Menu
Forums
New posts
Search forums
What's new
New posts
All posts
New media
New media comments
Latest activity
Media
New media
New comments
Search media
Resources
Latest reviews
New resources
Search resources
Attachment List
Log in
Register
What's new
Search
Search
Everywhere
Discussion Threads
This forum
This thread
Search titles only
By:
New posts
Search forums
Menu
Log in
Register
Forums
National and International Business System Standards
ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
JavaScript is disabled. For a better experience, please enable JavaScript in your browser before proceeding.
Scope Definition - Scope of ISO 9001 Registration
Thread starter
SmokeMonster
Start date
Apr 29, 2010
Prev
1
2
3
First
Prev
3 of 3
Go to page
Go
D
DrM2u
May 3, 2010
#21
May 3, 2010
#21
Now I agree with Sidney's statement.
Elsmar Forum Sponsor
Prev
1
2
3
First
Prev
3 of 3
Go to page
Go
You must log in or register to reply here.
Thread starter
Similar threads
Forum
Replies
Date
F
Definition
Commercial Distribution - Definition - Scope of Commercial Distribution
Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically
2
May 30, 2018
L
GDPR scope - "Personal data" definition - General Data Protection Regulation
EU Medical Device Regulations
5
Mar 14, 2018
H
Scope Definition - Scope of ISO 9001 Registration
Imported Legacy Blogs
1
May 1, 2010
Definition
Special Process Scope - CQI-11 & CQI-12 - Definition
Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically
10
Nov 7, 2007
R
"Medical devices" required in scope
ISO 13485:2016 - Medical Device Quality Management Systems
2
Friday at 10:28 PM
R
CB/Auditor Requiring a change in scope
ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
8
Friday at 9:56 PM
D
ISO 13485 scope (implantable) - Polymers for dental application
EU Medical Device Regulations
9
Mar 30, 2021
M
ISO 13485:2016 Certification Scope
ISO 13485:2016 - Medical Device Quality Management Systems
2
Mar 10, 2021
P
Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012?
EU Medical Device Regulations
1
Mar 8, 2021
M
Scope for ISO 13485 Certification of a Translation Service Provider
ISO 13485:2016 - Medical Device Quality Management Systems
17
Feb 24, 2021
H
Implementing ISO22301 on a Limited Scope
Business Continuity & Resiliency Planning (BCRP)
2
Feb 23, 2021
M
How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer
ISO 13485:2016 - Medical Device Quality Management Systems
9
Feb 8, 2021
Q
The scope of ISO 21534
Other Medical Device Related Standards
0
Jan 14, 2021
A
Scope of ISO 13485 certificate
ISO 13485:2016 - Medical Device Quality Management Systems
1
Oct 30, 2020
K
Medical Device Repairs and ISO Scope
ISO 13485:2016 - Medical Device Quality Management Systems
3
Oct 26, 2020
K
Software Updates in the Field and ISO scope
ISO 13485:2016 - Medical Device Quality Management Systems
2
Oct 26, 2020
I
IATF Lab Scope Testing Qualification and Competency Documentation
IATF 16949 - Automotive Quality Systems Standard
3
Oct 17, 2020
Laboratory Scope - Calibration vs. Test Methods - IATF 16949
IATF 16949 - Automotive Quality Systems Standard
3
Sep 29, 2020
Are risks in supply chain and development activities within scope of MDD?
EU Medical Device Regulations
4
Aug 31, 2020
D
Limited Scope for second site Question?
ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
5
Aug 21, 2020
J
Scope of ISO 9001 clause 10.2 in the product life cycle
ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
2
Jul 30, 2020
A
IATF 16949 4.3.1 - Determining the scope of the quality management system - supplemental
IATF 16949 - Automotive Quality Systems Standard
9
Jul 20, 2020
Existing process never included in AS9100 scope of certification
AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements
10
Jul 6, 2020
G
APQP Scope and scale tool
APQP and PPAP
2
May 7, 2020
R
NRTL - Scope Question - Off-the-Shelf Plug In
IEC 60601 - Medical Electrical Equipment Safety Standards Series
0
Apr 2, 2020
D
ISO 9001:2015 4.3 Determining the Scope of the QMS
ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
3
Mar 30, 2020
M
Scope of Combined ISO 9001 and IATF 16949 QMS - Non-automotive customers
ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
5
Mar 23, 2020
O
MDSAP Reduction in Scope
Other Medical Device Related Standards
0
Mar 12, 2020
D
Do non-IATF customers need to be included in audit scope?
