Sample Business Plans meeting QS9000 Requirements

M

Mike Fasci

#1
Business Plan

Can anyone lead me in the direction of sample business plans meeting the QS9000 requirement. We are currently developing our plan an want to ensure that we create a usable and thorough plan.

Any assistance would be appreciated.

Thank You
 
Elsmar Forum Sponsor
D

D.Scott

#3
There is a great Business Plan builder in Lotus Freelance. Very comprehensive but easy to work with.
Dave
 
O

outoftown

#6
Just some helpful advice before you start with business plans, ask your plant manager or your controller (or CFO) if they have a copy of the business plan. This may be a combination of a one year strategic operating plan and a longer term business plan or long range plan. You do not have to reinvent the wheel. Just be sure that in your documentation you address the methods to update or revise the business plan (ask your plant manager how they do this) and control that document via numbered pages or sections, controlled distribution, table of contents or whatever. Do not try to pull this document into the rest of your document control system. The information in the BP is too sensitive for that. The auditor should be happy by looking at the table of contents and cover (showing the controlled distribution). They may want to see it extends out 3~5 years, but they cannot look at the contents (data) or they are now privy to insider information, a big no-no. :p

[This message has been edited by outoftown (edited 18 March 2001).]
 
Thread starter Similar threads Forum Replies Date
M SOP Sample for BC/ISO22301 (Business Continuity) wanted Business Continuity & Resiliency Planning (BCRP) 4
Richard Regalado Sample Plan for Developing an ISO 22301 Business Continuity Management System (BCMS) Business Continuity & Resiliency Planning (BCRP) 3
M Do ISO requires Business Plan? Any sample template? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Minimum sample size - Guidance and statistical rationale Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
L Sample Procedure from Contract Manufacturer Prospective ISO 14971 - Medical Device Risk Management 1
D Adding a Class I to a sample box Canada Medical Device Regulations 5
P Unrealistic Packaging Validation Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
M ISO 9001:2015 case study sample ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Sample of Nonconformity report for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
B Control chart and sample time Statistical Analysis Tools, Techniques and SPC 1
J Control chart for huge sample size Statistical Analysis Tools, Techniques and SPC 9
D How to list multi-product sample pack in GUDID 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Is there a standard for sample size during R&D phase Other ISO and International Standards and European Regulations 18
M Minitab assistant: 1-Sample % Defective Test Using Minitab Software 1
J Sample size definition in an Automotive SMT pilot lot run Misc. Quality Assurance and Business Systems Related Topics 1
T ISO 27001 sample audit report IEC 27001 - Information Security Management Systems (ISMS) 0
B IATF 16949 - Is a Deviation required for sample components in a prototype build? IATF 16949 - Automotive Quality Systems Standard 13
D Sample Calibration SOP for ISO 13485 General Measurement Device and Calibration Topics 4
T Sample of 1st Article Inspection Report wanted APQP and PPAP 3
E Correct way to certify hydrostatic testing when it is not 100% (and Sample Size) Various Other Specifications, Standards, and related Requirements 6
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2
B Determining sample size for device sterility Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
A In which EU countries would it be okay to use sample labels for registration? EU Medical Device Regulations 0
D Determining of sample size for 'Operational Qualification' AQL - Acceptable Quality Level 5
F Bayes Success run Theorem for sample size during OQ&PQ Qualification and Validation (including 21 CFR Part 11) 4
Watchcat Identification of Test Sample in Test Reports? Design and Development of Products and Processes 22
M AQL table - I need to sample 1250pcs AQL - Acceptable Quality Level 3
K The correct way of doing a 2 Sample T test Reliability Analysis - Predictions, Testing and Standards 7
I Device modifications - Clinical sample size rationale EU Medical Device Regulations 5
M Informational How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities Medical Device and FDA Regulations and Standards News 0
J Sample size for creating a data base as a reference to a tested variable Other Medical Device and Orthopedic Related Topics 6
R Medical Device Design verification sample prototype Other Medical Device and Orthopedic Related Topics 14
J ISO 17025 - Please share a sample procedure for monitoring the validity of results ISO 17025 related Discussions 1
M Inputs on definition of very similar processes for multi site audit sample - IAF MD1 2018 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Qyu Autoclave and Sample Container - Pressure-steam cooking's effect Reliability Analysis - Predictions, Testing and Standards 1
J ISO 13485:2016 sample exam/test ISO 13485:2016 - Medical Device Quality Management Systems 3
M EU IVD Risk Determination of sample collection EU Medical Device Regulations 0
T Sample Size for Design Validation Design and Development of Products and Processes 4
C AS9138 Sample Size Determination AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
K Small Sample - Lower Limit Probability Statistical Analysis Tools, Techniques and SPC 0
S Can anybody share a sample risk assessment prepared based on ISO 17025:2017? ISO 17025 related Discussions 15
V Acceptable maximum RSD (relative standard deviation) for an sample size Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
E Sample size for design verification of variable in single use device Design and Development of Products and Processes 19
R Sample size for clinical validation/investigation EU Medical Device Regulations 4
I MDD Class I software technical documentation sample EU Medical Device Regulations 2
R Process Validation sample size selection Statistical Analysis Tools, Techniques and SPC 0
J Interesting Discussion Sample Size Determination for Medical Device Other Medical Device and Orthopedic Related Topics 9
S Calibration vs "Golden Part" ("Control Sample") General Measurement Device and Calibration Topics 9
P Is it possible to make an educated decision using a very very small sample size? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3

Similar threads

Top Bottom