QIC Guru

Step 5. Documentation: ISO9001:2008 requires that you establish and implement  a Quality Manual and six documented procedures. Don’t fall into the trap of over documenting your system, this will only lead to needless non-conformances. That said; let’s talk about each of these requirements and what is really necessary to meet them.

Quality Manual- Your quality manual must have a scope, justification for any exclusions, the documented procedures required by ISO9001:2008 or reference to them, and a description of the interrelationship of the processes within your quality management system.  There are no further requirements. You do not need a table of content, introduction, or objectives. The manual does not need to be twenty five pages long and does not need to include every work instruction, training procedure or anything other than what is discussed here. You can put as much as you like into your quality manual, but be advised, whatever you put in can and will be audited.

The scope of your quality management system should describe your organization’s processes, products (and /or services), and related sites, departments, divisions etc., to which the organization applies a formal quality management system. It should be based on the nature of your organization’s products and their realization processes, the result of risk assessment, commercial considerations, and contractual, statutory and regulatory requirements.

There are some pretty good iso 9001 templates available out there, that have proven track records for covering the required documentation. These templates can easily be revised to cover your organizational needs.