How much Process Description is required or needed?

M

Micked

#1
Hi fellow cavers,

I am building a quality system for a very small software company. As a part of the QMS I intend to define just two processes; the software development process and a small process where customer data are handled. I intend to omit the sales process as it is a one man show, and honestly don't believe that anything will be gained in formalizing it.

If you look at the classic representation of a company's processes, there is usually a management process at the top, one big business process in the middle and a few support processes at the bottom. The only value-add for this company, in my opinion, are the two processes mentioned above.

Any experience in having such an approach audited?
 
Elsmar Forum Sponsor

sagai

Quite Involved in Discussions
#2
audit based on legal and/or quality standard requirements.
in order to answer properly to your question we should know what are those for your company.
br
Sz.
 
G

George Weiss

#3
1) It sounds like the question was how simple can I make it?
2) How much should I cover?
.
#1: I would inject that a process diagram/chart is about a simple as you can get. A simple general flow diagram. More as needed or required.
.
#2: As just mentioned is the sticky "required". Knowing your organization's location in the business landscape would help. Selling shoes or bullets? ISO 9001?

my help flow chart :)
[good information in] => [good answer(s) out]​
 
#4
Hi fellow cavers,

I am building a quality system for a very small software company. As a part of the QMS I intend to define just two processes; the software development process and a small process where customer data are handled. I intend to omit the sales process as it is a one man show, and honestly don't believe that anything will be gained in formalizing it.

If you look at the classic representation of a company's processes, there is usually a management process at the top, one big business process in the middle and a few support processes at the bottom. The only value-add for this company, in my opinion, are the two processes mentioned above.

Any experience in having such an approach audited?
I would think that you omitting something from section 7.0 of the ISO 9001 requirements because it is a "one man show" and you "don't believe there's anything to be gained" - is probably going to be flagged as not a justification! Especially, since the identification of customer requirements etc. is 'where quality begins'....and I rather doubt that it's not actually done, in some way, shape or form!
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#5
Hi fellow cavers,

I am building a quality system for a very small software company. As a part of the QMS I intend to define just two processes; the software development process and a small process where customer data are handled. I intend to omit the sales process as it is a one man show, and honestly don't believe that anything will be gained in formalizing it.

If you look at the classic representation of a company's processes, there is usually a management process at the top, one big business process in the middle and a few support processes at the bottom. The only value-add for this company, in my opinion, are the two processes mentioned above.

Any experience in having such an approach audited?
I actually don't have experience having an approach as you described audited, as it's been my experience to see a QMS define as processes all the activities that can impact customer satisfaction, ranging from the quotation/sales process to after sales customer support. They are important enough to define and recognize as processes, even if only one person is doing them. I can't imagine an auditor who wouldn't have a similar viewpoint.

Maybe your expectations of process definition are bigger than they need to be. Lots of companies do well enough with flow charts and turtle diagrams in most cases. I wouldn't make this matter of defining a QMS harder than it needs to be.
 

sagai

Quite Involved in Discussions
#6
These minimum of 4 people are ready to help you ww, regardless our posting does not directly the answer as you expected, but at the end, you likely get more than you have expected :cool:
:biglaugh:
Sz.
 
M

Micked

#7
This is about a company to be audited against ISO 13485, sorry if I wasn't clear enough.

My question was more on the number of processes to describe, not how much detail to put in each of them.

Your feedback (all of you) is very valuable anyway, thanks!
 

sagai

Quite Involved in Discussions
#8
in 13485
The organization shall establish documented procedure:
- for design and development.
- to ensure that purchased product conforms tospecified purchase requirements.
- If servicing is a specified requirement, work instructions and reference materials and reference measurement procedures, as necessary, for performing
servicing activities and verifying that they meet the specified requirements.
- for the validation of the application of computer
software (and changes to such software and/or its application) for production and service provision that affect
the ability of the product to conform to specified requirements. Such software applications shall be validated
prior to initial use.
Records of validation shall be maintained (see 4.2.4)
- to ensure that medical devices returned to the organization are identified and distinguished from conforming product.
- for traceability.
- or documented work instructions for preserving theconformity of product during internal processing and delivery to the intended destination.
- s to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement
requirements.
- to determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate if
improvement of the effectiveness of the quality management system can be made.
- for the issue and implementation of advisory notices.
- If national or regional regulations require notification of adverse events that meet specified reporting criteria,
- to such notification to regulatory authorities.

+ CAPA - A documented procedure shall be established to define requirements

khmmm ... these are required and these shall be accordingly to the detailed requirements defined in 13485.

br.
Sz.
 
D

Duke Okes

#9
And I'm assuming these are in addition to documents required by ISO 9001, if 13485 uses it as its base.
 
M

Micked

#10
Sagai, thanks for your input.

Maybe I wasn't all that clear in my first post.
We *are* describing procedures for all the required activities in ISO 13485, that is not the issue here.

