Getting Started Documentation Kit

ISO 9001 Documentation Kit
Product # 9WSPK-14000A Rev: 8

Getting Started
Thank you for purchasing the ISO 9001 Documentation Kit. We hope you will find the information and resources
included in this package helpful as you work on your ISO 9001 project. We encourage you to read through this
Getting Started document before starting.
Please don’t hesitate to call our consulting office if you need additional clarification on anything included in the
package. You can reach us at 866-354-0300 or email us at support@9000world.com.
©2011 CORE BUSINESS SOLUTIONS, INC. 1

Table of Contents
ISO 9001 Documentation Kit.................................................... Error! Bookmark not defined.
Getting Started...................................................................... Error! Bookmark not defined.
WHAT’S INCLUDED .......................................................................................................... 3
1. Articles ................................................................................................................. 3
2. Quality Manual ...................................................................................................... 4
3. Forms .................................................................................................................. 4
4. Procedures ............................................................................................................ 4
5. Other Tools ........................................................................................................... 5
6. Webinars .............................................................................................................. 5
9000world Free Resources ................................................................................................. 6
DOCUMENTATION IMPLEMENTATION................................................................................... 7
1. Define Key Processes .............................................................................................. 7
2. Develop a Quality Policy .......................................................................................... 8
3. Determine Quality Objectives ................................................................................... 8
4. Collect Data .......................................................................................................... 9
5. Develop Documentation and Records ......................................................................... 9
6. Quality Manual ...................................................................................................... 9
7. Required Procedures ............................................................................................. 11
Control of Documents and Control of Records: ............................................................... 11
Control of Nonconforming Product: .............................................................................. 11
Corrective and Preventive Action: ................................................................................ 12
Internal Audit Procedure: ........................................................................................... 12
8. Optional Procedures ............................................................................................. 12
9. Work Instructions................................................................................................. 13
10. Forms ............................................................................................................. 13
Appendix A—Kit Contents and Matching ISO 9001 Standard Sections ...................................... 14
Appendix B—Editing Tips ................................................................................................. 18
EDITING THE SAMPLE K EY PROCESS MAPS (SEE PG. 12) ............................................................. 18
INSERTING THE K EY P ROCESS MAP INTO THE QUALITY MANUAL (SEE PG. 13) .................................... 19
EDITING THE QUALITY MANUAL (SEE PG. 15) .......................................................................... 20
EDITING THE PROCEDURE T EMPLATE (SEE PG. 17-18) ............................................................... 21
EDITING THE F ORM T EMPLATES (SEE PG. 15) .......................................................................... 22

WHAT’S INCLUDED
This section describes how the kit is organized. The CD labeled, ISO 9001 Documentation Kit, if
ordered, and the downloaded product is organized into several folders. A description of what’s
included in each of the folders is given below.
1. Articles
In this folder you will find articles written by Core Business Solution’s President, Scott Dawson,
about various ISO 9001 topics. These include:
Introductory Articles on ISO 9001:
 What is ISO9000
 ISO Explained Introduction
 ISO 9000 Done Right
 A Beginner's Guide to ISO 9001
Articles from the ISO Explained series on key sections of the ISO 9001 standard:
 4.2.2 The Quality Manual
 4.2.3 Document Control
 4.2.4 Control of Records
 5.0 Management Responsibility
 5.3 The Quality Policy
 5.4 Management Planning
 5.5.2 Management Representative
 6.2 Competence Training and Awareness
 7.4 Purchasing
 8.2.2 The Internal Auditor
 8.5.3 Corrective Action
Other Topics:
 ISO9001 Process Approach
 ISO9001 Implementing the Process Approach

