Knowing These Core Elements of a Quality Management System Can Get You Promoted

What Is A Quality Management System (QMS)?

That is a simple question and there is actually a simple answer. It is exactly what it sounds like. It is a formalized system that lets you define what quality means to your business. It is a simple way to make sure that your company is performing well and serving your customers’ needs in a properly documented and measurable procedure.

A Quality Management System (QMS) is designed to document procedures, processes, and responsibilities for achieving an organization’s quality objectives and policies. It is essentially a set of business processes implemented to ensure an organization delivers products that consistently garner customer satisfaction. This article will focus mainly on ISO 9001. For those in the medical device sector, ISO 13485 is the quality management system to use. There is value in understanding how the two connect and I will provide you with that later in the article. The bottom line is that both standards have grown up well together.

The Core Elements of a Quality Management System

Quality is “the degree to which a product or service meets or exceeds customer’s expectations.” As the definition is customer-driven, it tends to vary from industry to industry. The checks and balances that define quality in a small organization cannot be the same as those in larger organizations. There are also geographic or local regulations that can impact your QMS. Depending on your product, suppliers can quickly negatively affect your product’s quality, and the QMS system needs to be more robust.

Related: What is The Difference Between Quality Control and Quality Assurance?

Quality is dynamic; it heavily depends on the customer’s expectations and their level of satisfaction. QMS provides a standardized framework that organizations can use to create and maintain lasting customer relations. Satisfaction is achieved when there is an alignment of processes, people, and technology within the product life cycle.

The internationally accepted standard of QMS, ISO 9001:2015, has a series of quality principles that appear in other QMS standards like:

• Leadership
• Customer Focus
• Engagement of People
• Process Approach
• Improvement
• Evidence-based Decision Making
• Relationship Management

Consult with an expert to learn strategies for identifying and solving problems to fast-track your product approval and launch.

But Wait, I Am Working In The Medical Device Industry

What if you are involved with manufacturing medical devices? Then, ISO 13485 is the quality system for the medical device sector. It essentially covers ISO 9001 with some additional requirements. Manufacturers of medical devices sometimes fail to realize that comparing ISO 9001 and ISO 13485 is a valuable exercise. A useful exercise is to read through Annex B (informative) of ISO 13485:2016 on page 30. There are two tables that show the connections and similarities correspondence between ISO 13485:2016 and ISO 9001:2015. By understanding the differences between these two quality standards, you learn where device manufacturers need to raise the bar on quality.

The Birth of ISO 9001 in 1987 and ISO 13485 in 1996

These two quality standards grew up together and they stayed close friends even to this day. ISO 9001 was first published in 1987 and then revised to a second edition in 1994. The first edition of ISO 13485 followed in 1996. Then, in 2000, the third edition of ISO 9001 was published followed closely by the 2003 revision of ISO 13485 which further aligned the two quality standards.

In 2008, ISO 9001 was again revised and brought in many of the newer requirements of ISO 13485:2003. Now, both ISO 9001 and ISO 13485 have been revised, with the publication of the fifth edition of ISO 9001 in September 2015 and the publication of the third edition of ISO 13485 in March 2016. These two standards have been a model of sibling quality documents that remain closely aligned. Both ISO 9001 and ISO 13485 use Deming cycles (Plan-Do-Check-Act or PDCA). Another version of the PDCA cycle is the OPDCA. The “O” stands for observation or as some say, “Observe the current condition.”

If you are new to quality management, it is a wise choice to learn about ISO 9001. It forms a solid base on which to build your career. The general nature of and the industries that use ISO 9001:2015 are driven by customer focus and making the correct risk-based decisions to minimize the risk of customer dissatisfaction. Those are core values that begin your profession.

