SBS - The best value in QMS software

Warehouse and shipping/receiving activities need to be part of our scope?

J

Joe Cruse

#21
Anyway the "Scope" is meant to be what the organization intends and has to manage to help it's achieving customer satisfaction
Is the Scope not meant to be a "Here is what I do (make, serve, provide) that I want to be be registered to ISO 9001:XXXX system"????? My understanding, from both my registrar and what I have seen in the standard, is that the scope is meant to be a "declaration" of the "activity" which I wish to have the registration for, which would also be stated in some way on my certificate of registration. The "activity" stated in my scope would be concluded by a process, or series of processes, which are then defined in my QMS, along with detailing the interaction of all my processes that make up my registered "activity". Defining your registered "activity"'s processes and their sequence/interactions SHALL be defined in your QMS, but I see no SHALL for defining them in the Scope, nor do I notice where the OP wrote themselves into a corner for this.

I'm with Randy and Big Jim; appeal!!! And also agree that if this IS a major that they will not back off of, they owe your employer some $$$$ for letting you get to the surveillance audits with this "problem".

Good luck!
 
Elsmar Forum Sponsor

insect warfare

QA=Question Authority
Trusted Information Resource
#24
I appealed the Corrective Action and won the dispute. According to the new auditor (We requested a change of auditor), Our Key Processes covered all our functions. Thanks to everyone for the great advice.
I figured as much....I guess 50 million Elvis fans can't be wrong after all....:cool:

Brian :rolleyes:
 

LUV-d-4UM

Quite Involved in Discussions
#25
I work for a fastener company and recently went thru an ISO 9001-2008 Surveillance Audit. The auditor wrote us a Major CA, because "The warehouse and shipping/receiving activities were not noted in the scope". Is this something that must be on the scope?
Can you please tell what is the scope of your ISO as stated in the certificate?

Big JIM said that under th ISO9001:2008 you should appeal. And I agree.
 

LUV-d-4UM

Quite Involved in Discussions
#26
Thank for all your responses. It's been a great help.

Brian,
Our Scope reads:

This manual pertains to processes relating to: The manufacturing of fasteners for the fastener industry.

The manual and related quality system documentations are written to comply with the requirements of ISO 9001:2008, and PED 97/23/EC requirements.
I think the scope is OK because you still have to determine the processes in 4.1 and I am sure that you have already completed that. So repeal !!!! Good luck. These experts have your back.
 
M

Mahlon

#28
In agreement with all above - you need to escalate this to the Registrar as a challenge to the finding and either fire the auditor and/or the Registrar he or she represents. A Major NC is NOT a cert issue; it is at most an OFI and should have been caught/resolved at the initial Assessment audit during their S1 review.
 

phoenix2368

Starting to get Involved
#29
The auditor wrote us a Major CA, because "The warehouse and shipping/receiving activities were not noted in the scope". Is this something that must be on the scope?
Scope is basically the objective/ purpose of the document (i.e. in your case it was Quality Manual) .
I agree with all that this auditor had no idea what he was doing. :(
 
