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 | Quality Manuals and Quality Procedures

 

The ISO 9001 standard requires companies to write a quality manual that defines how each requirement of the rather broad ISO 9001 standard is applied at the company. In a sense, the ISO 9001 quality manual is a company specific version of the ISO 9001 standard.

 

While writing the quality manual already seems difficult to most companies, the quality procedures required by ISO 9001 are the documents that contain the detailed descriptions on how the ISO 9001 requirements are implemented at the company; in addition, ISO 9001 requires a quality policy and quality objectives. Most companies make the mistake of creating various different quality documents to meet these requirements; however, this tends to be the beginning of a cumbersome and bureaucratic ISO 9001 quality management system.

 

Our Advice: Combine the various documentation requirements (quality manual, quality procedures, quality policy, corporate quality objectives) in one single document to avoid redundancy and to create a document that adds value.

 

 

 | Work Instructions

 

In addition to the quality manual, quality procedures, the quality policy and quality objectives, ISO 9001 requires work instructions that provide detailed guidelines to employees on how to perform their work. However, the ISO 9001 standard is very clear that work instructions need only be created where they add value (for example, a trained painter will not find value in instructions on how to paint; on the other hand, brief instructions (possibly in form of pictures), displayed right on a machine, explaining how to perform an annual filter replacement could be a great time saver).

 

 

 | Forms

 

Forms, which must be kept on file after they are filled in (at that point, forms become records), are also part of any ISO 9001 quality management system. Some of the most common forms are the Corrective Action Report Form, the Employee Review Form, and the Customer Survey Form. It is important to note that ISO 9001 does not directly require to use these or any other forms; however, ISO 9001 calls for recording certain information, and well-designed forms not only collect the information, but also walk the user through the process.

 

 

 | Advantages of Templates

 

Using good templates for your entire ISO 9001 documentation (quality manual, quality procedures, quality policy, quality objectives, as well as forms and checklists) can have huge benefits.  Templates should be in an editable format (MS Word is most popular) so that you don't have to re-write them; they also should include detailed customization instructions so that you know how to modify them and make them fit your company's individual circumstances. These are the main advantages of using good templates:

  • Completeness

ISO 9001 is written in a very generic way so that it can be applied to any company of any industry. The disadvantage is that ISO 9001 is much less of a specific guidance for your particular circumstances, and it is often very difficult to find out what is actually required. Good templates will ensure that all ISO 9001 requirements are properly addressed.

  • Jumpstart

Writing a quality manual and quality procedures is at the beginning of any ISO 9001 implementation. It is usually a big hurdle to take, especially due to the "I don't even know where to start" factor. Using documentation templates gets you over this hurdle, and hence you can get a good jumpstart on your ISO 9001 implementation.

  • Savings

By using templates for your quality manual, procedures and forms, you can implement an ISO 9001 quality management system in very short time and without the use of expensive ISO 9001 consultants. You will spend much less time on researching the ISO 9001:2008 standard and its requirements, much less time on writing, and much less time on correcting your mistakes. Templates are typically a significant money and time saver.

  • Quick Certification

The reduced time to create your ISO 9001 documentation and implement your quality management system will allow you to achieve ISO 9001 certification very quickly. Once certified, you will be able to reap the marketing rewards that come with ISO 9001 certification. Together with the improvements to your company, this could lead to significant savings and increased sales and profits.

  • Quality

Good documentation templates lead to good ISO 9001 quality management systems. Using a good template to model your new ISO 900 system on allows you to start with a good ISO 9001 system from the beginning; or you can improve an existing ISO 9001 system when using a good template as guide for improvement.

  • Simplicity and User-Friendliness

The more user-friendly your ISO 9001 quality management system, the better! If you use an ISO 9001 documentation template that's efficient and business-oriented, you are already on your way to an ISO 9001 quality management system that makes business sense.

  • Benefit from Others' Mistakes

There are usually many mistakes made until a real good ISO 9001 quality management system is developed from scratch.If you use proven, successful templates for your quality manual, procedures and forms, you won’t have to make the same mistakes that others have already made; instead, you'll profit from the experience that is reflected in the templates.