IATF 16949 - Automotive Quality Systems Standard
23
Mar 11, 2020
K
Restricted Scope of ISO 13485 Certification
ISO 13485:2016 - Medical Device Quality Management Systems
7
Mar 9, 2020
C
IATF 16949 - Scope or not?
IATF 16949 - Automotive Quality Systems Standard
2
Feb 18, 2020
S
Similar scope medical products connected by WIFI
US Food and Drug Administration (FDA)
2
Jan 3, 2020
N
IATF 16949:2016 7.1.5.3.2 External Laboratory - How to approve the Testing Laboratory without accreditation scope
IATF 16949 - Automotive Quality Systems Standard
2
Dec 4, 2019
To raise a NC beyond the audit scope? Two signatures were missing
ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
11
Nov 28, 2019
D
CE Marking Requirements MDD & MDR - new product development covered under same scope
EU Medical Device Regulations
1
Nov 20, 2019
P
Scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11
IEC 60601 - Medical Electrical Equipment Safety Standards Series
3
Oct 11, 2019
M
ISO 27001 ISMS scope for companies with subsidiaries
IEC 27001 - Information Security Management Systems (ISMS)
0
Sep 11, 2019
T
AS9100D - Scope of QMS for New Company - Only Choosing a Function Subset Due to Management
AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements
14
Aug 29, 2019
R
Scope of ISO 13485 certification
ISO 13485:2016 - Medical Device Quality Management Systems
6
Aug 27, 2019
D
Scope of Facility - Our auditor asked us last week for our "Scope of the Facility"
AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements
12
Jul 15, 2019
L
Dying a slow SCOPE death - NEW ISO APG Paper on Scope and Applicability May 2020.
AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements
3
Jul 12, 2019
P
Dropping ISO 9001 limits the scope of the ISO 13485 audit?
ISO 13485:2016 - Medical Device Quality Management Systems
6
Jun 13, 2019
W
Scope of MRB (Material Review Board) Responsibilities
Misc. Quality Assurance and Business Systems Related Topics
5
Jun 13, 2019
P
ISO 80369-7 standard - Interpreting which Parts should be in scope
Other Medical Device Related Standards
7
Jun 5, 2019
I
Sales Documents in scope for ISO-9001:2015?
ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
3
May 14, 2019
V
Exclusion of 'Design and Development' from scope of certification
ISO 13485:2016 - Medical Device Quality Management Systems
9
May 4, 2019
S
ISO 13485 scope of certification - We are a virtual manufacturer
ISO 13485:2016 - Medical Device Quality Management Systems
1
Apr 12, 2019
F
API Spec Q1 Scope - Limiting the scope of certification
Oil and Gas Industry Standards and Regulations
3
Mar 24, 2019
M
How To Define ISMS (information Security Management System) Scope
IEC 27001 - Information Security Management Systems (ISMS)
18
Mar 13, 2019
ISO 9001:2015 8.5.1 f - Scope with customer special process requirements
ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
11
Feb 21, 2019
Similar threads
F
Definition
Commercial Distribution - Definition - Scope of Commercial Distribution
Started by funkgirl
May 30, 2018
Replies: 2
Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically
L
GDPR scope - "Personal data" definition - General Data Protection Regulation
Started by lzanini
Mar 14, 2018
Replies: 5
EU Medical Device Regulations
H
Scope Definition - Scope of ISO 9001 Registration
Started by harry
May 1, 2010
Replies: 1
Imported Legacy Blogs
Definition
Special Process Scope - CQI-11 & CQI-12 - Definition
Started by Manix
Nov 7, 2007
Replies: 10
Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically
R
"Medical devices" required in scope
Started by Ralba
Friday at 10:28 PM
Replies: 2
ISO 13485:2016 - Medical Device Quality Management Systems
R
CB/Auditor Requiring a change in scope
Started by Ralba
Friday at 9:56 PM
Replies: 8
ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
D
ISO 13485 scope (implantable) - Polymers for dental application
Started by Daliane
Mar 30, 2021
Replies: 9
EU Medical Device Regulations
M
ISO 13485:2016 Certification Scope
Started by MariaHj
Mar 10, 2021
Replies: 2
ISO 13485:2016 - Medical Device Quality Management Systems
P
Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012?
