Product Realisation without manufacturing

M

MareikeBausch

#1
Hi everyone,
at the moment I am helping in writing a quality manual as we are implementing a QMS according to 9001.
I am now working on section 7 product realization. Now our company does not manufacture anything. We are a distributor and we perform service and repair on some products.
What of section 7 does apply to us?
Can I define that for our company Sales and Service&Repair are "product realisation" as they are what we do to satisfy customers?
Thanks in advance for your help.
Mareike
 
Elsmar Forum Sponsor

dsanabria

Quite Involved in Discussions
#2
Hi everyone,
at the moment I am helping in writing a quality manual as we are implementing a QMS according to 9001.
I am now working on section 7 product realization. Now our company does not manufacture anything. We are a distributor and we perform service and repair on some products.
What of section 7 does apply to us?
Can I define that for our company Sales and Service&Repair are "product realisation" as they are what we do to satisfy customers?
Thanks in advance for your help.
Mareike
A couple of questions:

Does your product receives special processes.

Do you have equipment / tools that requires calibration.

If the answer to both questions are yes, then everything element of 7 is applicable.

It is the repair that separate you from distribution.
 
M

MareikeBausch

#3
Hi,
thanks for the quick reply.
So yes: whenever a product comes in for service and repair we perform a electrical safety test. And we have two devices in our service department that need calibration.
Can I then just classify service and repair as product realisation?
And what about: Design and development? We do not design any products.
Cheers Mareike
 

John Broomfield

Staff member
Super Moderator
#4
Hi everyone,
at the moment I am helping in writing a quality manual as we are implementing a QMS according to 9001.
I am now working on section 7 product realization. Now our company does not manufacture anything. We are a distributor and we perform service and repair on some products.
What of section 7 does apply to us?
Can I define that for our company Sales and Service&Repair are "product realisation" as they are what we do to satisfy customers?
Thanks in advance for your help.
Mareike
Mareike,

Instead of studying the standard for developing your management system you may find it better to analyze your organization as a system that is fulfilling its purpose.

In doing this you may find that your organization already includes processes for:

1. Planning for success*
2. Understanding, agreeing and committing to customer requirements*
3. Designing services (incl design change control) to fulfill customer requirements*
4. Selecting suppliers and purchasing*
5. Caring for customer property*
6. Fulfilling the service design specs*
7. Controlling any measuring equipment*
8. Controlling credit and providing timely and accurate invoices*

* including risk assessment and monitoring

Better to respect and reflect the management system that actually runs the business than to impose procedures that "implement" ISO 9001.

John
 

dsanabria

Quite Involved in Discussions
#5
Hi,
thanks for the quick reply.
So yes: whenever a product comes in for service and repair we perform a electrical safety test. And we have two devices in our service department that need calibration.
Can I then just classify service and repair as product realisation?
And what about: Design and development? We do not design any products.
Cheers Mareike
Yes - if the product is nt your product and you did not designed and developed it - exclusion is justifiable.

Product realization is in place because you meet instrument / tools / technical manual / M & M and on... so your repair service does fall under product realization.
 

John Broomfield

Staff member
Super Moderator
#6
Yes - if the product is nt your product and you did not designed and developed it - exclusion is justifiable.

Product realization is in place because you meet instrument / tools / technical manual / M & M and on... so your repair service does fall under product realization.
dsanabria,

I see no case for excluding service design from the requirements of 7.3 in clause 1.2.

John
 

dsanabria

Quite Involved in Discussions
#7
dsanabria,

I see no case for excluding service design from the requirements of 7.3 in clause 1.2.

John
In total agreement - but if all they do is change a wire and use the manufacturing (OEM) instructions then the case begins to develop. In fairness, much information is needed before making a case for exclusion.
 

somashekar

Staff member
Admin
#8
Hi everyone,
at the moment I am helping in writing a quality manual as we are implementing a QMS according to 9001.
I am now working on section 7 product realization. Now our company does not manufacture anything. We are a distributor and we perform service and repair on some products.
What of section 7 does apply to us?
Can I define that for our company Sales and Service&Repair are "product realisation" as they are what we do to satisfy customers?
Thanks in advance for your help.
Mareike
Distribution + servicing and repair is a realization activity
Manufacturing is an other realization activity
Can I define that for our company Sales and Service&Repair are "product realisation" as they are what we do to satisfy customers?
You are RIGHT.
What applies to you, now you determine.
Specifically on any clause / sub-clause when you are in doubt, ask with all details.
It will not be appropriate for anyone to say at this juncture, what does not apply to you, with the given information...
 
