Quality Management Systems
Implementing a quality management system allows you to demonstrate to customers and other stakeholders your ability to deliver products and services that meet applicable requirements
Implementation
The main objective is to identify, gather, and control all organizational operations to facilitate data analysis, decision-making, identification and fulfillment of established requirements, risk identification, mitigation, and management. This ensures the ability to provide products and services that meet customer requirements, applicable legal and regulatory requirements, while continually improving effectiveness.
The management system can be implemented by leveraging the company’s document structure, utilizing the existing ERP system (if customizable), or through a specific software application for management system implementation.
The key to successful implementation is tailoring the standard to fit the company.
A common mistake leading many companies to struggle with their management system is attempting to adapt the company to the standard, resulting in constant friction between the company’s daily work and the implemented management system.
Carjes Soluciones S.L. has developed a methodology for implementing management systems. Initially, the company’s processes are studied to identify changes and improvement opportunities, demonstrating compliance with the standards or reference standards for which certification is sought.
Synchronizing the management system with the company’s strategy is essential so that daily operations are focused on identifying improvement points and achieving objectives defined by management.
Audits
Audits are one of the most powerful improvement tools for a Management System.
Organizational management systems must be verified at planned and periodic intervals to ensure effectiveness and the achievement of expected results. Auditing is one of the most powerful tools available to organizations for enhancing management practices.
The success of an audit depends on the individuals conducting it. Auditors contribute to resource optimization and cost reduction, maximizing the benefits of the audit process and making it a true tool for improvement.
ISO 9001. Quality Management System.
ISO 9001. Quality Management System
The International Standard ISO 9001 establishes the necessary requirements for an organization’s management systems to improve quality and productivity based on a process approach.
Feedback from customers and other relevant internal and external stakeholders is used to assess and validate whether the objectives set by management have been achieved.
ISO 9001 has evolved to adapt its standards for applicability across all sectors, making it applicable to all types of companies and activities wishing to control and improve the quality of their products and/or services.
ISO 13485. Quality Management System. Medical Devices
The international standard ISO 13485:2016 defines criteria for a quality management system for the manufacturing of medical devices, ensuring all medical devices comply with appropriate regulatory requirements and meet customer needs.
ISO 13485 is focused on regulatory compliance, including specific requirements for organizations involved in the lifecycle of medical devices from design to market release, making it a prescriptive standard that demands thorough documentation of a Quality Management System (QMS).
The primary objective of ISO 13485 is to ensure consistency in the design, development, production, storage, distribution, installation, maintenance, and disposal of medical devices, serving as the reference standard for stakeholders involved in these activities.
MDSAP. Medical Device Single Audit Program
The Medical Device Single Audit Program (MDSAP) is an innovative collaborative approach aimed at simplifying and enhancing the efficiency of audits in the medical device sector. Through this program, companies can overcome compliance challenges arising from operating in multiple jurisdictions. Instead of undergoing multiple separate audits, MDSAP enables companies to undergo a single audit that meets the requirements of various regulatory agencies. Currently, it is a joint program among Australia, Brazil, Canada, the United States, and Japan.
This harmonized approach not only reduces administrative burden and costs associated with multiple audits but also promotes greater consistency and quality in assessing medical device conformity. By streamlining the process, MDSAP facilitates market entry into these five countries and many others affiliated with the program as associate members (Argentina, Korea, Israel, Mexico, Singapore, Taiwan).
Since its inception in 2017, certification of medical device manufacturers has grown significantly, with 229 certificates issued. Six years later, in the third quarter of 2023, the number of registered manufacturers has increased thirtyfold, reaching 6,891. The evolution is clear; it is now a recommended certification to compete in the international market. If this trend continues, it will soon become a standard element of a manufacturer’s regulatory strategy, driven by market demand.
At Carjes Soluciones S.L., we guide manufacturers through the MDSAP certification process with a proven formula that analyzes the organization’s specific situation, plans changes, and implements those changes in the company’s Quality Management System to successfully navigate the external MDSAP audit process. Additionally, we support manufacturers during the external audit to mitigate findings’ impact, help implement corrective/preventive actions resulting from the audit, and resolve any issues raised by the evaluating agent of the chosen Competent Authority.
In essence, from project inception to obtaining the MDSAP certificate, the organization will have an experienced partner generating the best strategy at each step to achieve the expected results.
ISO 14001
Implementing an Environmental Management System (EMS) provides control over an organization’s activities, products, or services and their interaction with the environment. This, in turn, can enhance the long-term viability of the organization and, where appropriate, increase consideration of its heritage value.
In a global market where all sectors must compete in one way or another, demonstrating ethical environmental leadership through “good environmental management” can be the deciding factor in being selected to supply the goods or services an organization provides.
A system that verifies compliance with legislation mitigates the risk of environmental liability. Although this does not directly save an organization money, the outcome of unregulated activities that negatively affect the environment will result in increasingly significant fines.
Most organizations or companies consume resources in one form or another. Although the Standard does not require an organization to measure anything specific, examining the resources consumed, such as energy, along with the waste produced, can lead to changes in usage and fundamental savings.
ISO 22716. Cosmetics. Good Manufacturing Practices (GMP)
ISO 22716 is the international standard defining Good Manufacturing Practices (GMP) within the cosmetics industry. Good Manufacturing Practices (GMP) are a set of instructions aimed at controlling human, technical, and management factors that can influence the quality and safety of manufactured products, establishing a link between cosmetic product safety and the company’s improvement tools that allow meeting consumer needs, legal, and regulatory requirements regarding safety in cosmetic products.
It is a standard that applies to all companies involved in any phase of the manufacturing and distribution process of a cosmetic product and can be integrated with other ISO standards, such as the ISO 9001 Quality Management System or the ISO 14001 Environmental Management System.
ISO 15189. Clinical Laboratories. Requirements for Quality and Competence.
ISO 15189 sets forth the requirements for technical competence and quality management in clinical laboratories. This certification is not only crucial for clinical laboratories conducting diagnostic tests directly for patients but also essential for manufacturer laboratories involved in analyzing biological samples from in vitro diagnostic products.
At Carjes Soluciones S.L., we understand the importance of meeting the most rigorous standards in the healthcare sector. Therefore, we offer comprehensive services for implementing quality management systems in accordance with ISO 15189, designed to assist clinical laboratories in achieving and maintaining the highest levels of quality and accuracy in their operations.
Our approach focuses on understanding the specific needs of each laboratory and developing customized solutions tailored to their processes and resources. We work closely with our clients to identify areas for improvement and design effective strategies for implementing ISO 15189 requirements.
From initial planning to the final audit, our team of experts is committed to providing the necessary support at every stage of the process. We ensure that your laboratory is fully prepared to meet the challenges of ISO 15189 certification by providing guidance and assistance in implementing effective and efficient quality management practices.
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