Definition Q - Definitions of all the Q's - QM, QMS, QP, QSR, etc.

J

Jimmy the Brit

#11
........... of course in European Pharmaceutical Manufacturing and Distribution a QP is a Qualified Person - a formal assessed appointment, the only person allowed to release pharmaceutical products onto the market. I always use the term Quality Policy in full to avoid any confusion.

Ain't acronyms grand!
 
Elsmar Forum Sponsor
D

Debbie Kerr

#12
Thanks for all your help. We were hoodwinked by a con artist who said she knew Quality but based all our 2007 SOPs on EN 46001!

Can someone tell me a quick definition and purpose of each document/manual?

Or is there some reference or source that explains it? I need a "chronological" order because I am surrounded by all these things and cannot make logical sense of it.

Thanks again - I'm still smiling through the frustration!:frust:
 

howste

Thaumaturge
Super Moderator
#13
Can someone tell me a quick definition and purpose of each document/manual?

Or is there some reference or source that explains it? I need a "chronological" order because I am surrounded by all these things and cannot make logical sense of it.
ISO 9000 (not 9001) defines terms used in ISO 13485.
 
P

Phil Fields

#14
Our start-up company made a bad decision in obtaining a Quality manual - which was very expensive and pretty useless! We are trying to make sure we are ISO 13485-based. This whole thing is new to me but I've found very helpful information on this site.

What I would like to know is a quick definition and differences for the following:
1. QSM (Quality System Manual)
2. QP (Quality Plan)
3. QMS
4. QSR
5. QM

Are any of these the same thing, just referred to with different letters?

Thanks for any help I can get!:confused:
Debbie,
Hello. Why is it important for you to know the definitions? Hopefully this is not an issue that is side tracking you from completing a goal of developing a Quality Management system.

Hopefully you have a copy of ISO 13485 and a copy of 21 CFR Part 820. I would read both of these, compare them and start to develop your system from there.

Obviously you are a medical device manufacturer since you a re looking at 13485. As you develop your system remember that 13485 is voluntary and 21 CFR Part 820 mandatory

I hope this helps,
Phil.
 
J

Jimmy the Brit

#15
Hopefully you have a copy of ISO 13485 and a copy of 21 CFR Part 820. I would read both of these, compare them and start to develop your system from there.
Good advice - I'd also add PD ISO/TR 14969:2004 to that list, which offers guidance on the application of ISO13485
 
D

Debbie Kerr

#17
Thanks for your input. I have the comparison and am looking at it.

The reason I want a definition is so I understand what I'm doing. For those of you who have been doing this for a while, it probably makes some kind of sense, but for a newcomer, it makes my head spin!:biglaugh:
 
P

Phil Fields

#18
Debbie,
For more information try AAMI.org, Association for the Advancement of Medical Instrumentation. AAMI provides training for ISO 13485 in conjunction with 21 CFR Part 820.
I have attended this course and it is very beneficial. I liked it since both AAMI and FDA representatives were presenters.
http://www.aami.org/meetings/courses/qs.html

Phil
 
D

Debbie Kerr

#19
The boss has plans for more training for me early next year!! That will be a blessing.

This site is great - and everyone is so helpful and knowledgeable. A BIG thanks to all .:thanx:
 
