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Important Quality Documentation Information

Canned vs. Pre-Formatted

Canned - When we refer to a canned program we are describing a software package. Many of the packages on the market today offer a true savings over creating the documentation from scratch. There are different levels or degrees of difficulty in regards to entering the data for your organization. In most cases this process is very similar to setting up a new accounting program. You simply enter the relevant data, and the program will apply this information through out the documentation were it belongs. The programs usually include all of the documentation you need to comply with ISO and much more. Herein lies the problem most users face as they modify the documentation program for their needs. What documentation is considered basic and minimum, and does the pre-written policies and procedures offer the simplest most efficient method to accomplish the required task? How easily can forms and records be changed? Can you create new records easily? How difficult is it to incorporate existing procedures and documents into the manuals? Still this is a viable option for an organization that can allocate the man-hours necessary to review the documentation and make the necessary changes. If you are considering this option, for your organization, take the time to research the helps included in the program, to ensure they are adequate.



Pre-Formatted - Obviously the term pre-formatted applies to the canned program documentation described. The difference with the Documentation Packages offered by ISO Quality Manuals dot com is it is not a computer program and there are no uncertainties regarding modification. We use Microsoft office documents, (word and excel), making the revision of the documentation simple and straight forward. Even with limited knowledge and experience using the Microsoft office applications the instructions we provide will guide you through the process easily.

The format follows ISO 9001:2000, and the content includes the simplest methods to accomplish compliance. There are no unnecessary policies or procedures. Our documentation includes only the minimum requirements as set forth by ISO 9001:2000, and the same minimum requirements found in any formal Quality Management System. It includes all of the core system elements your clients expect to see.

Formatted to follow ISO 9001:2000, making it easy for your registrar, or any auditor to follow and assess.

Understanding Quality Documentation  

Many clients seek assistance in creating documentation specific for their business and industry. While this request makes sense, it is important to understand what makes up a documented quality program. Quality documentation is divided into 2 parts or elements. Understanding this is very important to establish your program affordably. While it is reasonable to expect industry specific documentation to be required, the core elements of any Quality Management System are consistent and the same. Regardless of the type or size of your company your quality program will include the same elements used by everyone. This is the reason we can say with confidence this program documentation will work for your organization. 

Below we explain how to look at and evaluate your documentation needs by examining the documentation divisions.

Documentation Divisions

1. The Core or Administrative Elements - All documented Quality Management Systems contain similar elements. These elements are described in ISO 9001:2000. We refer to them as Core Elements, because they are at the center of the system and the entire quality program revolves around them. They represent the requirements of ISO and are critical to the success of any quality program. They include; document and data control, management responsibility, product realization, auditing, non-conformances, corrective and preventive action, improvement, etc. The policies required to satisfy these elements are included in your Quality Control Manual (QCM). 2. Industry Specific Elements - In addition to the core elements above, your program will typically involve elements specific to your industry. Examples of industry specific documentation include; welding, painting, testing, etc. What is required is dependant on the type of industry your organization is in, and the processes that are involved in your product realization. Often your clients are a source of information regarding the industry specific elements you will need to incorporate into your Quality Management System. The procedures to satisfy these elements are incorporated into your supporting documentation.

Advice To Save Time - It is important that this concept is understood. This and an understanding of the intent of ISO 9001:2000 will allow you to move forward with your documentation and the certification process very quickly. By starting with the Core Elements you can begin implementation of your program. Included in the core elements is the evaluation of critical processes and a method by which to measure them. The implementation of the core elements identifies the industry specific elements required.

Advice To Save Money - The results of failing to recognize the documentation divisions has cost many organizations thousands of dollars in consulting fees. If a consultant is hired to create your documentation, it is only reasonable that he understand your industry and determine what industry specific elements are required. Obviously this takes time and he is paid for his time. For the core procedures addressed above, it is frugal to modify generic documentation. By doing so you ensure all requirements are included and the administrative elements of your program may be implemented quickly.

Save money and time by purchasing documentation that contains the core elements of your quality management system. You will have the documented foundation of your system and can concentrate on identifying your industry specific requirements, yourself, as you go. After all you are the expert in your industry, therefore you are best qualified for the job.

Knowing What You Need 

You must begin with a solid foundation. A documentation package that covers the required Core Elements in the simplest method possible. A package that you can easily modify to make your own and improvements along the way and especially important, a package you can add your industry specific elements to as they are developed. The ISO Quality Manuals dot com Quality Documentation provides this foundation.

Our Complete Documentation Package will include 2 levels of documentation, as detailed below.

  • The Quality Control Manual (QCM) contains your company policies and will be easy to modify with your company information. The body of the text only requires the insertion of your company name, using the find and replace feature of word, to be ready to issue.
  • The Quality Systems Manual (QSM) will include all of the required procedures, forms and records you will need to accomplish the policies set forth in the QCM. This is typically an internal document and is not usually issued to clients. This is the manual you will add your industry specific documentation to.

 

 Special Documentation

Your industry and/or customers often determine the requirements for special documentation.

Examples of processes requiring special documents:

  • Welding – Procedures and qualification records to meet AWS or equivalent standards

  • Painting & Coating – Procedures to meet SSPC guidelines

  • Electrical Design and Installation – Procedures to meet NEC requirements.

As you identify and develop special documentation that may be required, it may be added to your new Quality Documentation very easily.


Work Instructions

It has been our experience many companies spend tremendous resources on documentation that is simply not required. It is a common misconception that you must document small details of every operation to comply with ISO. The fact is, work instructions are seldom required. The need for work instructions is based on the level of difficulty of the process or work performed and employee competence. In most cases verification of the employees qualifications, including experience and training satisfies the requirements of ISO.

A perfect example may be your engineering department. It is very unlikely an engineer with 20 years of experience in his or her field, will require instructions regarding how to perform the job.

If specific instructions are required or your company already uses work instructions, they may be added to your new Quality Documentation very easily.

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