Is there any difference between QUALITY SYSTEM RECORD & QUALITY MANUAL

S

somnathzambare

#1
#1
we have Quality Manual for a ISO certified plant .
Now we are planning for USFDA .
Kindly let me know is there any difference between QUALITY SYSTEM RECORD & QUALITY MANUAL.
can we use the quality manual instead of Quality system record?
Need urgent help.
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
John Broomfield

John Broomfield

Leader
Super Moderator
#2
#2
Re: Need help

somnath,

The plant's process-based management system may be described in its Quality Manual. In other words the manual describes what is. Some manuals describe what shall be.

If this system conforms to ISO 9001, it's manual describes, or refers to a procedure that describes, the plant's evidence of using an improving its management system to determine and fulfill customer requirements.

The quality system record describes what actually happened. History in other words.

You have both the manual and the records already.

Make sure the plant's management system fulfills the U.S. FDA requirements by identifying processes missing from the system and any controls missing from its processes. Invest in putting these missing processes and controls in place.

The updated management system will then generate the evidence of conformity to the U.S. FDA requirements.

In other words it's about what the plant actually does not about what documents and records say what is and what was done.

John
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
A Definition Difference between Quality System Procedure and Standard Operating Procedure (SOP) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
I Difference between ASQR (Aerospace Supplier Quality Requirements) and AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
S What is the difference between an API Q1 and API Q2 Quality Manual Oil and Gas Industry Standards and Regulations 5
L Difference between a Quality Plan and Inspection & Test Plan (ITP) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
K Difference between being a Management Representative and being a Lead Quality ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Difference between COQ (Cost of Quality) vs COPQ (Cost of Poor Quality)? Misc. Quality Assurance and Business Systems Related Topics 8
N The difference between a Quality Policy and Quality Manual ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Difference between Management System and QMS (Quality Management System) General Auditing Discussions 5
T What is difference between a Corporate Quality Manual and TQM? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
V The Difference between Specifications and Quality Attributes - FDA Definitions US Food and Drug Administration (FDA) 7
D Difference between Record and Quality Record ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
A Difference between a Quality Policy and a Quality Objective ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Difference between SPC (process control) and SQC (quality control) Statistical Analysis Tools, Techniques and SPC 12
S What is the difference between the quality process and quality procedure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
Y What is the difference between Quality System & Quality Procedures? Document Control Systems, Procedures, Forms and Templates 13
M Difference between the Quality Plan vs. Control Plan FMEA and Control Plans 8
A Difference between general PMCF and PMS EU Medical Device Regulations 0
F Difference between "misuse" and "off-label use" EU Medical Device Regulations 9
placebo_master What is the difference between "Fitness for Purpose" and "Calibration/Verification"? General Measurement Device and Calibration Topics 6
C Need to understand difference between an actual Calibration vs. a Calibration check General Measurement Device and Calibration Topics 3
H API monogram 4F, The difference between PSL-1 & PSL-2 Oil and Gas Industry Standards and Regulations 5
G What's the difference between 1.32 and 1.33 Cpk? Capability, Accuracy and Stability - Processes, Machines, etc. 18
W What is the difference between TYPE B and TYPE BF? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T The difference between ISO 14644-3:2005 and ISO 14644:2019 Other Medical Device Related Standards 2
Q Terminal Lugs sizes - Difference between 225/24 vs. 275/24 lugs Manufacturing and Related Processes 2
M Difference between "Production Trial Run" and "Run at Rate" IATF 16949 - Automotive Quality Systems Standard 8
D Difference between Test Method Validation and Gage R&R Qualification and Validation (including 21 CFR Part 11) 19
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R What's the major difference between Green Belt and Black Belt in term of training and project Six Sigma 3
T Difference between a subcontractor and a supplier ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
H Difference between Stainless Steel 316 ASTM F899 and ASTM A276 Other Medical Device Related Standards 3
A Exact terms for a plating failure and difference between rejection rate and failure rate Manufacturing and Related Processes 9
M Difference between MSA and MSE? General Measurement Device and Calibration Topics 1
gramps What is the difference between discrete and continuous variables? Problem Solving, Root Cause Fault and Failure Analysis 3
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
S Difference between EU-MDR Annex IX and the Annex-combo X&XI EU Medical Device Regulations 4
T ISO 17025:2017 Clause 4.2.2 - The difference between "be notified" and "be informed" ISO 17025 related Discussions 4
Jimmy123 What is the difference between Error Proofing and Controls? ISO/IATF 16949 - Control Plans FMEA and Control Plans 16
C IEC 60601-1-8, difference between table 4 and annex D IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A What is the difference between Basic UDI-DI and UDI-DI? EU Medical Device Regulations 6
Q What is the difference between AS9100D 9.3.2.f and 9.3.3.a AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Aluminum - What is the difference between 6061-T6 and 6061-T651 (both per ASTM B211)? Manufacturing and Related Processes 4
P What is the exact difference between Risk and Opportunity in context of ISO 27001? IEC 27001 - Information Security Management Systems (ISMS) 7
S Difference between Surface Finish (Ra) and Flatness (GD&T) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
O Air Flow - Which is the operational difference between LAF (vertical and horizontal) and RLAF? Manufacturing and Related Processes 2
S What the difference is between Stub Acme & Acme thread? Oil and Gas Industry Standards and Regulations 1
S DO 178B - What is the difference between review and verification? Federal Aviation Administration (FAA) Standards and Requirements 1
T The difference between SOP and Kaizen Standardization Lean in Manufacturing and Service Industries 2
K Difference between intended purpose and intended use of the device EU Medical Device Regulations 9
Q What is the difference between normal and licensed internal auditor? VDA Standards - Germany's Automotive Standards 9

Similar threads

Top Bottom