What are the 9 Core Elements of a Quality Management System? [Real Examples] (2022)

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Every life science company knows that quality is of the utmost importance, but defining what quality means and aligning that definition to what regulators require and what customers need requires a systematic approach such as a quality management system.

A QMS is a set of business processes that help an organization stay compliant and deliver products that consistently achieve customer satisfaction. An effective system for managing quality translates an organization's purpose and goals into policies and resources, which helps every member of the organization adopt standard operating procedures (SOPs). There are three important reasons to establish a quality management system: ensure consistent standards, demonstrate transparency for regulators, and define what quality means within an organization.

The use of management frameworks to ensure consistent quality isn’t new, but the purpose of quality systems has evolved slightly in recent years. Life science organizations and others use Quality Management System frameworks to guide process efficiency, optimize continuous improvement efforts, and adopt data for evidence-based decision making. Organizations in highly regulated industries such as pharmaceuticals seek certification with globally recognized standards like ISO 9001 to improve quality through transparency, documentation, and systemic approaches to improvement. The adoption of

quality management software

typically supports modern quality management systems.

Implementing a QMS can support compliance, profitability, and the development of a quality-driven culture. A quality management system for a life sciences company needs certain core elements in order to reap the maximum benefits of that system. Those core elements help to identify quality objectives, ensure all steps of product development are compliant, and monitor opportunities for continuous improvement.

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9 Core Elements of a Quality Management System

What are the 9 Core Elements of a Quality Management System? [Real Examples] (1)

A QMS is a multi-faceted set of processes that touch on every part of development, starting with high-level goals and going all the way through day-to-day operations. It starts by defining quality: a dynamic concept ultimately determined by customer expectations and satisfaction. A QMS provides a framework for organizations to create and maintain customer relationships by understanding the customer’s preferences and needs. Customer satisfaction is achieved with QMS through the alignment of people, processes, and technology throughout the product lifecycle.


One of the world’s most broadly adopted standards for quality management systems, ISO 9001:2015, includes a series of quality principles frequently reflected in other QMS standards, such as customer focus, leadership, engagement of people, evidence-based decision making, and more.

Medical device companies must also consider ISO 13485, a set of standards for companies no matter what part of the development lifecycle they are involved in—from design to supply chain to servicing device functionality. These requirements were developed to “respond to the latest quality management system practices” and puts more emphasis on “risk management and risk-based decision making,” according to ISO.

Organizations must adopt an interdisciplinary series of quality controls to achieve these principles. The nine core elements of a QMS should include quality objectives, a quality manual, organizational responsibilities, data management, and other practices.

1. Quality Policy and Objectives

When you begin creating a quality management system, the first step should be to draft a quality policy and follow it up with your objectives. While these are closely related, they’re different parts of your QMS that work hand-in-hand.

Quality Policy
Before you can do anything meaningful with a new quality management system, you first need to define what quality means within your company by writing a quality policy. A quality policy can also be your company’s mission, values, or statement of principles. Once you’ve crafted this, you’re then able to set expectations across the organization, from executives and upper-level management to supervisors and employees.

When creating the policy, make sure it is both scalable and flexible in case ISO standards change or are updated and you need to make adjustments. A quality management system for startups may be helpful in the beginning, and as you grow, you’ll need one that expands with you.

Quality Objectives
A pharmaceutical startup in the research phase may have identified a customer need for affordable therapeutics to treat a common skin condition. Since the product is being developed, the organization may create a quality policy with a stated goal: "To develop a safe, effective treatment for eczema patients which is available at a lower cost than alternatives."

The creation of quality objectives is a common requirement of QMS standards, including ISO 9001. These objectives are designed to encourage organizations to define strategic goals and a purpose for the QMS. Objectives translate an organization’s vision into practice by creating a link between customer requirements and specific, measurable, and attainable goals. Well-written objectives lend purpose to a quality management system initiative and establish a customer-centric culture in an organization.

For example, quality objectives for the pharmaceutical organization in the research phase could include:

  • To obtain total compliance with staff training requirements and raise average assessment scores from 90% to 95%.
  • To successfully implement a QMS software within three months and eliminate paper and spreadsheet-based record-keeping methods within six months.
  • To achieve a successful initial synthesis of the drug and complete all necessary processes for FDA initial review within 12 months.

Quality objectives should provide a clear vision for every member of the organization to understand the company's purpose and the value of a QMS. The objectives should provide a clear metric for measuring progress against strategic goals, including the timeline for achievement and a measurable parameter of improvement.

