4.2.1 General

ISO 9001 requires that certain aspects of the quality management system are documented. Specifically, this includes a quality policy, quality objectives, a quality manual, procedures, planning documents and quality records.

Procedures describe what is being done in an organization. They help to make things clear for personnel, and they can also help create consistency in work. A quality management system is not a set of procedures describing every minute detail of an organization’s operations. The quality management system should be an effective, user friendly balance of procedures, work instructions and forms, which will assist personnel in their day-to-day work.

The effectiveness of procedures depends on how they are applied to an organization. In a small organization with relatively simple processes and activities, procedures should be limited and simple. Larger organizations with more complicated activities should have more detailed procedures, but in all cases the procedures should still be as practical as possible.

Please note that ISO 9001 does not in all cases require documented procedures. In some cases there is no need to document existing practices. However, there must still be a procedure in place: a consistent way of performing the work involved.

In 2008 edition note below clause 4.2.1 is expanded and it explains that a single document may include the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.

In large organizations, it is difficult to define all the requirements of a documented procedure within one document due to restricted authority. Due to limitations of auditor’s vision many organizations faced problems during certification and in convincing the auditors. This note makes many things clear and will help organizations with complex processes and large hierarchy.

Organizations meeting requirement of one documented procedure in more than one document should prepare a reference chart for understanding within the organization, ease of audit and provide evidence of conformity to the requirement of the standard to claim certification.

What is a "document"?

You must remember that, according to ISO 9001 clause 4.2 ("Documentation requirements") documents may be in any form or type of medium, and the definition of "document" in ISO 9000 clause 2.7.2 gives the following examples:

• Paper ("hard copy") 
• Magnetic
• Electronic or optical computer disc
• Photograph
• Master sample

Factors affecting documentation

The notes after Clause 4.2 make it clear that where the standard specifically requires a "documented procedure", the procedure has to be established, documented, implemented and maintained. It also emphasizes that the extent of the QMS documentation may differ from one organization to another due to:

• the size of organization and type of activities
  A Bigger size organization may need several procedures depending upon work distribution and location.
• the complexity of processes and their interaction, and
  Products or services having complex manufacturing or delivery processes may require extra documentation to explain the things.
• the competence of personnel
  Organizations having skilled or competent persons may require less documentation.
  Examples:
  A truck driver need not be given a drivers manual but you definitely need a drivers training manual.
  A nurse may not be given a wok instruction to explain how to put injection but you need to define the person’s minimum qualification for various types of injections.
  
  Importance is given to overall personnel skill instead of simply preparing procedure or work instruction.

Guidance on Clause 4.2.1 of ISO 9001

• Quality Policy and Objectives:
  Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2000. Because the quality policy is a document, it must be controlled according to the requirements of clause 4.2.3. Some organizations that may be revising their quality policy for the first time, in order to meet ISO 9001:2000 requirements will need to pay particular attention to clause 4.2.3 (c), (d) and (g).
  
  Requirements for the quality objectives are defined in clause 5.4.1 of ISO 9001:2000. They are also subject to the document control requirements of clause 4.2.3.
  
  
• Quality Manual:
  Clause 4.2.2 of ISO 9001 specifies the minimum content for a quality manual. The format of the manual is a decision for each organization, and will depend on the organization's size, culture and complexity.
  A small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard. Large, multinational organizations may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation.
  
  
• Documented procedures:
  ISO 9001 specifically requires the organization to have "documented procedures" for the following six activities:
  
  1] Clause 4.2.3 Control of documents
  2] Clause 4.2.4 Control of quality records
  3] Clause 8.2.2 Internal audit
  4] Clause 8.3 Control of nonconforming product
  5] Clause 8.5.2 Corrective action
  6] Clause 8.5.3 Preventive action
  
  Some organizations (particularly larger organizations, or those with more complex processes) may require additional documented procedures in order to implement an effective QMS. Other organizations may require additional procedures, but the size and/or culture of the organization could enable these to be effectively implemented without necessarily being documented.
  In order to demonstrate compliance with ISO 9001, however, the organization must be able to provide objective evidence that its QMS has been effectively implemented.  
  
  
• Additional documentation:
  Documents required by the organization to ensure the effective planning, operation and control of its processes; In order for an organization to demonstrate the effective implementation of its QMS, it may be necessary to develop documents other than documented procedures. However, the only documents specifically mentioned in ISO 9001:2008 are:
  
  1] Quality policy (clause 4.2.1 (a))
  2] Quality objectives (clause 4.2.1 (a))
  3] Quality manual (clause 4.2.1 (b))
  
  There are several requirements of ISO 9001 where an organization could add value to its QMS and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Examples may include:
  
  1] Process maps (manufacturing flowchart)
  2] Organization charts
  3] Internal communications
  4] Production schedules
  5] Approved supplier lists
  6] Quality plans
  
  
• Records:
  Examples of records specifically required by ISO 9001 are given on page 4.2.4.
  
  Organizations are free to develop other records that may be needed to demonstrate conformity of their processes, products and quality management system. Requirements for the control of records are different from those for other documents, and all records must be controlled according to clause 4.2.4 of ISO 9001:2000.
  
  When you read the standard, you will find reference to clause 4.2.4 within bracket at many places. These requirements call for recorded evidence.