Does ISO9001:2015 require any specific "processes"?

D

DRAMMAN

#1
Does anyone feel ISO9001:2015 requires there be specific "processes"? The only example I found of explicit required processes is for a Product Development Process.
 
Elsmar Forum Sponsor
M

MayaP

#2
Technically it says you need those processes which are required to ensure quality. (I say product / service quality and system's quality)

I believe it depends on the size of your company and the nature of its business. Huge chocolate factory will have R&D, production, distribution, customer care, HR, H&S (in case of integrated systems). They need it because of food hygiene, shifts, etc etc, it is easier to control business via processes. Its not that much what you are going to prove to auditors, it is about logical and smoothly working system, so processes can be very useful, sometimes it is good to have more than 1. One man band mobile hairdresser would have service delivery process and within this process there would be things that she/he does and they just fit into simple procedures like purchasing consumables, pricing system, days for self development, service itself, it all makes up the process of her/his business.

I'd look at 4.4.1. and draw a process chart and go from there. I told my auditor that I had 11 perfectly functioning processes but as we grew, there is a new one, number 12 (Training). My company, I know the specifics of the job the best. Auditor agreed.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#3
Does anyone feel ISO9001:2015 requires there be specific "processes"? The only example I found of explicit required processes is for a Product Development Process.
Specifically, no. What processes you have now are covered in ISO 9001:2015. As MayaP said so well, this is supposed to be about your organization, so the standard is silent on this beyond process approach, such as in 0.3.1 and the [you will] "...establish, implement, maintain and continually improve...including the processes needed" in 4.4.1.
 
D

Duke Okes

#4
The clauses of the standard are most of the processes you need. For example, purchasing, calibration, control of documentation, auditing, contract review... all are processes with inputs, resources and outputs.
 
Thread starter Similar threads Forum Replies Date
J Does Every Staff need to read the ISO9001 Quality Manual from Cover to Cover? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
B ISO9001 Process Organisation Diagram - Does this make sense to you? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Al Rosen How does your registrar handle 2 certificates, one for AS9100 and one for ISO9001? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
D How does ISO9001 fit into a Recruitment Consultancy environment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Does ISO9001 require that a hard copy of a signed procedure be kept? Document Control Systems, Procedures, Forms and Templates 7
G Does ISO9001 require every nonconformance to have a root cause analysis? Problem Solving, Root Cause Fault and Failure Analysis 21
M Does any one know if company is allowed to submit appeal for rejected registration file Other Medical Device Related Standards 0
B Does TUS require load thermocouples? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
B Does anyone copyright their internal QMS documents? Document Control Systems, Procedures, Forms and Templates 24
D MDR technical file: does it need to contain duplicates of controlled documents EU Medical Device Regulations 2
D Does the MDR article 10 (14) needs to be documented word for word in a Procedure? EU Medical Device Regulations 1
S Why does GAGEpack drop the temperature and humidity readings out of the verification event card? Quality Assurance and Compliance Software Tools and Solutions 0
C Determining an as received OOT condition during calibration does not affect measurements taken prior to calibration. General Measurement Device and Calibration Topics 16
D Does the DoC require a technical documentation version? ISO 13485:2016 - Medical Device Quality Management Systems 1
S Local (country) registration of medical devices - Who does it in best case? Other Medical Device Regulations World-Wide 2
G When does containment event not require 100% sort? Nonconformance and Corrective Action 5
H Does this clause mean i must be in compliance with AS9100 or is 9001 enough? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Does ISO state in anyway that we MUST keep physical first piece parts? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
XRAY_3121 Class II heating pad - does the power supply have to have IEC 60601-1 testing?? US Medical Device Regulations 5
F Change in address for critical supplier - does NB need to be informed? CE Marking (Conformité Européene) / CB Scheme 20
S Brexit ISO 13485:2016 + Corrigendum - What does a UKCA DoC require? EU Medical Device Regulations 2
G Does anyone know about tobacco-free nicotine pouches? US Food and Drug Administration (FDA) 2
cgaro62 Does FDA apply to a non-medical 13485 certified custom manufacturing company? ISO 13485:2016 - Medical Device Quality Management Systems 11
R Does anyone use iQMS for their ISO based document control? Manufacturing and Related Processes 1
V How many hrs does it take to create a Technical File (TD)? EU Medical Device Regulations 4
M How does FDA determine OAI and VAI after inspection? ISO 13485:2016 - Medical Device Quality Management Systems 0
G Does TPI agencies comes under outsourced process as per Q1 Oil and Gas Industry Standards and Regulations 11
N FPY requested for an industry that does not have rework IATF 16949 - Automotive Quality Systems Standard 4
William55401 21 CFR 11 Password Aging - What does "periodically" revised mean in your org? Qualification and Validation (including 21 CFR Part 11) 3
I CQI-15 Welding System Assessment 2nd edition - Does not require Ultrasonic Welding anymore? Customer and Company Specific Requirements 0
Ajit Basrur Does "Refurbishment" fall under "Service"? ISO 13485:2016 - Medical Device Quality Management Systems 13
T Does marketing company require CE mark if manufacturer has CE mark on product? EU Medical Device Regulations 5
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 6 – How Does This Even Happen? Other US Medical Device Regulations 0
T What does VW mean by annual requalification? Customer and Company Specific Requirements 4
I Does BSI require suppliers to be ISO 9001 Certified? EU Medical Device Regulations 12
Watchcat Does Regulatory Affairs put the "no" in innovation? Other US Medical Device Regulations 14
Q Does anyone know what this call out means? Manufacturing and Related Processes 3
K COPLANARITY: Composite profile tolerance on multiple surfaces- what does" lower dimensional reference frame tolerance" control? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
H Does anyone has feedback on a notified body for small companies? EU Medical Device Regulations 3
M Does 4.5 - Alternative RISK CONTROL apply to the Particular Standards? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E Does IVD need to integrate with hospital IT infrastructure? Medical Information Technology, Medical Software and Health Informatics 2
D What does a level 1 (PSW) PPAP actually promise? APQP and PPAP 19
R GS1 DataMatrix code does not meet GS1 Specification EU Medical Device Regulations 0
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Why does load cell supplier requires force verification General Measurement Device and Calibration Topics 3
M Does C=0 strictly mean 1 bad, all bad, all the time? ISO 13485:2016 - Medical Device Quality Management Systems 6
C Does a medical device active (zinc oxide) needs BPR registration in EU? Other ISO and International Standards and European Regulations 6
D Does Risk Management apply to re-labeler (MDR) EU Medical Device Regulations 1
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0

Similar threads

Top Bottom