2. Quality Manual
In this folder you will find the Quality Manual template in two formats as well as some additional
items you will need to complete your manual. Inside this folder you will find:
 Quality Manual Template with Comments
 Quality Manual Template Without Comments
 Samples Folder—Contains examples of some key items you will need to establish and
define in your quality manual:
o Section 1.0: Sample Scope Statements
o Section 1:0: Exclusion Justification
o Section 2.0: Sample Organizational Chart (Excel® SmartArt format)
o Section 2.0: Sample Organizational Charts (Excel® Drawing Tools)
o Section 4.1: Outsourced Process Examples
o Section 4.1: Sample Key Process Maps
o Section 5.3: Sample Quality Policies
o Section 5.4.1: Sample Quality Objectives
3. Forms
The forms are organized by the sections in the ISO 9001 standard. Also included in each section’s
forms folder is a folder called Process Flows that contains process flows for many of the forms
(NOTE: Not all forms have a matching process map). See Appendix A for a complete list of
forms and which section of the standard to which they apply.
4. Procedures
The procedures are divided into two folders, Required and Optional. Regardless of what your
company does, you MUST develop and implement the required procedures:
 Control of Documents
You will see two versions of the Control of Documents Procedure. If you are using an
electronic document control system such as our DocBase Direct®, the Control of Documents
Procedure (DocBase) has been created for you. Otherwise, use the standard Control of
Documents Procedure.
 Control of Nonconformances (Services)
If you are a service-based industry, use this version of the procedure.
 Control of Nonconforming Product
If you manufacture or produce a product, use this version of the procedure.
 Control of Records Procedure
 Corrective/Preventive Action Procedure
The ISO standard refers to two different procedures, Corrective Action and Preventive
Action. We have chosen to combine these two procedures into one.
 Internal Audit Procedure

5. Other Tools
This folder contains some miscellaneous items you may find helpful. In here you will find the
following:
 ISO 9001 Glossary of Terms
 External Audit Readiness Checklist.
 What Should be Documented
 What Should be Measured
 Work Instruction Development Worksheet
 Work Instruction Template
6. Webinars
This folder contains one of our training webinars on the following topic:
 Writing Your ISO 9001 Documentation
9000 World has training video topics available on other key topics as well. You can see all of our
topics on our website by clicking on the following link: Webinars
These training videos may be purchased individually or as a complete set. If you are interested in
the complete set, call our customer service office to find out the price and details. Be sure to
mention that you have already purchased this kit to receive a special discounted price.

9000world Free Resources

The starting point for a company pursuing ISO certification is the planning and preparation of the
required processes and documentation specified in the ISO 9001 standard. While these
requirements are comprehensive in scope, meaning they apply to most areas of your business,
they are also very general in their descriptions, meaning they can be adapted to any type of
business. Because of this non-specific language, the ISO standard is extremely flexible and may
be implemented in a variety of ways to suit your specific way of doing business. In the Planning
stage, you should complete the following steps:
1. Learn ISO 9001 Basics

Our website, www.9000world.com has numerous resources available to learn the basics of
ISO 9001.
 Introduction to ISO 9001

http://www.9000world.com/index.php?app=ccp0&ns=display&ref=isovideos
 ISO 9001 Project Planning

http://www.9000world.com/index.php?app=ccp0&ns=display&ref=isovideos_project
 Review our many FAQ’s:

http://www.9000world.com/index.php?app=ccp0&ns=display&ref=isofaq
 We have also included several articles in our kit that will help give you some
understanding of ISO Basics. These are located in the folder, Articles:
o A Beginner's Guide to ISO 9001
o What is ISO9000 - ISO Explained
o ISO9000 Done Right
2. Purchase a copy of the ISO 9001:2008 Standard.
If you are located in the United States:
 ASQ
 ANSI
 TechStreet
If you are located outside the U.S. or Canada:
 TechStreet
 ISO.org

DOCUMENTATION IMPLEMENTATION
Implementation of your ISO system will take the majority of the time needed to achieve ISO
certification. Implementation consists of defining your company’s key processes, defining your
quality policy and objectives, writing documentation, and training employees. We will discuss each
step in detail in the sections that follow.
1. Define Key Processes
The starting point for any ISO implementation is to identify and define your key business
processes; that is, how you produce and deliver your products and/or services to your
customers. This is usually done through a simple one-page flowchart showing how work
flows through your organization from your sales process through completion of a customer
order or contract (see example below).
Use the following resources to help you with this task:
 In the folder, Articles, read the article titled, ISO9001 Process Approach and
ISO9001: Implementing the Process Approach.
 We have included a template (created in Excel®) you can use for documenting your
key processes found in the folder, Quality Manual>Samples, called Sample Key
Process Maps (see below).
See Appendix B for editing tips with regards to the Key Processes and inserting the
Process Map into the Quality Manual.

