New Job Position - Achieving ISO 13485 Certification

[JCarlos]

Hello everyone,

I discovered this forum today, and have been truly impressed with the amount of help and resources provided in here! I just wanted to share a quick background before throwing out there my questions...

I've been recently hired by a medical device company that manufactures IVD products. It's fairly small (around 30 employees), with a big R&D/investigational core but with a recent interest to develop a QMS and consequently achieve their ISO 13485:2016 certification tentatively next year (May 2021).

I'm the 1st person as part of this new full-on QA dept, and hired to achieve the implementation of a QMS while supporting different QA/QC activities.

I've undergone training and at the same time was tasked to review the existing Quality SOPs for an initial gap assessment from the ISO 13485 standard. I started digging into the standard and found that the following SOPs have been implemented already:

- GDP
- Document and Record Control
- Post-Market Surveillance
- Vigilance Reporting
- Risk Management
- Lot Numbers and Expiration Assignment
- Training and Qualifications

Honestly, I didn't find as many gaps from the standard for the existing SOPs, aside from a couple of observations; but I did establish the following documents as "missing" for the intended QMS (and as applicable to our process):

- Quality Policy
- Organizational Chart
- Quality Manual
- Design Control and Transfer
- Verification and Validation Requirements
- CAPAs
- Internal Audits
- Management Review
- Purchasing
- Statistical Significance
- Assessment of Vendors and Contractors
- Complaint Handling
- Non-Conformances Handling
- Product Release
- Rework / Reinspection

To be honest, at this point I find it a bit overwhelming (and exciting) the amount of work ahead, but I think I'm also influenced due to coming from very big companies where the QMS was as complex as its process and already defined by the time I started there.

I've been in touch with most of the areas integrating the QMS, but my experience has definitely been focused as an investigator (Complaints and NCs), managing post-market surveillance, internal audits, CAPAs, SCARs, product release and management reviews.

So my questions are:
1. What do you recommend for this 1st timer, where to start and a bit of a direction where to lead to?
2. From that first high-level gap assessment, are there any elements I may be missing?
3. Any other comments or personal experiences you may share, I'll appreciate it

Thank you!

 

[William55401]

Welcome to the Cove. Here's my quick take / free advice. While 30 people may seem small, it is not from a QMS standpoint. An org of this size will have specialists (individuals responsible for a function like purchasing, design, or mfg) who will operate to one or more procedures. You cannot do this alone. As the quality team member, you will certainly own the Q Manual, CAPA, internal audit, complaints, and training. There could be more. However, for a QMS to be effectively created and maintained, you need to engage process owners (the specialists) from functions to help create, implement, and maintain the procedures going forward. Those that operate a QMS procedure are in the best position to own it and adjust it on an ongoing basis to maintain compliance. Waiting for audit findings to take action on procedures is not the way to work. Create a culture of following procedures. When you can't, stop and fix them. Process owners are in the best position to do this. Quality cannot play this role alone.

One more. As you begin creating a wave of new content, put training early on your list. Ensure that the existing system is robust to deliver all the new content and that the records are organized and retrievable.

Last one. Have fun. Enjoy the ride.

 

[Tagin]

Create a culture of following procedures. When you can't, stop and fix them. Process owners are in the best position to do this. Quality cannot play this role alone.

This is where the company leadership comes in. If the leadership is not involved and championing quality, then it can be very difficult to get process owners and everyone else to think quality and follow along, depending on the company culture.

I'd also add that it can be necessary to teach the others that the quality dept. isn't 'where quality happens': quality becomes built into the processes and is part of everyone's responsibility. In my view, your role is not to be the dumping ground for all the problems and headaches that someone says is a 'quality issue'; but rather, your role is primarily the stewardship of the QMS and its successful integration/embedding into the business processes.

 

[JCarlos]

Thanks William55401! I really appreciate your input on this. I do agree that early engagement of the different process owners will definitely help creating the QMS in the most efficient way. I think it was missing practice here, hence why the idea of establishing a strong QA-driven presence for the first time.

Also, agree on putting training on the top of the list, it was identified as one of the first items "to work-on" during that gap analysis. This with the intention to establish and test the developing system.

 

[JCarlos]

Thanks Tagin! I agree on the importance of engaging the company leadership while creating/implementing the QMS, that in order to effectuate the drive for quality.

I appreciate the input, I agree that quality is something that should be part of our daily activities while being everyone's responsibility. I know it'll be something to work on from the get-go in order to establish the importance of everyone's participation to make the QMS effective.

