ISO 9001 Quality Management System

What is a Quality Management System (QMS)?

A Quality Management System (QMS) consists of policies and procedures that provide a formal framework describing the way an organisation conducts its core business and how it meets the requirements of the ISO 9001 standard.. Think of a QMS as a business manual that outlines how a business carry out its services.  Read more about the ISO 9001 Standard.

A good QMS should be simple and easy to follow. When developed properly, a QMS offers many benefits that will allow you to run your business better:

• Give you better management control
• Implement best business practices
• Increase operational performance
• Facilitate better communication and coordination in the business
• Ensure new staff are inducted swiftly and easily
• Achieve consistent level of service and product delivery
• Increase employee morale and motivation
• Support future business growth.
• Enables measuring performance and effectiveness and
• Continual improvement based on objective measurement.

Certifying your QMS will increase client confidence in your business, services and products and will allow you to gain you more business. ISO  certification is a pre requisite in most tenders

The Quality Management Principles focus on all three pillars of business: Process, People and Product. It emphasizes on improving your operational processes so that each delivery to the customer meets and exceeds his requirement. It requires active involvement of leadership, relationship management at all levels, and employee engagement to make sure people work together to achieve the business objectives. The principles also focus on measurements and fact-based decision making to improve the quality of the product/service that you are offering. Let’s explore these quality management principles, which are the backbone of ISO 9001, in more detail.

1. Customer Focus

“Profit in business comes from repeat customers, customers that boast about your project or service, and that bring friends with them”— Dr W Edwards Deming

This first principle of Quality Management System requires that the organizations focus on the customer and his/her expectations. Meeting customer requirements and ensuring that the customer gets what he wants is something every organization does. But to survive in today’s competitive environment, going a step further, providing value to the customer and ensuring customer delight is what this principle focuses on. An organization shall understand and capture customer’s requirements, both implicit and explicit, and make arrangements in the processes to meet these requirements. Apart from this, gathering customer feedback, understanding their expectation and providing value to customer ensures that the customer comes back to you for more. A happy customer also ensures you get referrals and enhances your market reputation, which goes a long way.

2. Leadership

“It is most important that top management be quality-minded. In the absence of sincere manifestation of interest at the top, little will happen below.” – Joseph M Juran

Leaders are the flag bearers of change required in an organization. Their role in establishing a quality management system and practices in an organization is paramount. This principle emphasizes the role of the leaders in creating a unity of purpose, driving and leading the quality management initiatives and promoting a culture of “Quality First” in the organization. Additionally, leaders need to provide the environment and resources to establish an efficient quality management system in the organization.

3. Engagement of People

“All anyone asks for is a chance to work with pride.” – Dr W Edwards Deming

People are the most important pillar of an organization. An organization which has empowered and engaged people has mastered the perfect recipe for success. This principle focuses on ensuring people are competent on the basis of their skills, experience and knowledge to ensure they are capable of meeting the customer’s requirements. Apart from this, organizations shall also work on creating engaged teams that create and deliver value to the customer.

4. Process Approach

“If you can’t describe what you are doing in a process, you don’t know what you are doing.” – Dr W Edwards Deming

A process is a set of interrelated activities which operates using some inputs and provides the desired output. This Quality Management Principle encourages an organization to bring in a process approach to the work. A process should have inputs, set of interrelated activities, and outputs. Measurements are another important aspect of a process. Adequate measurements and controls should also be put in place to ensure that the processes are achieving the business objectives. The processes should be consistent across and should ensure a predictable result.

5. Improvement

“The starting point for improvement is to recognize the need.” — Masaaki Imai

This principle focuses on imbibing a culture of continual improvement in the organization. The organization should reflect on its own processes, analyse data and bring in changes in the system to improve its results. Continuous improvement brings in new opportunities and strengthens the organization further.

6. Evidenced-based decision making

“Without data, you’re just another person with an opinion” – Dr W Edwards Deming

This principle requires that decisions should be based on evidence or facts and not driven by feelings. Mechanisms should be built into the organization to gather data from various sources, analyse the results of this data and make decisions based on this data.

7. Relationship Management

“The result of a long-term relationship is better and better quality and lower and lower cost.” – Dr W Edwards Deming

Strong relationships with your customers, suppliers, employees and other stakeholders goes a long way as each person work towards the achievement of a common goal. Keeping everyone on the same page, creating an understanding of the common goals and values is of paramount importance for a business to work efficiently and perform better with each day.

Here are the steps you will need to follow to develop a QMS

Before you embark on developing a QMS

Before you embark on developing a Quality Management System, it is essential to ensure that senior management is fully behind the need for a Quality Management System and is committed to supporting the development, implementation, ongoing maintenance of the system.

Step 1 – Appoint a project leader

Appoint a project leader who has an interest in Quality Management and the authority within the business to drive it forward.

Step 2 – Identify major functions within the business

Identify the major functions within the business and list the related processes for each function.

Step 3 – Document business processes

Document each process, identify responsibilities and related records.  This includes:

1. the steps of the process
2. who is responsible for critical steps of each process
3. what records are kept to document progress through the process
4. who completes them and
5. where and for how long are they stored and who has access to them.

Step 4 – Review the system against the standard

Having documented the processes, the procedures need to be reviewed against the standard to ensure all of the requirements have been met.

Step 5 – Management approval

Ensure that management review and approve the whole system. Management approval needs to be documented and recorded for the certification auditor.

Step 6 – Training

Now the system documentation can be formally released to the staff. The staff will need to be trained in using the documentation and made aware of their responsibilities with regards to the Quality Management System.

Step 7 – Conduct an internal audit of the system

Once the system has been successfully implemented, an internal audit of the system has to be conducted. An internal audit is a mandatory requirement of the standard; you must conduct at least one internal audit of the system before you can get certification.

The purpose of the internal audit is to determine whether work processes are operating in accordance with the documented procedures.

Step 8 – Hold a management review meeting

The meeting has to review the results of the internal audit, any changes to the business and any changes to the Quality Management System, customer feedback and other areas as indicated by the standard.

Step 9 – Engage a certification body

Engage a certification body to conduct the certification audit.

1. Keep your system simple, document how you are already operating your business;
2. Ensure strong leadership and management commitment to the process;
3. Assign the right person as a system coordinator; and
4. Involve all staff in the process.

When developing your system, it is important to keep in mind that there is no need to re-invent the way that a business operates just because you are implementing a Quality Management System.