SBS - The best value in QMS software

Avoiding ISO 9000 Registration - Hiding behind 'Customer Wishes'

A

Andy Bassett

#1
Hiding behind 'Customer Wishes'

I am currently working with a client that wants ISO 9000, but doesnt really want it, if you know what i mean.

They are trying to escape from a lot of requirements, ie Parts marking, Traceability, Inspection etc by saying that if the customers does not want it they do not do it.

It is true that that they are operating in a price sensitive industry, but what do you think? could they escape a lot of the ISO requirements using the defence that the customer does not want it (and the subsequent cost) but still become ISO certified.

Regards

------------------
Andy B
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Most of this is NOT required. Traceability is only required if it's a customer requirement or you just want to do it or maybe if it's an 'industry standard'. As far as insoections, it can be as simple as 'does it work if you plug it in'. It will be hard to justify no inspection whatsoever - they'll start quizzing you about your quality planning.

If you don't need it - don't do it.
 
A

Andy Bassett

#3
I suppose its all a question of degree. I think there is a little game going on here whereby something is not been done because the customer has not asked for it.

But i can well imagine a scenario where something goes wrong, the customers asks which products have this particular defect, the manufacturer replies that he does not have sufficient traceability systems to say exactly which ones have this problem, and the customer replies in disgust that he thought the manufacturer had a QMS.

All in all i think ill play this one by ear.

Regards

------------------
Andy B
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#4
Take Traceability:

If I injection mold toy soldiers I will probably not have any traceability. What for? What will it gain me? You could argue that the toy soldier is a total lack of traceability. You might argue that you track only bulk materials and that there is no need to track beyond that (no lot number on each soldier, for example).

On the other hand, if I injection mold covers for automotive air bags I will at least indicate manufacturing date (or lot number or other traceable indicator) - aspects such as several tear strip dimensions are critical safety features. If problems are identified we can implement containment.

These are just examples of two traceability situations. Each product and situation has to be considered on its own. ISO does not require traceability. Key words are in bold:

From ISO9001:2000:
--> ...7.5.2 Identification and traceability
-->
--> The organization shall identify, where appropriate, the product by
--> suitable means throughout production and service operations. The
--> organization shall identify the status of the product with respect
--> to measurement and monitoring requirements. The organization shall
--> control and record the unique identification of the product, where
--> traceability is a requirement
(see 5.5.7).

From ISO9001:1994
--> ...4.8 Product identification and traceability
-->
--> Where appropriate, the supplier shall establish and maintain
--> documented procedures for identifying the product by suitable means
--> from receipt and during all stages of production, delivery and
--> installation.
-->
--> Where and to the extent that traceability is a specified
--> requirement
, the supplier shall establish and maintain documented
--> procedures for unique identification of individual product or
--> batches. This identification shall be recorded (see 4.16).

It's a question of being ready to explain why (if / why not) and to what extent traceability is applicable to your product.

As an outsider I could argue that you would want each toy soldier identified for traceabilioty to batch (minimum) because you (as manufacturer) might get a batch of plastic which is (for some far fetched reason) poisonous (or some such reason). But then it goes on down to traceabiliy to lots shipped and could go further. We can all come up with 'what if' scenarios, but let's face it - the company has to come up with a reasoned answer for what it does and does not do.
I suppose its all a question of degree. I think there is a little game going on here whereby something is not been done because the customer has not asked for it.
Well, yes and no. It really depends on the product. Most companies do not add product features unless there is a requirement (design, customer, government or other).

I wouldn't say that traceability is a necessary element of a QMS. Typically you do see some level of traceability (particularly bulk material / lot traceability) - but, as in the toy soldier example, how far? Probably not very.

Hope this helps and doesn't confuse.

[This message has been edited by Marc Smith (edited 14 January 2000).]
 
A

Andy Bassett

#5
I agree with everything that has been said, i go along with all the business about where appropiate etc.

Its just that at the moment this company has 4 product lines for 2-3 customers, and they have zero incoming inspection, zero in process inspection, zero tracability, and an occassional final inspection which is not recorded in anyway, all becuase they say'the customer has not asked for it'.

If this is all possible, it will be the first time i have come across a company that wishes to be certified, but doesnt really aply any of the ISO elements.

I find myself writing in the manuals,'...becuase company xxxx is a small company reacting to company demands xxxxxx is only done if requested by the customer...' what else can i say? i cannot describe how they might do tracability becuase they simply arent doing it.

Regards

------------------
Andy B
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#6
Yes, they have to do something. The issue of continuous improvement will force them to.
 
