ISO 13485 & 9001 Specialist Parag Kumar

A Q & A with our New Mentor Parag Kumar

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We are excited to introduce a new quality mentor on Jomo247’s compliance platform: Specialist in Quality and Medical Device ISO Certification, Parag Kumar.

Parag has over 20 years of experience in quality management, ISO certification and auditing within organizations across multiple industries and countries.

Read on to find out more about Parag and his work or visit his profile and contact him here.


How did you get involved in ISO 9001 and ISO 13485?


My background comes from working in world class hotels, where quality is essential to everyday working practice.


Around 2000, I came in contact with a reputed Quality Management consultant, a retired Maj Gen of Indian Army, and did a small seminar on ISO 9001, and that was where my journey as a freelance quality consultant and auditor began.


He trained me, and together we did a project helping a training institute establish and implement their QMS. Subsequently I did a lead auditor’s course in ISO9001.


My early years saw me working in education, construction, manufacturing, healthcare and even a blood bank in India.


ISO 13485 came about because a medical device start-up approached me for ISO 9001, and later decided they wanted 13485 and they wanted me to continue advising them for same. I then trained in ISO 13485 and have since done my lead auditor’s course for ISO 13485:2016.



What are your specializations?


My expertise in quality management through ISO 9001 runs across many sectors and through ISO 13485 for medical devices. I have done lead auditor’s courses in ISO9001:2015 and ISO13485:2016.


The organisations I work with are the experts in their area and their involvement is necessary. I come in and understand how they work, and take them through the standards and  help them improve on what they are currently doing.



What is your favourite thing about quality and medical device ISO standards?


From the beginning the word quality has enthralled me.


Achieving and maintaining quality is possible through systematic working of well established processes and bringing improvement within such a system.


When working with someone on quality and medical device ISO standards, I am always on the lookout for how I can help the organisation to improve.


It’s also important to me to keep learning, as aforementioned I have trained in new ISO standards as and when they come up for my clients.



What does a typical day of working on quality and medical device ISO standards look like for you?


When starting a new project, I visit on-site for 2-3 days and analyse their current processes and understand them through process mapping.


I explain to top and middle management, the intricacies of ISO 9001 or ISO 13485, and how things need to be documented and evidenced to achieve compliance. A plan of action is discussed and finalized.


Then, 2 days of training happens for the task-force I help management to create, and development of QMS is started, coordinated by a designated person of the organization.


This takes about three months depending on the size of the organization and time devoted.


These 3 months are filled with process and procedure review, documentation management, and policy writing with periodic reviews with management to alter, look at points of improvement, and ascertain objectives.


Awareness seminars and required training is conducted before full implementation, and once the system has been implemented I help / advise management in ensuring that all activities are carried out as per established system.


During this period, I train the internal quality auditors and guide them to conduct an internal audit after about six weeks with the aim of ensuring that the new system is compliant.


I also advise the organization on subsequent corrective action process.


After the internal audit, I advise the top management on conducting a management review.


Internal quality audit and management review are repeated after about a month or so.


Once the implementation has stabilised, we then work together, if needed, to decide on certification bodies, and external audit to achieve certification.


In these pandemic times I help my clients remotely as well.



What interests you about becoming a mentor for Jomo247?


I am looking forward to becoming a mentor because I want to widen my reach, and be available to more people who would benefit from my help.



What do you think the next big thing will be in quality and medical device standards?


With ISO 9001:2015, the context of the organisation, and risk management has been brought into the standard, and I believe that this focus will stay for some time before it changes.


I have also noticed a sudden growth in automation with new compliance and ISO management softwares being brought in, and I think software that enables programming to specific needs of the organisation will be most useful to the industry.

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