  • Guidance through Forms

Good forms have two purposes: (1) to collect and record information, and (2) to guide the user through the process of collecting the information. A truly good form not only collects all the necessary information, it also does it in a very efficient manner. Often, a form can replace work instructions by guiding the user through an entire process that could extend beyond the mere collection of data.

  • Better Compliance through Forms

Good business forms can make it easy for employees to meet the ISO 9001 requirements. Instead of having to look at work instructions, forms can in a subtle way guide employees and ensure that they follow ISO 9001.

Our Advice: There are numerous companies that sell templates for quality manuals, quality procedures and forms. We urge you to carefully evaluate them before making a purchase decision and stay away from those that are convoluted, bureaucratic and cumbersome. Remember, only good templates will provide the above listed benefits, while bad templates could have a significant negative impact on your company's operations. To find out what criteria to look for, please see the sections on Simplified ISO 9001 Compliance and Simplified ISO 9001 Implementation.

 

 

 | Our Templates

 

Our affiliate website, 9001Simplified.com, provides excellent documentation templates, forms, and a comprehensive package so that you can set up a business-friendly ISO 9001 quality management system in-house without the need for an expensive consultant.

 

 

  The Implementation Manual
 
Implementation Manual 

 
The Implementation Manual is a comprehensive documentation template with customization instructions for your ISO 9001 quality manual, policies and procedures. Numerous unique features make the Implementation Manual the ideal template when setting up a new ISO 9001 quality management system.

 

Features of the Implementation Manual
The many unique features of the Implementation Manual include:
 •  Specifically designed to be a "Starter Manual" for first-time ISO 9001
     implementation
 •  Simplified ISO 9001 system that adds value to your company
 •  Lean, un-bureaucratic and free of unnecessary paperwork
 •  Easy to customize
 •  Unique and intuitive structure according to the "Process Approach" meets
    the spirit of ISO 9001:2008
 •  Completely up-to-date, meets all requirements and the simplified
    language
of ISO 9001:2008
 •  Professional layout with illustrations and side margin explanations and
    summaries

 

What is included with the Implementation Manual?
The Implementation Manual fully integrates all required ISO 9001 documents into a single user-friendly business manual. The following document templates are included:
 •  Quality Manual
 •  All Quality Procedures
 •  36 additional Procedures and Work Instructions
 •  Quality Policy
 •  Quality Objectives
 •  Process Flowchart
 •  Plus comprehensive Customization Instructions
 •  Plus free Consulting

   DETAILS 

90 Pages - 11 Illustrations
plus 22 Pages Customization Instructions

 

 

  The Streamlining Manual
 
Streamlining Manual 

 
The Streamlining Manual is an advanced documentation template with customization instructions for your second-generation ISO 9001 quality manual, policies and procedures. It is particularly useful for:
- Maintaining your ISO 9001 certification by easily meeting the
  ISO 9001:2008 requirement for continual improvement
- Improving any existing ISO 9001 quality management system to make it
  more efficient
- Upgrading an informal quality management system to a full ISO 9001
  system

Features of the Streamlining Manual
The many unique features of the Streamlining Manual include:
 •  Specifically designed to be a "second generation" manual to improve your
    existing ISO 9001 quality management system
 •  Concise and free of unnecessary wording and formalities
 •  Simplified ISO 9001 system that adds value to your company
 •  Lean, un-bureaucratic and free of unnecessary paperwork
 •  Easy to customize
 •  Unique and intuitive structure according to the "Process Approach" meets
    the spirit of ISO 9001:2008
 •  Completely up-to-date, meets all requirements and the simplified
    language
of ISO 9001:2008
 •  Professional layout with illustrations and side margin explanations and
    summaries

 

What is included in the Streamlining Manual?
The Streamlining Manual fully integrates all required ISO 9001 documents into a single user-friendly business manual. The following document templates are included:
 •  Quality Manual
 •  All Quality Procedures
 •  30 additional Procedures and Work Instructions
 •  Quality Policy
 •  Quality Objectives
 •  Process Flowchart
 •  Plus comprehensive Customization Instructions
 •  Plus free Consulting

  DETAILS  

91 Pages - 5 Illustrations
plus 14 Pages Customization Instructions

 

 

  The Forms Collection
 
Forms Collection 

 
The Forms Collection is a comprehensive collection of 33 customizable forms and checklists that are essential for any ISO 9001 quality management system. These forms will save you much time and also simplify your compliance with ISO 9001:2008!

