiving
2.0 Inspection
3.0 Stocking
5.0 Rejection, Discrepancies and Disposition
QP1150-1 Receiving Log
QP1150-2 Receiving And Inspection Report

QP1160 - SCHEDULING

1.0 Production Planning
2.0 Work Order Packets

QP1170 - MANUFACTURING

1.0 Kitting Work Orders
2.0 Production
3.0 Final Inspection.
4.0 Packaging and Labeling
5.0 Final Release

QP1180 - PART NUMBER ASSIGNMENT

1.0 Number Designation
2.0 Part Number Assignment/Record Keeping
3.0 Classification System

QP1190 - SERIAL NUMBER DESIGNATION

1.0 Serial Numbering

QP1200 - PRODUCT LABELING

1.0 Label Control
2.0 Identification Labels
3.0 Safety Hazard Labels

QP1210 - CUSTOMER PROPERTY

1.0 Receipt, Inspection and Stocking of Customer Supplied Items
2.0 Unsuitable or Missing Items
3.0 Customer Supplied Tooling and Fixtures
4.0 Intellectual Property
QP1210-1 Material Return Notice

QP1220 - CONTROL OF MONITORING AND MEASURING DEVICES

1.0 General requirements
2.0 Storage, Handling and Maintenance
3.0 Calibration System
4.0 Inspection of Special Tooling
5.0 Out-of-tolerance Conditions
6.0 Control of Subcontractor Calibration
7.0 Test Software
QP1220-1 Calibration Record

QP1230 - CUSTOMER SATISFACTION

1.0 General
2.0 Post-Sale Follow-Up
3.0 Customer Survey
4.0 Post-Service Follow-Up
QP1230-1 Post Sale Satisfaction Report
QP1230-2 Customer Satisfaction Survey
QP1230-3 Customer Satisfaction Report

QP1240 - INTERNAL QUALITY AUDITS

1.0 Audit Guide
2.0 Audit Process
3.0 Corrective Action
4.0 Audit Records
QP1240-1 Quality Assurance Audit Checklist

QP1250 - MONITORING AND MEASUREMENT OF PROCESSES

1.0 Effectiveness Criteria
2.0 Reporting
3.0 Improvement
4.0 Review

QP1260- CONTROL OF NONCONFORMING PRODUCT

1.0 Identification and Segregation
2.0 Nonconformance Report
3.0 Returned Goods
4.0 Disposition
5.0 Corrective Action
QP1260-1 Nonconformance Report

QP1270 - DATA ANALYSIS AND CONTINUAL IMPROVEMENT

1.0 Data collection
2.0 Data analysis
3.0 Continual Improvement

QP1280 - CORRECTIVE ACTION

1.0 Initiating a Corrective Action
2.0 Investigating the Cause
3.0 Taking Corrective Action
4.0 Preventing Recurrence
5.0 Verification and Closure
QP1280-1 Corrective Action Request

QP1290 - PREVENTIVE ACTION

1.0 Product Design
2.0 Process Design
3.0 Preventive Actions from Data Analysis

Table of Contents

QP1001 - DOCUMENT CONTROL

1.0 Document Distribution
2.0 Document Revision
3.0 Procedure and Work Instruction Format
4.0 Temporary Changes
QP1000-1 Request For Document Change (RDC)
QP1000-2 Document Change Control

QP1011 - QUALITY RECORDS

1.0 Identification of Quality Records
2.0 Record Generation
3.0 Record Maintenance
QP1010-1 Quality Records

QP1021 - MANAGEMENT RESPONSIBILITY

1.0 Planning
2.0 Management Representative
3.0 Responsibilities and Authorities
4.0 Management Review

QP1041 - COMPETENCE, AWARENESS AND TRAINING

1.0 New employee selection
2.0 New Employee Orientation

QP1221 - CONTROL OF MONITORING AND MEASURING DEVICES

1.0 General requirements
2.0 Storage, Handling and Maintenance
3.0 Calibration System
4.0 Inspection of Special Tooling
5.0 Out-of-tolerance Conditions
6.0 Control of Subcontractor Calibration
7.0 Test Software
QP1220-1 Calibration Record
QP1280-1 Correction Action Request

QP1241 - INTERNAL QUALITY AUDITS

1.0 Audit Guide
2.0 Audit Process
3.0 Corrective Action
4.0 Audit Records
QP1240-1 Quality Assurance Audit Checklist
QP1280-1 Corrective Action Request

QP1281 - CORRECTIVE ACTION

1.0 Initiating a Corrective Action
2.0 Investigating the Cause
3.0 Taking Corrective Action
4.0 Preventing Recurrence
5.0 Verification and Closure
QP1280-1 Corrective Action Request

