Understanding the “Code”

Key words and phrases used in the ISO 9001:2015 Standard

There is some specific language used in the ISO 9001 standard which may appear as a kind of code. If you
recognize these words and phrases and understand their meaning, the standard is easier to read.

• Quality Management System(QMS) =The processes, documents, and records defining how
the organization has implemented the ISO 9001 standard

• The Organization shall =No choice; what follows is not optional

-determine =Decide and agree on how it should be done
-document =Write it down on paper or in an electronic format
-monitor =Periodically review
-consider =Include as input to decision making
-establish =Put in place as part of the quality management system
-implement =Make sure we’re all following what’s documented
-maintain…. =You need to periodically review it and revise as needed

• …determine the processes =Decide what your step-by-step processes are

• …determine the sequence and interaction of these processes =QMS Map

• …monitor and measure =Determine a metric, collect data and look at the data

• Process shall be documented… =Write it down!

• Documented Information
… is maintained =a document describing what to do (e.g. procedure, work
instruction)
… is retained =a record of what was done (e.g. completed form)

• Process Performance =measures of how a process is performing, often

including effectiveness and efficiency.

• Product Conformance = measures showing how well product meets requirements

• Responsibilities and authorities are defined =Organization Chart

• Evaluating the effectiveness of the QMS =Internal Audit

• Improve the effectiveness of the QMS =Corrective Action