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ISO 9001ISO 9001
Executive OverviewExecutive Overview
W h a t i t i s, an d h o w t o ach ieve i t .
Copyright 2010 The 9000 Store
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Executive Overview
Who is ISO?
What is a QMS?
What are ISO 9000 and 9001?
What are the Benefits of ISO 9001?
What Does ISO 9001 Require You to Do?
How Do We Implement ISO 9001?
What are the Costs of Registration?
How Long Does it Take to Implement?
How do we begin?
In the following slides, the ISO 9001:2008 Standard is paraphrased for instructional purposes.
Please Refer to the standard for the actual text.
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Who is ISO?
The International Organization for Standardization gathersindustry professionals from 158 member countries todevelop and improve standards.
ISO authorizes organizations in each member country tomanage the process of accrediting Registrars (ANAB, etc.)
Registrars
audit individual organizations and recommend
them for certification.
It is a 3 year certification
Year 1
Registration Audit
Years 2 & 3
Surveillance Audits
(in addition to your internal audits performed constantly)
http://www.iso.org/iso/home.htmhttp://www.iso.org/iso/home.htmhttp://www.iso.org/iso/home.htmhttp://www.iso.org/iso/home.htmhttp://www.anab.org/accreditation/quality.aspxhttp://www.the9000store.com/ISO-9000-Tips-Selecting-a-Registrar.aspxhttp://www.the9000store.com/ISO-9000-Tips-Selecting-a-Registrar.aspxhttp://www.the9000store.com/ISO-9000-Tips-Selecting-a-Registrar.aspxhttp://www.the9000store.com/ISO-9000-Tips-Selecting-a-Registrar.aspxhttp://www.the9000store.com/ISO-9000-Tips-Selecting-a-Registrar.aspxhttp://www.the9000store.com/ISO-9000-Tips-Selecting-a-Registrar.aspxhttp://www.anab.org/accreditation/quality.aspxhttp://www.iso.org/iso/home.htm -
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A quality management system (QMS) is a set of policies, processesand procedures required for planning and execution in the corebusiness area of an organization. (Good business practices)
Core Areas -
Areas that can impact the organization's ability to meet
customer requirements:
Quotations, Purchasing, Production, Shipping, etc.,
Quality: Corrective/Preventive action of errors to achieve consistent results.
ISO 9001:2008 is an example of a Quality Management System.
Read more about a QMS
orclick to see demo
What is a QMS?(Quality Management System)
http://www.the9000store.com/what-is-iso-9001-quality-management-system.aspxhttp://www.the9000store.com/what-is-iso-9001-quality-management-system.aspxhttp://www.the9000store.com/what-is-iso-9001-quality-management-system.aspxhttp://www.the9000store.com/what-is-iso-9001-quality-management-system.aspxhttp://www.the9000store.com/what-is-iso-9001-quality-management-system.aspxhttp://www.the9000store.com/QMSDemo/qmsdemo.htmlhttp://www.the9000store.com/QMSDemo/qmsdemo.htmlhttp://www.the9000store.com/QMSDemo/qmsdemo.htmlhttp://www.the9000store.com/what-is-iso-9001-quality-management-system.aspx -
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What is ISO 9000?
ISO 9000 is a family of standards for a Quality Management System
Read about ISO 9000 Family
(including obsolete standardsISO 9002& ISO 9003)
ISO 9000:2005
Guidance: Fundamentals & Vocabulary for ISO 9000
ISO 9001:2008
The Requirements of the ISO 9000 Standard
You will need to buy a copy of the ISO 9001:2008 Requirements Standard
ISO 9004:2009
Guidance: Managing for sustained success
ISO 9000 is an internationally recognized QMS standard which acts asa quality benchmark when evaluating organizations.
ISO 9000 Registration means you have a QMS in place to control yourprocesses and deliver consistent results designed to meet thecustomers requirements.
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What is ISO 9001?
ISO 9001:Objective: customer satisfaction
Is industry generic (anyone can use)
Can be used by both manufacturing and service industries.
Only tells you WHATto do, not HOW to do it
Is NOT a product standard
it contains no product
requirements.
