Process Documentation Formatting - Requirements

S

shieldingintl

#1
We are in the process of 'chopping' some content from our canned QMS. Under Section 4.2.1 of ISO 9001:2008 it states under NOTE 3 that the documentation can be in any form or type of medium. Does this mean that we can format our documents as we see fit - for example by no longer having numbered sections and subsections in the document - and replacing with bolded captions and bullet points throughout?? If not, is there a sequential formatting requirement in ISO?
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Re: Process Documentation Formatting

No. ISO 9001 does not specify a particular medium or document format/layout. Present information in a manner that is beneficial and user-friendly to the user community at your organization.
 

howste

Thaumaturge
Super Moderator
#3
Re: Process Documentation Formatting

Does this mean that we can format our documents as we see fit - for example by no longer having numbered sections and subsections in the document - and replacing with bolded captions and bullet points throughout?? If not, is there a sequential formatting requirement in ISO?
Yes, you can do it however you want. No, there has never been a requirement for specific format or numbering.
 

normzone

Trusted Information Resource
#4
Re: Process Documentation Formatting

Things you may or may not choose to do...

Have a revision history at the end of the document. Rev. B, added additional requirement for inspection record to section 3.5, etc. This lends some help to the requirements of 4.2.3.

I have gone away from most of the formal formatting requirements I inherited when I moved in to my new home, but since my predecessor was a guy who wouldn't use 3 pages when 10 would do, that was easy.

Microsoft Word pushes you towards numbers and bullets, but depending on your skillset and training, the previous formats inherent in the document, and the version you are using your mileage may vary. I find some numbering and bulleting useful for referencing certain requirements in audit reports, etc.

But simpler is usually better. If it gets too big, split something out into a seperate document and cross reference the two.

:bonk:
 
Thread starter Similar threads Forum Replies Date
C Refreshing an old and boring topic - Job descriptions and Roles vs Process Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
J Where to Place Process Maps in our Documentation? Process Maps, Process Mapping and Turtle Diagrams 4
M What is the average time needed for process documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S How to start with ISO process in project based team - Documentation Document Control Systems, Procedures, Forms and Templates 4
A Process Documentation for ISO 9001:2015 Internal Auditing 2
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
D QMS Documentation Process - I want to put all the Process SOPs to a QMS system Document Control Systems, Procedures, Forms and Templates 3
M Accounting Process Documentation Content ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
V Transforming the Attitude and Culture towards Documentation and Process Controls US Food and Drug Administration (FDA) 2
B Process Approach - Convert System of Documentation into System of Managed Processes Misc. Quality Assurance and Business Systems Related Topics 2
B Complicated Production Process - Sub-Process Documentation Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Certification Body - Should I contact them before Documentation Process or After? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
K Revising Procedures, Process Documentation and Forms - Questions about ISO 13485:2016 - Medical Device Quality Management Systems 7
W Reducing Documentation for In-Process Inspections ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Process Documentation is extremely generic IATF 16949 - Automotive Quality Systems Standard 4
B ISO 9001 Documentation and PCF (APQC's Process Classification Framework) Document Control Systems, Procedures, Forms and Templates 21
D In Process Inspection Frequency and Documentation - CNC lathe/mill work Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
I Looking for Process Documentation - QMS Process Flow Diagram in Excel Document Control Systems, Procedures, Forms and Templates 2
F Process Documentation Tools - A study about process description Document Control Systems, Procedures, Forms and Templates 2
D SIPOC (Suppliers, Inputs, Process, Output, and Customers) for Documentation Policy Quality Management System (QMS) Manuals 3
S General Documentation Question-Training Center Process Document Control Systems, Procedures, Forms and Templates 2
F Process Owners and Process Documentation which Affects Multiple Departments Document Control Systems, Procedures, Forms and Templates 6
B 5S Cleaning Standards Documentation and the 5S Process Quality Tools, Improvement and Analysis 7
M Manufacturing Process Design Documentation - Inputs and Outputs Design and Development of Products and Processes 2
Z Process Mapping Documentation Location and Control Process Maps, Process Mapping and Turtle Diagrams 5
errhine Paperless office software - Electronicly sign process documentation with FAA approval Federal Aviation Administration (FAA) Standards and Requirements 7
A Process documentation in a ISO 27001:2005 ISMS implementation Document Control Systems, Procedures, Forms and Templates 10
K Documentation life cycle process flow? Document Control Systems, Procedures, Forms and Templates 9
S AS9100/AS9006 process documentation - Aerospace software consulting company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
E Linking of Process Control Plans To Process Documentation FMEA and Control Plans 6
L How Much Process Documentation is Required? We have 200+ products! ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T Where to Place Process Maps in our Documentation Process Maps, Process Mapping and Turtle Diagrams 20
Marc Functional vs Process Based Documentation Document Control Systems, Procedures, Forms and Templates 13
M Efficacy of an IT process after a cyber attack ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
N Sterilization Protocol Change in Validation Process and further impacts ISO 13485:2016 - Medical Device Quality Management Systems 1
N Riveting - special process Manufacturing and Related Processes 11
M Material incoming to the production process reflected in PFMEA FMEA and Control Plans 5
A API Spec Q1 Purchasing Process - Supplier Reevaluation based on Supplier Risks 5.6.1.4 Oil and Gas Industry Standards and Regulations 12
B Handling lower detection limits for SPC and process performance Statistical Analysis Tools, Techniques and SPC 1
S Approval Process for Disinfectant Sanitizers in Dubai Elsmar Xenforo Forum Software Instructions and Help 0
D Measurables for Plastic Injection molding process Manufacturing and Related Processes 1
S Cleaning process center change ISO 13485:2016 - Medical Device Quality Management Systems 4
Z Rapid audit template for plastic parts manufacturing process Manufacturing and Related Processes 12
R Inspection and Work order process Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
A How to reduce the process SPC monitoring Capability, Accuracy and Stability - Processes, Machines, etc. 3
John Predmore Configuration Management as a process instead of a procedure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
R PCBA process validation Qualification and Validation (including 21 CFR Part 11) 2
U Internal Auditor not trained but done Audit for some process Nonconformance and Corrective Action 5
B Two excellent examples of process capability analysis from Quality Magazine Capability, Accuracy and Stability - Processes, Machines, etc. 5

Similar threads

Top Bottom