2. Develop a Quality Policy
Next, develop a simple quality statement called a Quality Policy to define your company’s
commitment to meeting your customers’ requirements and to continual improvement. It is
required that all employees in your company be familiar with your quality policy.
Use the following resources to help you with this task:
 In the folder, Articles, read the article titled, 5.3 The Quality Policy - ISO
Explained.
 To get you started, we have some sample Quality Policies you can read through to
give you some ideas for developing your own. These are located in the folder,
Quality Manual>Samples, called Sample Quality Policies.
An additional tool you might consider is our webinar entitled, “Writing Your Quality Policy
and Objectives”. This webinar may be purchased separately on our website. Click here to
view details about this webinar or call our customer support office for details at 866-354-
0300, option 1.
3. Determine Quality Objectives
Based on your quality policy and defined processes, you’ll determine several Quality
Objectives, or performance measures, that will serve as your measures of the quality of
your business as you meet your customer’s requirements. Your quality objectives must be
relevant to your business. Examples might include on-time delivery, product quality,
customer satisfaction or other appropriate measures.
Important: Be sure your quality objective is specific and can be measured. The following
tools are available in the kit to assist you with this step:
 You will find a worksheet to help you determine whether something needs a
measure in the folder, Other Tools, called What Should Be Measured.
 There are two tools located in the folder Forms> 5.0 Mgmt Resp.
o Quality Objective Planning Form.
 We have provided some Sample Quality Objectives that can be found in the folder,
Quality Manual>Samples.

4. Collect Data
Once you have selected the quality objectives, set up methods to collect the data. This
might include using computer systems or developing simple forms that will collect the
information (such as the one referenced above in Step 3). It is also required that you set
up methods for reporting and analyzing the data results on a periodic basis, typically
monthly or quarterly, to determine if your goals are being met and if improvements need
to be made to your company processes.
 We have provided a reporting tool to assist you with this in the folder, Forms. In
the folder, 8.0 Measure_Analysis_Improv, you will find the form, Data Analysis
Summary (see below).
5. Develop Documentation and Records
In addition to defined processes and objectives, certain formal documents must be

developed and implemented to provide “control” of your processes. Required
documentation includes a quality manual, and several procedures. In addition you may
need to develop a few work instructions, and forms. Records needed are associated with
the required processes. It is very important to be careful not to “over-document” your
system, meaning make it more complicated than necessary. We will cover each kind of
documentation below as well as where to find information in our kit to assist you.
 Before starting your documentation, please take time to watch the webinar,
“Writing Your ISO 9001 Documentation” included in your kit in the Webinars
folder.
6. Quality Manual
We recommend starting with your Quality Manual which defines policies your company
follows based on the ISO 9001 requirements. The Quality Manual template found in our kit
has been developed by our consultants and has been used by our customers many times
over to achieve ISO 9001 certification.
You will find two versions of the Quality Manual Template in the kit (see below). These are
found in the folder, Quality Manual.

 Quality Manual Template With Comments
 Quality Manual Template Without Comments
Before beginning, read the article called, 4.2.2 The Quality Manual - ISO Explained found in
the folder, Articles.
We suggest that you print out the Quality Manual with comments and use it as a reference
tool. Use the Quality Manual without comments as your template to edit. The Quality
Manual with Comments gives you additional help information to assist you in understanding
what needs to be added in certain sections. Below is an example from the Quality Manual
with Comments.
Be sure to follow the instructions on the first page of the Quality Manual Template. When
you have finished drafting the manual, DELETE the first page containing the instructions.
Red text in the quality manual indicates a place where you must insert your company’s
specific information. Remove all Red Text before you finalize your quality manual (see
example above).
We have included some tools and resources for you for various sections of the quality
manual. We will list the resources available by section. For general tips for editing the
Quality Manual, see Appendix B.
Section 1: Scope and Exclusions
 You will find Sample Scope Statements in the folder, Quality Manual>Samples.
 You will find Exclusion Justification and Examples in the folder, Quality
Manual>Samples.
Section 2: Company
In this section you will see a place for you to insert your company’s organization chart. If
you already have one, just paste it into the space indicated. If you do not, we have
provided a template you can use:
 In the folder, Quality Manual>Samples, you will find the Excel® file, Sample
Organizational Chart.
Section 4.1: General Requirements

