Quality Management Systems Certification – ISO 9001

Organizations that implement an effective management system create trust between stakeholders in the ability of their processes and the reliability of their products and / or services. In addition, an effective management system serves to create the basis for continuous improvement that leads to increased customer satisfaction and ultimately to the organization success. ISO 9001 is the International Standard for Quality Management Systems. It is based on a set of principles that are consistent with good business practice. These include focusing on customers, involving all the people that affect your business, doing things systematically and constantly looking for ways to improve. All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. It can be applied in public and private sector, government institutions and private companies from small to very large companies. The standard covers all aspects of an organisation’s activities, including identifying its key processes, defining roles and responsibilities, policies and objectives, documentation requirements, the importance of understanding and meeting customer requirements, communication, resource requirements, training, product and process planning, design processes, purchasing, production and service, monitoring and measurement of products and processes, customer satisfaction, internal audit, management review, and improvement processes.

Benefits of ISO 9001 certification

The implementation of ISO 9001 system sets the basis for a continuous improvement environment in the business. In particular, with its proper implementation, organizations can derive benefits such as:
  • Greater competitiveness
  • Improved productivity / efficiency
  • Reduced costs
  • Improved quality of services / products
  • Enhanced reputation / Access to new markets / Satisfied Customers

ISO 13485 certification for medical devices

ISO 13485 “Medical Devices – Quality management systems – Requirements for regulatory purposes” is the international standard that defines quality management system (QMS) requirements for manufacturers of medical devices. This international standard provides the basis for medical device regulations to be harmonized around the world. The standard sets out the requirements for a quality management system specific to the medical devices industry. It is designed to be used by organizations throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal. ISO 13485 is also applicable to organizations that interact with the medical devices manufacturer, including those involved in:
  • repair and maintenance of medical devices,
  • supply of raw materials, components or subassemblies,
  • performance of services such as contract manufacture, sterilization, logistics or calibration of measurement equipment
  • import or distribution of medical devices
ISO 13485 helps an organization design a quality management system that establishes and maintains the effectiveness of its processes. It reflects a strong commitment to continual improvement and gives customers confidence in its ability to bring safe and effective products to market. In the medical devices industry, a quality management system (QMS) is required by regulators in most countries. ISO 13485 enables an organization to consistently provide safe and effective medical devices and fulfil customer and regulatory requirements. It is also flexible enough to meet the individual needs of different types of medical devices organizations. ISO 13485 does not set detailed requirements, but asks a medical devices organization to identify those regulatory requirements that are relevant to its individual situation and incorporate them into its QMS. ISO 13485 can help organizations involved in any part of a medical device’s life cycle:
  • Demonstrate compliance with regulatory and legal requirements
  • Ensure the establishment of QMS practices that consistently yield safe and effective medical devices
  • Manage risk effectively
  • Improve processes and efficiencies as necessary
  • Gain a competitive advantage
While ISO 13485 is a stand-alone standard, it is similar in scope and intent to ISO 9001 “Quality management systems”. ISO 13485 focuses less on business performance and more on risk management comparing. It contains additional requirements specific to organizations involved in the life cycle of medical devices, while other elements of ISO 9001 that are not relevant as regulatory requirements are not included. Although an audit performed under the ISO 13485 may include an examination of a product’s design and development, ISO 13485 is not a product certification standard. The certification based on ISO 13485 is not directly linked to the specification of the manufactured products. ISO 13485 certification indicates that the processes for designing and manufacturing medical devices are appropriate for providing consistent product quality and safety

Quality Management Systems in the health sector – EN 15224

EN 15224:2016 “Quality management systems – EN ISO 9001:2015 for healthcare” is the specified standard for healthcare facilities in order to sufficiently meet the special needs of healthcare services. It is a sector specific standard of quality management, based on the ISO 9001 standard and specifically tailored for the requirements of health care organizations. Basically, the requirements of EN 15224 agree with those of ISO 9001. However, EN 15224 requires more: it defines a total of eleven quality characteristics for health care, and emphasizes that the management of clinical risk is included in all processes for planning, execution, and control. The emphasis of this standard is on hospital process and risk management and the focus is on the patients as clients who have particular quality requirements, and especially on patient safety. Certification according to EN 15224 is suitable for all types of service providers within the health sector. These are mainly hospitals, but also include any institutions engaged in nursing or other health care, such as doctors’ and dentists’ surgeries, rehabilitation institutions, care and residential homes. Certified organisations provide objective evidence that they have installed a specific quality management system for healthcare which places the patient at the center and aims in providing the best in healthcare services. Management system implementation according to EN 15224 offers organisations the chance to identify and avoid risks, minimise waste and mistakes made, thereby increasing overall productivity and ensuring a high level of patient safety.

Why choose HTCert?

HTCert is dedicated to activities exclusively connected with healthcare and medical devices. We provide certification services to medical device manufacturers, importers and distributors; pharmaceutical and cosmetic companies; and healthcare providers. We provide reliable and independent services, with objectivity and confidentiality, utilizing qualified and competent auditors well acquainted with the requirements of the standards as well as the complicated requirements of the health technology sector.