To include Context and Interested Parties in Process Map?

Q

QAMTY

#1
Do you think that really add value to include interested parties and context as inputs to the a general process map where are shown the QMS processes?
maybe beside to client or instead of client?, because interested parties include it, having finally only as inputs, Context and interested parties.

Please share your thoughts
 
Elsmar Forum Sponsor

Sebastian

Trusted Information Resource
#2
Putting this information will be objective evidence of identification of interested parties. it is good idea not only because auditor should ask for it, but also it would help your organization to know who was and who was not identified as interested party in the past.
 

ousgg

Starting to get Involved
#3
Why do it just on the general process map? Why not break it out to individual process designs as well? Not only is that good evidence of interested parties analysis, but it is also exemplary of good leadership, as the interested parties list is being made relevant to process owners, not just a Top Management document (or worse, a document that has been produced just to pass an audit).

I ALSO include some Risk Management within process designs for similar reasons.
 
Thread starter Similar threads Forum Replies Date
K What to include in SOP Definitions section Document Control Systems, Procedures, Forms and Templates 3
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 0
G Any good examples of CAPA forms that include a risk based approach? ISO 13485:2016 - Medical Device Quality Management Systems 8
A EN ISO 14971:2019 does not include the Annex Zs ISO 14971 - Medical Device Risk Management 4
R Do Medical Device Complaints include Clinical Trials? Medical Device and FDA Regulations and Standards News 3
S 510k: What to include if your own device is the predicate US Food and Drug Administration (FDA) 5
B Include cost of quality (and other wastes) in an ISO 9001 system? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Watchcat Does 820.30 include the manufacturing process? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Watchcat Does ISO 13485 7.3 include the manufacturing process? ISO 13485:2016 - Medical Device Quality Management Systems 14
G Control Plan - Include the processes for each sub component? APQP and PPAP 2
B Does EN ISO 15223-1:2016 include the graphic symbols to be added to software and IFU? Other Medical Device Related Standards 9
M Technical File (STED) labelling - When you compile tech files do we have to include all the product labels? EU Medical Device Regulations 2
B MDSAP for OEM products in Canada for in vitro diagnostic test kit to include lancing device Other Medical Device Related Standards 0
F Determining what type of scrap to include in my internal PPM calculation Quality Manager and Management Related Issues 5
qualprod ISO 9001:2015 Clause 8.3 - Is it possible to exclude one product but include it in other? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q Calibration laboratory scope - Include software such as Gagetrak or Mini tab used? General Measurement Device and Calibration Topics 3
M Include IFU in Class II Medical Device Marketing Brochure? US Food and Drug Administration (FDA) 2
Q MDSAP Regions and how to include in procedures Other Medical Device Related Standards 2
G How to include machine error in uncertainty calculations? Measurement Uncertainty (MU) 5
P Quality objectives - must they include CAPA and internal audit topic? ISO 13485:2016 - Medical Device Quality Management Systems 28
B Quality Policy does not include a commitment to comply with legal requirements Quality Management System (QMS) Manuals 5
K Does ISO 13485:2016 - 7.2.3 Customer Communication include Marketing? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Does nonconforming product include reagents/disposables? ISO 13485:2016 - Medical Device Quality Management Systems 1
S Manufacturing Work Instruction examples that include process pictures Manufacturing and Related Processes 3
Q Does CE Marking include compliance to WEEE and packaging waste? CE Marking (Conformité Européene) / CB Scheme 4
T Does nonconforming product disposition include parts bought from the supplier? IATF 16949 - Automotive Quality Systems Standard 15
shimonv Does 510(k) submission need to include UDI Data Other US Medical Device Regulations 6
Q Where to include other types of Nonconformities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Paul Simpson Does Knowledge Management include aspects of Information Security? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J How to understand the word "include" in IATF 16949 IATF 16949 - Automotive Quality Systems Standard 2
Crimpshrine13 IATF 16949 Audits to include Processes and Products from Non Subscribing Customers IATF 16949 - Automotive Quality Systems Standard 20
E Updating DHF (Design History File) to include Alternative Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Include homogeneity uncertainty into budget table for thermocouples Measurement Uncertainty (MU) 1
J What does "other relevant management roles" include? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
I As a part of validation, should i include the acceptance criteria of CPk index >1.33? Qualification and Validation (including 21 CFR Part 11) 4
M Changing FMEA template to include Detection Ranking for the PFMEA FMEA and Control Plans 2
WEAVER Gage R&R Sample Selection - Can we include NG Samples? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
V ICH Q3 - To "Include OR Not to Include" impurities below reporting threshold General Measurement Device and Calibration Topics 2
P What to include in a Clinical Evaluation Plan EU Medical Device Regulations 2
D Include non-automotive in TS16949 Registration Scope IATF 16949 - Automotive Quality Systems Standard 1
G Does AS9100 Certificate include ISO 9001 Certification? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
B COA (Certificate of Analysis) - What information should they include? ISO 13485:2016 - Medical Device Quality Management Systems 2
H What does the PEM-gate review include? Manufacturing and Related Processes 3
P What should a Quality Plan Include and Examples Misc. Quality Assurance and Business Systems Related Topics 3
C Document Control - Details to include on Documents Document Control Systems, Procedures, Forms and Templates 2
D Need to include Premise of Outsourced Call Center in ISMS Surveillance Audit? IEC 27001 - Information Security Management Systems (ISMS) 4
C Include *ALL* business processes in QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
F Wireless Dongle - Include in Medical Device Testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
M How to include Gas Measurement Equipment Servicing & Calibration Scope to ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D IMR (Individuals and Moving Range) Chart for Short-Run SPC - How much data to include Statistical Analysis Tools, Techniques and SPC 1

Similar threads

Top Bottom