According to the requirements of ISO 9001, an organization must develop only six documented
procedures: (1) control of documents, (2) control of quality records, (3) internal audits, (4) control
of non-conformities, (5) corrective action, and (6) preventative action. A quality manual and
several records are also required. The development of other procedures, work instructions, and
other documents is largely at the discretion of the organization. From the very beginning of the
process, it is therefore essential that SMEs establish a balanced view between a short-term focus
(marketing/sales) and a long-term focus (achieving company-wide quality awareness through
TQM). ISO documentation should be considered as an enabler along that way and SMEs must
guard against the creation of unnecessary documentation