See free tutorial Basics of ISO 9001 to learn more.
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ISO 9001 is Based Upon Several Principles
You should understand these key items(click each of the following to learn more):
The Process Approach
The PDCA model
(Plan-Do-Check-Act)
Eight Quality Management Principles
Fundamentals of Auditing
http://www.the9000store.com/ISO-9000-Tips-Process-Approach.aspxhttp://www.the9000store.com/iso-9000-tips-plan-do-check-act.aspxhttp://www.the9000store.com/iso-9000-tips-plan-do-check-act.aspxhttp://www.the9000store.com/iso-9000-tips-plan-do-check-act.aspxhttp://www.the9000store.com/ISO-9000-Tips-Eight-Quality-Principles.aspxhttp://www.the9000store.com/Step7-iso-9001-internal-audits.aspxhttp://www.the9000store.com/Step7-iso-9001-internal-audits.aspxhttp://www.the9000store.com/ISO-9000-Tips-Eight-Quality-Principles.aspxhttp://www.the9000store.com/iso-9000-tips-plan-do-check-act.aspxhttp://www.the9000store.com/ISO-9000-Tips-Process-Approach.aspx -
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Internal Benefits
Improved productivity andefficiency
Cost reductions based uponreduced errors
Improved communications,morale and job satisfaction
Read aboutISO 9001 Benefitsand download a free PowerPointBenefits of ISO 9001
Benefits of ISO 9001
External Benefits
Improved consistency of service andproduct performance
Higher customer satisfaction levels
Improved customer perception
Competitive advantages andincreased marketing and sales
opportunities.
If you meet ISO 9001, a potential customerwill know you have a solid QMS in placeand likely have good quality.
This could be a DECIDING FACTORbetween you and your competition!
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Requirements of ISO 9001(click each of the following to learn more):
ISO 9001 has many requirements which can be summarized as:
Determine the customer requirements
Establish Quality Policy & Objectives and a work environment necessary to meetthese requirements.
Design and manage a system of inter-related processes to attain objectives.(QMS)
Measure and analyze the effectiveness of each process in meeting
goals and
customer requirements. (Audits)
Continually improve the Quality Management System
Download the ISO 9001 Requirements in Plain English
http://www.the9000store.com/ISO-9000-Tips-ISO-9001-Requirements.aspxhttp://the9000store.com/ISO-9000-Tips-Customer-Related-Processes.aspxhttp://www.the9000store.com/Step7-iso-9001-internal-audits.aspxhttp://www.the9000store.com/Step7-iso-9001-internal-audits.aspxhttp://www.the9000store.com/ISO-9000-Tips-ISO-9001-Requirements.aspxhttp://www.the9000store.com/ISO-9000-Tips-ISO-9001-Requirements.aspxhttp://www.the9000store.com/ISO-9000-Tips-ISO-9001-Requirements.aspxhttp://www.the9000store.com/Step7-iso-9001-internal-audits.aspxhttp://the9000store.com/ISO-9000-Tips-Customer-Related-Processes.aspxhttp://www.the9000store.com/ISO-9000-Tips-ISO-9001-Requirements.aspx -
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Requirements of ISO 9001
There are 8 sections in the ISO 9001:2008
Standard, summarized here:1. Scope2. References3. Terms and definitions4.
