ISO 9001 - 4.4 Establishing the QMS and Its Processes

The ISO 9001 Quality Management System standard emphasizes a process approach. The intent of the standard is for organizations to establish, implement, maintain and continually improve the processes needed for the QMS. These should be focused on achieving your organization’s desired outcomes. Continual improvement is a main focus of Clause 4.4 as the organization is required to continually monitor and review its context to ensure that the QMS remains effective.

In this blog post we will be discussing the following:

1. Establishing the Processes of QMS

2. Process Interactions

3. Effective Operation and Control

4. Resources needed

5. Managing and Controlling Processes

6. Continual Improvement

4.4 Standard Requirement from Standard (ISO 9001:2015):

4.4.1 The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.

The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:

a) determine the inputs required and the outputs expected from these processes;

b) determine the sequence and interaction of these processes;

c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;

d) determine the resources needed for these processes and ensure their availability;

e) assign the responsibilities and authorities for these processes;

f) address the risks and opportunities as determined in accordance with the requirements of 6.1;

g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;

h) improve the processes and the quality management system.

4.4.2 To the extent necessary, the organization shall:

a) maintain documented information to support the operation of its processes;

b) retain documented information to have confidence that the processes are being carried out as planned.

Establishing the Processes of Quality Management System (QMS)

We will begin with establishing the processes of the QMS by identifying all the processes that are essential to its QMS. These processes should support the products and services that have an impact on meeting customer needs and requirements while complying with laws and regulations. Each of the processes identified must be defined in terms of its Input, output, activities and how it contributes to the effectiveness of the QMS. These processes can be separated into three different categories.

· Management Processes – These make sure the system runs efficiently, and that leadership is accountable to the management system.

o Example: Planning, leadership, internal audits and management reviews

· Support Processes – These support the core processes

o Example: Training, maintenance, document control and human resources

· Core Processes - Directly related to delivering products and services

o Example: Production, design, delivery and customer support

Process Interactions

Defining how these different processes interact with each other is the next important step. These things include the understanding of the flow of information, materials, and the different responsibilities of functions or departments.

All these different interactions must be understood to ensure that flow of operations is seamless to avoid inefficiencies, gaps in quality and avoiding bottle necks.

For example:

Let us focus on the company ABE Manufacturing LLC. When the management team sat down and to discuss their core processes they identified the follow:

Core Processes Identified:

· Estimates and Quoting

· Design

· Product

· Distribution

To show how they interaction the organization developed an interaction of process diagram. Documenting the process of interactions for an organization can take many forms but here is an example of one:

You can clearly see the organizations core processes flowing from customer input for request for quote through their design, production and then distribution (aka shipping) of the material to their customers.

There are also several outsourced processes (yellow box) and several sub or accessory processes (grey boxes) that are both inputs and outputs of the system.

From this diagram we now know which processes are core or key processes for the organization quality management system. From here, we can take these processes and examine them to determine effective operational controls that will be needed for these processes to run efficiently and effectively.

Effective Operation and Control

In this next step in clause 4.4 the organization must define criteria and methods for the effective operation and control of these processes. This involves establishing performance criteria for each process and defining key performance indicators (KPIs) to measure the effectiveness of processes.

Some methods for controlling these processes may include:

· Resource allocation - what resources are needed for these processes?

· Process automation - can we automate or make these processes more efficient?

· Process Documentation - including procedures and work instructions?

Resources needed

The organization must ensure that each of these processes have the necessary resources to be able to function effectively and efficiently.

These resources can include:

· Information - what knowledge is required for these processes or staff?

· Infrastructure - is the building adequate for our purposes?

· Human Resources – Do we have the right people for the work, experience and number?

· Environment – is the work environment in place to achieve our desired outcome?

Managing and Controlling Processes

In this 5th step the organization must implement controls to ensure that processes are consistent produce desired outcomes and be able to manage these controls.

These controls can include:

· Risk-Based thinking

o Example: Identifying potential risks and opportunities

· Documented procedures

o Example: To provide clear instructions and standardize operations

· Monitoring and Measurement

o Example: Conducting inspections, audits or performance reviews

· Corrective and Preventive actions

o Example: Implementing measures to address failures, deviations or inefficiencies

Continual Improvement

Lastly, Clause 4.4 emphasizes that the organization must make continual improvements to its processes to enhance customer satisfaction, performance and overall quality. Making data-driven decision-making based on organizational performance metrics, customer feedback, internal audits, and management reviews.

Some important improvement methods can include:

· Corrective and preventive actions: entails taking the necessary steps to rectify problems and prevent recurrence.

· Six Sigma: entails using statistical methods to minimize defects and variability in processes.

· Lean principles: entails the reduction of waste in processes to improve overall efficiency and quality.

· Continuous improvement initiatives: entails making small but positive changes that can collectively result in significant improvements over time.

In conclusion as 4.4 wraps up clause 4.4 is about understanding the context of the organization is crucial because the QMS is tailored to your specific needs and circumstances of the organization. The QMS will be better aligned with the intent of the ISO 9001:2015 standard and be more effective by considering the relevant internal and external factors and addressing them. In addition, aligning the needs of interested parties will lead to enhanced customer satisfaction and sustained success.

Related Blog Posts:

Context of the Organization

https://www.wilkshireconsulting.com/single-post/iso-9001-context-of-the-organization-overview