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Step-by-Step Process of Setting Up a Successful Quality Management System (QMS)

August 24, 2021

 by Cindy Jin

A factory worker in uniform pointing upwards while another factory worker looks in that direction.

Quality is one of the key outputs of successful manufacturing (the others being cost, delivery, and safety).To ensure high quality throughout the manufacturing process, all factories should have a robust Quality Management System (QMS). A good QMS not only maintains a high & consistent quality of manufactured goods; it is also a useful tool to ensure the Key Performance Indicators (KPIs) and the profit are up to expectations.

Why is a factory profitable? Because it produces high-quality products at a low cost and delivers them to customers on time. While it is called a "Quality Management System", a good QMS is more of an overall factory management system.

Why Implement a QMS?

Many manufacturing plants are setting up a QMS in order to receive an ISO 9001 certification, to satisfy the requirements of customers, or to produce better products with lower costs.

These are good reasons to start; however a QMS is far too important to just be another checked box to receive business from a customer. In the long run, as a factory manager, you want a good system that keeps driving process improvement and better performance.

Step-by-Step Process To Setting Up a QMS Successfully

Step 1: Define Your Quality Policy

The Quality Policy states your company's mission (what your customer wants from you) in relation to quality. In essence, It is your mission statement. To set up your quality management system and write your quality policy, think about your commitment toward the customer:

  • Quality – What do you need to do to consistently satisfy your customer?
  • Cost - How low can you commit to your customer?
  • Delivery - What kind of performance can satisfy your customer?
  • Continuous Improvement – What do you need to do better to satisfy your customer more and more into the future?

Step 2: Define Your Quality Goals & Objectives

The quality goals or objectives have to be consistent with your quality policy, which should be communicated within the organization. Each employee must understand their role and the impact on quality.  The quality goals & objectives should be SMART:

  • S: Specific – Relate to a focused process and/or outcome.
  • M: Measurable – Add value in a way that can be collected and measured over time.
  • A: Attainable – your factory should realistically be able to achieve this goal. For example, full Six Sigma may be outside the reach of your current operations. 
  • R: Relevant – Connected to each job in the manufacturing process.
  • T: Timing – Specify when the results need to be achieved.

Step 3: Define the Core Structure To Implement the QMS

Form a dedicated team or a committee to implement all necessary QMS processes, from the very beginning to the end. This team should also actively be involved in the continuous improvement of the QMS.

The members could be composed of employees from different functions rather than just the quality department. It is extremely beneficial to have representatives from each function in the team to create greater buy-in and understand quality from a holistic perspective.

Step 4: Define and Map Your Key Production Process

Using a Process Map to define and describe all the production processes and their sequence, and at the same time to designate what is CTQ (Critical to Quality). That is a MUST when defining the process map. Do not forget the mandatory processes required by ISO 9001, ISO 13485, IATF 16949, or any other standard you want to comply with.

Step 5: Develop the Required Documents & Records for Each Process

Set up the necessary documents and records of each process, following the documentation rules specified by ISO 9001, i.e. quality manual, SOPs, WIs, Checklists, Records, etc. In addition, the rules and procedures to control the documents should be clearly defined.

Step 6: Define & Implement the Necessary Training

Analyze the training needs for the people involved in all the above processes and documents, define the trainee group(s), and implement the training -- preferably inside the organization, with immediate application on their daily work.

Step 7: Implement the QMS

Implement the QMS as described above, and collect all the feedback following the implementation. This feedback should include both positive and negative items. Iterate on the system.

Make it fit your company's processes and context. A mistake many companies make is copying another company's systems, and that usually doesn't work well.

Step 8: Identify & Act on Improvement Opportunities

The whole goal is to deliver continuous improvements, and this happens by:

  • Prioritizing improvement opportunities.
  • Carefully choosing opportunities that make a significant difference.
  • Reinforcing your commitment to quality to achieve better results.

The Bottom Line

Continuous improvement is the KEY to maintaining a good QMS in your factory. A QMS is never fully completed; it must always be improved and refined as time goes on. 


To learn more about how you can achieve quality improvements while cutting costs to maximize efficiency at your factory, download out our complimentary eBook below.

How To Cut Your Factory Costs Through Quality Improvement Activities eBook Download

Topics: Quality, Project Management Systems, Process Improvement

Cindy Jin

Cindy Jin

As Managing Director at CMC, Cindy has strong experience in lean manufacturing, cost control, implementation of management systems, and automation projects. With 20 years experience in these fields, Cindy has strong expertise in team setup, culture setup, cost control etc. Previous General Manager of a large factory. Expert in ISO9001, TL9000, ISO14001 and ISO/TS16949 core tools (APQP, PPAP, MSA, SPC, FMEA).

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