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
 

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
Super Moderator
#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
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) 0
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 "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
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
J Marking "Distributed By" to product with distributors' reference-code EU Medical Device Regulations 3
dinaroxentool Selling a product in Both UK and EU after Brexit UK Medical Device Regulations 9
P EU MDR Translation of Product Name EU Medical Device Regulations 3
N Is this a single integral drug device combination product EU MDR CE Marking (Conformité Européene) / CB Scheme 1
V New Product Model CE Mark Certification under MDR EU Medical Device Regulations 0
Sidney Vianna Informational APQP4Wind - Advanced Product Quality Planning for the Wind Power Supply Chain APQP and PPAP 3
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
G Adopting old product - compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
S How long does it take to register a product with MHRA? UK Medical Device Regulations 8
D Classification of product for clinical trials EU Medical Device Regulations 14
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
B Internal Auditor Competency - Product Auditors Internal Auditing 9
T PFMEA and Control Plans on legacy product FMEA and Control Plans 5
P FDA Approved Product Contact Parts ISO 13485:2016 - Medical Device Quality Management Systems 6
S AS9120B - 8.5.2 Delivering Split Product AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
S Classification of a product according to MDR EU Medical Device Regulations 3
optomist1 Informational Training IMDS - Management of Product Chemical Regulatory Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 2
L AS9100 - Product and Service Provision 8.5.1q AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
Felony Melony New Product Launch - Safe Launch Customer and Company Specific Requirements 1
Marcel DS How do I know if my product is required be RoHS certified? REACH and RoHS Conversations 6

Similar threads

Top Bottom