Corelation Of The Intent Between Business Plan, Company Data And ISO 9000 4.1?

H

hwang

#1
#1
Business Plan

Marc,

I am new comer.

thanks in advance for further help.

what's the corelation of the intent between business plan ,comany data and iso9000 4.1?

do we need establish lab if we only calibrate the gage for ourselves?
 
Paper to QMS ad
Elsmar Forum Sponsor
A

Al Dyer

#2
#2
My background is in QS-9000 but I think the following thoughts apply to general business planning as well as to ISO/QS-9000.

The business plan is used to document company goals and expectation. As a means to determine if these goals and expectations are met we use company level data. We usually use the well used term "Key Measureables".

These key measureable form a major part of element 4.1 (Management Review). The measureables document that company goals and expectations are tracked and that the current quality system is suitable and effective.

I don't know your tier level or if you are even in the automotive field, but calibrations need to be performed by labs that are accredited (registered?) to ISO-17025 lab guidelines and that all calibrations are traceable to "national Standards".

I believe this area of ISO/QS/TS is in minor chaos and am waiting for the dust to settle and have some more definitive directions.

Looking forward to more input!

ASD...
 
H

hwang

#3
#3
I like the clear explanation.

can you show me a brief example?

quality objective is part of the company goal? if it is,quality system would involve a lot.

how does the company data work? use benchmarking and update the goal?
 
H

hwang

#4
#4
I like the clear explanation.thank you very much.and,

can you show me a brief example?

quality objective is part of the company goal? if it is,quality system would involve a lot.

how does the company data work? use benchmarking and update the goal?
 
Geoff Cotton

Geoff Cotton

Quite Involved in Discussions
#6
#6
Al,

Why do you have to have calibration done by a 'registered lab'? We don't use one.

Our in-house calibration dept. leaves some 'registered labs' looking a bit sick.

Geoff
 
A

Al Dyer

#7
#7
Geoff,

Perhaps I should use the term "accredited" instead of registered lab, whether it be internal or external. In the case of automotive, I know that the customer (or their approved second-party) may choose to assess a lab to ensure it meets Guide 25 guidelines.

I agree with you that there are some suspect labs out there and we are currently setting up our own lab that will be accredited to ISO-17025. If you have any tips on setting up such a lab I would be grateful for any input.

ASD...


------------------
Al Dyer
Mngt. Rep.
[email protected]
 
Marc

Marc

Hunkered Down for the Duration
Staff member
Admin
#8
#8
Each company is different in how they address calibration. If you're just calibrating a few instruments in-house you're probably not going to have a lab per se. But you have to have calibration records, calibration instructions, etc. You will need, I believe, a statement of scope of the calibrations you do. Basically you do have to meet the Guide 25 requirements.

You asked:
> ...what's the corelation of the intent between business plan
> comany data and iso9000 4.1?

You do realize this is the QS 9000 forum, don't you?

I agree with Al's comments in regard to this.
 
H

hawson

#9
#9
thank you for your reply.
quote:
You do realize this is the QS 9000 forum, don't you?

--why qs9000 add the clause business plan?

my friend told me qs9000 additional clause are not additional requirement but specified way to iso9000, how do you think such plan is
for which iso clause?
 
Marc

Marc

Hunkered Down for the Duration
Staff member
Admin
#10
#10
QS-9000 is ISO 9001 PLUS a bunch of FORD, GM and Chrysler requirements (such as the business plan requirement). QS-9000 is really a customer requirement - it is not an international specification.

> my friend told me qs9000 additional
>clause are not additional requirement

Wrong -- The additional stuff QS 9000 has that ISO 9001 doesn't have are indeed requirements.