In this section, paste your Process Map that you developed in Step 1 above in section 4.1
on the page where you see our sample Process Map. (See Appendix B for instructions to
paste the Process Map into the Quality Manual).
 To help you determine any Outsourced Processes you might have, we have included
some Outsourced Process Examples in the folder Quality Manual>Samples.
Section 5.3: Quality Policy
Insert your company’s quality policy as developed in Step 2 above.
Section 5.4.1: Quality Objectives
Insert your company’s quality objectives as developed in Step 3 above.
Section 10.0: Change Log
If you are using an electronic document control system like DocBase Direct ®, you may
delete this section. Otherwise, be sure to complete the information in this final section.
7. Required Procedures
Additionally, six administrative procedures must be documented and implemented.

Templates for all of these procedures are found in our Kit. We suggest drafting your
procedures in the following order. For general tips for editing the Procedures, see
Appendix B.
Control of Documents and Control of Records:

A document defines how work is to be done (e.g. procedures, instructions, blank forms). A
record provides evidence of work done (e.g. purchase orders, signed contracts, completed
forms).
There are two Control of Documents procedures. If you have chosen to use electronic
document control software, like DocBase Direct®, use the Control of Documents Procedure
(DocBase). If you are controlling your documents manually, use the Control of Documents
Procedure. The following resources are available in the kit to assist you with these:
 The procedures are found in the folder Procedures>Required Procedures
 In the folder, Articles, read the articles titled, 4.2.3 Document Control - ISO
Explained and 4.2.4 Control of Records - ISO Explained.
There are specific requirements that must be recorded and tracked for both documents and
records. You must have a master list of your documents and records.
 In the folder, Forms, located in the folder, 4.0 Quality Mgmt System, you will
find the Document Master List template and the Record Master List template.
An additional tool you might consider is our webinar entitled, “Document and Records
Control”. This webinar may be purchased separately on our website. Click here to view
details about this webinar or call our customer support office for details at 866-354-0300,
option 1.
Control of Nonconforming Product:

You will also find two procedures for Control of Nonconforming Products. The procedure
called, Control of Nonconformances (Service) is for service-based organizations. If you are
a manufacturer, you should use the procedure called, “Control of Nonconforming Product.”
 The procedures are found in the folder Procedures>Required Procedures

 In the folder Forms>8.0 Measure_Analysis_Improvement you will find a form for

service industries, Nonconformance Form (Service), and a form for product based
industries, Control of Nonconforming Product.
Corrective and Preventive Action:

We have chosen to combine the Corrective Action and the Preventive Action procedures
into one procedure. As soon as you have implemented your Corrective/Preventive Action
process, begin documenting a few corrective as well as preventive actions. The auditor will
expect you to have at least a few of each.
 The procedure is found in the folder Procedures>Required Procedures
There are several resources available in the kit to assist you with this procedure:
 In the Articles folder, read the article, 8.5 Corrective Action
 In the Forms>8.0 Measure_Analysis_Improvement folder you will find the

Corrective/Preventive Action form and the Corrective/Preventive Action Status Log.
 Also located in the Forms>8.0 Measure_Analysis_Improvement folder is a

form called Root Cause Analysis Checklist.
An additional tool you might consider is our webinar entitled, “Effective Root Cause and
Corrective Action”. This webinar may be purchased separately on our website. Click here
to view details about this webinar or call our customer support office for details at 866-
354-0300, option 1.
Internal Audit Procedure:

