Limited Scope in Quality System

P

painter

We are a small coatings
company. We are starting our process of developing all the stuff (Q. Policy, Levels I to IV ,etc.), but our Manager only wants to certify 4 functions: Production, Q.C., Maintenance and Warehouse.
As we are making paints for a Non automotive market we don´t need any QS or 16949 and we are not responsible for design, so we will persue ISO 9002.
We are building our Q. Manual and the easy part is writing a note in the 4.4 saying that 4.4 is not applicable for above reasons.
But the problems started when we arrived to 4.3. Our sales department same as other departments are barely starting to be formed.Same case is Purchasing, H.R. and so on.
I know that is valid to declare in my scope only a part of my company, but that doesnt mean that the rest of the functions (needed to complete the quality system) will never take a participation, hence my idea is to consider activities such 4.6, 4.18, 4.11 as "services suppliers", which could be into my company or from outside (e.g. a corporate function, because we have a corporate group)They have to deal with us and agree the needs to be covered. We will give them our Training, materials and calibration needs and they will ensure the quality of those services.Then my Q. Manual will describe those "external services" and our responsibilities in each chapter. But in the case of 4.3 ,... can our Operations or production manager or anybody else take the responsibility of Contract review, due that Sales dept. will not be part of our Scope?.

I hope that my doubts have been more or less clear (my domestic language is spanish)and I will appreciate any help on how to handle both my documentation and related links and implementation in order to prepare my company for a certification of mentioned areas in about 8 --10 months.In a near future we will certify the entire company.

Thank you in advance

Painter
 
A

Al Dyer

Only a suggestion, but shouln't you be persuing registration/compliance to ISO-9000/2000? I'm not even sure a Registrar would register you to the 1994 standard.

ASD...

[This message has been edited by Al Dyer (edited 24 March 2001).]
 
L

Laura M

You say you are a small coatings company, but have a corporate HQ somewhere - so the entire company isn't that small?

Like Al, I wonder if you want certification or compliance. If anything is "outsourced" then you need to show how you control them...the purchasing requirements may come into play. I was in a situation where "oursourcing" occurred. You are still responsibile for the results of the outsourcing - someone to review (internally audit) that what is being done meets the requirements. You can't scope it out however, but document how you address the requirement.
 
P

painter

Laura and Al:

Thanks for your help.
Well, when I mentioned that we are a small company I meant less than 50 people. When I said "corporate" i tried to describe the first company founded by the owner( about 40 people). Our plant is a new branch of that first (making no paints), owned by the same person. They do not have any certification.
I certainly agree that the best would be to work on the 9001:2000, but I will try to convince them to do that, But anyways, if I apply the new one I still have the problems with inputs like 7.4, 6.2.2,7.6 and outputs such as 5.2/7.2.1, 7.2.2,7.2.3

Meanwhile, I would like to know oppinions on how to write the Manual Chapters realated to external functions

painter
 
D

Dan Larsen

I believe some of your confusion may be coming what a certification applies to. All four functions that you want to certify use the services that you want to "write around". Remember that the certification applies to your system, not specific operating functions within the system.

With respect to purchasing, for example, the functions that you wish to certify all require purchased items to create output. In your case, you manufacture paints. Raw materials are purchased to make the paints. Who orders the raw materials? Who inspects them upon receipt? What type of controls do you place on your supplier? Purchasing is part of the system and should be addressed in your policy. Keep in mind that you don't need a "purchasing department" in order to control the purchasing process. In many small companies, various managers and supervisors have buying authority. In effect, all of them are purchasing agents and all of them should be aware of the policy requirements.

Training is another area that you very likely can't ignore. You mention that you have 50 employees. How do you address their training needs? How do you document that they are trained? You can outsource some of the training (for example forklift training or hazardous material training) but once it's completed, your company is still responsible for documenting that the training was performed. I also suspect that you do a fair amount of on-the-job training that you should take credit for.

As for contract review, you have to define the person with the authority for deciding whether or not you accept the customer order based on the customer requirements for product and delivery. That person has the contract review responsibility.

Take another look at the standard, keeping in mind that it applies to the system and not the individual functions and I think it will start to become clear.

(An afterthought: Take a look at Figure 1 in ISO 9001:2000. The circle is your company. The functions you mention are within the small box titled "product realization". When you get certified, you get certified for the entire circle, not each individual box. Now, that's not to say you can't outsource some of the other small boxes. But remember that outsourcing is nothing more than purchasing, therefore by the standard you have to apply controls. Help any?)
 
