ISO 13485:2016 certification

Introduction

ISO 13485:2016 sets out criteria for a quality control program where a company needs to demonstrate the ability to provide medical devices and related services that regularly meet consumer and regulatory requirements applicable. Such organizations may be involved in one or more stages of the life-cycle, including design and development, production, storage and delivery, installation or maintenance of a medical device, and the design and development or provision of related activities (e.g. technical assistance). ISO 13485:2016 can also be used by suppliers or external parties providing the product to these organizations, including services relevant to the quality management system.

ISO 13485:2016 standards apply to organizations irrespective of their size and form except where expressly specified. Wherever specifications are defined as being applicable to medical equipment, they apply equally to related facilities as offered by the organization.

In the medical device industry, ISO 13485 is simply a QMS, which is why it is sometimes known as 'MD QMS.' ISO 13485 certificates assure potential customers and stakeholders that a product was developed in compliance with the globally accepted standard ISO 13485. ISO 13485 Audit by CDG ensures that an organization meets all ISO 13485:2016 guidelines and that is why CDG is a trusted ISO 13485 certification company in the industry.

Benefits of certification

Whether you're looking to work globally or grow locally, ISO 13485 Certification will help you boost quality efficiency, reduce confusion, and increase opportunities for the market. Organizations with this certification advise both consumers and regulators of a commitment to quality.

a. Enhance market access worldwide

b. Specify how to review and improve processes around the business

c. Improve efficiency, cut costs, and track performance in the supply chain

d. Demonstrate that you manufacture medical devices that are safer and more efficient

e. Meet regulatory and customer expectations

f. ISO 13485 increases the performance of the medical devices business or its product and process

g. ISO 13485 is universally recognized and covers regulatory and statutory requirements in most countries the company has spent access to the market

h. ISO 13485 works as a brand ambassador for your medical devices and will, therefore, reduce your sale & marketing costs.

Procedure and Documentation

STEP 1 Apply for ISO 13485:2016 certificate by submitting the application form filled out in ISO 13485 (soft or hard copy).

STEP 2 Our ISO 13485 auditor/specialist will review the application form and will issue a quote for ISO 13485 certification if approved.

STEP 3  Upon submission of the ISO 13485 certification fee, we will send you the ISO 13485 audit plan (stage 1) and audit will be conducted thereafter.

STEP 4  CDG will send you to stage -2 ISO 13485 Audit Plan after successful stage-1 audit closure of the NC's (if any). After a successful audit, the auditor will recommend an ISO 13485 certification for your organization.

Documents required for certification

a. Quality Manual

b. Responsibility and authorities

c. Medical devices file

d. Procedure for design and development

e. Document control procedure

f. Training Procedure

Processing of certification may take 30 working days to get complete