Started by prkpr
Mar 8, 2021
Replies: 1
EU Medical Device Regulations
M
Scope for ISO 13485 Certification of a Translation Service Provider
Started by mickob21
Feb 24, 2021
Replies: 17
ISO 13485:2016 - Medical Device Quality Management Systems
H
Implementing ISO22301 on a Limited Scope
Started by Hala0
Feb 23, 2021
Replies: 2
Business Continuity & Resiliency Planning (BCRP)
M
How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer
Started by MJ_Connors
Feb 8, 2021
Replies: 9
ISO 13485:2016 - Medical Device Quality Management Systems
Q
The scope of ISO 21534
Started by QuaffReg
Jan 14, 2021
Replies: 0
Other Medical Device Related Standards
A
Scope of ISO 13485 certificate
Started by akp060
Oct 30, 2020
Replies: 1
ISO 13485:2016 - Medical Device Quality Management Systems
K
Medical Device Repairs and ISO Scope
Started by KatieQA
Oct 26, 2020
Replies: 3
ISO 13485:2016 - Medical Device Quality Management Systems
K
Software Updates in the Field and ISO scope
Started by KatieQA
Oct 26, 2020
Replies: 2
ISO 13485:2016 - Medical Device Quality Management Systems
I
IATF Lab Scope Testing Qualification and Competency Documentation
Started by IRONPOORER
Oct 17, 2020
Replies: 3
IATF 16949 - Automotive Quality Systems Standard
Laboratory Scope - Calibration vs. Test Methods - IATF 16949
Started by Crimpshrine13
Sep 29, 2020
Replies: 3
IATF 16949 - Automotive Quality Systems Standard
Are risks in supply chain and development activities within scope of MDD?
Started by silentmonkey
Aug 31, 2020
Replies: 4
EU Medical Device Regulations
D
Limited Scope for second site Question?
Started by DeKamp
Aug 21, 2020
Replies: 5
ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
J
Scope of ISO 9001 clause 10.2 in the product life cycle
Started by J.R. Strickland
Jul 30, 2020
Replies: 2
ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
A
IATF 16949 4.3.1 - Determining the scope of the quality management system - supplemental
Started by Anthony Purdie
Jul 20, 2020
Replies: 9
IATF 16949 - Automotive Quality Systems Standard
Existing process never included in AS9100 scope of certification
Started by hockeyhead
Jul 6, 2020
Replies: 10
AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements
G
APQP Scope and scale tool
Started by g_dep1
May 7, 2020
Replies: 2
APQP and PPAP
R
NRTL - Scope Question - Off-the-Shelf Plug In
Started by rwend07
Apr 2, 2020
Replies: 0
IEC 60601 - Medical Electrical Equipment Safety Standards Series
D
ISO 9001:2015 4.3 Determining the Scope of the QMS
Started by daisisrus
Mar 30, 2020
Replies: 3
ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
M
Scope of Combined ISO 9001 and IATF 16949 QMS - Non-automotive customers
Started by M.Serg
Mar 23, 2020
Replies: 5
ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
O
MDSAP Reduction in Scope
Started by Oz32
Mar 12, 2020
Replies: 0
Other Medical Device Related Standards
D
Do non-IATF customers need to be included in audit scope?