Quality Manual

The core elements of a QMS should include a quality manual, data management, quality objectives, organizational responsibilities, and other relevant practices. The quality manual is defined as the first QMS documentation. It states the motivation behind adopting a specific QMS framework and the role that quality plays within an organization. The ISO 9000 is a family of quality management systems standards that helps organizations meet customer needs within specific regulatory requirements. The standard states the six conditions for an adequate quality manual. Such a document should (i) Detail the requirements of the QMS framework or standard, (ii) Reference specific quality procedures enforced within the organization, (iii) Explain the organization’s quality objectives and policies, (iv) Describe the QMS scope, (v) List any elements of the QMS excluded from the implementation, and (vi) Provide visual documentation of critical processes using a flowchart.

Related: Document Control Systems: What You Need to Know

Data Management

The modern approach to quality management is data-driven. As a result, the quality of data and its availability determine a QMS framework’s success. If an organization has less than excellent data management practices, its product quality will suffer from inconsistencies, compliance risk, inefficiencies in operations, low profits, and poor customer satisfaction.

Data management systems need to support continuous efforts to foster improvement and corrections. Data management policies need to define collection methods, storage, analysis, disposal, data types, and sources. The data types and sources to be termed as adequate should include: (i) Supplier Performance, (ii) Customer Satisfaction, (iii) Trends, (iv) Product and Process Monitoring, (v) Preventive or Corrective Action, (vi) Non-Conformances.

Quality Objectives

These are a requirement in most QMS standards. They are designed to ensure organizations define the strategic purposes and goals of the QMS. The objectives turn vision into practice as they link customer requirements to attainable, specific, and measurable goals within an organization.

They should also offer a clear vision for company members to understand the value and purpose of the QMS and a clear metric for measuring strategic goals and overall improvement.

Organizational Structure and Responsibilities

An exact and updated model of the organization’s structure needs to be part of a QMS. This can be displayed in a flowchart.

A QMS should include a clear and updated model of an organization’s structure and responsibilities of all individuals. 

Process

A QMS is usually a process-driven approach to quality assurance and control. The standards used to guide quality management can only be designed if an organization identifies and defines the processes that help convert inputs into outputs.

Once the processes have been identified, the organization can then define tangible standards for measuring success metrics.

Discover how our quality management service can help you get your products approved efficiently. Predictability in approval is a competitive advantage.

Customer Satisfaction with Product or Service

The main reason why an organization produces goods or offers services is to meet the needs of customers. If they fail, then they are of little use to the organization. There needs to be a proper monitoring system in place for tracking and assess customer satisfaction. A QMS is one such system, and it offers insightful information that can be used to drive production.

Quality Instruments

Every organization needs to use tools that can measure quality data and give quantitative results. These results are essential to the success of a QMS.

While implementing a QMS, an organization should heed the little details like gaps in the calibration of instruments, calibration procedures, adjustment, and post-calibration adjustment. This will help realize its quality objectives in absolute terms.

Continuous Improvement

The market will always be competitive, and only the best survives. As a result, all organizations need to evolve and change to maintain viability in the market arena. Continuous adaptation and improvement are critical to the success of a business. An excellent way to ensure this is by using compliance requirements, risk-based thinking, quality planning procedures, innovation, safety design, and assessment of the QMS.

Related: Potential Benefit versus Potential Risk (Residual Risk)

Establishing and Implementing a QMS

The design of any QMS should be highly influenced by the organization’s needs, products, objectives, and services it provides. The structure should be based on the PDCA cycle to allow for continual improvement of the QMS.

Benefits of Quality Management Systems

If a quality management system is appropriately implemented in an organization, it will affect performance at each level. The benefits of a fully documented QMS include (i) Meeting customer requirements. This translates to more customers, increased sales, and repeat business, and (ii) Meeting the organization’s needs. This helps ensure compliance with regulatory standards and providing services and products in a resource and cost-effective manner.

Take Away

For a QMS to be successful, it needs to be purpose-driven to fit an organization’s objectives and compliance requirements. Moreover, it should balance standardization and flexibility, giving an organization the ability to consistently improve and drive quality products.

I have a provocative, but very simple question. How do you know your QMS is working? Leave your comments below.

Contact us today to learn how to get your products approved with the proper quality management system in place.

David R Rutledge, Pharm.D., FCCP, FAHA

President & CEO

Silicon Valley, California,

+1 (630) 846-0350 cell

[email protected]