The Internal Audit Procedure was drafted to include all the components included in our kit
that correspond to the audit. For the most part, we recommend you keep the process
defined in the procedure the way we have it written. There are only a few things you will
need to add to complete this procedure.
The procedures can be found here:
 In the folder, Procedures, located in the folder, Required Procedures.
The location of the other items referenced in the procedure are given below.
 In the Forms>8.0 Measure_Analysis_Improvement folder you will find the

Internal Audit Form.
8. Optional Procedures
Beyond these basic six procedures, your company must determine any additional
procedures needed to effectively implement your QMS. In prior editions of ISO 9001 (prior
to 2000), there were numerous “required” procedures. More recent versions of the
standard have reduced the focus on required documentation and increased focus on control
and improvement of your key business processes. We have included some of the most
common optional procedures in our kit. A complete list of procedures included in our kit
can be found in Appendix A at the end of this guide. For general tips for editing the
Procedures, see Appendix B.
 The procedures can be found in the folder, Optional Procedures.
 In the folder, Other Tools, you will find a document called, What Should be
Documented.

9. Work Instructions
Work instructions are what are referred to as third tier documents. These are NOT needed
by every type of company; however, you may need to develop at least a few work
instructions for your QMS system. For example, work instructions may be created to use
as step-by-step instructions for performing a task or perhaps operating a piece of
machinery. We have included several tools in our kit to help you determine if a work
instruction is needed and tools to help you develop work instructions.
 In the folder, Other Tools, refer to the document, What Should be Documented.
 Also, in the Other Tools folder, you will find the Work Instruction Development
Worksheet and the Work Instruction Template.
10. Forms
You may already have forms that you use in your business. The first step would be to
review what forms you have and determine if they are adequate to continue using. You
may need to make some changes based on the ISO 9001 standard requirements.
Although forms are not the only way to document your company records, most companies
find they must develop several forms to meet the requirements of the QMS system. We
have included approximately 60 forms for you to use “as is” or edit to suit your needs. A
Complete list of forms can be found in Appendix A at the end of this guide. For many of
the forms in our kit, we have included a related Process Flow to show how the form should
be used. These Process Flows can be edited by you to fit your form using Microsoft®
Excel® 2003 or greater. For tips on editing the form templates, see Appendix B.
 The forms are found in the Forms folder. The individual forms and process flows
are located in the folder for the ISO section to which they apply (See Appendix A).

Appendix A—Kit Contents and Matching ISO 9001 Standard Sections
ISO Section Kit Contents

Articles
4.2.2 4.2.2 The Quality Manual - ISO Explained
4.2.3 4.2.3 Document Control - ISO Explained
4.2.4 4.2.4 Control of Records - ISO Explained
5.0 5 0 Management Responsibility - ISO Explained
5.3 5.3 The Quality Policy - ISO Explained
5.4 5.4 Management Planning - ISO Explained
5.5.2 5.5.2 Management Representative - ISO Explained
6.2 6.2 Competence, Training and Awareness - ISO Explained
7.4 7.4 Purchasing - ISO Explained
8.2.2 8.2.2 The Internal Auditor - ISO Explained
8.5.3 8.5.3 Corrective Action
ISO 9001: A Beginner's Guide
ISO Explained Introduction
ISO9000 Done Right
4.1 ISO9001 Implement Process Approach
4.1 ISO9001 Process Approach
Managing Your ISO Registrar's Audit
Transitioning to ISO 9001:2008
What is ISO9000 - ISO Explained
Forms
6.2.2 60-Day Progress Report
6.4 Accident Illness Investigation Form
6.2.2 Annual Employee Appraisal
7.4.1 Approved Supplier List
7.6 Calibration Form
7.6 Calibration Log
8.2.4 Certificate of Conformance
8.3 Control of Nonconformance (service)
8.3 Control of Nonconforming Product
8.5 Corrective Preventive Action Form
8.5 Corrective Action Log
7.2.3 Customer Complaint Form
7.2.2 Customer Contract Review Form
7.2.1 Customer Order Inquiry Form
7.5.4 Customer Property Log


