SBS - The best value in QMS software

Quality Department Structure in a Small Medical Device Company

T

terry31575

#1
I am at a small device start-up. We are working towards being ISO 13485 and 21 CFR 820 compliant.

I am the quality manager and I have one document control person working for me. I am in the process of hiring a QC person as move into manufacturing. I do not have a specific QA person.

Does anyone see a problem with the Quality Manager acting as QA and being the direct supervisor of QC? I can see how this would be a conflict of interest but we are also small company and can only hire so many employees. Is there a guidance or regulation around this?

Thanks
Terry
 
Elsmar Forum Sponsor

John Broomfield

Staff member
Super Moderator
#2
Re: Quality Department Structure

Terry,

I see no problem with the Quality Manager ensuring the QMS delivers confidence that the requirements will be fulfilled.

This is the essence of QA.

Whether the regulators agree may be another matter!

John
 

DannyK

Trusted Information Resource
#3
I am at a small device start-up. We are working towards being ISO 13485 and 21 CFR 820 compliant.

I am the quality manager and I have one document control person working for me. I am in the process of hiring a QC person as move into manufacturing. I do not have a specific QA person.

Does anyone see a problem with the Quality Manager acting as QA and being the direct supervisor of QC? I can see how this would be a conflict of interest but we are also small company and can only hire so many employees. Is there a guidance or regulation around this?

Thanks
Terry
There should be no problems whatsoever.
 

mihzago

Trusted Information Resource
#4
I'm not sure if I understand what the problem would be, where is the conflict of interest?
I would think that it is advisable for QA Manager to be a supervisor of a QC function. Unless, as a QA manager you are somehow directly involved in production.
 
J

Jordan Thornes

#5
We've never had a problem with auditors or inspectors with this type of arrangement. It's far less of a conflict of interest than QC reporting into operations or production. Neither ISO 13485 or 21 CFR Part 820 regulates the reporting structure in the company. It's more that certain arrangements (such as QA reporting to operations) may invite additional scrutiny from an auditor due to being more likely to lead to nonconformities.

I understand your concern is that you are signing the release of a product based on the manufacturing and QC test results. Since the QC operator reports to you, you may take is easier on "one of your own"
 
Thread starter Similar threads Forum Replies Date
F Risk for Quality Assurance Department in a Hospital - Hospital Incident Reporting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T Question about Quality Department employee position titles Quality Manager and Management Related Issues 10
J Implementation of Total Quality Management/Starting a Quality Department Reliability Analysis - Predictions, Testing and Standards 9
T Setting up a quality department in an Engineering Firm Quality Management System (QMS) Manuals 11
S Quality Department Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
Q Department Expansion as a Quality Objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G Should the Quality Department originate a Request for Deviation to the Customer? Nonconformance and Corrective Action 3
A Quality Department - Operational Framework Service Industry Specific Topics 2
L Supplier Approval Process – Should the Quality Department be Excluded? Misc. Quality Assurance and Business Systems Related Topics 7
A Operational Procedure for an IT Service Industry Quality Department Service Industry Specific Topics 1
T Internal Audit not done for Quality Department Internal Auditing 11
A IT Managed Services Company Quality Department - Operational Document ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S ERP Software and Quality Department Procedures Integration Misc. Quality Assurance and Business Systems Related Topics 4
S Is it a Finding if all Internal Auditors are from the Quality Department? Internal Auditing 18
Antonio Vieira Thoughts on implementation of Quality Management System in a Police Department ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
K Are Quality Objectives applicable on HSE Department? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
C Starting a Quality Department from Scratch and Implementing ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
M Internal Quality Audit for Maintenance Department ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Auditing IT department quality General Auditing Discussions 2
P ISO9001 in Quality Control Department - Control of Nonconforming Product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Should the Quality Department be independent of Operations Misc. Quality Assurance and Business Systems Related Topics 15
J Quality Objectives for Engineering Department and R&D Quality Manager and Management Related Issues 5
Q Global Organisation Chart for the Quality Management Department Quality Manager and Management Related Issues 1
D Determining Quality Objectives for the Finance Department ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
I Business Plan for Setting Up a Quality Department Quality Manager and Management Related Issues 4
F Quality Department in an IT Services Company Quality Manager and Management Related Issues 4
K Global Quality Department Organizing and Planning Quality Manager and Management Related Issues 3
M Quality Assurance Department Staffing Quality Manager and Management Related Issues 6
A Can I Audit Quality Procedures if I come from the Quality Department Internal Auditing 5
R Defining Department wise Quality Objectives in terms of Effectiveness and Efficiency ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Z Involvement of Management representative (ISO 3834) in Quality Department Misc. Quality Assurance and Business Systems Related Topics 7
A How to Audit the Quality Department (Internal Audit) Internal Auditing 15
kedarg6500 What is a Quality Engineering Department? What are the functions it handled? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Z Department of Defense (DoD) Quality Plan Document Control Systems, Procedures, Forms and Templates 11
C Quality Objectives for my Sales Department ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
G Must the QMS Management Representative be part of the quality department? Quality Manager and Management Related Issues 23
U Question about test management tool (softwares) for Quality assurance department Quality Assurance and Compliance Software Tools and Solutions 10
L Is an internal audit of quality department required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Starting a quality Department - What are the things I need to initiate it? Misc. Quality Assurance and Business Systems Related Topics 5
K What are the goals for your Quality Department? Quality Tools, Improvement and Analysis 8
K Quality department & Regulatory department split - Need suggestions on scope Quality Manager and Management Related Issues 12
S Creating a system to capture Quality related issues for design department Design and Development of Products and Processes 10
T Titles for Quality Functions - Very small business quality department query ISO 13485:2016 - Medical Device Quality Management Systems 17
M Should QA (Quality Assurance) be its own independent Department? Quality Manager and Management Related Issues 33
I High COPQ (Cost Of Poor Quality) from Our Quality Department IATF 16949 - Automotive Quality Systems Standard 7
F What are the Performance Indicators for Supplier Quality Management Department Supplier Quality Assurance and other Supplier Issues 11
S How to Calculate Quality Department Resources? Misc. Quality Assurance and Business Systems Related Topics 3
A Measurable Quality Objectives of the Corporate Communication Department ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
J Quality Department Job Opening - High Point, North Carolina Career and Occupation Discussions 0
J Does your Quality Assurance Department have its own Independent Budget? Misc. Quality Assurance and Business Systems Related Topics 19

Similar threads

Top Bottom