I guess the business plan requirement is something they decided was a 'basic' business requirement.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Sidney Vianna Informational New IAQG Document - AS9100 Clarifications of Intent AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
M Informational Health Canada advises Allergan of its intent to suspend its licences for Biocell breast implants as a precautionary measure Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Final Guidance – Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements Medical Device and FDA Regulations and Standards News 0
M Medical Device News Health Canada Notice of intent: Strengthening the post-market surveillance and risk management Canada Medical Device Regulations 1
S What is the intent of the term "document" in ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 1
T PPAP - Intent of an ISIR ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T ISO 13485 Clause 4.2.1 - Clarification of Intent ISO 13485:2016 - Medical Device Quality Management Systems 6
M What is the intent of the NOTE under 8.2.4 M/M of Product IATF 16949 - Automotive Quality Systems Standard 3
M Accountability for all product - Why it is important? Intent of 7.5.1 g) AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 8
R ISO 10012, ANSI/NCSL Z540, ISO 17025 reference meet ISO 9001 7.4.2 (a) intent? ISO 17025 related Discussions 13
S AC7101-3 - What is the intent of Para 9.0? Temperature Measurement AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
B AS9100 7.5.1.F and 7.5.1 G Intent - Control of Production and Service Provision AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 16
R Customer, Statutory and Regulatory Requirements - Intent of Clause 4.1, Note 3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M What is the intent of ISO 9001 Clauses 8.2.4 & 7.1 d? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
somashekar Intent of "Declaration of Conformity" - MDD ANNEX II EU Medical Device Regulations 8
I Does a QMS defined by the element-by-element approach meet the intent of 4.1a? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
J Identification and (material) traceability - Intent of the Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
H Clause 4.2 (d) intent - Framework for setting and reviewing environmental objectives Miscellaneous Environmental Standards and EMS Related Discussions 7
M ISO 13485 training - Understanding of intent and implementation of risk management Training - Internal, External, Online and Distance Learning 1
R 4.2.3.1 Engineering Specifications - Intent? What does this clause apply to? IATF 16949 - Automotive Quality Systems Standard 7
B Example Flow Chart meeting the intent of ISO 9001 Clause 4.2.2c ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q Each ISO9000:2000 requirement has intent? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Prioritized Reduction Plans - What is the intent of section 4.13.2.1? Nonconformance and Corrective Action 1
E Web Site Quality Statement - Stating the Intent to Register (We have a plan) Other ISO and International Standards and European Regulations 9
Marc ISO 9001 - Meeting the INTENT vs. Meeting the REQUIREMENT ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
R Is a letter of intent on file good enough for audit considerations? General Measurement Device and Calibration Topics 5
L Contract Review - Interpreting the intent of Contract Review - Open POs - Clause 4.3 Contract Review Process 16
S ISO Plots vs. Gage R&R - Do ISO plots meet intent of MSA? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
T Difference between a subcontractor and a supplier ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
K %GRR was between 10-30% so we have to have a "backup plan" per auditor IATF 16949 - Automotive Quality Systems Standard 15
H Difference between Stainless Steel 316 ASTM F899 and ASTM A276 Other Medical Device Related Standards 1
A Exact terms for a plating failure and difference between rejection rate and failure rate Manufacturing and Related Processes 9
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 15
M Difference between MSA and MSE? General Measurement Device and Calibration Topics 1
G What is the difference between discrete and continuous variables? Problem Solving, Root Cause Fault and Failure Analysis 5
R Plea for advice on transitioning between Notified Bodies (label updates) Medical Device and FDA Regulations and Standards News 1
M Measuring FIM (TIR) - Two inside diameters - Conflicting readings between inspectors Manufacturing and Related Processes 1
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
S Difference between EU-MDR Annex IX and the Annex-combo X&XI EU Medical Device Regulations 2
T ISO 17025:2017 Clause 4.2.2 - The difference between "be notified" and "be informed" ISO 17025 related Discussions 4
Jimmy123 What is the difference between Error Proofing and Controls? ISO/IATF 16949 - Control Plans FMEA and Control Plans 16
DuncanGibbons Clear differences between ISO 13485 and AS 9100D requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
H What is different between PED certificate and CPR certificate? Manufacturing and Related Processes 2
B Angle between two surfaces Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
D Variation between Faro Arms Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
K Differences between Manufacturing Process Audit & Layered Process Audit Lean in Manufacturing and Service Industries 4
P Risk acceptability alignment between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 6
C IEC 60601-1-8, difference between table 4 and annex D IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Reorganizing responsibilities between management teams and Employees in them ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Compatibility between MDD and MDR devices EU Medical Device Regulations 7
Similar threads
Top Bottom