Quality Management system(Documentation)5. Management responsibility
(Commitment)6. Resource Management
(People, Environment, etc.)7. Product realization(Production, or what you do)
8. Measurement, Analysis and Improvement(Proof)
Sections 4,5,6,7 & 8 contain the requirements and you willneed to address each of them. Specifically(next page)
Buy a copy of the ISO 9001:2008 Standard
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Major Requirement Clauses of ISO 9001(click each of the following to learn more):
Management Responsibility
Commitment, Customer focus, Policy, Planning, Responsibility,Authority & Communication, Review
Resource Management
Human Resources, Infrastructure, Work Environment
Product Realization
Customer Requirements, Design, Purchasing, Operations,Calibration
Measurement and Analysis
Customer Satisfaction, Audit, Process/Product Control, Non-
conforming product, Data Analysis, Improvement
http://the9000store.com/ISO-9000-Tips-Management-Responsibility.aspxhttp://the9000store.com/ISO-9000-Tips-Resource-Management.aspxhttp://the9000store.com/ISO-9000-Tips-Product-Realization-Process.aspxhttp://the9000store.com/ISO-9000-Tips-Product-Realization-Process.aspxhttp://the9000store.com/ISO-9000-Tips-Corrective-and-Preventive-Action.aspxhttp://the9000store.com/ISO-9000-Tips-Corrective-and-Preventive-Action.aspxhttp://the9000store.com/ISO-9000-Tips-Product-Realization-Process.aspxhttp://the9000store.com/ISO-9000-Tips-Resource-Management.aspxhttp://the9000store.com/ISO-9000-Tips-Management-Responsibility.aspx -
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Required QMS Documentation
Quality Policy
Your Organizations Commitment to Quality
Quality Objectives
Measurable Quality Goals
which support the Policy
Quality Manual
What you do to meet the standard
Procedures & Work Instructions
Outlines steps referencedin the Quality Manual
Quality Records
Records & Tables as evidence of QMS performance
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Steps to ISO 9001 Certification(click each of the following to learn more):
Your implementation plan should cover these items:1.
Learn and understand ISO 9001
Review ISO 9001 Standard and supporting materials
2.
Perform a Gap Analysis
Evaluate your current quality system vs. ISO 9001
3.
Plan your project and allocate resources
People, Money, Time, etc.
4.
Train your organization
Management Rep, Project Team, Employees, etc.
5.
Create & Document a QMS
Adding/revising processes
6.
Use and Improve your QMS
Run your normal organizational activities following the QMS
7.
Audit your QMS to ensure you meet objectives
Corrective and Preventive Action when addressing errors
8.
Registration Audit of your QMS (3 year Certification)
Year 1 = Registration Audit
Year 2 & 3 Surveillance Audits
http://www.the9000store.com/Step2-perform-gap-analysis.aspxhttp://www.the9000store.com/Step1-what-is-iso-9001.aspxhttp://www.the9000store.com/Step3-ISO-9001-implementation-plan.aspxhttp://www.the9000store.com/Step2-perform-gap-analysis.aspxhttp://www.the9000store.com/Step4-ISO-9001-Training.aspxhttp://www.the9000store.com/Step3-ISO-9001-implementation-plan.aspxhttp://www.the9000store.com/Step3-ISO-9001-implementation-plan.aspxhttp://www.the9000store.com/Step4-ISO-9001-Training.aspxhttp://www.the9000store.com/Step6-Implement-ISO-9001-QMS.aspxhttp://www.the9000store.com/Step3-ISO-9001-implementation-plan.aspxhttp://www.the9000store.com/Step7-iso-9001-internal-audits.aspxhttp://www.the9000store.com/Step6-Implement-ISO-9001-QMS.aspxhttp://www.the9000store.com/Step8-iso-9001-Registration-Audit.aspxhttp://www.the9000store.com/Step7-iso-9001-internal-audits.aspxhttp://www.the9000store.com/Step8-iso-9001-Registration-Audit.aspxhttp://www.the9000store.com/Step8-iso-9001-Registration-Audit.aspxhttp://www.the9000store.com/Step7-iso-9001-internal-audits.aspxhttp://www.the9000store.com/Step6-Implement-ISO-9001-QMS.aspxhttp://www.the9000store.com/Step3-ISO-9001-implementation-plan.aspxhttp://www.the9000store.com/Step4-ISO-9001-Training.aspxhttp://www.the9000store.com/Step3-ISO-9001-implementation-plan.aspxhttp://www.the9000store.com/Step2-perform-gap-analysis.aspxhttp://www.the9000store.com/Step1-what-is-iso-9001.aspx -
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ISO 9001 Project Timeline
Varies with Size & Complexity of Org.