8.2.1 Customer Satisfaction Interview Form
8.2.1 Customer Satisfaction Survey Form
7.2.3 Customer Service Communication Log
8.4 Data Analysis Summary Form
7.3.7 Design Change Form
7.3.1 Design Plan and Schedule
7.3.7 Deviation Notice Form
4.2.3 Document Change Request Form
4.2.3 Document Master List
6.2.2 Employee Skill Certification Record
6.2.2 Employee Training Record (Group)
6.2.2 Employee Training Record (Individual)
6.2.2 Employee Training Record Matrix
6.3 Equipment Inventory Log
6.3 Facility & Equip Repair Request
8.2.4 Final Inspection Log
8.2.4 Final Inspection Record
7.4.3 Incoming Quality Record Form
8.2.2 Internal Audit Form
7.2.3 Invoice (Product)
7.2.3 Invoice (Service)
6.3 Maintenance Log
5.6 Management Review Agenda
5.6 Management Review Minutes
8.5.1 Meeting Agenda, Minutes and Action Items
6.2.2 New Hire Checklist
8.5.1 Opportunity For Improvement Form
7.2.3 Packaging Slip
7.1 Product Quality Plan Form
7.4.2 Purchase Order
7.4.2 Purchase Request Form
5.4.1 Quality Objective Planning Form
7.4.3 Receiving Log
4.2.4 Record Master List
8.2.4 Release Authorization Form
7.2.3 Return Material Authorization Form
7.2.3 Return Material Authorization Log
8.5 Root Cause Analysis Checklist
7.5.5 Shelf Life Log
7.5.2 Special Process Validation Form


7.4.1 Supplier Audit Form
8.5.2 Supplier Corrective Action Form
7.4.1 Supplier Qualification Form
6.2.2 Training Evaluation Form
8.3 Trouble Ticket
6.4 Work Environment Controls Form
Quality Manual
7.0 Exclusion Justification & Examples
4.1 Outsourced Process Examples
4.2.2 Quality Manual Template (with comments)
4.2.2 Quality Manual Template (without comments)
4.1 Sample Key Process Maps
5.5.1 Sample Organizational Chart (Draw Tools)
5.5.1 Sample Organizational Chart (SmartArt)
5.4.1 Sample Quality Objectives
5.3 Sample Quality Policies
1.0 Sample Scope Statements
Procedures
6.2.2 Competence, Training, and Awareness
4.2.3 Control of Documents Procedure (DocBase)
4.2.3 Control of Documents Procedure (Standard)
8.3 Control of Nonconformances (Service)
8.3 Control of Nonconforming Product
4.2.4 Control of Records
8.5 Corrective_Preventive Action
6.3 Equipment Maintenance
6.2.1 Hiring
7.5.3 Identification & Traceability
8.2.2 Internal Audit
7.6 Monitoring and Measuring Equipment
7.3 New Product Design and Development
7.5.5 Preservation of Product
7.4 Purchasing
7.4.1 Supplier Qualification and Monitoring
7.5.2 Validation of Special Processes
Process Flows
6.4 Accident Illness Invest Form PF


7.6 Calibration Form PF
8.3 Control of Nonconformances-Product PF
8.3 Control of Nonconformances-Service PF
8.5 Corrective Preventive Action Form PF
7.2.3 Customer Complaint Form PF
7.2.2 Customer Contract Review PF
7.2.1 Customer Order Inquiry Form PF
7.3.7 Design Change Form PF
7.3.1 Design Plan and Schedule PF
7.3.7 Deviation Notice Form PF
4.2.3 Document Change Request Form PF
6.2.2 Employee Skill Certification Form PF
6.2.2 Employee Training Plan PF
6.3 Facility & Equip Repair Request Form PF
8.2.4 Final Inspection Record PF
7.4.3 Incoming Quality Record Form PF
8.2.2 Internal Audit Form PF
8.5.1 Opportunity For Improvement Form PF
7.4.2 Purchase Order Form PF
7.4.2 Purchase Request Form PF
7.1 Quality Plan Form PF
7.2.3 Return Material Authorization Form PF
7.4.1 Supplier Audit Form PF
8.5.2 Supplier Corrective Action Request Form PF
7.4.1 Supplier Qualification Form PF
8.3 Trouble Ticket Form PF
Other Tools
ISO 9001 Glossary of Terms
4.2.1 What Should be Documented
8.2.3 What Should be Measured
7.5.1 Work Instruction Development Worksheet
7.5.1 Work Instruction Template
Webinars
Writing Your Documentation

