Understanding ISO 9001:2015
4.4 Quality management system and
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.
of a Quality Management System (QMS )
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.
QMS serves many useful purposes including:
· It manages
the interacting processes and resources required to provide value and realize results for relevant interested
· Enables top
management to optimize the use of resources considering the long and short term consequences of their
· 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
including product and service provision (realization) processes. Your QMS must include processes and
sub-processes for leadership; planning; support; operations; performance evaluation and
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.
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.