- ISO 13485 Certificate shows that you comply with the current legal requirements.
- ISO 13485 Certificate documents that the firm is working in compliance with international standards and it gives trust to the customers.
- Meeting the requirements of ISO 13485 Certificate can help you to decrease the customer complaints.
- Meeting the requirements of ISO 13485 Standard can reduce the number of nonconforming products.
- Analyzing the records through the ISO 13485 Quality Management System can improve your revenue.
- ISO 13485 Certificate is frequently asked in exporting processes.
- With ISO 13485 Quality Management System, operational activities can be systematically reviewed by the top management.
- ISO 13485 Standard Quality Management System for Medical Devices can determine and prevent the disruptions in operational activities.
ISO 13485 Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support).
The requirements in ISO 13485 Standard can also be used by suppliers or other external parties providing product (e.g. raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to such organizations.
Information marked as “NOTE” is for guidance in understanding or clarifying the associated requirement.
The quality management system requirements specified in this International Standard are complementary to the technical requirements for product.
The adoption of a quality management system is a strategic decision of an organization. The design and implementation of an organization’s quality management system is influenced by the organizational environment, changes in that environment, and the influence that the organizational environment has on the conformity of the medical devices; organization’s varying needs; organization’s particular objectives; product the organization provides; processes the organization employs; organization’s size and organizational structure; regulatory requirements applicable to the organization’s activities.
There is a wide variety of medical devices and some of the particular requirements of ISO 13485 Standard only apply to named groups of medical devices. These groups are defined in Clause 3.
0.2 Process approach
This International Standard is based on a process approach to quality management.
Any activity that receives input and converts it to output can be considered as a process.
Often the output from one process directly forms the input to the next process.
For an organization to function effectively, it needs to identify and manage numerous linked processes.
The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach.”
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements
This International Standard includes some particular requirements for organizations involved in the life-cycle of medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management system meets all the requirements of ISO 9001.
Requirements of this International Standard are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to this International Standard reflect any exclusion of design and development controls.
If any requirement in Clauses 6, 7 or 8 of this International Standard is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system.
For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2..
When a requirement is qualified by the phrase “as appropriate”, it is deemed to be appropriate unless the organization can justify otherwise. A requirement is considered appropriate if it is necessary for:
– product to meet requirements;
– the organization to carry out corrective action.
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000 apply, together with the following.
The following terms, used in this edition of ISO 13485 to describe the supply chain, have been changed to reflect the vocabulary currently used:
supplier ————-> organization ———-> customer
The term “organization” replaces the term “supplier” used in ISO 13485:1996, and refers to the unit to which this International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”.
Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.
Wherever requirements are specified as applying to “medical devices”, the requirements apply equally to related services as supplied by the organization.
The following definitions should be regarded as generic, as definitions provided in national regulations can differ slightly and take precedence.
3.1 Active medical device
Any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy.
3.2 Advisory Notice
notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary information or to advise on action to be taken in the:
— use of a medical device,
— return of the medical device to the organization that supplied it, or
— destruction of a medical device
3.3 Customer complaint
written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device that has been released from the organization’s control or related to a service that affects the performance of such medical devices
3.4 implantable medical device
medical device which can only be removed by medical or surgical intervention and which is intended to:
— be totally or partially introduced into the human body or a natural orifice, or
— replace an epithelial surface or the surface of the eye, and
— remain after the procedure for at least 30 days
Note: This definition of implantable medical device includes active implantable medical device
label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents
3.6 medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of: — diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
— investigation, replacement, modification, or support of the anatomy or of a physiological process;
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
— providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.
3.7 sterile medical device
Medical device intended to meet the requirements for sterility.
ISO 13485 Certificate is given to medical device producers after their quality management system is audited and approved by an accredited notified body indicating that the essential requirements stated in the applicable standards are met by the firm. ISO 13485 Standard is created based on the conditions stated in ISO 9001 Standard. It is an international standard that has essential requirements for medical devices. Getting an ISO 13485 Certificate is mandatory for medical device producers by Turkish Republic Minister of Health. (See. 08.05.2009 dated B.10.0.THG.0.13.00.04/90.04/18491 numbered announcement)
ISO 13485 is the standard that medical device producers should use as a basis to build their infrastructure, to document their production process and to ensure the continuity of this operation. ISO 13485 Standard is guide for the producers on the points that must be taken into consideration as the producer manages and documents the processes such as purchasing, production, sales, setting up, post sales services such as maintenance and customer feedback (customer demands, complaints, suggestions etc.). ISO 13485 indicates that all these processes must be designed and managed based on the quality management system. Additionally, ISO 13485 demands for the producer to review and apply improvement activities continuously in order to eliminate any risk and, if there is any, to prevent its recurrence, before it disrupts the process.
If there are any other standards applicable to the management of these processes such as things to consider when designing a label and preparing a user’s manual etc., the requirements of these standards must be integrated to the risk management processes.
Since the technical file that will be constructed for the product will be based on the requirements of ISO 13485 quality management system, all these requirements must be known, planned and conducted by the firm.
All the processes required to produce the product and to present it to the market (to purchase, store, and produce etc.) are determined in compliance to the ISO 13485 Standard. Next, the infrastructure and documentation which are necessary to develop, implement and record these processes, are formed. As these processes are implemented, the efficiency and efficacy of the processes are reviewed.
With the support of TıbbiCE Consulting, a quality team responsible of ISO 13485 processes will be formed. Our consultants will work closely with your quality team to plan the certification process and will visit your firm periodically to check the work done and to plan the next visit.
Choosing a consultant for ISO13485 Certification is a critic decision to work efficient and fast during this process.
When the firm is able to meet all the requirements of the Quality Management System, the firm can get audited by accredited national or international notified buddies and receive its ISO 13485 Certificate.
TıbbiCE Consulting, Training and Validation Services, offers consulting, training and validation services to domestic and overseas medical device producers during their CE and ISO 13485 Certification (93/42/EEC) process. With its expert staff from different backgrounds including but not limited to biology and biomedical, mechanical and metallurgy engineering, TıbbiCE Consulting, Training and Validation Services is the medical device consulting company with the largest expert staff in Turkey.
TıbbiCE Consulting, Training and Validation Services’ principle for product and quality management system is to give a “Purpose-driven, Solution and Customer Satisfaction Oriented” service that grounds on data confidentiality with its expert consultants.
We share the knowledge and experience we have gained in 9 years through working with more than 140 medical device producers and being involved in the CE and ISO 13485 Certification processes of more than 300 medical devices. We conduct the certification process professionally and aim to complete it in optimum time.