Last edited:
Thread starter Similar threads Forum Replies Date
E Is clause 7.1 (product realisation) relevant to wholesaler? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Validation of software used for product realisation ISO 13485:2016 - Medical Device Quality Management Systems 4
Q What are the Product Realisation processes that manage Finances? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Product Realisation Process Map - Need some help, please review and comment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C API Q1 Clause 7.1.1 Planning of Product Realisation Oil and Gas Industry Standards and Regulations 2
M Compliance with ISO 9001 Clause 7.1 - Planning of Product Realisation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
F Realisation of Product in regards to ISO 9001 for Private School (Education) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
E Product Realisation and Life Cycle Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M ISO 9001:2000 - Types of Processes Other Than Product Realisation Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 53
B Establishment and Product Registration Procedure - UK & EU UK Medical Device Regulations 0
M Process & Product Characteristic in Control Plan FMEA and Control Plans 13
L 1 product multiple factories EU Medical Device Regulations 0
C Product Lifetime on Labeling 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
P API Q1 - Monogram Product & API 4F - Proof Load Test Oil and Gas Industry Standards and Regulations 3
R CE marked product sold in UK no EU rep CE Marking (Conformité Européene) / CB Scheme 2
JoCam On-product labels for Medical Devices EU Medical Device Regulations 3
Awais How to mistake proof - Shipping Orders with Shortages - Product Quantity Accountability mismatch with Job Traveller? Manufacturing and Related Processes 17
L Product and process Deviation procedure Manufacturing and Related Processes 1
H Using/Selling power banks with your product as a "mobile version" CE Marking (Conformité Européene) / CB Scheme 3
H Electronic care product on patient bed side - Flammability requirements (62368-1) Hospitals, Clinics & other Health Care Providers 0
B Design Responsibilities for Mature Acquired Product Lines ISO 13485:2016 - Medical Device Quality Management Systems 3
D Dental application - medical product or not? Other US Medical Device Regulations 8
Q Product Quality vs Product Defects Manufacturing and Related Processes 4
J Verification of purchased product / supplier questionnaires ISO 13485:2016 - Medical Device Quality Management Systems 2
E Any template/ form of Monitoring and Measurement of Processes and product to ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 1
S Product Code 510(k) exemption US Food and Drug Administration (FDA) 1
M REACH assessment of PCBA/finished product REACH and RoHS Conversations 2
J Validity of CE mark on distributed product when company ceases trading EU Medical Device Regulations 3
Q News cradle to grave - Product life cycle ISO 14001:2015 Specific Discussions 5
J Using of CE marking - Two CE markings on the product CE Marking (Conformité Européene) / CB Scheme 5
W Final Report re: Market withdrawal of radiation-emitting product Other US Medical Device Regulations 0
M Combination Product - New MAA EU Medical Device Regulations 0
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
Z REACH compliance for low volume product REACH and RoHS Conversations 1
chris1price Notified Body responsible for product safety under MDD? EU Medical Device Regulations 4
S Does a refurbished product required a new UDI? US Food and Drug Administration (FDA) 3
lanley liao How to understand and master the requirements of each section in API monogram product. Oil and Gas Industry Standards and Regulations 5
H Verification Process for the existing MDS Product IEC 62304 - Medical Device Software Life Cycle Processes 5
A UDI for product already packed up EU Medical Device Regulations 0
A Migrating from whole product CE marking to modular approach CE Marking (Conformité Européene) / CB Scheme 5
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Extension to shelf life of new product under MDR EU Medical Device Regulations 1
lanley liao Are there guidelines for application of all API monogrammal product? Oil and Gas Industry Standards and Regulations 2
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2
K Interesting Discussion "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
R IATF 16949 Certification for new site with transferred product--what is the impact with CSR and scorecards? IATF 16949 - Automotive Quality Systems Standard 4
William55401 Distributed By Product - Best Practices for Configuration Management and Purchasing Controls ISO 13485:2016 - Medical Device Quality Management Systems 0
R Compatibility studies - combination product CE Marking (Conformité Européene) / CB Scheme 4

Similar threads

Top Bottom