Challenges in 
Designing a QMS

#1 : Multiple Standards & Regulations

Most organisations will choose to comply, or be obliged to comply, with more than one set of standards and regulations.

Standards:- National, regional and international
Health & Safety : Quality : Environmental : Data protection : Governance : & others

Regulations:- National, regional and international
UK : Europe : USA : and many other countries and regions

Standards & regulations are not fixed forever. 
They are continually evolving.

We can't have a separate Management System for each one. We need a single QMS that is able to meet the requirements of them all, now and in the future.

 

#2 : Things keep changing !

Start-ups and young developing organisations are constantly evolving. Even in a mature business things change from time to time.

  • Changes in departmental and functional structures as the company develops and grows
  • Changes in roles, responsibilities, reporting lines and personnel
  • Changes and updates in standards and regulations

We can't be changing the structure of the Management System every time that the organisation changes.

We need a structure for the QMS that is, as far as possible, independent of these operational changes.

What is The Answer ?

The Process Approach

The ISO quality management standards strongly encourage us to take a process approach to the design of the Management System and increasingly regulations are expecting the same thing.

ISO 9001 Definition of the Process Approach:-
“The process approach involves the systematic definition and management of processes and their interactions . . and their application throughout the organization . .”

Quality Factors can build for you a company-wide process model based on how your organisation really works.

The model will provide a structure that is robust against change and aligns well with the processes that Quality Management Standards expect us to have in place.

The Concept of 
the Process Approach

An example

Almost every business will have a Purchasing process for acquiring products, materials or services.

  • It does not matter how the organisational structure or reporting lines or personnel change, it will still be the Purchasing process
  • It does not matter how often the quality standards or product regulations change, we will still need to have a Purchasing process

By focussing on defining and managing processes we can make the QMS future proof when other things around us are changing

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