Features of the Forms Collection
The many features of the Forms Collection include:
 •  Efficient: meet several ISO 9001:2008 requirements with one form in one
    easy step.
 •  Self-explanatory: our forms walk the user through the process - no need
    to refer to separate work instructions.
 •  User-friendly: clear, easy to understand and easy to use.
 •  Effortless: meet ISO 9001 record-keeping requirements with minimal
    efforts.
 •  Extremely simple customization.
 •  Professional and appealing layout.
 •  Up-to-date: meets all requirements and even includes the simplified
    language
of ISO 9001:2008.

 

What is included in the Forms Collection?
 • Annual Performance Evaluation Form
 • Audit Report Forms

 • Calibration Form
 • Corrective and Preventive Action Plan Form
 • Corrective and Preventive Action Plan List
 • Customer Complaint Instructions and Form
 • Customer Survey Template

 • Engineering Change Request
 • Forklift Operator’s Daily Checklist
 • Gap Analysis

 • Inspection Form
 • Job Description & Performance Standard Form
 • Management Review Agenda (corporate)
 • Management Review Agenda (local)
 • Meeting Notes Form
 • Meeting Notes Form (detailed)
 • New Hire Checklist
 • Performance Evaluation Memory Notes
 • Quality Planning Instructions and Checklist
 • Record Retention Guide
 • Registrar Evaluation Form
 • Role Description Template
 • Storage Form
 • Supplier Disqualification Request
 • Supplier Evaluation Template
 • Training Evaluation Form
 • Training Plan and Record for Management Representative
 • Training Plan and Record for New Hires
 • Training Plan and Record for On-The-Job Training
 • Training Plan Form
 • Training Record and Attendance Roster

 • Plus free Customer Service

 

  DETAILS  

33 Forms and Checklists - 118 Pages

 

  The Complete Package 
 
Complete Package 

 
Everything you need!

The Complete Package includes everything that beginners need to jump-start their ISO 9001 implementation, set up a lean and business-friendly ISO 9001 quality management system, quickly reach ISO 9001 certification, and maintain their certification in the future by meeting the ISO 9001:2008 requirement for continuous improvement. Plan ahead and save much with this package! Everything you need is included:

  • the Implementation Manual

          Comprehensive documentation template with customization
          instructions for your ISO 9001 quality manual, policies and
          procedures. It's the ideal template when setting up a new
          ISO 9001 quality management system.

  • the Streamlining Manual

          The Streamlining Manual is designed to help you
          maintain your ISO 9001 certification by meeting the "continual
          improvement" requirement of ISO 9001:2008. Use the ISO 9001
          Streamlining Manual approximately 1-2 years after your initial
          ISO 9001 certification.

  • the Forms Collection

          Comprehensive collection of 33 customizable forms and
          checklists that are essential for any ISO 9001 quality
          management system. 

  • Important Startup Documents

          Invaluable guides and tips for your ISO 9001 implementation
          (available only with the Complete Package).

  • Guide to ISO 9001 Compliance

          The Guide to ISO 9001 Compliance explains step-by-step
          the entire ISO 9001 implementation from the very beginning until
          you reach ISO 9001 certification and beyond. It is easy to
          understand and ideal for beginners. 

  • free Consulting

          Free and unlimited expert customer service included 7 days a
          week.
 

Benefits
The Complete Package provides real benefits to your business, including:
 •  Easy ISO 9001 implementation through a complete package with
    everything you need.
 •  Maintaining your ISO 9001 certification through our unique ISO 9001
    Streamlining Manual.

 •  An ISO 9001 quality system that adds value to your business by
    improving business processes and efficiency, and by eliminating
    bureaucracy and unnecessary paperwork.

 

  DETAILS  

Implementation Manual:
90 Pages - 11 Illustrations
plus 22 Pages Customization Instructions

Streamlining Manual:
91 Pages - 5 Illustrations
plus 14 Pages Customization Instructions

Forms Collection:
33 Forms and Checklists - 118 Pages

Startup Documents:
7 Documents - 16 Pages

Guide to ISO 9001 Compliance:
34 Pages

 

 

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