Does a process require an SOP? we have a requirement in our QMS and ISO 13485 to communicate the effectiveness of the QMS at least monthly to management. We conduct weekly management meetings without formal documentation. Reviewing data from the last several years these meetings have occurred and the requirements are being met weekly.
Further -
0.3 Process approach
This International Standard is based on a process approach to quality management. Any activity that
receives input and converts it to output can be considered as a process. Often the output from one
process directly forms the input to the next process.
For an organization to function effectively, it needs to identify and manage numerous linked processes.
The application of a system of processes within an organization, together with the identification and
interactions of these processes, and their management to produce the desired outcome, can be referred
to as the “process approach.”
When used within a quality management system, such an approach emphasizes the importance of:
a) understanding and meeting requirements;
WE ARE
b) considering processes in terms of added value;
An SOP adds no value
c) obtaining results of process performance and effectiveness;
MINUTES OF MEETINGS ARE RECORDED AND DEMONSTRATE EFFECTIVENESS.
d) improving processes based on objective measurement.
OBJECTIVE DATA SHOWS THIS IS BEING MET.
Is this acceptable?
Further -
0.3 Process approach
This International Standard is based on a process approach to quality management. Any activity that
receives input and converts it to output can be considered as a process. Often the output from one
process directly forms the input to the next process.
For an organization to function effectively, it needs to identify and manage numerous linked processes.
The application of a system of processes within an organization, together with the identification and
interactions of these processes, and their management to produce the desired outcome, can be referred
to as the “process approach.”
When used within a quality management system, such an approach emphasizes the importance of:
a) understanding and meeting requirements;
WE ARE
b) considering processes in terms of added value;
An SOP adds no value
c) obtaining results of process performance and effectiveness;
MINUTES OF MEETINGS ARE RECORDED AND DEMONSTRATE EFFECTIVENESS.
d) improving processes based on objective measurement.
OBJECTIVE DATA SHOWS THIS IS BEING MET.
Is this acceptable?