Thread starter Similar threads Forum Replies Date
E Where to put QMS Definitions, e.g. forms, policies, etc ISO 13485:2016 - Medical Device Quality Management Systems 8
K What to include in SOP Definitions section Document Control Systems, Procedures, Forms and Templates 3
T OFI (Opportunity for Improvement) vs. AOC (Area of Concern) - Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
Ajit Basrur Definitions - Short-term and Brief exposure Occupational Health & Safety Management Standards 2
M Medical Device News TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia Medical Device and FDA Regulations and Standards News 0
L Definition Mini Builds - Quality Assurance Terms and Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
D Supporting Process Definitions - Remote Locations IATF 16949 - Automotive Quality Systems Standard 4
C Specification Developer or Consultant? Definitions 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Russia - Medical Device Regulation Including Definitions Needed Other Medical Device Regulations World-Wide 3
T Definition Sole source VS. Single Source - Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
T Primary & Secondary Inspection Definitions - Incoming, In-process & Final Inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
O Definition Korean Definitions - Korean Language Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
Mikishots Definition Issue - "Issue" vs. "Risk" in ISO 9001:2015 and AS9100 Rev D (Definitions) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
P IATF Definitions - Reworked product (8.7.1.4) vs Repaired product (8.7.1.5) IATF 16949 - Automotive Quality Systems Standard 40
S ISO 13485 Definitions - Medical Device Component Supplier ISO 13485:2016 - Medical Device Quality Management Systems 4
G Definition Certificate of Conformance vs. Certificate of Conformity definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 8
M Definition Design & Development Definitions - Are they synonymous? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
E Medical Device Directive 93/42/EEC definitions help EU Medical Device Regulations 3
K FDA definitions - Repackager vs. Domestic Distributor US Food and Drug Administration (FDA) 5
S Definition MTBF and MCBF Correct Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 5
F "Labeling" vs "Accompanying Documentation" - FDA Definitions IEC 62366 - Medical Device Usability Engineering 2
L Definitions for Minor & Major Nonconformances ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
B Definition Sort vs. Rework - Differences and Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
J Requirements vs. Change Requests - IEC 62304 Definitions IEC 62304 - Medical Device Software Life Cycle Processes 4
MarilynJ6354 Definition Improvement Suggestion vs. Preventive Action - Clear Definitions and Differences Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 6
Moncia Definition Natural, Synthetic definitions needed as in ISO 9235 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
M Definition Major vs. Minor Non Conformance Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 14
P ISO 22002-1 - Food Defence, Biovigilance and Bioterrorism Definitions Food Safety - ISO 22000, HACCP (21 CFR 120) 3
bio_subbu GHTF issues revised document "Definitions of ?Medical Device? and ?IVD? Other Medical Device Regulations World-Wide 1
N Total Productive Maintenance (TPM) Portuguese Definitions and Terms Quality Tools, Improvement and Analysis 4
Q Definition Claims or Complaints? ISO 9001 Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 6
S Definition Output and Outcome - Differences and Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 13
M TS 16949 Cause 7.4.1: Type of Control vs. Extent of Control (Definitions) IATF 16949 - Automotive Quality Systems Standard 5
N Clean Room Validation and Certification Methods and Definitions ISO 13485:2016 - Medical Device Quality Management Systems 2
C Chrysler Quality Definitions? Chrysler has identified six types of quality Quality Manager and Management Related Issues 1
M Special Characteristics Definitions in TS 16949 IATF 16949 - Automotive Quality Systems Standard 7
optomist1 Definition Measurement Uncertainty - Standard definitions for Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 8
Q Definition Rockwell Hardness definitions - BW 96 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
A Medical Devices - Direct vs. Indirect Body Contact - Definitions Other US Medical Device Regulations 4
C List of Potential Hazards Definitions in Annex E of BS EN ISO 14971:2009 ISO 14971 - Medical Device Risk Management 4
C Out of Calibration vs. Out of Tolerance - Calibration Definitions Nonconformance and Corrective Action 7
W Patient Circuits / Patient Connection / Applied Parts - Medical Device Definitions IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
G Production Permit (aka Waiver) vs. Concession (aka Deviation) - Definitions Quality Manager and Management Related Issues 4
S Dates That Require to Stated in Standard Operating Procedure (SOP) & Definitions Document Control Systems, Procedures, Forms and Templates 1
M VDA Specifications - Common definitions, acronyms, etc. VDA Standards - Germany's Automotive Standards 1
C MBD (Model Based Definitions) and Characteristic Accountability AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D Correction and Degree of Error - Metrology Definitions and Differences General Measurement Device and Calibration Topics 1
J What is Quality Risk? ISO/TS 16949 Definitions IATF 16949 - Automotive Quality Systems Standard 1
I IEC 62304:2006 Definitions - Software System, a Software Element and Software Unit IEC 62304 - Medical Device Software Life Cycle Processes 13
B Overhaul vs. Repair vs. Rework - FAA Definitions Federal Aviation Administration (FAA) Standards and Requirements 7

Similar threads

Top Bottom