SBS - The best value in QMS software

Outline of the Structure of Documentation in Quality Manual

Jim Wynne

Jim Wynne

Staff member
Admin
#11
#11
GStough said:
Well, he stated that the quality manual does not contain the outline of the structure, etc. (my emphasis). This, to me, would lead one to believe that there is a specific diagram outline or some other specific document....
Click to expand...
Your QM includes a description of the structure that is not graphical, correct? Just ask the auditor to provide some rational basis for his apparent belief that "outline"="drawing." You may want to show him this, from the American Heritage Dictionary:
[SIZE=-1]NOUN:[/SIZE]1a. A line marking the outer contours or boundaries of an object or figure. b. The shape of an object or figure. 2a. A style of drawing in which objects are delineated in contours without shading. b. A sketch done in this style. 3a. A general description covering the main points of a subject: an outline of American literature. b. A statement summarizing the important points of a text. c. A summary of a written work or speech, usually analyzed in headings and subheadings. 4. A preliminary draft or plan, as of a project or proposal.
Click to expand...
 
Quickly Organize an Intelligent TDP from DISCUS
Elsmar Forum Sponsor
GStough

GStough

Staff member
Super Moderator
#12
#12
Jim Wynne said:
Your QM includes a description of the structure that is not graphical, correct? :
Click to expand...
Yes, that is correct. It is a statement that fits perfectly the definition of "outline" in 3b, according to the dictionary excerpt posted above.
 
Last edited:
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
T Quality Manual shall Outline Structure of Documentation - Clause 4.2.2 ISO 13485:2016 - Medical Device Quality Management Systems 10
A AS9102 FAI Case Outline Difference AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
G Can anyone outline the advantages to an organisation - ISO 9001 Benefits ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
J Outline of Data Integrity Training or a Data Intergrity Agreement example wanted Quality Manager and Management Related Issues 2
DanteCaspian Procedure outline for hiring process Misc. Quality Assurance and Business Systems Related Topics 1
C Need a procedure or outline on Good Practices for Completing Quality Records/Document Document Control Systems, Procedures, Forms and Templates 2
M An outline for a Total Quality Management programme to present to senior executives Preventive Action and Continuous Improvement 9
D Quality Team Structure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Documentation structure - Do I need Work Instructions? Document Control Systems, Procedures, Forms and Templates 23
M How to complete structure Analysis and Function analysis sections' columns of AIAG-VDA DFMEA form FMEA and Control Plans 0
U IT Process is Taken From company and Added to Corporate Structure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Informational IMDRF proposed document – IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) – Anne Medical Device and FDA Regulations and Standards News 0
D China - Where I can get NMPA complete structure/organogram chart and GB/YY format list China Medical Device Regulations 1
S MDR Technical File Structure Requirements EU Medical Device Regulations 12
M FMEA/DCP Structure and Quantity - Similar Parts and Processes FMEA and Control Plans 7
E Department Plan for QA and HSE (profile, plans, structure, goals, etc.) Misc. Quality Assurance and Business Systems Related Topics 2
R How to create a Work Breakdown Structure? Registrars and Notified Bodies 2
F Business expanding - Campus vs Multi Site Certification Structure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D Technical file structure/content requirements for Class IIa devices & new MDR EU Medical Device Regulations 14
Paul Simpson Informational The role of Annex SL - High Level Structure of ISO MSS's - Revision Update February 2019 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
E High level structure - Planning and operation control Occupational Health & Safety Management Standards 2
S Has anyone created a Turtle Diagram reflecting the new ISO 9001:2015 Structure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
P Japan MHLW Ordinance No 94. (QMS structure Regulation) Japan Medical Device Regulations 1
M ISO 13485 and the High Level Structure (HLS) ISO 13485:2016 - Medical Device Quality Management Systems 0
P Is the next revision of ISO 15378 following the High Level Structure? Other ISO and International Standards and European Regulations 5
M Kinds of plastic for molded parts in a main frame as structure Manufacturing and Related Processes 7
M Organizational Chart - Organizational Structure example wanted Quality Manager and Management Related Issues 2
P Do I need to Register with FDA? How shall my structure of processes look like? US Food and Drug Administration (FDA) 4
F Quality Manager - Conflict of interests in organisational structure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S How to Add Water to a MDS Tree Structure RoHS, REACH, ELV, IMDS and Restricted Substances 4
J Setup/structure of IDE in the US Other US Medical Device Regulations 3
R ISO 14001 - EH&S Reporting Structure & Products and Process ISO 14001:2015 Specific Discussions 2
T Quality Department Structure in a Small Medical Device Company Quality Manager and Management Related Issues 4
E Is GHTF Classification Structure similar to EU MDD Calssification EU Medical Device Regulations 3
M ISO 9001 Work Instruction Structure Document Control Systems, Procedures, Forms and Templates 1
M Please help to change the numbering in level 3 of structure Document Control Systems, Procedures, Forms and Templates 1
T Information and Structure for Technical Documentation for Firmware ISO 13485:2016 - Medical Device Quality Management Systems 1
D Internal Audit Structure and Focus Internal Auditing 7
Marc ISO 9001:2015 Structure - Top Level Clauses ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
insect warfare How is the Management Review structure of your company set up? Management Review Meetings and related Processes 5
J How to structure a DHF when all manufacturing is done by Contract Maufacturers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Structure and Content of Job Descriptions General Measurement Device and Calibration Topics 2
A Organisation Structure and Responsibilities - Clarification Misc. Quality Assurance and Business Systems Related Topics 6
G Structure and Method behind the Planning of 8.2.2 Internal Audit Internal Auditing 6
B Controlled document training requirements and structure ISO 13485:2016 - Medical Device Quality Management Systems 2
S Company Structure for OHSAS Certification - Holding Company with Subsidaries Occupational Health & Safety Management Standards 5
Q Minimum Organization Structure to support TS16949 IATF 16949 - Automotive Quality Systems Standard 5
D New Structure for ISO-14001 and other Management System Standards ISO 14001:2015 Specific Discussions 7
R Registering Medical Device in Brazil ANVISA - Fee Structure Other Medical Device Regulations World-Wide 1
A Documentation Confusion - Agile BOM Structure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4

Similar threads

Top Bottom