P

painter

Dan:
Thank you for stop by and devote some of your time to give a great help.
I personally think it is more complicated the way my management wants to handle ISO certification, because as you said, the entire system is who makes the quality, customer satisfaction and continuous improvement. The PDCA cycle will never run if someone remains jammed or not involved.
I think the best idea is to try to involve all key departments (even waiting some weeks to fill some vacant positions we are try to fill).
Of course I will follow your advices and hope to continue in touch with you and the rest of the folks. Thank you again.

painter
 
Thread starter Similar threads Forum Replies Date
G Why are 17025 scope angle measurements limited to 5 to 85 degrees? ISO 17025 related Discussions 2
H Implementing ISO22301 on a Limited Scope Business Continuity & Resiliency Planning (BCRP) 2
D Limited Scope for second site Question? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
N ISO 9001 certification with limited scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Control of Duplicate Documents - Limited Scope (long) Document Control Systems, Procedures, Forms and Templates 5
B Is limited scope a CAPA System Weakness? Preventive Action and Continuous Improvement 14
N QMS Scope length limited to 10 to 15 words maximum - How is that possible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q Attribute MSA with limited test samples Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
D Limited Range Calibration - 5000 lb Industrial floor scale General Measurement Device and Calibration Topics 3
S How PMEL does a limited calibration - Tensiometers ISO 17025 related Discussions 1
J Design Control - Can Validation be based on a limited/first Production Run ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
T How to study for the SQE exam but am limited on funding Career and Occupation Discussions 1
M Offered Management Position - Limited Experience - Any Concerns? Quality Manager and Management Related Issues 13
S Differentiate ISO 9001 System MNC vs. Public Limited Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
AnaMariaVR2 Agila Specialties Private Limited Warning Letter US Food and Drug Administration (FDA) 0
D How is transport of Dangerous Goods (limited quantity) regulated for Bulk Transport? RoHS, REACH, ELV, IMDS and Restricted Substances 9
M Conducting Limited Internal Audits of QMS Elements - Simple question I hope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
P Capability Analysis for Limited Resolution (thickness of sheets) Capability, Accuracy and Stability - Processes, Machines, etc. 6
J O & D can not be predetermined, assigned or limited by the customer, only the S. FMEA and Control Plans 1
M Limited Calibrations - An instrument that will not pass a full calibration, OOT General Measurement Device and Calibration Topics 8
M Limited manufacturing release (LMR) vs. Full manufacturing release (FMR) EU Medical Device Regulations 3
C Company is not FDA/ISO regulated - Limited ISO/FDA experience in Resume! Career and Occupation Discussions 8
D Control of Records limited to ISO 9001 Required Records - ISO 9001 Clause 4.2.4 Records and Data - Quality, Legal and Other Evidence 1
G Limited Calibration requirements in ISO 13485 - Temperature controller ISO 13485:2016 - Medical Device Quality Management Systems 3
P Are Sales Offices with limited and controlled tasks Remote Locations IATF 16949 - Automotive Quality Systems Standard 3
M Limited Duty Workers - If a person is hurt on the job and transferred to another job Various Other Specifications, Standards, and related Requirements 1
D Certification - Changing from 'Partnership' to 'Private Limited Company' Misc. Quality Assurance and Business Systems Related Topics 6
R Cl. 4.15 Limited Shelf Life materials ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Z Design verification test sample size under the scope of first in human study submission in Europe Medical Device and FDA Regulations and Standards News 3
L Review of Scope of Mangement System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Adding a Processing site to scope, shipping before certification? IATF 16949 - Automotive Quality Systems Standard 2
L AS9100 work for another site outside scope AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Audit Duration Calculation - ISO9001 + EN9100 with different scope General Auditing Discussions 2
S Smart Scope Fixturing Quality Tools, Improvement and Analysis 3
B ISO 13485 Certificate Location / Scope ISO 13485:2016 - Medical Device Quality Management Systems 9
S 7.1.5.3.1 Internal Lab Scope IATF 16949 - Automotive Quality Systems Standard 15
Tagin Corporate HQ handles AR/AP - Outsourced or Out-of-scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D API Q1 clause (1.0) Scope Oil and Gas Industry Standards and Regulations 1
Q Considering addition of mass calibration to ISO17025 scope ISO 17025 related Discussions 6
C ISO13485 scope as Legal Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 2
Ed Panek ISO 9001 Cert Scope Adjustment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
H IEC 62368-1 Scope of Testing CE Marking (Conformité Européene) / CB Scheme 3
A Laboratory scope on the IATF IATF 16949 - Automotive Quality Systems Standard 5
I Restricting scope to one part number for one customer IATF 16949 - Automotive Quality Systems Standard 6
A ISO 9001- any advise please with transitioning from a paper based system to eQMS and multi site scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S F-108 Request for Expansion of Scope of Accreditation ISO 17025 related Discussions 2
S Scope of management review ISO 13485:2016 - Medical Device Quality Management Systems 5
D Do all products fall under scope of AS9100? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M PROBLEM IN SCOPE OF ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
N ISO 13485 Scope Reduction Other ISO and International Standards and European Regulations 2

Similar threads

Top Bottom