Appendix B—Editing Tips

In this Appendix you will find some general tips and instructions for editing some of the documents
included in the kit. For additional help, please refer to the Help documentation provided with the
Microsoft® application. Our customer support will not be able to provide additional support
regarding any of the Microsoft® applications used to develop the templates.
EDITING THE SAMPLE KEY P ROCESS MAPS (SEE PG . 12)
The following are some basic instructions for editing the Sample Key Process Maps found in the Kit.
1. DO NOT remove the first Process called, “Quality Management”. This should stay on your
key process map to show the integration of your Quality Management System (QMS) with
the other Key Business Processes you define.
2. Edit the labels to match your company's Key Business Processes.
 In general, just select the text inside the boxes and type your own text.
3. To create additional boxes, copy an existing one and paste it, or click on an existing box,
and while holding down your CTRL key, drag a copy of the box to where you would like to
place it.
4. The arrow lines are created by using the drawing tools in Excel®.
a. Click on the "Insert" ribbon button in the Excel® toolbar
b. Choose “Shapes”
c. Then choose "Lines"
d. Use the line called "Elbow Arrow Connector" (see below)

e. Drag the arrow line starting with the first shape (you will see connector points),
and drag to a connector point of the second shape. (see below).
f. Repeat for any other lines.
5. When you are finished, set the Print Area of your diagram. You should try to get everything
on 1 page.
I NSERTING THE KEY P ROCESS MAP INTO THE QUALITY MANUAL ( SEE PG . 13)
To paste the process map, follow these steps:
1. In the Key Process worksheet, drag to select the entire diagram.
2. Copy (CTRL+C) the diagram.
3. Locate the page in the Quality Manual where you will paste the diagram.
4. Choose Paste> "Paste Special" and then choose the option as shown below:
You can use the Picture Tools in Word to crop, rotate or resize the graphic.

EDITING THE QUALITY MANUAL ( SEE PG . 15)
The following are some basic instructions for editing the Quality Manual and the screenshots that
follow are based on Microsoft® Word® 2010.
All text is assigned to a style. The styles we used in the templates will appear in your Styles
section on the “Home” ribbon in Microsoft® Word® (see screenshot below). They all begin with
“9K…” If you are not familiar with how styles work, refer to the help section for Word. Our office
will not be able to assist you with the use of Microsoft products.
To edit the information in the header or footer, follow these steps:
1. On your document, double-click in the header or footer area.
2. Change the Red “Revision Level 000” to black text. The first revision of the manual should
begin with Revision Level 0. If you need to change it to something different, change it
here. This should match the Revision level you reference on your Document Master List.
3. Be sure to replace the red text “[Your

Company Name/Logo Here]” with your
company’s name or logo. To insert your
logo, just choose the Insert Tab and then
choose “Picture” (see right).
4. We recommend that you leave the text in the footer. This is a Control Statement that says
the document is only valid for 24 hours from printing unless it is otherwise marked
“Controlled”.
5. To exit the header or footer, click on the Close Header and Footer button located in the
Toolbar or just double-click anywhere in the document.

EDITING THE P ROCEDURE T EMPLATE ( SEE PG . 17-18)
The instructions and screenshots that follow are based on Microsoft® Word® 2010. Be sure to read
the instructions at the beginning of each Procedure. When you have finished drafting a procedure,
be sure to DELETE the second page containing the instructions (the page just after the Title Page).
Red text in the procedure indicates a place where you must insert your company’s specific
information. Be sure you remove all Red Text before you finalize your procedures (see example
below).
All text is assigned to a style. The styles we used in the templates will appear in your Styles
section on the “Home” ribbon in Microsoft® Word® (see screenshot below). They all begin with
“9K…” If you are not familiar with how styles work, refer to the help section for Word. Our office
will not be able to assist you with the use of Microsoft products.
To edit the information in the header or footer, follow these steps:
1. On your document, double-click in the header or footer area.
2. Change the Red “Revision Level 000” to black text. The first revision of the form should
3. Be sure to replace the red text “[Your Company

Name/Logo Here]” with your company’s name
or logoTo insert your logo, just choose the
Insert Tab and then choose “Picture” (see
right).

