SBS - The Best Value in QMS software

New Job Position - Achieving ISO 13485 Certification

#1
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!
 
Elsmar Forum Sponsor

William55401

Quite Involved in Discussions
#2
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

Trusted Information Resource
#3
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.
 
#4
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.
 
#5
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.
 
#6
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
 
Thread starter Similar threads Forum Replies Date
A Shall I apply for this job position (Quality Manager)? Career and Occupation Discussions 5
K What is the entry level position/job in the field of Quality? Career and Occupation Discussions 14
C Your position and ethics on your job - Unqualified Personnel Career and Occupation Discussions 19
R Help with Job Interview presentation - Position of Management Auditor Career and Occupation Discussions 8
C Need opinions to make decision on New Job position Career and Occupation Discussions 18
M ISO 9001 vs. QS9000 vs. ISO 14001 - Job interview tomorrow night for a QM position Career and Occupation Discussions 4
M ISO 9001 Truck Transportation Position (Job) Description Career and Occupation Discussions 1
T How should I approach REACH, CM, etc. as a job shop? RoHS, REACH, ELV, IMDS and Restricted Substances 18
was named killer Job Opportunity-Quality Engineer-Tampa Florida Job Openings, Consulting and Employment Opportunities 0
Marc Job Opportunity – Quality Assurance Specialist - Suspense 7 April 2021 Job Openings, Consulting and Employment Opportunities 0
L Job Aids for administrative staff in GLP environment Document Control Systems, Procedures, Forms and Templates 6
B Qualifcations of Staffing Agency Employees to meet job description General Auditing Discussions 6
K Looking for a job as Quality Engineer Career and Occupation Discussions 3
XRAY_3121 New Job with Wholesale Distributor Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
N Looking to Impress - New Job - Advice, Thoughts, Comments Welcome Career and Occupation Discussions 23
C Refreshing an old and boring topic - Job descriptions and Roles vs Process Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
BeaBea Organizational Charts and Job Titles Process Maps, Process Mapping and Turtle Diagrams 20
M IATF 16949 8.5.1.3 Verification of job set-ups - Do we need secondary check? IATF 16949 - Automotive Quality Systems Standard 7
B Product Safety Responsibility - Job shop such as a machine shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
JAMESH Job Safety - Lockout/Tagout and Respiratory Protocols Manufacturing and Related Processes 3
S Regulatory job in pharma vs. medical device US Food and Drug Administration (FDA) 16
S Regulatory job in pharma vs. medical device CE Marking (Conformité Européene) / CB Scheme 0
M Do I Expect Too Much of Job Candidates? Career and Occupation Discussions 33
JAMESH Building a "Lean" Job Shop Training Program Training - Internal, External, Online and Distance Learning 0
I "On the job training" as a response to how someone was trained? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 75
M Nonconformity for missing form number on the job description document Nonconformance and Corrective Action 1
Sidney Vianna Are the Accreditation Bodies doing their job? Keeping CB's accountable Registrars and Notified Bodies 0
T QMS Template Help - Small machine shop/job shop Manufacturing and Related Processes 1
I ISO 9001:2015 - On the Job Training and Records Training - Internal, External, Online and Distance Learning 4
G Job interview - So I have to do a presentation on PPAP APQP and PPAP 16
F Job Travelers questions - unsigned operations AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 41
Marc Posting Job Openings - Read Me Please - 27 January 2019 Job Openings, Consulting and Employment Opportunities 0
K Assigning the Correct Procedures Applicable to Job Titles General Auditing Discussions 15
W Job Card/Router sign off - Want to go paperless AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
S Is management representative a temporary post or a job title Management Review Meetings and related Processes 16
Q Have you ever "excluded" certain job descriptions from the QMS? ISO 13485:2016 - Medical Device Quality Management Systems 10
C IATF 16949 Cl 8.5.1.3 - Verification of job set up IATF 16949 - Automotive Quality Systems Standard 4
D How do you use statistics in your job Statistical Analysis Tools, Techniques and SPC 6
Sam Lazzara Notified Body CE Project Manager - Worst job ever? EU Medical Device Regulations 6
D Job Titles referenced in Procedures IATF 16949 - Automotive Quality Systems Standard 18
Marc How did you "get" a full-time job? (A 2017 discussion) Career and Occupation Discussions 11
M Apply for a job when no opening is posted? Career and Occupation Discussions 64
M AS9100D excluding Design and Development - Small Job Shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
A Splitting Paper Routing Job Worksheets AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
N I updated my Job Description - Critiques Appreciated Career and Occupation Discussions 22
S Job travelers through a machine shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
L South of England - experienced Auditor / QMS looking for a new job Career and Occupation Discussions 1
I ISO 17025 Job Descriptions - People who have mutiple roles ISO 17025 related Discussions 2
A Best Method of Auditing an Installation Process at a client job-site ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
H Job Interview Question - Faulty machine Manufacturing and Related Processes 8

Similar threads

Top Bottom