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None of the ISO 9001 standard, ISO 13485 standard or
others require specific formats for documents used in a quality
management or
environmental management system. Particular requirements may apply if
you choose to follow particular national or international standards and
reference them in your quality system as external documents. For
example, a format for drawings becomes a requirement, if we choose to
comply with ASME-Y14.1.
It is a good practice though to provide guidelines on how to format your
ISO 9001 documents, ISO 13485 procedures or ISO 14001 quality or environmental management
system manual, a procedure or an instruction. This will help to create
documents with a consistent format and professional appearance. To
specify a format for a quality manual, a procedures and instructions
let’s issue a document called Document Template Procedure. The cover
page of this document may look like the one shown below:
Order your ISO 9001, ISO 13484 or ISO
14001 Documentation Set today! Visit our
Products page to see how our Documentation can help improving your
quality or environmental management system.

Order your ISO 9001, ISO 13484 or ISO
14001 Documentation Set today! Visit our
Products page to see how our Documentation can help improving your
quality or environmental management system.
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