R

Russ Jackson

#7
Andy, can you name for this board the products or industry involved (toy soldiers, automotive parts, chemicals, etc.)? You may get more useful informtion from someone that has experience in the same industry. In some cases where the customer does not ask or specify something specifically, either your company needs or industry requirements and expectations may have more significant influence on what you do with respect to ID and traceability. The company is doing some form of ID else they would have difficulty in providing the correct products to fulfill a customer order. Traceability is probably much more vague, however.
 
A

Andy Bassett

#8
Maybe a good suggestion Russ.

The products are Routers or other small similar electronic assemblies.

Does anybody have an experience about how much inspection and traceability you would expect to have for such products.



------------------
Andy B
 
P

pdboilermaker

#9
Andy:
Although I have no experience in the area of routers, with this client saying we dont need to do this, that, and the other thing it may be a good idea to have them get a letter from their customer stating this and just keep a copy of this in their quality manual for furture reference.

The reason I say this is that an auditor will certinaly question all of these "do not have to do's", if not out loud, certianly in his/her own mind.

What better than a letter from the customer to put your "claims" to doubt.

Just being the devils advocate
 
M
#10
I'm sorry but I cannot accept "the customer does not want it" as justification for excluding requirements of ISO9001. The only time this is valid is for "traceability", where an order or contract should specify traceability requirements if required. The customer wants relaibility and consistency from a supplier, and this is exactly what ISO9001 sets out to achieve, by having certain controls in place. By default the customer DOES want it. This is why some tender documents require the supplier to be certified to ISO9001 - so they have confidence that they will get what they want, when they want it, NOT to instigate a beaurecratic (I hate trying to spell that word....) paper system.
If the client wants certification to ISO9001/2, then they must comply with the requirements, although this can be achieved in many ways, not neccesarily by wads of procedures.
 
Thread starter Similar threads Forum Replies Date
M Avoiding Pitfalls in ISO 9001:2015 Transition - Free webinar Training - Internal, External, Online and Distance Learning 0
Claes Gefvenberg ISO 9001: Avoiding Over Documentation Document Control Systems, Procedures, Forms and Templates 26
O Informational Scaling back internal audits due to corona virus while avoiding a NC Internal Auditing 7
P Avoiding an Ultrasound System HIPOT Test during Manufacture IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
L Avoiding Recurrence of the Supplier?s Quality Problems Supplier Quality Assurance and other Supplier Issues 5
B Avoiding Rust on 410 Stainless Steel Design and Development of Products and Processes 15
C Guidance for avoiding human error Quality Tools, Improvement and Analysis 24
A Avoiding mixup - Similar parts for two different customers QS-9000 - American Automotive Manufacturers Standard 1
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO 2768-mk print call out Other ISO and International Standards and European Regulations 11
T ISO 17024, clauses 4.3.8. and 5.1.1. Other ISO and International Standards and European Regulations 4
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 8
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
John C. Abnet ISO 26262 ISO 26262 - Road vehicles – Functional safety 3
Marc ISO 26262- Road vehicles – Functional safety ISO 26262 - Road vehicles – Functional safety 0
John C. Abnet ISO 26262 IATF 16949 - Automotive Quality Systems Standard 0
A ISO/DIS 15223-1:2020 - Country of manufacture label (IEC 60417 No. 6049) - Which national law requires this symbol? Other Medical Device Related Standards 0
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
K PDCA cycle and ISO processes alternative model Quality Management System (QMS) Manuals 14
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2
D Which ISO Standard to purchase? ISO 13485:2016 - Medical Device Quality Management Systems 7
V ISO 10360-5: 2020 Gap analysis and Action plan Excel .xls Spreadsheet Templates and Tools 1
Q ISO 9001 - Reseller Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
C ISO 45001 6.1.2.1 Hazard Identification Occupational Health & Safety Management Standards 1
T The difference between ISO 14644-3:2005 and ISO 14644:2019 Other Medical Device Related Standards 2
S Any ISO standards around Artificial Intelligence and Machine Learning? Medical Information Technology, Medical Software and Health Informatics 4
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 2
N ISO 9001 - Training business with fewer than 5 employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
J Opportunity in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
P ISO 8 classified medical manufacturing room Qualification and Validation (including 21 CFR Part 11) 1
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
B ISO 6508 and portable hardness measurement instruments General Measurement Device and Calibration Topics 0
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
S Knee Implant (Femoral -Cobalt chrome)-Sub chronic toxicity test (ISO 10993-11)choice of root Medical Device and FDA Regulations and Standards News 2
Sidney Vianna Release of ISO 10013:2021, Quality management systems – Guidance for documented information Other ISO and International Standards and European Regulations 0
K Integrating ISO 9001:2015 with ISO 17025:2017 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 13485 Certification for Resin Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4

Similar threads

Top Bottom