9001 executive overview

8/7/2019 9001 Executive Overview

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the9000store.comThe Tools You Need to Achieve and Maintain ISO 9001

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Copyright 2010 The 9000 Store

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 .



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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.
http://www.the9000store.com/what-are-iso-9000-standards.aspxhttp://www.the9000store.com/what-are-iso-9000-standards.aspxhttp://www.the9000store.com/what-are-iso-9000-standards.aspxhttp://www.the9000store.com/what-are-iso-9000-standards.aspxhttp://www.the9000store.com/what-are-iso-9000-standards.aspxhttp://www.the9000store.com/what-is-iso-9002.aspxhttp://www.the9000store.com/what-is-iso-9003.aspxhttp://www.the9000store.com/what-are-iso-9000-standards.aspxhttp://www.the9000store.com/what-is-iso-9000.aspxhttp://www.the9000store.com/what-are-iso-9000-standards.aspxhttp://www.the9000store.com/buy-standards.aspxhttp://www.the9000store.com/what-are-iso-9000-standards.aspxhttp://www.the9000store.com/what-is-iso-9004.aspxhttp://www.the9000store.com/what-is-iso-9001.aspxhttp://www.the9000store.com/buy-standards.aspxhttp://www.the9000store.com/what-is-iso-9004.aspxhttp://www.the9000store.com/what-is-iso-9004.aspxhttp://www.the9000store.com/buy-standards.aspxhttp://www.the9000store.com/what-is-iso-9001.aspxhttp://www.the9000store.com/what-is-iso-9000.aspxhttp://www.the9000store.com/what-is-iso-9003.aspxhttp://www.the9000store.com/what-is-iso-9002.aspxhttp://www.the9000store.com/what-are-iso-9000-standards.aspx


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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.
http://the9000store.com/step1-what-is-iso-9001.aspxhttp://the9000store.com/step1-what-is-iso-9001.aspx


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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!
http://the9000store.com/ISO-9000-Tips-Benefits-of-ISO-9001.aspxhttp://the9000store.com/ISO-9000-Tips-Benefits-of-ISO-9001.aspx


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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
http://www.the9000store.com/buy-standards.aspxhttp://www.the9000store.com/buy-standards.aspx


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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
http://www.the9000store.com/iso-9001-quality-manual-and-procedures.aspxhttp://www.the9000store.com/iso-9001-quality-manual-and-procedures.aspxhttp://www.the9000store.com/iso-9001-quality-manual-and-procedures.aspxhttp://www.the9000store.com/ISO-9000-Tips-How-Much-Does-it-cost.aspxhttp://www.the9000store.com/iso-9001-internal-auditor-training.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-9001-internal-auditor-training.aspxhttp://www.the9000store.com/ISO-9000-Tips-How-Much-Does-it-cost.aspxhttp://www.the9000store.com/iso-9001-quality-manual-and-procedures.aspx


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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?
http://www.the9000store.com/Free-ISO-9001-Explained-Kit.aspxhttp://www.the9000store.com/Free-ISO-9001-Explained-Kit.aspxhttp://www.the9000store.com/Free-ISO-9001-Explained-Kit.aspxhttp://www.the9000store.com/Testimonials.aspxhttp://www.the9000store.com/whythe9000store.aspxhttp://www.the9000store.com/whythe9000store.aspxhttp://www.the9000store.com/Testimonials.aspxhttp://www.the9000store.com/Free-ISO-9001-Explained-Kit.aspx

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