4. We recommend that you leave the text in the footer. This is a Control Statement that says
the document is only valid for 24 hours from printing unless it is otherwise marked
“Controlled”.
5. To exit the header or footer, click on the Close Header and Footer button located in the
EDITING THE F ORM TEMPLATES ( SEE PG . 15)
The following are some basic instructions for editing the Form Templates, and the screenshots that
follow are based on Microsoft® Word® 2010. The form templates are laid out using the table tools
in Microsoft® Word®.
1. To change any of the field labels, select the text and type the label you would like.
2. To edit the information in the header or footer, follow these steps:
a) On your document, double-click in the header or footer area.
b) Change the Red “Revision Level 000” to black text. The first revision of the manual should
c) Be sure to replace the red text “[Your

Company Name/Logo Here]” with your
company’s name or logo. To insert your
logo, just choose the Insert Tab and then
choose “Picture” (see right).
d) To exit the header or footer, click on the Close Header and Footer button located in the

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ISO 9001 Documentation Kit

Product # 9WSPK-14000A Rev: 8

ISO 9001 Documentation Kit

©2011 CORE BUSINESS SOLUTIONS, INC. 1

©2011 CORE BUSINESS SOLUTIONS, INC. 2

Introductory Articles on ISO 9001:

 ISO Explained Introduction

 ISO 9000 Done Right

 A Beginner's Guide to ISO 9001

 4.2.2 The Quality Manual

 4.2.3 Document Control

 4.2.4 Control of Records

 5.0 Management Responsibility

 5.3 The Quality Policy

 5.4 Management Planning

 5.5.2 Management Representative

 6.2 Competence Training and Awareness

 8.2.2 The Internal Auditor

 8.5.3 Corrective Action

 ISO9001 Process Approach

 ISO9001 Implementing the Process Approach

©2011 CORE BUSINESS SOLUTIONS, INC. 3

 Quality Manual Template with Comments

 Quality Manual Template Without Comments

o Section 1.0: Sample Scope Statements

o Section 1:0: Exclusion Justification

o Section 2.0: Sample Organizational Chart (Excel® SmartArt format)

o Section 2.0: Sample Organizational Charts (Excel® Drawing Tools)

o Section 4.1: Outsourced Process Examples

o Section 4.1: Sample Key Process Maps

o Section 5.3: Sample Quality Policies

o Section 5.4.1: Sample Quality Objectives

 Control of Nonconformances (Services)

If you are a service-based industry, use this version of the procedure.

 Control of Nonconforming Product

If you manufacture or produce a product, use this version of the procedure.

 Control of Records Procedure

 Corrective/Preventive Action Procedure

 Internal Audit Procedure

©2011 CORE BUSINESS SOLUTIONS, INC. 4

 ISO 9001 Glossary of Terms

 External Audit Readiness Checklist.

 What Should be Documented

 What Should be Measured

 Work Instruction Development Worksheet

 Work Instruction Template

 Writing Your ISO 9001 Documentation

©2011 CORE BUSINESS SOLUTIONS, INC. 5

9000world Free Resources

1. Learn ISO 9001 Basics

 Introduction to ISO 9001

 ISO 9001 Project Planning

 Review our many FAQ’s:

2. Purchase a copy of the ISO 9001:2008 Standard.

If you are located in the United States:

If you are located outside the U.S. or Canada:

©2011 CORE BUSINESS SOLUTIONS, INC. 6

1. Define Key Processes

Use the following resources to help you with this task:

©2011 CORE BUSINESS SOLUTIONS, INC. 7

2. Develop a Quality Policy

Use the following resources to help you with this task:

3. Determine Quality Objectives

o Quality Objective Planning Form.