 

[rudra]

Hello everyone,

I discovered this forum today, and have been truly impressed with the amount of help and resources provided in here! I just wanted to share a quick background before throwing out there my questions...

I've been recently hired by a medical device company that manufactures IVD products. It's fairly small (around 30 employees), with a big R&D/investigational core but with a recent interest to develop a QMS and consequently achieve their ISO 13485:2016 certification tentatively next year (May 2021).

I'm the 1st person as part of this new full-on QA dept, and hired to achieve the implementation of a QMS while supporting different QA/QC activities.

I've undergone training and at the same time was tasked to review the existing Quality SOPs for an initial gap assessment from the ISO 13485 standard. I started digging into the standard and found that the following SOPs have been implemented already:

- GDP
- Document and Record Control
- Post-Market Surveillance
- Vigilance Reporting
- Risk Management
- Lot Numbers and Expiration Assignment
- Training and Qualifications

Honestly, I didn't find as many gaps from the standard for the existing SOPs, aside from a couple of observations; but I did establish the following documents as "missing" for the intended QMS (and as applicable to our process):

- Quality Policy
- Organizational Chart
- Quality Manual
- Design Control and Transfer
- Verification and Validation Requirements
- CAPAs
- Internal Audits
- Management Review
- Purchasing
- Statistical Significance
- Assessment of Vendors and Contractors
- Complaint Handling
- Non-Conformances Handling
- Product Release
- Rework / Reinspection

To be honest, at this point I find it a bit overwhelming (and exciting) the amount of work ahead, but I think I'm also influenced due to coming from very big companies where the QMS was as complex as its process and already defined by the time I started there.

I've been in touch with most of the areas integrating the QMS, but my experience has definitely been focused as an investigator (Complaints and NCs), managing post-market surveillance, internal audits, CAPAs, SCARs, product release and management reviews.

So my questions are:
1. What do you recommend for this 1st timer, where to start and a bit of a direction where to lead to?
2. From that first high-level gap assessment, are there any elements I may be missing?
3. Any other comments or personal experiences you may share, I'll appreciate it

Thank you!

Hello everyone,

I discovered this forum today, and have been truly impressed with the amount of help and resources provided in here! I just wanted to share a quick background before throwing out there my questions...

I've been recently hired by a medical device company that manufactures IVD products. It's fairly small (around 30 employees), with a big R&D/investigational core but with a recent interest to develop a QMS and consequently achieve their ISO 13485:2016 certification tentatively next year (May 2021).

I'm the 1st person as part of this new full-on QA dept, and hired to achieve the implementation of a QMS while supporting different QA/QC activities.

I've undergone training and at the same time was tasked to review the existing Quality SOPs for an initial gap assessment from the ISO 13485 standard. I started digging into the standard and found that the following SOPs have been implemented already:

- GDP
- Document and Record Control
- Post-Market Surveillance
- Vigilance Reporting
- Risk Management
- Lot Numbers and Expiration Assignment
- Training and Qualifications

Honestly, I didn't find as many gaps from the standard for the existing SOPs, aside from a couple of observations; but I did establish the following documents as "missing" for the intended QMS (and as applicable to our process):

- Quality Policy
- Organizational Chart
- Quality Manual
- Design Control and Transfer
- Verification and Validation Requirements
- CAPAs
- Internal Audits
- Management Review
- Purchasing
- Statistical Significance
- Assessment of Vendors and Contractors
- Complaint Handling
- Non-Conformances Handling
- Product Release
- Rework / Reinspection

To be honest, at this point I find it a bit overwhelming (and exciting) the amount of work ahead, but I think I'm also influenced due to coming from very big companies where the QMS was as complex as its process and already defined by the time I started there.

I've been in touch with most of the areas integrating the QMS, but my experience has definitely been focused as an investigator (Complaints and NCs), managing post-market surveillance, internal audits, CAPAs, SCARs, product release and management reviews.

So my questions are:
1. What do you recommend for this 1st timer, where to start and a bit of a direction where to lead to?
2. From that first high-level gap assessment, are there any elements I may be missing?
3. Any other comments or personal experiences you may share, I'll appreciate it

Thank you!

Hi Carlos,

I am exactly in a similar position as you are/were. I am with a small startup that mainly serve as importer/distributor of IVD and tasked wiht developing a QMS. can you advice and provide suggestions on where i can start and the best approach to take ? this is my first time working in quality however i am aware of the regs . i am wondering if you may have some valuable suggestions as you mention that your experience mainly was in managing post market surveillance, complaints, NC , pdt release and CAPS etc.

I greatly appreciate any help.

Thank you