Infrastructure and work environment

D

donnammurphy

#1
#1
Another help topic...Would you define infrastructure as something tangible and a work environment as intangible? I am trying to get a clear understanding of what is meant by this. After speaking with my auditor, he stated the work environment may include such requirements as those found in ISO 14000 and DTF or lean manufacturing. He explained infrastructure as the building and may include preventive maint programs, but infrastructure could also include the resources within the building. Such as part (c) supporting services. Any help would be greatly appreciated. Thanks.

------------------
 
Paper to QMS ad
Elsmar Forum Sponsor
G

goose

#2
#2
Donna

Work environment: conditions under which work is performed;i.e physical, social, environment (temperature, ergonomics, possibly recognition)

Infrastructure: the system of facilities, equipment, services etc. needed for an organization to function.

These are from notes I had in up-grade course ofr auditors. Think they came from IS0 9000:2000-vocabulary.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
D Infrastructure: Equipment, Work Environment and Contamination Control ISO 13485:2016 - Medical Device Quality Management Systems 4
G Infrastructure and Environment for the operation of processes (ISO 9001 7.1.3 & 7.1.4) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Environment Control for Fruit Industry - Infrastructure of Papaya Production Area Food Safety - ISO 22000, HACCP (21 CFR 120) 9
Douglas E. Purdy Infrastructure (6.3) and Work Environment (6.4) In Relation to 7.4.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
R TS 16949 - 6.3 Infrastructure and 6.4 Work Environment IATF 16949 - Automotive Quality Systems Standard 4
C SOP Template needed for ISO 13485 6.3 Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 9
Mr Roo ISO 9001 - 7.1.3 Infrastructure - questions concerning evidence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
L AS9100 - Infrastructure or Product? Inflight internet connectivity network AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
G ISO 9001 8.4 applied to 7.1.3 - Suppliers of infrastructure requirements - IT and Print solutions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J ISO 13485 Audit Nonconformance written against 6.3 Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 25
R Process Mapping a Civil Infrastructure Construction company Process Maps, Process Mapping and Turtle Diagrams 4
Q ISO 9001 cl. 7.1.3 Infrastructure - How can a auditor audit this? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
C ISO13485/9001 clause 6.3 (Infrastructure) ISO 13485:2016 - Medical Device Quality Management Systems 3
C ISO 13485:2016 Cl. 6.3 - Infrastructure - Almost Everything is Outsourced ISO 13485:2016 - Medical Device Quality Management Systems 2
T ISO13485:2016 Clause 6.3 - Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 1
A Career Path Options for Quality Assurance Engineer in Roads & Infrastructure Field Career and Occupation Discussions 2
T Exclusion of 7.3 for infrastructure consulting company Service Industry Specific Topics 4
H ISO 9001 Clause 6.3 Infrastructure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M AS9100 - 4.2.4 Control of Records and 6.3 Infrastructure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B ITIL (Information Technology Infrastructure Library) Foundation Certificate Career and Occupation Discussions 1
C Clause 6.3 Infrastructure - Clearing the Confusion ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
K Audit Nonconformity on Defining 'Outsourced' Infrastructure Maintenance Quality Manager and Management Related Issues 21
B ISMS Certified - Any requirement for Insurance Coverage for Infrastructure Assets? IEC 27001 - Information Security Management Systems (ISMS) 4
M AS9100 Rev C - Determining, Providing and Maintaining" Infrastructure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
Anerol C How should I control subcontracted infrastructure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A ISO 20001 (ITIL) Information Technology Infrastructure Library IT (Information Technology) Service Management 2
J IT Department Network Infrastructure - 7.3 Design and Development Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
pammesue 6.3 Infrastructure Procedure/Requirement - Example wanted Document Control Systems, Procedures, Forms and Templates 10
E Meeting AS9100 Clause 6.3 Infrastructure Requirements - Preventive Maintenance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
T Infrastructure - How do you address it in your manual? ISO 9001 Clause 6.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q ISO 9001 Clause 6.3 Infrastructure - Preventive Maintenance Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
D Cl 6.3, Infrastructure - How detailed I should get with this clause? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
H ISO 9001 6.3 Infrastructure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C Understanding Concepts of Information Technology & Infrastructure Library (ITIL) Misc. Quality Assurance and Business Systems Related Topics 1
I ITIL (the OGC's IT Infrastructure Library) Version 3 - Published Today Various Other Specifications, Standards, and related Requirements 0
T 3 levels of TS 16949 Infrastructure - Process, Documented & Trained, Sustainable IATF 16949 - Automotive Quality Systems Standard 0
F ISO 13485 Clause 6.3 - System to determine and provide infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 5
E Infrastructure - What to do for ISO 9001 Clause 6.3? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
Raffy Clause 6.3 - Infrastructure - How do I document our design? Design and Development of Products and Processes 6
A 6.3 Infrastructure - 8.2.1 Customer Satisfaction - 8.4 Data Analysis ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Raffy Infrastructure - Does this includes floor plan of the building, its size and location ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
N Medical Devices in oxygen rich environment IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A IEC 60601 11.2.2.1 Risk of Fire in an Oxygen Rich Environment, Source of Ignition IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D Controlled Environment requirements Miscellaneous Environmental Standards and EMS Related Discussions 1
K What is mean by Oxygen Rich Environment as per the IEC 60601-1 clause no 11.2.2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
F Hi friends, can anyone show me an example of a procedure for ISO 13485 6.4.1 Work Environment? ISO 13485:2016 - Medical Device Quality Management Systems 2
M Informational US FDA draft guidance – Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Medical Device and FDA Regulations and Standards News 0
P IEC 60601 11.2.2 - Oxygen Rich Environment sources of ignition IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Practical ideas for information labelling in healthcare environment IEC 27001 - Information Security Management Systems (ISMS) 2
I CAP/CLIA Environment - Part 11 Compliance Qualification and Validation (including 21 CFR Part 11) 3

Similar threads

Top Bottom