Tips on ISO 9001 Quality Management System Documentation What is a document? Lets begin with some definitions.

A document is information that is written or recorded on some medium such as paper or computer. A document may specify requirements (e.g. a drawing or technical specification); provide direction (e.g. quality plan); or show results or evidence of activities performed (e.g. records). What is a procedure? A procedure is a specific way to perform an activity or process (methods or practice used by an organization) and it may or may not be written. If it is written, it is called a documented procedure. The same reasoning applies to work instructions (which are ways to perform a discrete task) which may or not be documented. What purpose does QMS documentation serve? QMS documentation provide the following benefits and objectives: 1. Communication of Information - needed by the organization to plan, operate and control its processes. The type and extent of the documentation will depend on the criteria listed above, as well as the degree of formality of communication systems and the level of communication skills within the organization, and the organizational culture. 2. Evidence of conformity - provides evidence that what was planned and what has actually been done. 3. Knowledge reservoir and sharing - to preserve and disseminate the organizations experiences; business and technical know-how. A typical example would be a technical specification, which can be used as a base for design and development of a new product. 4. Training tool - to train personnel in performing their responsibilities 5. Consistency of performance - by having all personnel perform to the same method, practice or procedure 6. Promote best practice - document the best way of performing activity using internal and external knowledge What are the ISO 9001 requirements for QMS documentation? Clause 4.2.1 specifies all the different types of documentation needed for your QMS. You must have documented statements of your quality policy and objectives. Specific requirements for these documents are stated elsewhere in clause 5 of the standard. You must have a documented Quality Manual. There are many ways to document your Quality Manual; and this would be determined by the size,

structure and complexity of your organization. Clause 4.2.2 specifies more requirements for the contents of the quality manual. This standard is not heavy on documented (written) procedures as was the case with previous standards. Clause 4.2.1d requires you to have documents needed to ensure the effective planning, operation and control for QMS processes. The nature and extent of such documentation will vary from organization to organization, based on factors listed below. What criteria should an organization use to determine how much QMS documentation it should have? The need to have additional documentation beyond those specified in this standard may depend upon - customer, regulatory and your own organizational requirements. Other factors to consider may include complexity of products and processes; effect on quality; risk of customer dissatisfaction; economic risk; effectiveness and efficiency; competence of personnel; workforce stability and past quality problems and nonconformities. For example, the complex your products or processes are, the greater the risk of problems occurring. The use of documentation and other controls serve to prevent or reduce these risks. If you have a highly educated and stable workforce, then the amount of documentation needed may be significantly less than an organization that has a high workforce turnover and lower educational requirements. Regardless of how and to what extent you document your QMS, you must demonstrate the effective implementation of your QMS in terms of conformity to ISO 9001, customer, regulatory and your own organizational requirements. In what medium should QMS documents be communicated? Any combination of media is acceptable for documents and records provided they conform to requirements specified in clause 4.2.3 control of documents and clause 4.2.4 control of records. These may include, but not limited to: paper, magnetic. electronic or optical computer disc, photograph, audiovisual, etc. What are the mandatory documented procedures required by ISO 9001:2000? Under ISO 9001, you must have documented procedures for - clause 4.2.3 - Control of documents; clause 4.2.4 - Control of records; clause 8.2.2 Internal audit; clause 8.3 - control of nonconforming product; clause 8.5.2 Corrective action and clause 8.5.3 - Preventive action. These documented procedures have to be controlled in accordance with the requirements of clause 4.2.3

