ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

HOW TO USE ISO 13485 2016

ISO 13485:2016 develops a quality management system for medical devices and related services and then use this system to:

- Show that your organization is consistently capable of providing medical device products and services that meet customer requirements and comply with all relevant & regulatory requirements.

- Assess your organization ability to consistently provide medical device products and services that meet customer requirements and comply with all relevant & regulatory requirements.


ISO 13485 Medical devices - Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.

ISO 13485 is an international standard in the field of medical devices. Forerunners were the EN46001 standard which had to be combined with ISO 9001: 1994. ISO 13485:1996 was based on ISO 9001:1994. The current ISO 13485: 2016 is a single standard which is largely based on ISO 9001:2008.

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. It has recently been revised, with the new version published in March 2016.

ELEMENTS OF ISO 13485:2016

The key elements can be described as follows:

Clinical Evaluation, Labelling, Medical Device Family, Sterile Barrier, System Sterile Medical Device, Medical Device File Work, Environment Contamination, Control Planning of Product Realization, Design & Development, Cleanliness of Product


The objectives should be designed to be S.M.A.R.T (specific, measurable, achievable, realistic and time-based).

Examples of MD-QMS Objectives

  • Requirement compliance rate
  • Complaint Corrective Action Closure Time
  • Reduction of internal waste
  • Improvement of productivity rate
  • Increase the client satisfactory level (x to y)
  • On-time delivery %
  • To increase the rate of on-time delivery by 5% in the next 12 months.
  • To decrease the rate of defective product shipped to customers by 1% in the next 12 months


The Certification process shall consist of the following key stages :-

  • Application Review & Contract Review
  • Initial Certification Audit: Stage-1 & Stage 2 Audit
  • Certification Decision
  • Continual Assessment (Surveillance Audit)
  • Renewal Audit
  • Suspending, Withdrawing, Extending or Reducing Scope of Certification


With the right consulting, implementation, preparation and a good understanding of what is required for ISO 13485 Certification, Some documentation needed ready for Certification Process. The documentation will define:

  • MD-QMS Manual
  • Organisation Structure
  • Who should record information and what information is recorded
  • Responsibilities of Employees
  • Internal Audit & Management Review Meeting
  • Policy & Objective
  • Technical File - Medical Device File
  • Sterilization Process & Validation Process
  • Documented Work Instruction - SOP
  • Documented Procedures

BENEFITS OF ISO 13485:2016

  • Guarantees high quality of provided services and products
  • Reduces production loss rate
  • Reduces operational costs and reduces risk
  • Increases effectiveness across the whole organization
  • Increases your customers trust in you as a safe supplier or producer
  • Identify and develop a quality management system for medical devices
  • Utilize the quality systems and control processes for medical devices
  • Monitor and maintain quality management system for medical devices
  • Increase efficiency, cut costs and monitor supply chain performance
  • Meet regulatory requirements and customer expectations
  • Demonstrate that you produce safer and more effective medical devices

ROAD MAP FOR ISO 13485:2016

Roadmap and plan for ISO 13485 Covering key Points:


Training on Standard Requirement Organizations needs to have the knowledge, skills and capability to support a standard beyond the certification audit.


GAP Analysis: We do gap analysis & risk analysis to identify what you do and what ISO 13485 recommends to do, it may be process addition or modification to adopt International Best Practices.


System Document Development: Based on the training the client reviews their own management system and evaluates their existing policies and procedures and modifies them to comply with the best practice.

Internal Auditor: Training Regular internal audits against the system are the requirements of the standard.


Standard Implementation: Client must ensure that their employees are adopting the new protocols and procedures inline of the standards.

Internal Audit: Client conducts an internal audit of their management system implementation. They must examine their own processes and procedures in terms of effectiveness.

Management Review: Client to discuss the future of their management system with their senior management about the strengths and weakness of the system to identify areas for continual improvement.


Pre-Assessment: A pre-assessment audit done prior to and outside the formal scope of certification to identify area that need more work whilst also preparing key employees for the eventual audits. A useful audit to rehearse ,align and de-bug your system:

Stage 1 - Assessment: Document Review.

Stage 2 - Assessment: Run through of the implemented systems.


Certification Issue A certificate is provided to your organization.


Continuing assessment Visit
A routine surveillance visit which every year or 12 months cycle over a three year period to monitor and evaluate continuing systems performance.

Re-Assessment Re certification of your management system is required every three years after the initial certification and covers a comprehensive review of the whole system. It may include an additional stage 1 review where significant problems have been encountered during the course of the certification cycle.


Contact Us: If you plan to go for ISO 13485 Certification, you may ask for Quotation by providing your organization’s information in application form, you can download the inquiry form available at the website or submit your inquiry through feedback. Alternatively, you may send your inquiry through mail to or call us at: 09898078093