Started by Dan M
Mar 11, 2020
Replies: 23
IATF 16949 - Automotive Quality Systems Standard
K
Restricted Scope of ISO 13485 Certification
Started by KatieQA
Mar 9, 2020
Replies: 7
ISO 13485:2016 - Medical Device Quality Management Systems
C
IATF 16949 - Scope or not?
Started by csullivan
Feb 18, 2020
Replies: 2
IATF 16949 - Automotive Quality Systems Standard
S
Similar scope medical products connected by WIFI
Started by Shawna
Jan 3, 2020
Replies: 2
US Food and Drug Administration (FDA)
N
IATF 16949:2016 7.1.5.3.2 External Laboratory - How to approve the Testing Laboratory without accreditation scope
Started by Ng Hang
Dec 4, 2019
Replies: 2
IATF 16949 - Automotive Quality Systems Standard
To raise a NC beyond the audit scope? Two signatures were missing
Started by qualprod
Nov 28, 2019
Replies: 11
ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
D
CE Marking Requirements MDD & MDR - new product development covered under same scope
Started by Device2020
Nov 20, 2019
Replies: 1
EU Medical Device Regulations
P
Scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11
Started by pyo
Oct 11, 2019
Replies: 3
IEC 60601 - Medical Electrical Equipment Safety Standards Series
M
ISO 27001 ISMS scope for companies with subsidiaries
Started by meysam270
Sep 11, 2019
Replies: 0
IEC 27001 - Information Security Management Systems (ISMS)
T
AS9100D - Scope of QMS for New Company - Only Choosing a Function Subset Due to Management
Started by tmarinon
Aug 29, 2019
Replies: 14
AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements
R
Scope of ISO 13485 certification
Started by racglobal
Aug 27, 2019
Replies: 6
ISO 13485:2016 - Medical Device Quality Management Systems
D
Scope of Facility - Our auditor asked us last week for our "Scope of the Facility"
Started by doctall41
Jul 15, 2019
Replies: 12
AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements
L
Dying a slow SCOPE death - NEW ISO APG Paper on Scope and Applicability May 2020.
Started by lorenambrose
Jul 12, 2019
Replies: 3
AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements
P
Dropping ISO 9001 limits the scope of the ISO 13485 audit?
Started by psp1234
Jun 13, 2019
Replies: 6
ISO 13485:2016 - Medical Device Quality Management Systems
W
Scope of MRB (Material Review Board) Responsibilities
Started by Watermelonsg
Jun 13, 2019
Replies: 5
Misc. Quality Assurance and Business Systems Related Topics
P
ISO 80369-7 standard - Interpreting which Parts should be in scope
Started by player64
Jun 5, 2019
Replies: 7
Other Medical Device Related Standards
I
Sales Documents in scope for ISO-9001:2015?
Started by ISO_Man
May 14, 2019
Replies: 3
ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
V
Exclusion of 'Design and Development' from scope of certification
Started by v9991
May 4, 2019
Replies: 9
ISO 13485:2016 - Medical Device Quality Management Systems
S
ISO 13485 scope of certification - We are a virtual manufacturer
Started by Shonver
Apr 12, 2019
Replies: 1
ISO 13485:2016 - Medical Device Quality Management Systems
F
API Spec Q1 Scope - Limiting the scope of certification
Started by ferize
Mar 24, 2019
Replies: 3
Oil and Gas Industry Standards and Regulations
M
How To Define ISMS (information Security Management System) Scope
Started by maurice
Mar 13, 2019
Replies: 18
IEC 27001 - Information Security Management Systems (ISMS)
ISO 9001:2015 8.5.1 f - Scope with customer special process requirements
Started by qualprod
Feb 21, 2019
Replies: 11
ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
Share:
Twitter
Pinterest
WhatsApp
Email
Link
Forums
National and International Business System Standards
ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
This site uses cookies to help personalise content, tailor your experience and to keep you logged in if you register.
By continuing to use this site, you are consenting to the use of cookies.
Accept
Learn more…
Top
Bottom