Thread starter Similar threads Forum Replies Date
L Writing a Shipping and Receiving Procedure - Designated Warehouse Locations ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T Outsourcing Shipping Product directly from our Warehouse to the End Customer ISO 13485:2016 - Medical Device Quality Management Systems 2
Q Control plans for Incoming, Warehouse and Shipping process FMEA and Control Plans 5
J Warehouse Floorspace Utilization Manufacturing and Related Processes 3
R Product Recall - medical devices in the hospital warehouse Canada Medical Device Regulations 2
L Significant change notice for outsourced warehouse Medical Device and FDA Regulations and Standards News 2
M Pharmaceuticals Warehouse temperature control (room temperature) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
B Software for setting up New Warehouse Manufacturing and Related Processes 0
R Is there a mandatory medical device warehouse standard for europe? EU Medical Device Regulations 3
G How to cover another manufacturing "site" or warehouse into current ISO 13485 cert ISO 13485:2016 - Medical Device Quality Management Systems 7
P Non Conforming Material in the Warehouse..to tag or not? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D AS9100 section for Warehouse/Preservation of materials? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R Brand New Warehouse - FMEA example wanted FMEA and Control Plans 9
B Fire Extinguisher Requirements for a Warehouse Vehicle Miscellaneous Environmental Standards and EMS Related Discussions 2
S Package Storage Direction in an I.T. Warehouse ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M FDA Wall Clearance Requirements For Warehouse 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
M Critical Limits for CCP in a food storage warehouse Food Safety - ISO 22000, HACCP (21 CFR 120) 4
A Food Warehouse ISO 9001 Audit and Newbie Introduction ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Calibration in Warehouse Environment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Movement of Final Product from One Warehouse to Another Manufacturing and Related Processes 2
R HACCP for Packaging, Labeling and Warehouse of Food Products Food Safety - ISO 22000, HACCP (21 CFR 120) 13
S Building and Warehouse requirements of OHSAS 18001 Occupational Health & Safety Management Standards 8
S Single Warehouse used by two different companies - One is ISO 13485 registered Quality Manager and Management Related Issues 1
J HACCP and ISO22000 - Brewery and Warehouse Food Safety - ISO 22000, HACCP (21 CFR 120) 13
M Kanban vs. Line Balancing - Process Engineering our Warehouse Process Lean in Manufacturing and Service Industries 3
M Internal Warehouse Handling - A Reverse Logistic Case! Process Maps, Process Mapping and Turtle Diagrams 6
N 100% Inspection in Retail Warehouse which Ships Products to Customers Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
B TS 16949 Upgrade for Distribution Warehouse IATF 16949 - Automotive Quality Systems Standard 4
Q Electronic Process Examples (IT Data Warehouse) Human Factors and Ergonomics in Engineering 1
N Managing Subcontracting Process - Material Traceability from Warehouse to Processing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Warehouse Layout Design Lean in Manufacturing and Service Industries 11
bgot62 Secondary Operations and an uncontrolled document in the warehouse ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
H Forklift Safety - Driver loses control in warehouse (Video) Occupational Health & Safety Management Standards 2
R VMP template for Temperature Data Loggers in a Pharma Warehouse Qualification and Validation (including 21 CFR Part 11) 4
P Warehouse Audit - Nonconformance or not - That is the question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
A Rental Warehouse Audit required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
G Manufacturing -> Warehouse -> Tier 1/OEM - Process flow, PFMEA, & Control Plan FMEA and Control Plans 9
D Should I put Warehouse under Manufacturing Department? Misc. Quality Assurance and Business Systems Related Topics 8
A Production Planning, Scheduling and Warehouse Management Manufacturing and Related Processes 8
I How to Balance a Warehouse System Lean in Manufacturing and Service Industries 2
I Time Analysis of Logistics in a Warehouse Lean in Manufacturing and Service Industries 3
C Requirements for Process Chemical Storage in a Warehouse Miscellaneous Environmental Standards and EMS Related Discussions 20
M Dock to Stock Template for Distributor/Warehouse of Industrial Metals Document Control Systems, Procedures, Forms and Templates 5
A Warehouse Internal Audit - Seeking Tips and Advice Internal Auditing 17
J Free Warehouse Layout & Planning Guide and Facilities & Workplace Design guide Design and Development of Products and Processes 10
M President of company wants ISO 17025 for testing - Warehouse distributor ISO 17025 related Discussions 3
M Warehouse Space Utilization Spreadsheet Document Control Systems, Procedures, Forms and Templates 5
L Warehouse Design Layout - FDA Regulated Medical Manufacturer Design and Development of Products and Processes 3
T Warehouse Fire: QMS Involvement? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
D Segregation of Product by Type and Production Week - Warehouse General Auditing Discussions 2

Similar threads

Top Bottom