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Ultimate Guide to ISO 13485:2016 (Medical Devices Standard) Transition

The international Medical Devices Quality Management Systems (QMS) ISO 13485 standard has been updated with some more useful amendments published in March, 2016 resulting in ISO 13485:2016.

The Clock is Ticking!. Tik Tok!..

The time is running out very speedily! All the medical industry manufacturers has to comply with updated version of ISO medical device standard i.e. ISO 13485:2016 by 28th February, 2019 so get your teams ready to get on transition journey to ISO 13485:2016.

Confused where to start? Call Sync Resources experts today!

How to Start?

You can start off with following baby steps with the help of Sync Resources experts and your team:

  1. With the help of Sync Resources team, a comparison will be drawn between current management system and ISO 13485:2016 standard clauses.
  2. An action plan with time bound activities will be advised and tracked.
  3. Frequency of internal audits will be set accordingly.
  4. Top leadership team will be involved to review internal audit reports and previous audit records.
  5. Challenge your team to exhibit change adaptability habit.

What was wrong with Older Version of ISO 13485?

The older version of ISO 13485:2003 standard’s foundation is based on another older version of Quality management system i.e. ISO 9001:2000 (not the latest version which is ISO 9001:2015) and with the passage of time new technologies have been introduced in the healthcare and medical standard so with modern ways getting applied in medical industry, there was a crying need to update medical device standards that will go hand in hand with new medical technologies.

Fulfilling Legal Requirements

Prior to updating ISO 13485:2003, the term “statutory and regulatory requirements” was used which has now been replaced by relatively simpler term which is “regulatory requirements” which demonstrates the meaning of statutory, legal, local/national requirements.

Noteworthy Amendments in ISO 13485

Here is a quick guide to gear up your transitioning journey to ISO 13485:2016:

  1. Risk Based Approach

With reference to product safety and performance in medical device industry, risk based approach has been put special emphasis in updated version of ISO 13485:2016. However, risk based approach consists of many factors including to identify all risk that have potential to harm or to create disturbance in system, measuring likelihood, urgency to resolve and prioritization of risks according to severity, mitigation and substitution of risks in accordance with their severity, any incident plans with complete documentation of action plan and their expected outcomes and proper storing of all documented information.

  1. Regulatory Requirements Goes Hand In Hand With Regulatory Documentation

All the regulatory documentation must be linked with Regulatory and legal requirements.

  1. Design and Development

The product quality starting from drawing board design to final outcome, ISO 13485:2016 covers it all. This clause comes into action specifically when release management process is ongoing to ensure everything is risk and defect free. Internal and external feedbacks on the outcomes are properly being recorded, reported and addressed. Verification process is also sandwiched between updated rules of compliance which should be supported by documented information. ISO 13485:2016 comes into action when testing new products after finalizing their design and development phase.

  1. Training and Development of Human Capital

All employees must receive relevant trainings in order to perform their role and responsibilities correctly meeting deadlines. The level of competency, skills and experience must be enhanced when an employee gets onboard especially for the staff that is designated in production areas, quality control and quality assurance areas. It is advised to identify competency gaps of employees and arrange trainings from the subject matter expert so that competency gaps can be fulfilled within described time frame.

  1. Suppliers and Vendors Management

More effective regulations for monitoring and suppliers management has been introduced in ISO 13485:2016 which majorly includes transparency in suppliers’ performance and utilization of proper tools to gauge their performance leading to periodic re-evaluation of each major and minor supplier over the period of time, risk based approach to measure supplier based risk that have potential to damage the performance along with documented detailed assessment of all potential risks involved with their minimization and substitution action plan having time bound activities.

  1. Compliant Handling

Creation of a proper complaint handling channel is mandatory in ISO 13485:2016 implementation plan where creating and documenting all complaints with proper registration number is mandatory, periodic regular surveying of customers with their documented feedback from all areas, reporting of every registered complaint to regulatory bodies to resolve complaint, corrective action identification, accomplishment of tasks within deadlines to meet customers’ satisfaction level, observe and record the impact of customers’ complaints.

  1. Harmonizing Software with Different Software Application

Process control software, other monitoring, recording and measurement software should be harmonized with the requirements of different clauses of updated ISO 13485:2016 standard.

  1. Appropriate Infrastructure

Production and quality control infrastructure in particular must be in appropriate conditions so that production of sterile medical devices can be ensured and validation of sterile barrier properties can also be done.

  1. Internal Audits

ISO 13485:2016 states that you must conduct internal audit activity as per planned according to your schedule but it should be effective and focused with time bound activities meeting the planned arrangements, fulfilling the requirements of the ISO 13485:2016 standard and also meeting the requirements of the management system of the organization. Internal audit activity must state the “Status and Importance” of all the processes being audited and areas being internally audited by internal auditors. However, internal auditors must audit the areas fairly and with unbiased approach. It is mandatory to audit every 12 months (besides other planned activity of internal audit that has been advised keep ing your current management system in consideration. The results of previous audits must also be reviewed more specifically the critical points or major and minor conformities (if any).

Meta Description:

ISO 13485:2016 is a revised form of ISO 13485:2003 which was based on ISO 9001:2000. ISO 13485:2016 is based on new version of ISO 9001:2015. Hence it is more integrated with quality management standard.