ISO 13485 Certificate is given to medical device producers who implement the Standard requirements to their own product and organization as they construct their own quality management system, and successfully pass the audits of one or more accredited notified bodies. ISO 13485 (Medical devices — Quality management systems — Requirements for regulatory purposes) Standard demands from the firm to construct a quality management system that will document and keep the records of all the process necessary to produce the final product (purchasing, production, quality control, storing, sterilization etc.), review and analyze these records periodically.
ISO 13485 Certificate is asked as a prerequisite for most of the government tenders. Additionally, ISO 13485 Certificate is necessary for the product to be listed on the data banks of the international authorities and thus for the product to be exported. ISO 13485 Certification Consulting is a very strategic step to efficiently plan, design and conduct the certification process. Getting a professional ISO 13485 Certification Consulting service will help you to get your ISO 13485 Certificate in optimum time, to improve your staff’s knowledge on quality, to understand the requirements of ISO 13485 Standard clearly and to apply them in an efficient and improvable manner without unnecessary spending.
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.
Why should you get an ISO 13485 Certificate?
- 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.
- What is ISO 13485 Standard?
- What is the purpose of ISO 13485 Standard?
- How to Form the ISO 13485 Standard Quality Management System?
- ISO 13485 Certificate Quality Management System
What is ISO 13485 Standard?
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)
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