My question was more about how many *processes* you must formally describe in the quality manual. What we did so far was to describe only SW development (from ideas/inputs to release) and one more customer service-oriented process.

Based on the feedback I got (thanks all of you!), maybe I will change my approach a bit.
It sounds more reasonable to list all processes (HR, purchasing, management...) and document them in simple turtle diagrams. Won't bring any value to the company (a very small operation) but the auditor will feel at home...
 
Thread starter Similar threads Forum Replies Date
M Hiring Decisions - How much effort do you put into the hiring process these days? (7/2020) Misc. Quality Assurance and Business Systems Related Topics 6
P So much turnover, How to improve our training process? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
J Process Capability - How much percentage of tolerance? VDA Standards - Germany's Automotive Standards 3
R How much Training for Process Validation? Process Performance Qualifications Qualification and Validation (including 21 CFR Part 11) 5
R Updated Process FMEA: How much detail? Closure of an External Corrective Action FMEA and Control Plans 3
L How Much Process Documentation is Required? We have 200+ products! ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M In-Process Inspection Data?? How Much? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
M Do I Expect Too Much of Job Candidates? Career and Occupation Discussions 33
B ISO 9001:2015 Transition: Much Easier Than You Think! Misc. Quality Assurance and Business Systems Related Topics 0
E How much a bioequivalence study will cost in the UK Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
T ISO 9001:2008 to 2015 transition - How much work to change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
P ISO 9001:2015 4.2 and 6.1 - Interested Parties - How much detail is required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
I How much does an eQMS (Electronic/Software QMS) cost? Quality Assurance and Compliance Software Tools and Solutions 1
W How much would it cost to setup a Quality System for a Repackager or Relabeler? Quality Manager and Management Related Issues 1
G How much to pay a Freelance Six Sigma Trainer in India Six Sigma 1
M 7.5.3.2 Traceability - How much traceability is required? ISO 13485:2016 - Medical Device Quality Management Systems 6
S How much do trainers charge typically for an Adobe Connect / WebEx based training? Training - Internal, External, Online and Distance Learning 3
kedarg6500 How much test force to be applied for Vickers hardness Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
D AS9100 Recertification Audits - How much in advance of the Certificate Expiration AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
J Sourcing a Sterile Product - Asking for supplier for too much regulatory stuff? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D IMR (Individuals and Moving Range) Chart for Short-Run SPC - How much data to include Statistical Analysis Tools, Techniques and SPC 1
V How much Supplier Information do I have to provide to a Customer? APQP and PPAP 6
V For an RSM, how much R-sq is good R-sq Using Minitab Software 3
R How much Protective Current Rating of Building Branch Circuit should be considered? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R How much "harder" is an ISO 13485 Registration Audit compared to ISO 9001 ISO 13485:2016 - Medical Device Quality Management Systems 6
M MSA - According to the formula cg how much tolerance should be put in place? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
Sidney Vianna The frequent flyers that flew too much... Unlimited AAirpass Coffee Break and Water Cooler Discussions 11
E Consulting Fees - How much to charge Career and Occupation Discussions 33
A How Much Validation is needed for OTS Software - Marketing material only 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G How much time must pass after the first Certification Audit for us to appear in OASIS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
A Advice on setting up BD Distribution Deals - How much oversight is required? Quality Manager and Management Related Issues 2
K Key Employees and Officers - How much conflict is tolerable? Quality Manager and Management Related Issues 19
A How much effort is needed for Certification of Class II Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 9
Stijloor Thank you very much!! Covegratulations 5
K Supplier Audit - How much information do we have to give them? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Document Control Procedure - Too much detail? Document Control Systems, Procedures, Forms and Templates 8
somashekar Too much data, Too little analysis - Manual Stages Assembly Shop Data Collection Quality Tools, Improvement and Analysis 2
R OASIS Database Fees - How much are you paying your CB? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
M Defining what is a Medical Device Accessory and what isn't - Much Confusion EU Medical Device Regulations 8
A Customer SQE - Within Specification but too much Variance Customer Complaints 7
A What to do when customer requirements are too much? Quality Manager and Management Related Issues 29
D How much Tolerance do I use to Calibrate a 150kgs capacity Scale? General Measurement Device and Calibration Topics 5
D How much Deviation is Acceptable when Calibrating a Hygrometer? General Measurement Device and Calibration Topics 3
L FDA Audit - How much advance notice do foreign manufacturers get? ISO 13485:2016 - Medical Device Quality Management Systems 4
R MSDS Sheets for Products - How much is too much - Or is there ever too much? Occupational Health & Safety Management Standards 12
T How much information should I keep in my Master Document Register? Document Control Systems, Procedures, Forms and Templates 8
4 Change Control Systems - How much is too much? Document Control Systems, Procedures, Forms and Templates 10
Marc Saying "I only had one beer" doesn't mean much any more Coffee Break and Water Cooler Discussions 3

Similar threads

Top Bottom