(Video) What is Quality Management System (QMS) | Elements of Quality Management System

2. Quality Manual

A quality manual is defined as the first documentation of a QMS. It states the motivation for adopting a QMS framework and the role of quality within the organization. ISO 9000 requirements for a quality manual prescribe that this document should:

  • Describe the scope of the QMS
  • Detail the requirements of the QMS standard or framework
  • List any elements of the QMS which are excluded from the implementation
  • Reference specific quality procedures used within the organization
  • Provide visual documentation of critical processes via flowchart
  • Explain the organization’s quality policies and objectives

3. Organizational Structure and Responsibilities

A QMS should include a clear and updated model of the organization's structure and the responsibilities of all individuals within the organization.

Within the context of a QMS, “the organization” describes both people and structure. For a life sciences company in the early phases of the product development lifecycle, a list of organizational components might look like this:

  • Personnel
  • Equipment
  • Information systems
  • Tools for assessment
  • Facilities
  • Purchasing and inventory
  • Process controls
  • Documents and records

The organizational structure documentation should address the entire product lifecycle using techniques such as flowcharts which depict the “path of workflow.” Defining responsibilities requires an organizational chart with clearly defined roles that can be linked to standard operating procedures (SOPs).

4. Data Management

Data quality and availability are critical to the success of a QMS framework to drive continuous improvement and preventative quality control activities. Organizations with ineffective data management practices can experience inconsistent product quality, operating inefficiencies, compliance risks, poor customer satisfaction, and low profitability.

An organization must be able to provide meaningful data evidence of effective quality controls. Data management systems should start by defining the types of data gathered by the organization and third-party sources. The policy for data management should address data types, sources, collection methods, responsibilities, storage, disposal, and analysis.

The types of data required to demonstrate effective QMS performance can vary significantly between organizations. However, at a minimum, it should include the following sources:

  • Customer satisfaction
  • Supplier performance
  • Product and process monitoring
  • Non-conformances
  • Trends
  • Preventative or corrective action

5. Processes

The entire QMS approach to quality control is to establish standardized, replicable processes. Standards for quality management require organizations to identify and define all organizational processes which use any resource to transform inputs into outputs. Virtually every responsibility in the organization can be tied to a process, including purchasing.

(Video) Quality Management Systems

Initial efforts to define processes should create a high-level picture of how processes serve the organization and intersect with resources such as employees, machines, or technology. After identifying processes, organizations can begin to define standards and success metrics:

  • Identify organizational processes
  • Define process standards
  • Establish methods for measuring success
  • Document a standardized approach to ensuring quality output
  • Drive continual improvement

6. Customer Satisfaction with Product Quality

A core component of QMS is the requirement for organizations to monitor customer satisfaction to determine if quality objectives are achieved. Some standards do not prescribe specific methods for measuring customer satisfaction since the definition of product quality and available data can vary significantly between organizations.

A first step to establishing monitoring systems for customer satisfaction should be the definition of appropriate methods for measuring customer attitudes and complaints. This could include:

  • Satisfaction surveys
  • Complaint procedures
  • Analytical applications to measure satisfaction trends
  • Management review of customer satisfaction

7. Continuous Improvement

What are the 9 Core Elements of a Quality Management System? [Real Examples] (2)

A QMS dictates that continual improvement is an organization-wide responsibility. However, ISO 9001 is clear that leadership should play a core role in implementing a quality-driven culture. Clause 5.1.1 states, "Top management shall demonstrate leadership and commitment with respect to the quality management system by taking accountability for effectiveness."

Designing organizational processes to meet QMS standards for continuous improvement requires clear documentation of controls across the organization. Improvement documentation should encompass, at a minimum:

  • Quality planning procedures
  • Compliance requirements
  • Safety design
  • Risk-based thinking
  • Corrective action (CAPA)
  • Gradual and breakthrough improvement
  • Innovation
  • Assessment and audit of the QMS

8. Quality Instruments

The control and calibration of tools used to measure quality are integral to the success of a QMS. If machines or equipment are used to validate products or processes, this equipment must be carefully controlled and calibrated according to industry standards. Depending on the instrument, this could involve periodic calibrations or calibration before every measurement.

The QMS system design within an organization should dictate a clear policy for the maintenance of quality instruments based on nationally or internationally recognized standards for each piece of quality equipment. This documentation should address:

(Video) What makes a Quality Management System Effective

  • Intervals for instrument calibration
  • Recognized standards for instrument calibration
  • Manufacturer instructions for adjustment
  • Procedures for identifying and documenting calibration
  • Controls against tampering or adjustment post-calibration
  • Methods to protect instruments and equipment from damage

In addition to these requirements, the QMS should address effective documentation of calibration results, including procedures for maintaining complete records of activities and calibration results.