You may choose to include your procedures and lower level documentation in your quality manual or organize them in some other fashion. The practicality of this would depend on the size of your organization, complexity of products and processes; competency of personnel, media used for documentation (hard copy versus computerized); ease of use and understanding by personnel; maintainability; etc. Depending on these same criteria, you may decide to have additional procedures (beyond the mandatory six) or carry over some or all the procedures you had under previous QMS systems. Some of the mandatory procedures can be combined, e.g., correction and preventive action may be combined as long as you address the specific requirements of each clause 8.5.2 and 8.5.3. You could also have more than one procedure for any of the mandatory clauses listed above. Note there are several ways to write procedures, other than the conventional narrative form. In fact, narrative documentation has been found to be the least effective way to promote user comprehension and ease of use. Procedures may be documented graphically (e.g. flowchart; video; series of pictures or photographs, etc.). Can you provide examples of documents, other than policies, quality manual and procedures, that an organization may need for its QMS? In addition to the documents specifically called out in ISO 9001, clause 4.2.1d calls for documents deemed necessary for effective management and control of your processes. These could include - process maps, process flow charts and/or process descriptions; organization charts; quality plan, material specifications; competence criteria, product specifications, packaging specifications, manufacturing specifications, work and test instructions; forms; schedules; set-up specifications, etc. ISO 9001 calls for many records to provide evidence of effective planning, operation and control of processes. Examples include - management review records; calibration records, internal audit records; corrective action records, etc. Again, your processes may call for additional records beyond those expected by ISO 9001. Many clauses do not specifically call for documents and records, but there is a strong implication in the wording of the need to have them. This is where you must be guided by clauses 4.2.1d and 7.1b for documents and 4.2.1e; 4.2.4 and 7.1d for records. Use these clauses to determine what documents and records are needed to provide evidence of effective planning, operation and control. Remember to use the requirements of clause 4.2.3 to control all documents you choose to include in your QMS; and the requirements of clause 4.2.4 to control all QMS records.

What should be documented in my Quality Manual? The quality manual (QM) is a special type of document that describes your QMS. Your QMS is comprised of a number of business processes needed to satisfy customer and other stakeholder requirements. For your QMS manual to be meaningful, provide a brief description of each of these processes and the key ISO 9001 control requirements that apply to them. Do not follow the common practice of writing back the clauses of the standard. This serves no useful purpose to anyone. Your quality manual must also include a description of the interaction of your QMS processes. This can be done in any number of ways including - process maps; flowcharts; process diagrams; spreadsheets; etc. You QM must define the scope of your QMS. Your QMS scope should include - facilities (manufacturing and support locations), products, processes, your policies for Quality Management and other standards, etc. Customers will want to know the extent of your product, QMS and manufacturing capabilities and the Certification Body (Registrar) will want to determine the time and effort needed to audit your organization. Provide details of any clause exclusions from your scope, e.g. 7.3 Product Design and Development, and your justification for it. You must justify all exclusions and remember, exclusions can only be made from clause 7. Besides describing your QMS, your quality manual could provide information on organizational background and capabilities. It may be used by customers, regulatory bodies, suppliers and company personnel for a variety of purposes. There are many other acceptable ways to document your quality manual. You have flexibility in whether or not to include your procedures and lower level documentation with your quality manual or organize them in some other fashion. You may include all or some of your procedures in your Quality Manual or reference them to your Quality Manual. Keep a listing or index at the front or back of your Manual showing the complete list of your procedures whether included or referenced. The practicality of all this would depend, of course, on the size of your organization; complexity of products and processes; competency of personnel; media used for documentation (hard copy versus computerized); ease of use and understanding by personnel; etc. So go ahead and organize your documentation to facilitate ease of use; understandability, availability and maintainability. As a part of your QMS (see 4.2.1) documentation, the quality manual is subject to all of the controls in clause 4.2.3. How does an organization demonstrate conformance to ISO 9001, if

it has minimal documentation? In order to claim conformity with ISO 9001:2000, the organization must be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2000 defines "objective evidence" as "data supporting the existence or verity of something" and notes that "objective evidence may be obtained through observation, measurement, test, or other means." Note that organizations may be able to demonstrate conformity without the need for extensive documentation. Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2000. In some cases, (for example, in clause 7.1(d) Planning of product realization, and clause 8.2.4 Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence. Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the requirements of clause 5.6 and it can also be used for both internal and external conformity audit purposes.