ISO 13485 : 2016

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services.

INTERESTED IN ISO 13485 CERTIFICATE!
TALK TO OUR CONSULTANT

HIGHLIGHTS

Global Recognition

ISO 13485 is the internationally recognized global standard for quality in the medical device industry.

Customer Satisfaction

Demonstrate that you produce safer and more effective medical devices.

Increase Performance

Increase efficiency, cut costs and monitor supply chain performance.

Integrated Processes

Integrated process approach helps not to focus at the individual processes but also at the interactions of those processes and to find areas for improvement .

Continual Improvement

With continual improvement as the main output, one can attain ever-increasing gains in savings of time, money and other resources.

Employee Engagement

The more employees understand their roles in delivering quality products and services, the more engaged they are, which leads to increased efficiency.

OVERVIEW

ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.

Process

ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

Standard harmonization

ISO 13485:2016, the Medical Device Quality Management System standard, has been harmonized to the European Medical Devices Directives: MDD, AIMDD and IVDD. EN ISO 13485:2016 now replaces the previous version of the standard, EN ISO 13485:2012, in the EU Official Journal, with the date of ‘cessation of presumption of conformity’ of EN ISO 13485:2012 stated as 31 March 2019.

Standard harmonization allows manufacturers to use their compliance to the standard as evidence of conformity to the requirements of relevant legislation.The harmonization of EN ISO 13485:2016 is another step towards compliance to the recently published Medical Devices and IVD Regulations, which will supersede the current Directives in 2020 and 2022, respectively. Find out more about MDR transition and IVDR transition.

3M Management Consultants provides one stop solution for ISO 13485 Certification requirements to its all clients.

IMPLEMENTATION PROCESS

Design & Build
Deploy
Control
Measure
Review
Improve

DELIVERABLES

Executive Plan

Awareness about the ISO Standard
ISO Certificate from Internationally Reputed Board

Premium Plan

Training
Quality Manuals
Internal Processes
Procedures, Instructions and Records
ISO Certificate from Internationally Reputed Board

READY TO GET ORGANIZATION ISO CERTIFIED !!!

FREQUENTLY ASKED QUESTIONS

1. Are our obligations for MDSAP met if we are certified to ISO 13485:2016?

MDSAP requires audits to be carried out by designated Auditing Organizations (AO). These audits include an assessment of conformance with regulatory requirements specific to the program. Therefore, whilst ISO 13485:2016 forms a good foundation to meet the requirements of MDSAP, you must ensure that your Quality Management System (QMS) meets all of the applicable regulatory requirements

2. Will Canada recognize ISO 13485:2016 for CMDCAS or MDSAP certification?

Yes, Canada will adopt ISO 13485:2016 for its CMDCAS and MDSAP asse

3. Are medical device manufacturers required to maintain both ISO 13485:2016 and ISO 9001:2015?

No, ISO 13485 is the harmonized standard for quality management systems for medical devices. ISO 9001 is a quality management standard and is not specific to the type of product or service. Some countries require ISO 13485 certification to support regulatory approval. BSI is not aware of ISO 9001 being required to support regulatory approval in any country.