ISO 13485: 2016 for medical devices

Quality management system

“ExpertCertifier is a catalyst for business and process excellence, your business and process excellence is
guaranteed through ISO certification with ExpertCertifier in Bangalore “

Up your business, talk to our ExpertCertifier masters who are available for you to coach and on how to get
your business and process certified with ISO 13485, ISO 14001, ISO 45001,ISO 22000,ISO 27001,ISO 20000-1
and HACCP.

ISO certification

Big and small corporations running business in Bangalore are in need of real strong system to deliver the
customer needs. Corporations here have to anticipate and the changing business needs of the client to
deliver the best and stay in top of the most sought after vendor list. By implementing ISO 13485 the
corporations shall have compelling processes and can deliver the product and services at the best.

What is ISO 13485 stand for?

ISO 13485 is an international standard that specifies requirements for a quality management system
(QMS)for design and manufacturing of medical devices . Organizations implement the requirements of
the standard and demonstrate the ability to consistently provide products and services that meet
customer and regulatory requirements

What are ISO 13485 requirements in Bangalore?

A corporation running business in Bangalore must produce legal documents and several other internal
process related documents like procedures, policies and records along with the audit report to get the
compliance certificate. The internal process documents, policies and procedure report that the
corporation is able to produce the quality product and services consistently.
Are you are taking action to get your Bangalore office ISO certified? Looking to find the latest ISO 13485
requirements and the best consultant? ExpertCertifier is the answer.

ISO Certification Mandatory Documents and Requirements in Bangalore

 Monitoring and measuring equipment calibration records

 Records of training, skills, experience and qualifications
 Product/service requirements review records
 Record about design and development outputs review
 Record about design and development inputs
 Records of design and development controls
 Records of design and development outputs
 Design and development changes records
 Characteristics of product to be produced and service to be provided
 Records about customer property
 Production/service provision change control records
 Record of conformity of product/service with acceptance criteria
 Record of nonconforming outputs
 Monitoring measurement results
 Internal audit program
 Results of internal audits
 Results of the management review
 Results of corrective actions

ISO Certification Non-Mandatory Requirements in Bangalore

 Procedure for determining context of the organization and interested parties

 Procedure for addressing risks and opportunities
 Procedure for competence, training and awareness
 Procedure of equipment maintenance and measuring equipment
 Procedure for document and record control
 Sales procedure
 Procedure for design and development
 Procedure for production and service provision
 Warehousing procedure
 Procedure for management of nonconformities and corrective actions
 Procedure for monitoring customer satisfaction
 Procedure for internal audit
 Procedure for management review

Do all companies need ISO 13485: 2016 in Bangalore?

All organizations can get ISO certified. If you own a business and wish scale up with strong system and
continuously improve, then it is highly recommended to attract and run through the process and gain
ISO 13485.
 Advantages of attracting ISO 13485:2016 in Bangalore

1.Attract Tender /Contract : The primary reason to attract ISO 13485:2016 in any location and by
businesses is to maximize the business opportunity by attracting tenders/contracts.

2.Improvement of customer satisfaction

One of the key elements in this international standard is to improve customer satisfaction. By
improving the satisfaction level customer retention is at higher side, such customers help directly or
indirectly in generating more business.

3.Increase your credibility and image

By getting your business ISO certified, credibility and image of your brand runs up sharp in the
international and domestic market. When a company is looking for supplier or service provider, it is
often a requirement to have a clean system in order to consider.

4. Improvement of employee satisfaction

The staff is highly satisfied and pumped up once there are clean roles, responsibility and accountability,
a well defined show of how the roles of the staff create a impact on quality and overall success. This
international standard will help organization frame up a structure that helps staffs morale increase.

5. Increased business

Research has proven that ISO certified companies have shown improvements in the area of finance. The
ISO certified image attracts more business in both domestic and international market.

6. Process Consistency

A well documented system helps in minimizing process related errors. Even a minor change in the
process has to be documented and implemented in best possible pattern.

How to get ISO 13485:2016 certification in Bangalore – Consultants in Bangalore?

Our masters have more than 15 plus years of global experience, with hands-on experience in the field of
ISO certification, assessment and training.

With ExpertCertifier your Business and process excellence is guaranteed.

Reach us at : contact@ExpertCertifier.com