Are COPs, SOPs, and MOPs required by IATF 16949?

mindytanner

Starting to get Involved
#1
Are COPs, SOPs, and MOPs required by IATF 16949? I can find nothing in the standard that tells me I shall designate my processes in this fashion. What is the value in doing this?
 
Elsmar Forum Sponsor

AMIT BALLAL

Trusted Information Resource
#2
The standard asks audits based on importance, status and risk of the process.

Not every process has same importance. Use of COP, SOP and MOP categorization helps to fulfill importance part of the requirement.
 
#4
Are COPs, SOPs, and MOPs required by IATF 16949? I can find nothing in the standard that tells me I shall designate my processes in this fashion. What is the value in doing this?
Required? No. In fact, the only reason they came about is to help hapless CB auditors think about what they were auditing - nothing more, nothing less. I've yet to hear of anyone in business refer to their process this way.
 
Thread starter Similar threads Forum Replies Date
Q COPS, MOPS and SOPS - Where is the shall? IATF 16949 - Automotive Quality Systems Standard 6
J TS 16949 - Has anyone used this form for your COPS, MOPS & SOPS? Document Control Systems, Procedures, Forms and Templates 4
A Process Tool Attached - 'Process title page' to describe all links, COPs, MOPs, SOPs IATF 16949 - Automotive Quality Systems Standard 5
Hershal Giving Back - Teddy Bear Cops Coffee Break and Water Cooler Discussions 0
U Management Action Plan (MAP) for the COPs. Does ISO/TS required MAP? IATF 16949 - Automotive Quality Systems Standard 8
B Objectives for each process, COPs, MOP's and SOP's - How many is enough? IATF 16949 - Automotive Quality Systems Standard 5
S TS 16949 Clause 4.1: COPs (Customer Oriented Processes) and Process Flow IATF 16949 - Automotive Quality Systems Standard 14
M Customer Oriented Processes: Where are the COPS IATF 16949 - Automotive Quality Systems Standard 8
R COPs (Customer Oriented Processes), Turtle Diagrams and an Octopus or Two Quality Tools, Improvement and Analysis 24
A Unused SIP/SOPs - IEC 60601-1 and IEC 60601-1-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
S SOPs applicable for Regulatory Affairs department Other ISO and International Standards and European Regulations 1
F Process Review - What is the ISO requirement for reviewing SOPs and quality documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
L Templates for three ISO 13485:2016 SOPs ISO 13485:2016 - Medical Device Quality Management Systems 8
M Referencing the MDR by name in QMS SOPs EU Medical Device Regulations 2
D QMS Documentation Process - I want to put all the Process SOPs to a QMS system Document Control Systems, Procedures, Forms and Templates 3
I Best visual description for SOPs? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
S How to number and control translated SOPs - Three languages Document Control Systems, Procedures, Forms and Templates 4
M SOPs, Plans and Report templates for Clinical Evaluation of EU MDR Other Medical Device Related Standards 9
Q Any good Checklists for ensuring SOPs cover ISO 13485:2016 and 21CFR 820? ISO 13485:2016 - Medical Device Quality Management Systems 3
S How to enforce my colleagues to update SOPs? Document Control Systems, Procedures, Forms and Templates 4
J Purpose of Reference Section in SOPs Document Control Systems, Procedures, Forms and Templates 6
S ISO 13485:2016 - How I can integrate a risk management approach in our SOPs ISO 13485:2016 - Medical Device Quality Management Systems 1
S Employee Training Matrix - Keeping track of employee training on various SOPs ISO 13485:2016 - Medical Device Quality Management Systems 4
V Periodic review criteria for reviewing/updating SOPs US Food and Drug Administration (FDA) 1
W Update of SOPs for ISO 13485:2016 / MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 28
V Which SOPs are required by GMP? US Food and Drug Administration (FDA) 2
R Training Production Employees When We Have SOOO Many SOPs Training - Internal, External, Online and Distance Learning 9
L What are some SOPs that a Quality Manager should have? Document Control Systems, Procedures, Forms and Templates 6
SteveK Do you have all your SOPs in place vis a vis 2013/473/EU CE Marking (Conformité Européene) / CB Scheme 3
moritz Defining a good Scope for Critical SOPs ISO 13485:2016 - Medical Device Quality Management Systems 7
M Difference B/W Calibration Methods & SOPs General Measurement Device and Calibration Topics 4
R Do SOPs contained within the QSM require a "Point of Use" and/or "File In" footnote? Quality Manager and Management Related Issues 6
J Should a company create different SOPs for ISO14971? ISO 14971 - Medical Device Risk Management 1
J How do you Create SOPs for Multiple Authorities? EU Medical Device Regulations 8
N Sponsor asked to view our SOPs remotely using File Sharing Document Control Systems, Procedures, Forms and Templates 1
A ISO 13485 required high level SOPs ISO 13485:2016 - Medical Device Quality Management Systems 6
J Guidance on how often company SOPs need to be reviewed per FDA Regulations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
V SOPs and Internal Audit Criteria for Regulatory Affairs (Submissions Function) US Food and Drug Administration (FDA) 4
R SOPs in Manufacturing - Has anyone got a management process that works? Document Control Systems, Procedures, Forms and Templates 4
AnaMariaVR2 [White Paper] Writing & Enforcing Your SOPs for GxP Compliance Success Document Control Systems, Procedures, Forms and Templates 0
M SOPs for a new Cosmetic Product Development Laboratory Calibration Frequency (Interval) 1
T Does FDA consider Flow Charts sufficient instruction for SOPs? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
K ROBUST Indexing System for SOPs - Recommendations wanted Document Control Systems, Procedures, Forms and Templates 8
W Chain of Custody for Documents - Preventing Misplaced SOPs Document Control Systems, Procedures, Forms and Templates 4
N Putting SOPs in place in preparation for ISO certification - where to start? Service Industry Specific Topics 5
P Essential List of SOPS for a Medical Device Development & Submission Process? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Business Process Outsourcing - Call Center QA SOPS for Telemarketing Campaigns Quality Manager and Management Related Issues 6
L IT - Software Development SOPs (Standard Operating Procedures) Software Quality Assurance 3
B Policies, SOPs (Standard Operating Procedures) and WIs (Work Instructions) Quality Manager and Management Related Issues 2
L Software Development and Validation SOPs Software Quality Assurance 14

Similar threads

Top Bottom