ISO 13485:2016
Medical Devices
Quality Management System
WHAT IS ISO 13485
HISTORY OF ISO 13485:2016
The latest version of 13485:2016
The Intent of ISO 13485:2016
ISO 13485:2016 Structure
Requirements of ISO 13485
Medical equipment and services must be manufactured in accordance with ISO 13485:2016, which details the standards for a Quality Management System to ensure that these needs are always met. Unless where otherwise noted, the requirements of ISO 13485:2016 are universal and can be applied to organisations of any size or kind. Whenever a condition is stated to apply to medical equipment, it also applies to any related services provided by the company.
The ISO 13485 structure is split into eight sections, with the first three being introductory, and the last five containing the mandatory requirements for the Quality Management System. Here is what the five main sections are about:
QUALITY PRINCIPLES OF ISO 13485:2016
Know all about ISO 13485
Note: Issuance of an advisory notice can be required to comply with applicable regulatory requirements.
Mandatory Documentations for ISO 13485:2016
ISO 13485:2016 Standard Process
Benefits of ISO 13485
The ability to enter new markets is the certification’s most obvious practical value. Without this accreditation, the firm cannot legally sell its goods or even function in the medical device industry in most countries. The biggest obstacle to entering a market is generally something like this.
Besides the most apparent advantage, firms having ISO 13485 certification can also:
In terms of quality control in the medical device sector, the ISO 13485 certification is the gold standard. Customers can be certain that they are receiving a product of the highest quality thanks to this certification, which also notifies them that the company has a quality assurance standard in place.
ISO 13485 certification is vital for medical device makers to demonstrate quality and safety, and it also serves as a potent marketing tool for any business.
The company’s dedication to quality has been validated by ISO 13485 accreditation. Management receives data on a consistent basis, which they may utilise to make choices that are more in line with the company’s long-term objectives.
There will be consequences if management notices a lag in attaining the targets.
One of the tenets of ISO quality management systems is the continual improvement. The adoption of a QMS causes a shift in perspective amongst an organization’s leadership and workforce, who now actively seek for ways to enhance operations.
High performance, strategic leadership, and employee engagement may all result from the implementation of systematic procedures that are designed to limit the occurrence of errors and the volume of labour required. It in turn means better final results for consumers.
Employees are better equipped to play their part in ISO 13485 implementation when processes are well-documented and controlled. Employees are overjoyed when they are given the opportunity to contribute to the company’s success by looking new ways to improve existing procedures.
Employees are more invested in the company when they feel they have a meaningful role to play. Because of this, productivity and efficiency are improved.
The pursuit of 100% customer satisfaction is key to the ISO 13485 implementation process. Customers have more trust in businesses that have earned the ISO 13485 standard certification. Customers have high expectations since they know the organisation has a solid quality management system.
Relevant Industries For ISO 13485
Medical device developers, factories, and retailers can all benefit from ISO 13485 certification. Moreover, certification can increase a company’s marketability because more and more manufacturers are insisting on it as a prerequisite for doing business with a supplier or service provider.
ISO 13485 is the worldwide standard for quality management systems (QMS) in the medical device industry. It specifies the minimum standards for a QMS in these fields.
The MDR 2017/745 mandates that all businesses operating inside the European Union have a Quality Management System (QMS) that is ISO 13485:2016 certified. Companies that fall under this category include:
FUTURE of ISO 13485
Joining Over SIS Certifications Best ISO Certification Agency
“We do not sell, We certify.”