Nature of references allowed to be cited in the SOP

v9991

Trusted Information Resource
#1
what is the impact(acceptablity) of citing literature in the references section of SOP; ( viz., any industry-white paper or professional forum viz., ASQ or even elsmar )

is there a requirement / expectation which restricts/guides to cite only ones from regulatory authorities or regulatory recognized bodies?
 
Elsmar Forum Sponsor

John Broomfield

Staff member
Super Moderator
#2
References are open to interpretation. SOPs should not be. A documented procedure, instruction, form specifies the organization’s approved interpretation.

The system will help process owners to monitor changes to laws and regs that are relevant to the process in question and should cause the documented procedures to be updated so the process remains compliant.

The process owner will also be familiar with any relevant references as part of their competence.
 

v9991

Trusted Information Resource
#3
The system will help process owners to monitor changes to laws and regs that are relevant to the process in question and should cause the documented procedures to be updated so the process remains compliant.
hence by that definition, it is not 'appropriate' to cite an site viz., Elsmar -repository as an reference in SOP.;
because, it is not an standard but an compilation of industry practices if not best practices. ( i am referring to various files section of CAPA , or devices related files etc)
obviously, it is not a standard for which the process owner need to be updated or compliant with.

thank you for the clarification.
 
Thread starter Similar threads Forum Replies Date
Jen Kirley Risk Based Thinking and acts of God/Mother Nature Business Continuity & Resiliency Planning (BCRP) 1
V Examples of investigation or root-cause categories - Mother Nature (Environment) Problem Solving, Root Cause Fault and Failure Analysis 3
C Recording "nature of non-conformities" - Any way out of this?? ISO 13485:2016 - Medical Device Quality Management Systems 7
J Critical Characteristics need to be measured 100% if they are variable in nature Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
M Is 6 sigma suitable for ship building where the nature of work is non repetitive? Six Sigma 12
K Change of business nature & scope before surveillance - ISO9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Douglas E. Purdy Maintain records of the "Nature of Nonconformities" - ISO 9001 Clause 8.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Are MSDS Sheets required on ALL items of a chemical nature? Miscellaneous Environmental Standards and EMS Related Discussions 3
A QMS Overhaul - Reorganizing and Renaming Documents - Internal References Document Control Systems, Procedures, Forms and Templates 18
Watchcat Authoritative References about the Research Question? Quality Tools, Improvement and Analysis 0
A Supporting Site Quality Manual and References Requirements IATF 16949 - Automotive Quality Systems Standard 14
K Essential Requirements Checklist references EU Medical Device Regulations 10
N Control plan references FMEA and Control Plans 6
J CQE References allowed in the Exam Room Professional Certifications and Degrees 18
M Harmonized standards vs. EN ISO References EU Medical Device Regulations 5
M Current standard references IEC 60601:1988 instead of current version EU Medical Device Regulations 5
P Document references need to be updated to correspond to the current year? Document Control Systems, Procedures, Forms and Templates 5
Q Use of standard references in documentation (PRS, Technical File) Document Control Systems, Procedures, Forms and Templates 1
V Classification of Audit Observations - Regulatory References US Food and Drug Administration (FDA) 1
R Japanese Requirements for Medical Devices - JPAL Ordinance 169 + "law" references Japan Medical Device Regulations 5
K Implications of References in Documentation Document Control Systems, Procedures, Forms and Templates 4
V Excellent references on Lean & Six Sigma ...from MIT Book, Video, Blog and Web Site Reviews and Recommendations 0
V AHU (Air Handler Units) and Clean Room References Qualification and Validation (including 21 CFR Part 11) 3
J Calibration Manual Specification References AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
R Medical Device Labeling Standards References 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
K Audit Nonconformance? Employee References Work Instruction Internal Auditing 17
B Checklist Contents - Do ISO clause references need to be included? Internal Auditing 4
S References to CECC 68000 Other ISO and International Standards and European Regulations 2
A Finding Literature References for Clinical Evaluations per Annex X of MDD 93/42/EEU EU Medical Device Regulations 2
T Suggestions for Obsoleting References ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
J Standard Comparison Chart to have references to all standards in one location ISO 13485:2016 - Medical Device Quality Management Systems 2
A Document Relationship Matrix - Keeping Track of References to Related Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B References for GMP Consultants in Illinois (trade/commercial printer/packaging) Quality Manager and Management Related Issues 3
C ISO 3834-2 references ISO 3834-5 for the list of documents required for conformity Other ISO and International Standards and European Regulations 1
T Obsolete Document References in other Documents AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
T Should I include Normative References in our Systems Manual ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
AnaMariaVR2 Regulatory References for the Operation, Maintenance and Calibration of GLP equipment US Food and Drug Administration (FDA) 6
Ted Schmitt Rental Car References wanted - July in California Travel - Hotels, Motels, Planes and Trains 10
E Particular standard IEC 60601-2-40 references obsolete EMC standard IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
ScottK How to choose professional references when applying for a job? Career and Occupation Discussions 1
O AS References - AS4897, AS2078, AS1946, and AS1055 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
C Notified Body References and Reviews - Changing ISO 13485 Registrars EU Medical Device Regulations 8
M ASME NQA-1-1994 Standards - Struggling with the supplement references Various Other Specifications, Standards, and related Requirements 16
B What happened to Part 804? 820.198 (3) references part 803 or 804 Other US Medical Device Regulations 4
M References to JCAHO Standards in Other Standards Development Hospitals, Clinics & other Health Care Providers 1
D Design For Cost (DFx) resources, references and training material Quality Tools, Improvement and Analysis 1
F Should I remove references to AS9120 / ISO 9001 from my Quality Manual and QMS? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 7
M 21 CFR Part 11 references checklist Qualification and Validation (including 21 CFR Part 11) 8
R Good References and Books in the field of Calibration General Measurement Device and Calibration Topics 4
K Old Drawing from the 1940's references A.I. 2400. Various Other Specifications, Standards, and related Requirements 3
Similar threads


















































Top Bottom