We help you obtain other accreditations and certifications
Take another step forward on the path to your organization’s quality
What can we do for you?
We offer you our auditing and consulting services with a single objective: to help you obtain the certifications and accreditations you need. You will have access to our team of consultants, professionals with over 25 years of experience in implementing systems in different types of laboratories.
We provide different solutions depending on your needs and type of organization, always with a strong consulting component and the goal of helping you improve.
We put all our experience at your disposal
Our objective is to improve your competitiveness and open the door to new markets while helping you take another step in quality management thanks to the following standards:
Good Laboratory Practices (GLP) are a type of certification aimed at ensuring a quality management system in all facilities where preclinical testing is carried out. Obtaining it is mandatory to secure marketing authorization for any new product, as it determines the potential effects that the product may have on people, animals, and the environment.
The principles of GLP certification apply to non-clinical safety testing of pharmaceutical products, cosmetics, veterinary drugs, industrial chemicals, pesticides, and additives in both food and feed.
Currently, there are two bodies responsible for this type of certification: AEMPS and ENAC.
- The Spanish Agency of Medicines and Medical Devices (AEMPS) oversees laboratories conducting non-clinical testing on substances and chemical products, whether for human or veterinary medicines, cosmetics, or medical devices.
- The National Accreditation Body (ENAC) carries out the same function in the area of pesticides, with the aim of assessing and certifying compliance with GLP requirements in analyses conducted on plant protection products, feed additives, and industrial chemicals (including biocides), as well as food additives, flavors, enzymes, novel foods, and processing aids (Source: ENAC).
We place special emphasis on this, as CE marking guarantees and certifies that a product complies with the applicable European harmonization legislation, allowing free circulation within the European Economic Area (EEA) while also ensuring greater confidence for users by confirming that it meets the health, safety, and environmental protection levels established by the EEA.
CE marking is mandatory and must be included before any product, whether new or second-hand imported from third countries, is made available for the first time in the EU market, unless a specific directive states otherwise. The manufacturer is responsible for complying with European legislation—meaning any natural or legal person who produces a product, or has it designed or manufactured, and markets it under their name or trademark.
Inspection Bodies play an important role in terms of safety. Their function is to ensure that the population is protected from potential risks that products and industrial facilities may pose.
To ensure these risks are prevented and controlled, public administrations are responsible for establishing industrial safety policies within their areas of competence. They do this by regulating requirements and conducting periodic inspections throughout design, installation, production, and service life, thus ensuring that safety conditions are maintained.
UNE-EN ISO/IEC 17021 evaluates conformity in certification bodies, meaning it accredits compliance with the necessary requirements for proper auditing and certification of management systems by any organization. Its objective is to increase trust in certificates issued under management system standards such as ISO 9001 or ISO 14001.
Its specific function is to determine both new requirements and useful parameters for the analysis of management systems, as well as auditor competence, thereby increasing the value of management system certification in both public and private organizations.
UNE-EN ISO/IEC 17065 evaluates compliance with the requirements related to the certification of products, processes, systems, and services. Its purpose is therefore to accredit proper compliance during validation by any certification body or entity.
The function of this standard is to establish requirements for the competence, consistency, and impartiality of such bodies. Thanks to it, any organization can certify that it works based on legal competence and consistent, sustainable development, all under the impartiality of the institutions responsible for certifying the products they offer.
UNE-EN ISO/IEC 17024 evaluates compliance and sets general requirements for bodies certifying individuals.
Personnel certification is an internationally established tool aimed at helping demonstrate that professionals have the knowledge, professional skills, and specific aptitudes of their professional profile. In addition, it guarantees that all these aspects have been assessed by an independent entity with technical competence.
This standard ensures that medical devices and related services comply with the appropriate requirements, regulations, and customer needs. It is essential for ensuring safety in healthcare, both for professionals and patients, whether in hospitals, clinics, or any type of medical center.
The main purpose of the regulatory requirements of UNE-EN ISO 13485 is to ensure the proper design, production, and market release of any medical device by manufacturers, certifying that they are completely safe and suitable for their specific healthcare use.