QP1291 - PREVENTIVE ACTION

1.0 Product Design
2.0 Process Design
3.0 Environmental Processes
4.0 Preventive Actions from Data Analysis

QP1000-1 Request For Document Change (RDC)
QP1000-2 Document Change Control
QP1010-1 Quality Records
QP1030-1 Job Description Format
QP1070-1 Customer Service Log
QP1070-2 Customer Service Contact Form
QP1080-1 Returned Goods Authorization
QP1090-1 Limited Warranty
QP1100-1 Design Completion Checklist For Electromechanical Devices
QP1100-2 Design Completion Checklist For Non-Electromechanical Devices
QP1100-3 Request For Engineering Action (REA)
QP1110-1 Engineering Change Notice
QP1120-1 Product Design Release Form
QP1130-1 New Vendor Notification
QP1130-2 Vendor Survey Form
QP1140-1 Purchase Requisition
QP1140-2 Purchase Order
QP1140-3 Purchase Order Log
QP1140-4 Purchase Order Follow-Up
QP1150-1 Receiving Log
QP1150-2 Receiving And Inspection Report
QP1210-1 Material Return Notice
QP1220-1 Calibration Record
QP1230-1 Post Sale Satisfaction Report
QP1230-2 Customer Satisfaction Survey
QP1230-3 Customer Satisfaction Report
QP1240-1 Quality Assurance Audit Checklist
QP1260-1 Nonconformance Report
QP1280-1 Corrective Action Request

Business Reports and Forms

Absence Request Form

Accounts Receivable Collection Control Form

Accounts Receivable Write-off Authorization

Approval Form for Labels and Labeling

Asset Disposition Form

Authorization (Proxy) to Vote Shares

Bi-Weekly Time Sheet

Calibration Card

Capital Asset Requisition

Check Request

Chronological Log of Events

Credit Application

Credit Inquiry

Customer Satisfaction Survey

Customer Service Contact

Customer Service Satisfaction Report

Department Reporting Summary

Design Completion Checklist for Electromechanical Devices

Design Completion Checklist for Non-Electromechanical Devices

Device Master Record

Device Master Record Index

Device Specification

Disaster Recovery Log

Emergency Services Listing

Employee Hiring Packet Checklist

Employee Personal Profile

Employee Self-Appraisal

Employment Application

Employment Interview Questions Chart

Engineering Change Notice/Document Change Control

Entertainment and Business Gift Expense Report

Equipment Request Form Inventory

Family and Emergency Notification Information

File Server Configuration Worksheet

Finish Product Release

General Workplace Safety Rules

Inventory Inspection Levels

Invoice

Job Description Format

Key Issue/Policy

Limited Warranty

List of Hazardous Chemicals and Index of MSDS

Master File Guide Index

Minutes of Annual Meeting of Stockholders

Minutes of the Board of Directors

Network Installation Checklist and BOM

New Vendor Notification

Notice of Annual Meeting of Stockholders

Part Number Record

Payroll Deduction - Stock Purchase

Performance Appraisal

Personnel Change Notice

Personnel Requisition

Post Sale Satisfaction Report

Printing Request

Purchase Order

Purchase Order Follow-Up

Purchase Requisition

Quality Assurance Audit Checklist

Receiving and Inspection Report

Receiving Log

Reconstruction Worksheet

Recovery Worksheet

Request for Credit Approval

Request for Engineering Action

Request for Training

Restoration Worksheet

Resumption Worksheet

Returned Goods Authorization

Safety Suggestion Sheet

Sales Lead Tracking Form

Sales Order

Sample Account Codes

Sample Reconciliation of Bank and Book Balances to Correct Balance

Selecting an Alarm System/Vendor

Show Registration

Six Week Cash Flow Report

Special Incident Report Form

Stock Issuances Journal

Stock Option Exercise Letter

Stock Transfer Ledger

System Maintenance Record

System Trouble Report Worksheet

TCP/IP Address Worksheet

Testing of Solutions Documentation

Trade Show Checklist

Trade Show Worksheet

Trade Show/Exhibit Summary

Trade Show/Exhibit Supply Checklist

Travel and Miscellaneous Expense Report

Travel Arrangements Form

Two Track GMP Inspection Strategy and Compliance Program

Two Track GMP Inspection Strategy Flow Chart

Vendor Survey Form

Waiver of Notice of Annual Meeting

Weekly Financial Report

Workplace Safety Action Plan

Workplace Safety Self-Inspection Checklist

Workstation Configuration Worksheet

Fast Quality Procedures for ISO 9001 Implementation

ISO 9001 Quality Policies, Procedures & Forms Manual comes with over 400 pages of practical documentation in proper ISO format as required by the latest ISO changes. You will get prewritten quality policies, 38 quality procedures and 30 forms.

Plus you get a detailed explanation of ISO 9000 and helpful information on producing your own QMS quality manual.