Controls to ensure that Quality Plans are accurate

Moumen H

Registered
Hi Everybody,

Please can anyone help with examples of Controls that can be implemented to ensure that Quality Plans are accurate prior to use.

Many thanks in advance for your help.
 
L

locutus

Moumen, what do you by how to check if Quality Plans are accurate prior to use? Do you mean implementing a quality plan for a product line? In my experience, a quality plan would be a document reviewed and approved/accepted by a group of individuals that have the most knowledge and qualifications to determine if the quality plan is sufficient. Applying controls to the use of quality plans would be a circular activity in my mind. You should refer to ISO 10005 that gives good content and information behind how to implement and use quality plans in a management system.
 

Moumen H

Registered
Hi Locutus,

Many thanks for your replay and guidance. The meaning here, is how to make sure that the information that is collected in Quality plan is accurate.
 
Thread starter Similar threads Forum Replies Date
austin_howell Labeling Controls affecting Probability and Risk ISO 14971 - Medical Device Risk Management 7
Q ISO 13485 Contract Manufacturer Controls and Quality System Requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
Q Risk Controls in PFMEA ISO 14971 - Medical Device Risk Management 12
Bev D Development Process: FMEA, Critical Characteristics, Spec Setting and Controls Misc. Quality Assurance and Business Systems Related Topics 0
P E-Signature components and controls in 21CFR11 Qualification and Validation (including 21 CFR Part 11) 1
P Controls over Systems Documentation in 21 CFR Part 11 Qualification and Validation (including 21 CFR Part 11) 1
H Pre-production units & Purchasing/Supplier/Material controls ISO 13485:2016 - Medical Device Quality Management Systems 6
C Process owner for Supplier Controls ISO 13485:2016 - Medical Device Quality Management Systems 11
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 4 – Design Controls Other US Medical Device Regulations 0
JoCam Sub-distributor controls EU Medical Device Regulations 2
J Acceptance authority media and controls AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R GFE Audit - Violation? GFE Location Controls AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Special Controls and Standards Other US Medical Device Regulations 0
I RWE Studies and Design Controls US Food and Drug Administration (FDA) 1
D Use Error Risk Controls and Control Verification ISO 14971 - Medical Device Risk Management 6
N Help with understanding Process Controls Manufacturing and Related Processes 7
A Purchasing Controls on Change Management of Literature/Labeling ISO 13485:2016 - Medical Device Quality Management Systems 3
William55401 Distributed By Product - Best Practices for Configuration Management and Purchasing Controls ISO 13485:2016 - Medical Device Quality Management Systems 0
A IEC 62304 safety classification, External Controls and off-label use related risks IEC 62304 - Medical Device Software Life Cycle Processes 5
D Design controls - Inputs, outputs, V&V, DHF, DMR ISO 13485:2016 - Medical Device Quality Management Systems 10
Dean Bell Implementation of Controls as per SOA for Stage 2 Audit IEC 27001 - Information Security Management Systems (ISMS) 0
G Logistic organization and controls - IATF/ISO 9001 audit Nonconformance and Corrective Action 2
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C Compliance with ISO 17025 requirement 8.4.2 - Controls - Records recovery ISO 17025 related Discussions 4
M Special Controls and Class II Medical Devices Medical Device and FDA Regulations and Standards News 18
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Completing Design Controls after 510(k) Clearance Other US Medical Device Regulations 11
H Do purchasing controls apply to non-medical parts? ISO 13485:2016 - Medical Device Quality Management Systems 5
Jimmy123 What is the difference between Error Proofing and Controls? ISO/IATF 16949 - Control Plans FMEA and Control Plans 16
D Reduction of software class based on multiple external risk controls IEC 62304 - Medical Device Software Life Cycle Processes 5
R Supplier Controls we can place on Single-Source Suppliers ISO 13485:2016 - Medical Device Quality Management Systems 2
K Supplier Controls for Animal Tissue Suppliers for Medical Devices Other Medical Device Regulations World-Wide 0
J ISO 9001 8.4.1 - Determining controls applied to externally provided processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M IATF 16949 - 8.5.6.1.1 Providing a list of process controls: Does this requirement add value to QMS? IATF 16949 - Automotive Quality Systems Standard 4
D Risk management according to ISO 14971 - When to document risk controls? ISO 14971 - Medical Device Risk Management 10
V Additional Controls for processing the raw data on different computers (processing system) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 5
S Outsourcing manufacturing - Who controls the suppliers of parts to the CMO? ISO 13485:2016 - Medical Device Quality Management Systems 2
shimonv 'Beta testing' & Design Controls 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
J Supplier controls for consumer-grade off-the-shelf products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
F CQI-23 Special Process Molding - Controls IATF 16949 - Automotive Quality Systems Standard 7
M Outsourcing and internal controls Internal Auditing 1
G More on IATF 8.5.6.1.1 - Temporary Change of Process Controls IATF 16949 - Automotive Quality Systems Standard 4
M Controls for Suppliers of Translation Services - Receiving and Verification Supplier Quality Assurance and other Supplier Issues 8
T Temporary Change of Process Controls - IATF 16949 Clause 8.5.5.1.1 IATF 16949 - Automotive Quality Systems Standard 16
V Purchasing Controls - Prerequisites for Batch Release or even before Purchase Order 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
V Design Controls for Combination Drug Product Manufacturer (ANDA) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P IATF 16949 Clause 8.5.6.1.1 - Temporary Change of Process Controls IATF 16949 - Automotive Quality Systems Standard 21
dubrizo Initial Supplier Identification, Review and Controls ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
J How to understand IATF 16949 Clause 8.5.6.1.1 - Process Controls IATF 16949 - Automotive Quality Systems Standard 2
S Organizing Risk Analysis and Controls for a New Medical Device (ISO 14971) ISO 14971 - Medical Device Risk Management 4

Similar threads

Top Bottom