9. Document Control and Management

What are the 9 Core Elements of a Quality Management System? [Real Examples] (3)

The definition of a document in a quality-driven organization is broad, according to ISO. It includes all records of:

  • Communications
  • Evidence
  • QMS conformity
  • Knowledge sharing

A QMS outlines standards for the types of documentation necessary to support quality management at a minimum, which may not be reflective of all the documents needed for accurate quality control. This generally includes quality objectives, a quality manual, procedures, process documentation, and records keeping. Document management systems must contain all evidence necessary to prove QMS performance objectively.

Effective record-keeping is crucial to the success of the QMS, the ability to obtain certification with QMS standards, and regulatory compliance. During QMS design, organizations should create specific definitions of records within the organization and policies for document creation, retention, and editing. While QMS standards do not typically prescribe a method for document management, being able to capture and retain all supporting evidence is generally best accomplished with quality management systems software.

The Role a Quality Management System Plays in a Life Sciences Company

The products created by pharmaceutical and medical device companies must go through a rigorous approval process, and part of that involves measuring their quality. The FDA, EMA, and other international regulatory agencies all have quality guidelines life sciences companies must follow, and many of them align with the guidelines laid out in ISO 9001 and ISO 13485.

So, the QMS your company puts in place helps you follow those quality guidelines, thus making it easier on you when your products go through the regulatory agency’s approval process. Accurate documentation and standardized processes are how you prove that your data is sound and your product works as promised.

Make sure you see success with your QMS.

Quality management systems are not designed to provide a prescriptive checklist for total quality management. Instead, a QMS is intended to serve as a framework that guides the organization in achieving quality objectives, continuous improvement, and customer satisfaction. Use your QMS to keep your life sciences company’s policies and procedures aligned with launching and scaling life-saving products.

(Video) Bringing it all Together: Exploring all the Components of a Quality Management System

The most successful QMS implementations balance simplicity and customization. A QMS needs to be purpose-built to fit an organization's objectives, industry, and compliance requirements to have a meaningful impact on culture. Simultaneously, every customization to the QMS should provide clear value without needless complexity. The right QMS design is a mixture of flexibility and standardization. Organizations need enough standardization to produce consistent results and enough flexibility for continuous improvement to create a quality-driven culture. If you're looking for quality management software to help set the foundation of your QMS, contact us today for a product demo.


What is a quality management system example? ›

An effective quality management system incorporates customers. For example, a company might design a survey system, review process or call center. Businesses can document and record customer data to track and ensure quality.

What are the core elements of quality management? ›

The Core Elements of a Quality Management System
  • Leadership.
  • Customer Focus.
  • Engagement of People.
  • Process Approach.
  • Improvement.
  • Evidence-based Decision Making.
  • Relationship Management.
2 Feb 2021

What are the 7 quality management principles provide some examples of how they are used in 7 different industries? ›

The seven principles of quality management are:
  • Engagement of people.
  • Customer focus.
  • Leadership.
  • Process approach.
  • Improvement.
  • Evidence-based decision making.
  • Relationship management.

What is an example of a quality objective? ›

Examples of quality objectives:

Obtain 100% customer on-time-delivery. Reduce production defects by 10% Average operation efficiency to be >90%

What are some real life examples of total quality management TQM in practice? ›

Examples of TQM. Automobile manufacturer Toyota is one example of TQM. The adoption of TQM and kaizen at Toyota led to higher product and work quality at all levels of the organization. Toyota adopted a related practice called statistical quality control (SQC) in 1949.

What is total quality system give an example? ›

TQM Example: One of the most famous examples of total quality management is Toyota. Toyota implemented Kanban System to make its assembly line more efficient. The company decided to keep just enough inventories to fulfill customer orders as they were generated.

What are the 9 Elements of total quality management? ›

9 Core Elements of a Quality Management System
  • Quality Policy and Objectives. ...
  • Quality Manual. ...
  • Organizational Structure and Responsibilities. ...
  • Data Management. ...
  • Processes. ...
  • Customer Satisfaction with Product Quality. ...
  • Continuous Improvement. ...
  • Quality Instruments.
22 Sept 2021

What are examples of quality standards? ›

Examples of quality management standards
  • the remaining ISO 9000 family, including ISO 9000 and ISO 9004.
  • the ISO 14000 family for environmental management systems.
  • ISO 13485 for medical devices.
  • ISO 19011 for auditing management systems.
  • ISO/TS 16949 for automotive-related products.

