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Understanding ISO 9001:2015

4.4 Quality management system 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.

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.


ISO 9001 Home
◦  ISO 9001:2015 FAQ
◦  Purpose of the Standard
◦  Scope of the Standard
◦  Normative References, Terms and Definitions
◦  Context of the organization
◦  Understanding the needs of interested parties
◦  Determining the Scope of your QMS
◦  QMS and its processes
◦  Leadership and Commitment
◦  Customer Focus
◦  Quality Policy
◦  Organizational roles, responsibilities and authorities
◦  Risk Based Thinking
◦  Quality Objectives
◦  Planning For Changes
◦  Resources - General
◦  clause 7.1.2 -People
◦  clause 7.1.3 Infrastructure
◦  Environment for the operation of processes
◦  Measuring and Monitoring Resources
◦  Organizational Knowledge
◦  Competence
◦  Awareness
◦  Communication
◦  Documented Information
◦  Operational Planning and Control
◦  Customer Communication
◦  Determining requirements related to products and services
◦  Design and Development Planning
◦  Customer Communication
◦  Review of requirements related to products and services
◦  Design & Development Inputs
◦  True False Questions
◦  Sample Test Questions
ISO 9001 Consulting
◦  How To Select An ISO 9001 Consultant
◦  Compelling Reasons To Use An ISO 9001 Consultant
◦  What Services Can An ISO 9001 Consultant Provide?
◦  How To Select a Certification Body (Registrar)
◦  What Is The Process Approach?
◦  Useful Resources To Help You Implement ISO 9001
◦  What Are Outsourced Processes?
◦  What Are Quality Objectives?
◦  What Is Continual Improvement?
◦  What Is Customer Satisfaction?
ISO 9001 Implementation Guide
◦  Free Resources To Help You Implement ISO 9001
◦  Quality Policy
◦  Quality System Documentation
ISO 9001 Certification

Understanding ISO 9001:2008