MEDICAL DEVICES MANAGEMENT
ISO 13485:2016 is the International Standard for
Quality Management Systems for Medical Devices.
ISO 13485 is the medical industry’s optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings.
ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonised medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing of medical devices and calls for:
This standard allows companies to reduce safety and legal risks while creating more economical work environments. As an internationally recognised standard of quality and safety for medical device manufacturing, having ISO 13485 certification helps companies get recognised as more reputable, trustworthy providers. The most recent version of ISO 13485 is reviewed every five years and revised according to the new requirements and needs of the industry.
ISO 13485 has seen a 33.1% increase in worldwide certificates in 2020, showing the growth and importance of UKAS accredited certification in recent times. Statistics straight from the most recent ISO Survey.
Looking to implement an ISO 13485 management system? Not sure where to start? Take a look at our ISO 13485 Implementation Guide here.
One benefit of the ISO 9001 certification is that it is a flexible framework. It doesn’t tell a potential consumer that one way of running a business is better than any other; instead, certification verifies that a particular business meets ISO 9001’s quality management system standards. It also verifies that their method of manufacturing a product or providing a service has been designed to ensure a high-quality outcome for the customer.
ISO 9001 sets the international standard for companies looking for ways to meet or exceed quality control metrics. At the same time, it helps consumers distinguish between companies, allowing them to make educated choices when choosing a vendor. It does this by identifying best practices for each industry, standardizing those practices and promoting adherence to those practices.
Deliver products that consistently meet customer requirements and a service that is dependable and can be relied on.
Continual improvement of processes and resulting operational efficiencies mean money saved.
Improve the perception of your organization with staff, customers and suppliers.
Understand how statutory and regulatory requirements impact your organization and its customers.
Greater consistency and traceability of products and services means problems are easier to avoid and rectify.
Independent verification against a globally recognized industry standard speaks volumes.
Understand how statutory and regulatory requirements impact your organization and its customers.
Any organization can benefit from achieving ISO 9001 certification and implementing ISO 9001:2015 as its requirements are underpinned by universal management principles:
The Annex SL structure provides a common language between ISO management systems that streamlines the path to compliance related certifications.
The focus on risk identifies areas of concern in advance and allows you to allocate resources where they are most needed.
The leadership requirement engages upper-level management and brings quality assurance more in line with overall business objectives.
The performance evaluation and self-governance components can foster innovation and deliver enhanced value for stakeholders.
The emphasis on organizational context looks at quality management from a big-picture perspective.
Complete a Quote Request Form so we can understand you and your business. We will then use this to personally prepare a proposal for your certification and define what is known as your 'scope of assessment'.
We will then contact you to book your assessment with an ICB assessor. This consists of two mandatory visits that form the Initial Certification Audit. Please note that you must be able to demonstrate that your management system has been operational for a minimum of three months, has been subject to a management review and a full cycle of internal audits.
Following a successful two stage audit, a decision is made and if positive, your certification is issued by ICB. You will receive both a hard and soft copy of the certificate. Certification is valid for three years and maintained through surveillance audits (years one and two,) and a recertification audit in year three.