What are the elements of a system of quality control identify and explain each? ›

The quality control policies and procedures applicable to a firm's accounting and auditing practice should encompass the following elements: Independence, Integrity, and Objectivity. Personnel Management. Acceptance and Continuance of Clients and Engagements.

What are 3 examples of quality control? ›

Examples of quality control activities include inspection, deliverable peer reviews and the software testing process.

What are the 10 elements of total quality management? ›

10 Elements of Total Quality Management – Explained!
  • (i) Management's commitment to quality: ...
  • (ii) Customer satisfaction: ...
  • (iii) Preventing rather than detecting defects: ...
  • (iv) Measurement of Quality: ...
  • (v) Continuous improvement: ...
  • (vi) Corrective action for root cause: ...
  • (vii) Training: ...
  • (viii) Recognition of high quality:

What are the 10 steps to quality? ›

Ten Steps to Quality
  1. Establish awareness for the need to improve and the opportunities for improvement.
  2. Set goals for improvement.
  3. Organize to meet the goals that have been set.
  4. Provide training.
  5. Implement projects aimed at solving problems.
  6. Report progress.
  7. Give recognition.
  8. Communicate results.
12 Jul 2022

Which is an example of a process objective? ›

Process objectives, by their nature, are usually short-term. Example of a SMART process objective: By (month/year), (X%) of providers who reported incorrect gonorrhea treatment in County Z will be contacted within 1 month. end result of a program.

What is an example of objective in a sentence? ›

1, Our objective must be to secure a peace settlement. 2, It is impossible to be completely objective. 3, His objective was to finish by October. 4, Winning is not the prime objective in this sport.

How can you apply TQM in your daily life explain? ›

Highlight what your habits were BEFORE and what CHANGES you will do to live a meaningful life after studying TQM.
  2. Sort — Eliminate whatever is not needed.
  3. Straighten — Organize whatever remains.
  4. Shine — Clean the work area.
  5. Standardize — Schedule regular cleaning and maintenance.
13 May 2017

What is total quality management in simple words? ›

A core definition of total quality management (TQM) describes a management approach to long-term success through customer satisfaction. In a TQM effort, all members of an organization participate in improving processes, products, services, and the culture in which they work.

What do you understand by total quality management explain with examples it is application in library and information services? ›

TQM is basically for the customer focused organisations and for those involving all employees for producing quality products and rendering quality services. TQM is a structured system of continuous improvement, employing participative management technique and centered around the needs of the customers.

How do you explain quality system? ›

A quality system is a structure for managing the quality of the output of a manufacturer. We have a very stringent quality system for inspecting items and delivering the best products. A good quality system prevents errors from occurring rather than correcting them after they have happened.

What are the different types of quality management systems? ›

The ISO family of quality standards are the most common types of quality management system used in many industries.
Types of Quality Management System Standards
  • All industries: ISO 9001.
  • Automotive: IATF 16949.
  • Medical device: ISO 13485.
  • Food: ISO 22000.
  • Services: ISO 2000000.
  • IT: ISO 27001.
  • Aerospace: AS 9100D.

What are the elements of a successful total quality management program? ›

To successfully implemented TQM organization should focus on 6 key elements: Confidence, Training, Teamwork, Leadership, Recognition and Communication (Bhat et. al., 2009). It is a result of integrity and ethics of the organization without trust cannot be built within the work of TQM.

What is total quality management and its elements and benefits? ›

Total quality management (TQM) is the continual process of detecting and reducing or eliminating errors in manufacturing, streamlining supply chain management, improving the customer experience, and ensuring that employees are up to speed with training.

How many elements are there in total quality management? ›

The eight principles of TQM are customer focus, employee involvement, integrated system, process-centric approach, systematic flow, continual efforts, fact-based decision-making, and relationship management.

What are 5 examples of standards? ›

Below are a few examples of standards you can set.
  • Wealth. Save up for a child's college fund within 6 years. ...
  • Health. Limit your cheat meals to once a week. ...
  • Relationship. Spend time with people you love (at least an hour a day). ...
  • Learning/Growth. Read at least 30 books every year. ...
  • Social. Maintain a zero drama policy. ...
  • Play.

What is an example of a good quality product? ›

Finishing and Build Quality

A good product would always have proper finishing without rough edges or poor visual quality. As an example, Phones of good companies are often sleek in design and have good build quality and materials used as compared to low quality phones.

What is an example of quality of design? ›

Quality design means that it should have simple, easily understood messaging. For example, if there are multiple elements to the design, it makes use of visual hierarchy to highlight the important parts of the message.

What is the purpose elements design of quality management system? ›

A quality management system (QMS) can be defined as a collection of business processes that focus on meeting customer requirements on a consistent basis. Its purpose is to ensure that, every time a process is performed, the same information, methods, skills and controls are used and applied in a consistent manner.

