ISO 13485 Certification in Philippines

ISO 13485 Certification – QMS for medical devices organization in Philippines

The medical device manufacturers and suppliers always need to ensure the proper quality of their products. Without the right certifications, they cannot prove their credibility. Thus, we have developed this platform to help them in achieving the ISO certifications. ISO 13485 is the best certification, establishing the fact that you always deal with the quality medical kits. Thus, rely on our services for ISO 13485 accreditation in Philippines. This ISO 13485:2016 certification in Philippines will help you to fulfil the regulatory requirements related to medical device manufacturing and installation. For this certification, you have to ensure-

  • Quality Management System installation with various improvements
  • Process validation
  • Effective recall systems and product traceability
  • Compliance with regulatory and constitutional requirements

Why choose ISO 13485 certification in Philippines?

We will show you the clear reasons, for which you can decide on ISO 13485 implementation in Philippines.

Reduced cost of operation– Consistent adjustment of the process makes the standard of the process much better

Legal compliance– Identify the way in which the regulatory requirements affect your business

Better relationship with the stakeholders– Your suppliers, employees, and customers will have a better perception of your business

Effective risk management– Higher traceability and consistency of services and products help in avoiding the problems.

Capability of winning more deals– Certification creates a win-win situation in your business. The businesses in the regulated sectors will get more benefits.

Thus, to have these values, you can choose to have ISO 13485 implementation in Philippines.

The version ISO 13485:2016 focuses on medical device life-cycle- its development, design, production, distribution, storage, installation, decommissioning and servicing. This standard helps you to deal with the management system of your company, and thus, we can take a stronger step for risk management.

ISO 13485 with the new version

Our team will give you clear information about the revised versions of ISO 13485 standard. The latest version ISO 13485:2016 has replaced the previous ones ISO 13485:2012 and ISO 13485:2003. While you presently have ISO 13485 with the older version, we encourage you to have the transition. The cost of ISO 13485 certification in Philippines may be different from that of the transition.

Both ISO 9001 and ISO 13485 are the proofs of commitment to the quality of an organization. By having the certification on quality management, you can ensure your regulators and customers that you value quality. You may have our consulting services for both the ISO certifications.

ISO 13845 accreditation in Philippines is an international standard for Medical Device Quality Systems that provides robust quality processes of medical devices, helps an organization mitigate QMS risks, enhance profitability, improve customer satisfaction, standardize quality operations, minimize quality related deviations and helps an organization achieve continual improvement of their QMS operations. As per Wikipedia & available research data, ISO 13485 accreditation in Philippines is known to help organizations in Philippines to improve effectiveness of quality management system for design and manufacture of medical devices, profitability, business performance and a better success with sustainability of QMS in Philippines.  ISO 13485 focuses on needs of customers including regulatory requirements and maintaining QMS effectively for medical device manufacturers. The standard follows the process approach and it manages the quality management system as a set of interrelated processes. Demonstrate your commitment for a world class Medical Device Quality Systems in Philippines with ISO 13845 certification in Philippines.

Medical Devices ISO 13485 accreditation in Philippines makes sure that your medical kits in various places validate the same quality and reliability. While you are transferring your products to remote places, this ISO 13485 certification is highly advantageous to you. Thus, you can invest in our services and know about ISO 13485 certification requirements in Philippines.

How can we help you?

Contact us at the ISO Consulting & ISO Certification nearest to you in the Philippines to submit an enquiry and get ISO Certified.

On behalf of Sky Tactic Aero Philippines, Inc., I would like to extend our deepest appreciation to you and to Ms. Asuncion on helping our team to accomplish our ISO 9001:2015 Certification in a short period of time.

We are truly grateful on your patience and guidance, and for sharing with us your expertise towards this endeavor. Our experienced in this ISO journey is truly amazing and our teamwork and collaboration proves that, we as a team can do more better. We know that ISO is a continuous process and, as we are now certified, our team is dedicated to adhere on those standards set to us.

We look forward in getting your Consultancy in our next Certification journey.

Dean Cambe
President & CEO - Sky Tactic Aero Philippines, Inc.

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