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Understanding ISO 9001:2015

ISO 9001 Requirements Clause 4.4 QMS and its processes

In my opinion this is the most important clause of the ISO 9001 standard. This clause coupled with
Clause 0.3 Process Approach form the backbone of this ISO standard.

Definition of a Quality Management System (QMS)

ISO 9000:2015 defines a QMS as comprising of activities by which the organization identifies its
objectives and determines the processes and resources required to achieve desired results.

A QMS serves many useful purposes including:

· It manages the interacting processes and resources required to provide value and realize results for
relevant interested parties.

· Enables top management to optimize the use of resources considering the long and short term
consequences of their decision.

· Provides the means (through risk management) to identify actions to address intended and unintended
consequences in providing products and services.

The primary focus of this clause is to identify, manage and control all your QMS processes including
product and service provision (realization) processes. Your QMS must include processes and sub-
processes for leadership; planning; support; operations; performance evaluation and improvement.

The ‘Process Approach’ must be used in defining your QMS. Please go back and review clause 0.3
Process Approach of my eBook for a good understanding of how the process approach and the PDCA
cycle may be used in identifying, managing and controlling your organization’s QMS processes (COP’s;
SOP’s; MOP’s; QMP’s.
ISO 9001 Requirements Clause 4.4 QMS and its processes

The main focus of process control is to establish prevention based controls using risk management
before and during the operation of processes to:

· Eliminate or mitigate the possibility of problems occurring;

· Assure that processes operate within defined process parameters or acceptance criteria;

· Assure that output (materials, product, services, information, etc) from each process and sub-process
will meet defined quality objectives and customer (internal & external) requirements.

QMS processes may also include detection based controls. These controls will typically be applied during
and after process completion. Again the focus can be on both the output of each process (e.g. product
or service inspection through sampling plans) and monitoring of process performance itself (SPC charts;
automated alarms, etc).

In my eCourse “Understanding ISO 9001:2015” I provide 12 pages of discussion and action items you
must take to address the subclause requirements 4.4.1 a to h. Get this clause right and the rest of your
QMS will fall into place.