QMS: Quality Management System (SMQ: Système de Management de la Qualité in French) is a set of policies, processes, and procedures designed to help an organization meet the requirements of its stakeholders.
This system is based on the PDCA cycle (Plan-Do-Check-Act), a four-step management method used in companies for the control and continuous improvement of processes and products.
What are the benefits of a QMS?
Implementing a quality management system affects all aspects of an organization’s performance. The benefits of a documented quality management system include:
- meeting customer requirements, which helps inspire confidence in the organization, thereby increasing the number of customers, sales, and repeat business
- Meeting organizational requirements, ensuring compliance with applicable regulations and enabling products and services to be delivered in the most cost- and resource-efficient manner, creating room for expansion, growth, and profit.
These advantages offer other benefits, including:
- Defining, improving, and controlling processes
- Reducing waste
- Preventing errors
- Lowering costs
- Facilitating and identifying training opportunities
- Engaging staff
- Setting direction for the entire organization
- Communicating a commitment to producing consistent results
Quality management
In the medical device sector, regulatory authorities require the implementation of a QMS in most countries. ISO 13485 enables organizations to consistently provide safe and effective medical devices and to meet customer and regulatory requirements. It is also flexible enough to meet the specific needs of different types of organizations in the medical device industry.
Regulatory requirements and ISO
Regulations vary considerably from one country to another. For this reason, ISO 13485 does not establish detailed requirements but rather invites organizations in the medical device sector to determine the regulatory requirements that are relevant to their specific situation and to integrate them into their QMS. In addition, the standard is compatible with the requirements of other management systems used by an organization.
Ensuring regulatory compliance
The quality management system is essential to ensure that all products manufactured and supplied meet regulatory standards. By systematically checking all product parameters, the QMS confirms that each item meets quality specifications and regulatory compliance. This comprehensive control is facilitated by QMS software, which automates tracking and ensures that every step, from raw material selection to the final product, meets established quality criteria.
What are the different QMS frameworks?
There are several frameworks to guide the development of a QMS, including:
- ISO 9001
- the ISO 9000 series
- the ISO 14000 series (environmental management systems)
- ISO 13485 (quality management systems for medical devices)
- ISO 19011 (management system auditing)
- IATF 16949 (quality management systems for automotive-related products)
- AS 9100 (quality management systems for aviation, space, and defense).
Several sectors have also developed standards, based on ISO 9001, which provide specific guidance on additional expectations associated with their activities.
ISO 9001 is the most widely recognized and applied quality management system standard in the world. ISO 9001 specifies the requirements for a QMS that organizations can use to develop their own programs.
The standard is based on seven quality management principles. Quality management principles are guiding beliefs that, when used for organizational decision-making, ensure long-term success from the perspective of customers, employees, and other stakeholders. Quality management principles demonstrate the depth of an organization’s commitment to quality. Well-formulated principles should be timeless and not dependent on temporary circumstances.
The principles of ISO 9001:2015 are as follows:
- Customer focus
- Leadership
- Commitment of people
- Process approach
- Continuous improvement
- Evidence-based decision making
- Relationship management
How to establish and implement a QMS?
Each organization has its own culture, which influences the most effective and efficient QMS methods. Instead of developing a QMS by meeting every expectation described in a given model, organizations should highlight the approaches currently used to manage quality and meet customer expectations.
A basic model for gathering customer expectations can be structured according to the following four steps:
- plan your customer data system,
- collect customer data,
- understand the data
- deploy (use) the data.
Next, these approaches should be compared to the appropriate QMS framework or model. For each gap identified, the organization must determine whether it is in its best interest to seize the opportunity and must clearly understand the potential benefit before implementing changes.
The design of the QMS should be influenced by the organization’s objectives, needs, products, and services. This structure is largely based on the plan-do-check-act cycle and allows for continuous improvement of the product and the QMS.
The fundamental steps in implementing a QMS are as follows:
- Design
- Build
- Deploy
- Control
- Measure
- Review
- Improve
- Design and implementation
The design and development stages enable the structure, processes, and implementation plans for the QMS to be developed. Senior management must oversee these stages to ensure that the needs of the organization and its customers are a driving force in the development of the system.
Example of QMS application in pharmaceutical development
The quality management system applies to all phases of pharmaceutical development:
- commercial manufacturing
- Control of materials, utilities, and equipment
- Process development and plant scale-up
- Development of analytical methods
- Production of active pharmaceutical ingredients (APIs)
- Isolation and detection of impurities
- Pharmaceutical formulation
- Biotechnology and biologics development
- Quality control and assurance, and distribution
This application helps organizations effectively manage workflows, from planning and preparation to tracking and updates throughout the year.
About ISO
ISO (International Organization for Standardization) is an independent, non-governmental international organization with 162* members, which are the national standards bodies of 162 countries.
Through its members, the Organization brings together experts who pool their knowledge to develop voluntary, consensus-based International Standards that are relevant to the market, support innovation, and provide solutions to global challenges. ISO has published more than 21,000* International Standards and related publications, covering almost all sectors of industry – from technology to food safety, and from agriculture to health.
FAQ: Frequently Asked Questions
What is a QMS?
A Quality Management System (QMS) is a structured set of processes, procedures, and resources implemented by an organization to plan, control, and continuously improve the quality of its products or services. It defines responsibilities, working methods, and performance indicators to meet customer requirements and the company’s strategic objectives.
Why implement a QMS?
Implementing a QMS improves customer satisfaction by ensuring consistent product or service quality. It optimizes operational efficiency by reducing non-compliance and waste, strengthens the company’s credibility with partners and customers, and facilitates regulatory compliance. A QMS also promotes continuous improvement and employee engagement in a shared quality approach.
How to obtain ISO 9001 certification?
To obtain ISO 9001 certification, the company must first implement a QMS that complies with the requirements of the standard. It then conducts an internal audit to verify the system’s compliance. Once ready, it calls on an accredited certification body to perform a two-stage certification audit: a document audit followed by an implementation audit. If the audit is successful, the ISO 9001 certificate is issued for a period of three years, with annual surveillance audits.
How much does an SMQ cost?
The cost of a QMS varies depending on the size of the company, its sector of activity, and the complexity of its processes. It includes staff training costs (€1,000 to €5,000), support from an external consultant (€5,000 to €20,000), certification costs (€3,000 to €10,000 for the initial audit), and annual surveillance audits (€1,500 to €3,000). The internal resources mobilized also represent a significant investment in time.
What is the difference between SMQ and ISO 9001?
A QMS is a comprehensive quality management system specific to each organization, while ISO 9001 is an international standard that defines the requirements that a QMS must meet in order to be certified. In other words, any company can have a QMS without being ISO 9001 certified, but to obtain this certification, its QMS must comply with all the criteria of the ISO 9001 standard.
Sources et pistes pour aller plus loin
- See job profile: Quality & Regulatory Affairs Manager in the medical device & equipment sector
- See the standard: ISO 13485 – Medical devices
- ISO website section dedicated to Health: www.iso.org/iso/fr/health
- ISO website section dedicated to Management system standards: www.iso.org/iso/fr/management-standards
