The minimum documentation requirements as defined in element 4.2.1 of ISO 9001: 2000 are as follows:

a) Quality Policy or Statement and Quality Objectives
b) Quality Manual
c) Procedures
d) Other Documents (work instructions, control plans, etc.) needed by the company to ensure the effective planning, operation and control of its processes
e) Quality Records

Once a company decides to adopt ISO 9000 (or any other quality standard) as a company lifestyle, it exposes itself to the following challenges:

Establishing a quality system documentation that clearly and simply describes the company's processes and activities (Document what you do);
Ensuring that the employees follow the documented plans, procedures, and instructions (Do what you document);
Generating and maintaining records (Prove it); and
Keeping the documentation current and valid (Control it).

In order to meet these challenges, it is essential to have a quality system that is well documented and user friendly.We present you with some suggestions that will help you establish and maintain your quality system documentation:

A) Identify the Need for Documentation
Once a company decides to become ISO 9000 compliant, it tends to become documentation oriented. Many companies make their quality system heavy on documentation, complex, and static.

In actuality, it is not necessary to document everything: every process, every task, every activity, etc. As defined in element 4.2.1, Note 2 of ISO 9001: 2000, the extent of the quality system documentation differs from one company to another due to:

a) The size of the company and the type of its activities;
b) The complexity of processes and their interactions and interrelations; and
c) The competence of the company's personnel.

ISO 9000 allows a company to determine the level of detail and complexity of its documented system. The range and detail of the documentation, especially the procedures, depend on the complexity of the work, the methods used, and the skills and training needed by employees involved in carrying out the companies' tasks and activities.

Tip: If you feel that your process and its activities are not complicated, and/or your employees are skilled and well trained, then you can avoid unnecessary documentation. Keep in mind that everything you document is subject to an audit.

B) Keep Your Documentation Simple
No matter how complicated the process, it can still be documented and described in a simple way. When writing quality system documentation, consideration should be given to the fact that the personnel being addressed belong to all levels of the organizational structure: sales, procurement/purchasing, production, assembly, manufacturing lines, quality inspectors, executive management, etc.

Tip: Stay away from fancy and sophisticated words. It is not necessary to use graduate level language. Go back to the basics. Keep your sentences short and to the point. Use subject-verb-object format. Use active tense rather than passive.

C) Prepare a Simple Quality Policy (Quality Statement)
The Quality Policy defines the company's understanding of and commitment to quality. It states or addresses the company's goals and objectives. It is prepared by Executive Management and sets the stage for meeting and exceeding the customers' requirements and expectations. The Quality Policy should be easy to understand and remember by all employees.

Many companies write a quality policy that exceeds one page. When writing a Quality Policy, consideration shall be given to how it impacts the personnel who live it every day and their understanding of it.

Tip: The Quality Policy is one of the most asked questions during an audit. Employees not only have to know it, but they have to know what it means and understand how it applies to their job activities. So keep your Quality Policy simple, understandable, and easy to remember.

D) Quality Manual
The Quality Manual states the Quality Policy, and defines and describes the company's quality system. The Quality Manual should address all the requirements of ISO 9000 or any other applicable quality standard.

If an element or a section of ISO 9000 or another quality standard does not apply, the Quality Manual must state the non-applicability. The ISO 9001: 2000 standard requires that the Quality Manual include details of and justification for any permissible exclusions (see element 4.2.2).

The ISO 9001: 2000 standard permits companies to exclude compliance with specific requirements that neither affect their abilities, nor absolve them from their responsibility, to provide product that meets their customers and applicable regulatory requirements, yet still conform to the ISO 9001: 2000 standard. Permissible Exclusions are restricted to clause 7 of ISO 9001: 2000 and do not apply to any other clauses of the standard.

Tip: The Quality Manual must be a summary of your company's quality system. You should ensure that it meets all of the ISO 9000 requirements or the requirements of any other applicable quality standard your company may choose.

ISO 9001: 2000 requires that the Quality Manual contain or reference the company's procedures (see element 4.2.2. b). We recommend only referencing the procedures in the Quality Manual. Create a separate manual for the procedures, and, if needed, another one for work instructions. Keep the Quality Manual and the Procedures Manual two different and separate entities.

Keep the Quality Manual fairly generic. Do not write it as if you are writing a procedure.

The Quality Manual may include:

Table of Contents
Company Background
Quality Policy
Glossary
Introduction

E) Procedures
A procedure is defined as a specified way to perform an activity, a task, or an operation. It defines the Who, What, When, Where, and How for the activity.

Tip: When you start developing and writing procedures, start with the body of the procedure. Once you know the process and the flow of activities you want to document and describe in the procedure, the remaining sections will be easy to identify and document.

A procedure may include the following sections:

Title
Document number
Document revision
Purpose and scope
Responsibilities and authorities
The body of the procedure
Reference to related documentation

F) Work Instructions
A work instruction provides specific direction for performing an activity. It is like a procedure, but has more details. It gives 100% instruction on how to complete a specific activity or task. It defines the Who, What, When, Where, and How for the task.

Tip: Your company may not need to have work instructions, at least not for every activity or task its personnel perform. In certain circumstances, the company's traveler, work order, or any other controlled plan may substitute the need for a work instruction.

A work instruction may include the following sections:

Title
Document number
Document revision
Purpose and scope
Responsibilities and authorities
The body of the work instruction
Reference to related documentation

G) Forms and Records
A form is a tool used to document an activity or a task.

A blank form is considered a document, and should be controlled under the Document and Data Control System.

Once a form is filled out, it becomes a quality record. A quality record is used as objective evidence to prove that a quality requirement has been fulfilled, and to demonstrate that the quality system is operating effectively.

Tip: When you create a form, make it a stand-alone document. We recommend only referencing and not including it in the quality manual, procedure, and/or work instruction. Forms may be revised, updated, and/or changed more frequently to meet the ever-changing business process.

H) Approval Authority
Many companies fall in the documentation approval trap. They set up a complicated approval process for documentation release and change.

One of the most common findings during an audit is the use of uncontrolled and unreleased documents.

When the Document and Data Control System is too bureaucratic and complex, employees will not take the time to obtain approval for the release or change of a document. They will go around the system by creating and using any document they may need without controlling it. As a result, the Document and Data Control System will fall apart.

Tip: Create a Document and Data Control System that is simple, and that requires an employee-friendly approval process. Here are some suggestions and recommendations to make your process for document approval, release, and revision more effective and robust:

a) Quality Manual
Keep the approval authority for the Quality Manual at the executive management level, preferably with the Management Representative (MR) and/or the President. Since the Quality Manual describes the company's quality system in a fairly generic way, there is no need for all executives to be involved in the approval, release, and update process of the Quality Manual.

b) Procedures
Keep the approval authority for procedures at the executive management level, preferably with the owner of the procedure (i.e. department head) and/or the Management Representative (MR).

c) Work Instructions and Forms
Keep the approval authority for work instructions at the middle management level, preferably with the owner of the work instruction (i.e. department supervisor, cell head) and/or the Management Representative (MR).

I) Correlation
Correlation of company documents with the applicable standard is auditor friendly. It allows the auditor to go through the company's documentation easily and more efficiently. Hence, often times, leading to a more value added and quicker audit.

Tip: Correlate your documentation with the applicable quality standard with which they comply. This applies to all levels of documentation (i.e. Quality Manual, Procedures, Work Instructions). Also, ensure that all levels of documentation correlate with each other.