How Can Iso 13485 Help Manufacturing Companies?

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ISO 13485:2016 is an international standard for manufacturers of medical devices. It specifies the requirements for a quality system in which the manufacturer wants to prove its ability to deliver safe medical devices. The main goal of ISO 13485 is to establish a system that is fully accomplished of meeting applicable legal and quality system requirements.
It trusts heavily on the ISO 9001:2008 structure, but it contains certain specific requirements for medical devices, such as risk analysis, sterile production, rework, and traceability. An “ISO 13485-certified company” means an organization that has executed an ISO 13485 Quality Management System (QMS) and has successfully met all the appropriate requirements, audited by the certification body.
How ISO 13485 is Appropriate for Manufacturing Companies?
ISO 13485 is intended for any organization partly or fully involved in the medical device lifecycle, regardless of the organization’s size or type, or the type of medical device. The chief purpose of an ISO 13485 QMS is to verify the manufacturer’s commitment to the safety, effectiveness, and performance ...
... of medical devices.
• Design and development process:
The point is that medical devices must be designed in a correct manner to confirm the safety of patients and users, and they must accomplish in accordance with their intended use. Introducing ISO 13485 into design and development process will guide to define precisely and in detail what input parameters are, how to collect them, and who is responsible for each input parameter. It will also give control over design changes, so know at all times at what stage new medical product development is. Also, ISO 13485:2016 needs to confirm traceability throughout the design and development process. This is important because anyone can quickly gain insight into what stage the design is, check out some exact designs or risky elements, or be up to date with certain changes. Appropriately implemented traceability allows company agility in managing the design and development process.
Also, the ISO 13485:2016 design and development requirements instruct to monitor product risks at the very start of the design, which significantly rises the safety of the final product. ISO 13485 wants the company to continuously review, verify, and validate each stage of a development project. This confirms that there is complete control over the development process and confirms that the final product is safe.
• Production realization:
The goal of every medical device manufacturer is for the production procedure to be under maximum control so that the product that comes out is in accordance with consumer requirements, is safe to use, and is fit for the probable intended use. ISO 13485 permits easy definition of production processes, control steps, traceability, process performance monitoring, and performance monitoring of the complete product. The following elements are also essential to maintain proper production: defining requirements for infrastructure and equipment, maintaining and monitoring infrastructure and equipment, defining ambient conditions for production, defining the essential cleanliness, etc. ISO 13485 permits total control over the production process, which is important for the production of a safe medical device.
• Storage and distribution:
It is very significant to properly store and protect material, parts, and medical devices through the complete lifecycle: production, storage, handling, and distribution. ISO 13485:2016 asks to protect product from any alteration, contamination, or damage. This may include monitoring temperature, humidity, and any contamination. As in the warehouse, also protect product during its transport to the consumer. This means that if product requires refrigeration, ensure that the product travels at the correct temperature during transport. Requirements and criteria must be prescribed, and there must be evidence of their monitoring.
• Installation:
If a medical device wants installation at the point of use, then installation necessities and specifications must be defined. There should be recognized installation protocol, acceptance criteria, and an installation report. It is very significant that the manufacturer of the medical device delivers a fully valid medical device ready for use.
• Servicing:
Certain medical devices need servicing, for which requirements and specifications must also be defined. It is very significant to confirm that, once serviced, the product still meets the basic necessities of the medical device. The performance and safety of the product must not be changed after the service. There must be some service records and those records must be maintained.
• Technical support:
If the production of a medical device wants other technical support, the company providing that support is expected to comply with ISO 13485. Technical support can be, for example, sterilization service, or the production service of a particular part that wants to be incorporated into medical device. The advantage of introducing ISO 13485 in such companies is that the medical device manufacturer has complete traceability of the entire manufacturing process. Ultimately, the manufacturer of a medical device is solely responsible for that medical device once it enters the market.
ISO 13485 Benefits for Manufacturing Companies:
• Opportunity of contracting with larger companies – many large medical device companies prefer to work with suppliers who are ISO 13485 certified. Large companies are responsible for confirming that their subcontractors comply with ISO 13485, which means that subcontractors who are already certified are likely to have priority.
• The ISO 13485 standard was created to confirm that medical devices in different countries show the same reliability and quality. If considering exporting a product, ISO 13485 certification can give a benefit.
• By executing ISO 13485, the organization is proving that it meets all appropriate legal, regulatory, contractual, and marketing requirements.
• Signifying product safety to the patient/end user – ISO 13485 instructs manufacturers to produce a safe product using a risk-based approach. The organization must analyze the entire production process from the point of view of risk in order to decrease risk to a minimum.