Auditing Product and Services doubts

qualprod

Trusted Information Resource
#1
Hello everybody

In your opinion how important is to take care into an ISO 9001 System P and S?

In this sense, we know that, which is manufactured, fabricated, built, is PRODUCT.

If I have a business which sell training, it could be SERVICE.

But in both options exist in my point of view, product and service.

In the first case, to fabricate something is product, but when is given some assistance or advise to client, a Service is provided.

In the second case, if training is provided, it could be considered a Product.

In the auditor point of view, is it important to define in the scope
Product or Service?

What should be considered into the System as special actions if we have products or services?

Would it be recommended to declare applicability (yes/not) in one of them if we only produce or only offer services?

Thanks for your clarifications.
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
In scope statements we would state the type of products or services provided.

  • Manufacturing of widgets for the abc industry
  • Assembling of widgets for the abc industry
  • Distribution of widgets for abc industry
  • Selling of ready product: Sales of widgets manufactured by organizations that may or may not be ISO xxxx certified
  • Creation of training materials (product) for using widgets in the abc industry
  • Delivery of training (service) for using widgets in the abc industry
  • Manufacturing as well as training for how to use widgets (manufacturing and service) in the abc industry
I hope this helps!
 

dsanabria

Quite Involved in Discussions
#3
Hello everybody

In your opinion how important is to take care into an ISO 9001 System P and S?

In this sense, we know that, which is manufactured, fabricated, built, is PRODUCT.

If I have a business which sell training, it could be SERVICE.

But in both options exist in my point of view, product and service.

In the first case, to fabricate something is product, but when is given some assistance or advise to client, a Service is provided.

In the second case, if training is provided, it could be considered a Product.

In the auditor point of view, is it important to define in the scope
Product or Service?

What should be considered into the System as special actions if we have products or services?

Would it be recommended to declare applicability (yes/not) in one of them if we only produce or only offer services?

Thanks for your clarifications.
The purpose of the scope is to identify what you do. In any case it could be either both or one. Your auditor will need to understand the scope of activities to determine what is audited.

In other case, you can have both but chose to have only one item on the scope.
 

John Broomfield

Staff member
Super Moderator
#4
qualprod,

It seems to me that your company provides manufacturing services. Does it advise customers in any way?

Or does it wait to receive an RFQ and provide a price hoping to win the job by being the lowest bidder?

Usually companies seek to add value for their customers by avoiding commodification (selling products on price alone). They do this by investing the design and improvement of their services.

Take a look at your sales process and see if it advises customers on how best to satisfy their needs.

Is it this or any other part of your manufacturing services that create loyal (profitable) customers?

These service aspects of your system may be the most valuable to your company’s owners, employees and customers. Make sure they are covered by your management system so no one takes them for granted.

John
 
Thread starter Similar threads Forum Replies Date
K Auditing New Product Introduction Process General Auditing Discussions 21
Anerol C Internal Auditing: New Product Launch Internal Auditing 11
C Auditing of Installation of Product at Customers Sites General Auditing Discussions 6
M Auditing Product Realization - Advice on common oversights to look for? General Auditing Discussions 8
C List of MDSAP Auditing Organizations Medical Device and FDA Regulations and Standards News 1
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 4
cscalise Suggestions for MDR Auditing tools EU Medical Device Regulations 1
J Auditing of Support Function IATF 16949 - Automotive Quality Systems Standard 9
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
S Risk based internal auditing Internal Auditing 6
Randy Remote auditing (for disaster, disease, disturbance etc...) during the Neo Coronavirus Pandemic and Social Distancing Registrars and Notified Bodies 7
K ANVISA B-GMP Auditing requirements for Contract Manufacturers Other Medical Device Regulations World-Wide 0
F AS9100D Internal auditing requirements Internal Auditing 3
R Does any here use an internal auditing tool that works on different platforms? Internal Auditing 3
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
G Best Practices for IT auditing - Is a session-id necessary for a complete audit trail? IEC 27001 - Information Security Management Systems (ISMS) 0
I Questions to ask when auditing for Organizational Leadership and Planning for the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
blackholequasar Internal Auditing Inspiration - Getting volunteers to perform internal audits. Internal Auditing 22
W Internal Auditing carried out by a 3rd party - Review of previous audits AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
tony s What is the automotive process approach for auditing? IATF 16949 - Automotive Quality Systems Standard 2
S Internal Auditing for API Spec Q1 - auditor qualification requirements Oil and Gas Industry Standards and Regulations 6
R I've been auditing for a CB for 18 years General Auditing Discussions 10
P Consultant Auditing Qualifications Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
E Informational Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work) Internal Auditing 146
M We still have not received our certificate due to a 'backlog' with our auditing body Registrars and Notified Bodies 25
N Online Internal Auditing Course for ISO 13485 - Suggestions ISO 13485:2016 - Medical Device Quality Management Systems 8
A Agenda for 8D audit on Supplier's side - Auditing Corrective Actions General Auditing Discussions 5
U Internal auditing - Company employees or contract second party Internal Auditing 10
J Recomended Values - Auditing process in a supplier IATF 16949 - Automotive Quality Systems Standard 18
M Canada - Registrars that allow e-auditing for ISO 9001? Registrars and Notified Bodies 4
K Internal Auditing - Umbrella QMS and Multiple Standards Oil and Gas Industry Standards and Regulations 4
D Auditing Our Outsourced 2nd-3rd Party Internal Audit Company ISO 13485:2016 - Medical Device Quality Management Systems 6
supadrai Auditing Organization dragging their heels on issuing our MDSAP Surveillance Audit Confirmation Letter - everyone is nervous ... are we the only ones? Canada Medical Device Regulations 7
Ed Panek Supplier Auditing - No purchases from our key suppliers in the last 24 months ISO 13485:2016 - Medical Device Quality Management Systems 5
P Auditing "process validation" process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
qualprod Effective Auditing advice needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
M Acceptance of remote auditing techniques - Can you help me with my research? General Auditing Discussions 0
GStough Auditing Against Criteria Unfamiliar to Auditee - Yea or Nay? General Auditing Discussions 11
R Auditing support and management processes General Auditing Discussions 7
F It is acceptable moving remote locations staff to manufacturing plant for auditing? IATF 16949 - Automotive Quality Systems Standard 3
D MSDS / GHS Walk-through / Auditing Occupational Health & Safety Management Standards 6
Pmarszal Supplier Auditing Services (Audit Needed?) General Auditing Discussions 4
S ISO 9001 Audit Observations - Transitioning my career into auditing Career and Occupation Discussions 16
G AS9101 Rev F - Worksheets for internal auditing AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
N API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers Oil and Gas Industry Standards and Regulations 5
M Auditing processes followed by employees placed on client's site Internal Auditing 4
S ISO 13485:2016 and MDSAP internal auditing ISO 13485:2016 - Medical Device Quality Management Systems 6
M Auditing a Contractor in EMS and Non Conformity Report General Auditing Discussions 1
Richard Regalado ISMS Auditing Guideline V2 (based from ISO/IEC 27001:2013) IEC 27001 - Information Security Management Systems (ISMS) 7

Similar threads

Top Bottom