ISO 13485:2016 – QMS for the Medical Devices

What is ISO 13485?

ISO 13485  Medical devices – Quality management systems – QMS. It represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.

ISO 13485 requirements include compliance to ISO 9001 and Other sector specific requirements. These include:

  • The promotion and awareness of regulatory requirements as a management responsibility.
  • Controls in the work environment to ensure product safety
  • Focus on risk management activities and design control activities during product development
  • Specific requirements for inspection and traceability for implantable devices
  • Specific requirements for documentation and validation of processes for sterile medical devices
  • Specific requirements for verification of the effectiveness of corrective and preventive actions

While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A principal difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 Certification requires only that the certified organization demonstrate the quality system is effectively implemented and maintained. Additionally, the ISO 9001 requirements regarding customer satisfaction are absent from the medical device standard.

VIDEO : ISO 13485


Hassle-free ISO 13485:2016 Certification with PQSmitra

ISO 13485 Certification being a specific standard for the design and manufacture of medical devices, the requirements are very stringent as it directly associated with human health and safety. The manufacturing and administrative controls expected to be implemented are at shop floor and office processes as well. In such a scenario, the practical, easy and effective implementation of the system is very essential. PQSmitra team with expertise of more than 20 years has supported many clients implementing ISO 13485 and getting successful certification. The ISO 13485:2016 implementation process is described below:

Simple & Practical Methodology


Initial Review

  • Review of the existing Quality Management System
  • Gap analysis and planning for the documentation


  • Designing and developing of forms, formats, and procedures
  • Training on sector specific requirements and its implementation
  • 100% documentation support

Effective Verification

  • Internal audit for verification of implemented system
  • Management review

Achieve Certification

  • Certification audit –
    Stage 1 & Stage 2
  • Closure of non-conformities support if any
  • Rewarding the certificate to the organization

PQSmitra offers only Genuine Certifications Options.

We ensure that ISO 13485 Certification adds value to your brand rather than distracting from it by getting counterfeit/local certification. Your certificate’s international traceability helps in passing the Certificate Verification process conducted by your overseas customers.

PQSmitra Service Features Appreciated by Clients

PQSmitra’s contribution towards cultural improvement is highly appreciated by Industry & Business Establishment.
This simple & practical solution of performance measurement system has added value towards business excellence.

Simple &
Practical Approach

20+ years of

Successful Projects

Only Genuine

Certification Bodies Associated with PQSmitra

Frequently Asked Questions (FAQ)

  • Integration of customer requirements specific to design and manufacture of medical devices
  • Standardization of the manufacturing processes and other business processes
  • Risk management and Contingency planning
  • Formulating Quality Policy and Objectives
  • Setting up system for documentation and records.
  • Management information system
  • Business performance and sustainability.

The organization shall demonstrate continual improvement in the field of quality management system for medical devices by maintaining, establishing, implementing and providing documented information.

The documented information required for ISO registration

  • The organizations scope for Medical Devices
  • The organizations Quality policy and Quality Objectives
  • A Quality Manual (Medical Devices)
  • Standard operating Procedures
  • Records at individual process / department. E.g. Sales, Purchase, Production, Quality Assurance, Maintenance, Customer Service.
  • The certification is availed primarily by the companies which are into design and manufacture of medical devices. This ISO 13485 standard can also be used in other industry sectors when a quality management system with additional requirements over an ISO 9001:2015 system is needed.

NOTE : The eligible organizations shall be able to furnish data related to design and manufacture of the medical devices while ISO 13485 certification audit.

  • Opportunity to supply ISO 13485 medical devices and/or supply to medical devices OEM.
  • Recognition and opportunity to cater to the export market
  • Recognition of the certificate and the system by other industry sectors
  • Improved product safety and traceability management
  • Manufacturing process controls enhancing Quality and Productivity
  • Business process streamlining and efficiency improvement
  • Better business performance and Enhanced sustainability.
  • Year 1996 – ISO 13485 standard was published
  • Year 2000 – EN ISO 13485 the European Committee for Standardization (CEN) unifies the European version with the International standard and withdrawing the previous EN 46001
  • Year 2003 – 2nd Revision of the standard (2nd Edition)
  • Year 2012 – EN ISO 13485 harmonized European version with three European directives associated with the medical sector 93/42/EEC, 98/79/EC, 90/385/EFC
  • Year 2016 – 3rd Revision of the standard (3rd Edition)
  • ISO 9000:2015 – Quality management system (QMS)
  • ISO 10012, Measurement management systems — Requirements for measurement processes and measuring equipment.
  • Generally, whenever there is a revision, the previous standard is kept valid for 2 to 3 years. It is also called a transition period. Earlier the organization certified as per previous standards is expected to upgrade and get certified in accordance with the revised new standard.
  • This dependence on a number of factors, like the size of your firm, the complexity of your processes, the procedures you already have in place, and so on. Implementation can take 2-3 months for a smaller company (less than 100 people) and 5- 6months for a larger organization (more than 100 employees). The procedure is also influenced by the amount of time and resources your firm has to devote to implementation. That time should be factored into your overall schedule ahead of time, especially if you have a registration deadline to meet.
  • The ISO certification cost is determined by a variety of criteria, including internal resourcing capabilities, pre-existing management system documentation, as well as the size and scope of products and services offered by the organization. The cost of the Certification Body and the cost of the ISO Consultant are two of the most important charges involved.
  • It takes 15 to 20 days after the 2nd stage of the ISO Audit.
  • An ISO certification will need time, effort, and improvement from a variety of departments inside a company. The steps that must be done, however, are well worth it for any organization. Owners, staff, and customers will all gain from it.
  • To identify the authenticity of your accreditation body, one must
  • Visit the IAF – International Accreditation Forum website home page
  • Go to the IAF – International Accreditation Forum MLA–Multilateral Recognition Arrangement signatory’s category
  • Select the recognized AB – Accreditation Body sub category or recognized region sub category
  • From there you will select your country or the country your accreditation body belongs to
  • After which you can visit the website and look for your certification body.

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