Many clients are between 3-6 months
Depends on time and resources applied
Create QMS
From a few days to several months
Use/Improve QMS & Internal Audit
Usually 2+ months due to business cycle
Registration Audit - 2 days
Follow up to fix non-conformances
The 9000 Store provides several freeISO 9001 project timelines.
http://www.the9000store.com/ISO-9000-Tips-How-Long-Does-It-Take.aspxhttp://www.the9000store.com/ISO-9000-Tips-How-Long-Does-It-Take.aspxhttp://www.the9000store.com/ISO-9000-Tips-How-Long-Does-It-Take.aspx -
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Costs of Registration(Costs vary depending on size and complexity of organization)
Creating QMS
Use templates
to save time
Consultant: $5,000-$50,000
Internal Auditing (No certification is required)
Train Internal Team of Auditors In House $500
Send to Internal Auditing Course ~$1200/person
Hire 3rd Party ~$1000/day
$400
Costs of Registration Audit (Click to contact a Registrar for a Quote)
Allowable audit times follow ISO 17021, but vary with Organization
~$1400/day
$200, PLUS travel expenses
Registration Audit: 2+ days
Surveillance Audit: 1+ days
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Where Do You Begin?(click each of the following to learn more):
Follow the 9000 Store Project Managers Guide
Step by Step Guide to ISO 9001 Certification
Buy ISO 9001 Certification Package, which includes:
Gap Checklist Toolkit
Complete QMS Documentation with Quality Manual, Procedures and FormTemplates for all 20 requirements
2.5 Hour Project Team Training
Employee Training for the Whole Company
Internal Audit Training & Checklist
The 9000 Store provides Free Support for the length of your project
Call 877-942-6572
Email
questions for your entire project
Online Resources
Registration - Well help you find a Registrar
http://www.the9000store.com/Free-ISO-9001-Explained-Kit.aspxhttp://www.the9000store.com/complete.aspxhttp://www.the9000store.com/complete.aspxhttp://the9000store.com/iso-9001-Gap-Analysis-Checklist.aspxhttp://the9000store.com/iso-9001-implementation-training.aspxhttp://the9000store.com/iso-9001-quality-manual-and-procedures.aspxhttp://the9000store.com/iso-9001-internal-auditor-training.aspxhttp://the9000store.com/iso-9001-implementation-training.aspxhttp://the9000store.com/iso-9001-Employee-Training.aspxhttp://the9000store.com/iso-9001-internal-auditor-training.aspxhttp://www.the9000store.com/ISO-9001-Technical-Support.aspxhttp://www.the9000store.com/faq.aspxmailto:[email protected]?subject=Website%20Questionmailto:[email protected]?subject=Website%20Questionmailto:[email protected]?subject=Website%20Questionmailto:[email protected]?subject=Website%20Questionhttp://www.the9000store.com/ISO-9000-Tips-Selecting-a-Registrar.aspxhttp://www.the9000store.com/faq.aspxhttp://www.the9000store.com/ISO-9000-Tips-Selecting-a-Registrar.aspxhttp://www.the9000store.com/ISO-9000-Tips-Selecting-a-Registrar.aspxhttp://www.the9000store.com/faq.aspxmailto:[email protected]?subject=Website%20Questionhttp://www.the9000store.com/ISO-9001-Technical-Support.aspxhttp://the9000store.com/iso-9001-internal-auditor-training.aspxhttp://the9000store.com/iso-9001-Employee-Training.aspxhttp://the9000store.com/iso-9001-implementation-training.aspxhttp://the9000store.com/iso-9001-quality-manual-and-procedures.aspxhttp://the9000store.com/iso-9001-Gap-Analysis-Checklist.aspxhttp://www.the9000store.com/complete.aspxhttp://www.the9000store.com/Free-ISO-9001-Explained-Kit.aspx -
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C i ht 2010 Th 9000 St
Simplify Your Certification Project
Consult the ISO 9001:2008 Project Managers Guide
for detailed step by step instructions
The 9000 Store has helped thousands of organizations in
more than 40 countries reach certification since 2001.
Were the original source for ISO 9001 solutions
Can your organization afford to trust their quality to
anything less than the best?
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