What are the elements of a quality management system list any five? ›

5 Essential Elements of a Quality Management Software
  • Quality Objectives. Start by creating quality objectives. ...
  • Organizational Structure and Responsibilities. A results-driven eQMS will have a clear organizational structure with well-organized roles and responsibilities. ...
  • Processes. ...
  • Continuous Improvement. ...
  • Document Control.
22 Dec 2020

What is the importance of quality management system? ›

A QMS can provide a systematic approach to lean process improvement. It can help identify quality issues, eliminate unnecessary activities, and close gaps in performance. The purpose of a Quality Management System is to provide a formal system of tools and processes and allow certification via an independent agency.

What are the four 4 types of quality management systems? ›

2.3. 5 Development and Certification of the QMS. Four types of quality processes are prominent in many industries: ISO 9001, AS9100, Six Sigma, and CMMI. Choosing one depends on its fit to the industry and the understanding of the particular QMS by both employees and customers.

What is your quality management system? ›

A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.

What are 3 examples of quality control? ›

Examples of quality control activities include inspection, deliverable peer reviews and the software testing process.

What is quality management system explain? ›

A quality management system (QMS) is a documentation of a business' processes, functions and policies necessary for the continuous improvement of quality aimed to ensure customer expectations and requirements are met or exceeded.

What are the 9 Elements of total quality management? ›

9 Core Elements of a Quality Management System
  • Quality Policy and Objectives. ...
  • Quality Manual. ...
  • Organizational Structure and Responsibilities. ...
  • Data Management. ...
  • Processes. ...
  • Customer Satisfaction with Product Quality. ...
  • Continuous Improvement. ...
  • Quality Instruments.
22 Sept 2021

What are examples of quality standards? ›

Examples of quality management standards
  • the remaining ISO 9000 family, including ISO 9000 and ISO 9004.
  • the ISO 14000 family for environmental management systems.
  • ISO 13485 for medical devices.
  • ISO 19011 for auditing management systems.
  • ISO/TS 16949 for automotive-related products.

What are the 8 principles of QMS? ›

The 8 principles of QMS
  • Principle 1: customer focus. ...
  • Principle 2: leadership. ...
  • Principle 3: people involvement. ...
  • Principle 4: process approach. ...
  • Principle 5: systematic approach to management. ...
  • Principle 6: continual improvement. ...
  • Principle 7: factual approach to decision making. ...
  • Principle 8: mutually beneficial supplier relations.
13 Oct 2018

What is the importance of Quality Management System? ›

Why is a quality management system important? A QMS enables a business to protect its reputation, accelerate change and meet customer needs. A QMS also provides protection in the face of litigation.

What is the importance of quality management? ›

Benefits of Quality Management

It helps an organization achieve greater consistency in tasks and activities that are involved in the production of products and services. It increases efficiency in processes, reduces wastage, and improves the use of time and other resources. It helps improve customer satisfaction.

What is ISO in simple words? ›

ISO (International Organization for Standardization) is a worldwide federation of national standards bodies. ISO is a nongovernmental organization that comprises standards bodies from more than 160 countries, with one standards body representing each member country.

What is quality control give one real life example? ›

The quality control used in a business is highly dependent on the product or industry. For example, in food and drug manufacturing, quality control includes ensuring the product does not make a consumer sick, so the company performs chemical and microbiological testing of samples from the production line.

Which is the example of quality analysis? ›

Typical examples of such quality analysis techniques are used in performance evaluation, reliability estimation, and security analysis. Such methods are good at exploring the unknown quality problems in a design. However, each of them also aims at a single quality attribute.

What is an example of a control process? ›

Process control is the ability to monitor and adjust a process to give a desired output. It is used in industry to maintain quality and improve performance. An example of a simple process that is controlled is keeping the temperature of a room at a certain temperature using a heater and a thermostat.

How can you apply Total Quality Management in your life? ›

Applying the Principles of Total Quality Management to Your Real...
  1. Initial Standards. You can't meet or exceed a standard you haven't set, so determining your standards is the first step. ...
  2. Meeting the Standard. Given that you want to lose weight, we already know you aren't meeting the standard. ...
  3. PLAN. ...
  4. DO. ...
  5. STUDY. ...
  6. ACT.
21 Apr 2017

What are the benefits of QMS to our industry today? ›

An effective QMS can have a transformative impact on company culture by creating a formal system of process, procedure, responsibilities, and software. Regulatory risk, compliance, and certification are critically important objectives for implementing a QMS.


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