What should I know about ISO 9001?

A standard for your long term success!

Introduction

Welcome to: What should I know about ISO 9001?

Presenters:• Craig Cochran• Richie Ybarra - ISO Coordinator

ReadyOne Industries • Ed Boerst - Corporate Quality Director

Professional Contract Services, Inc.

Session Objectives

• Provide an overview of the ISO 9001 Standard• Discuss the benefits and challenges of

implementation• Provide examples from the CRP community• Reduce fear related to ISO implementation

Craig CochranBusiness Coach

cochran@gatech.edu

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A Management System…

A systematic way to manage operations at all levels of the organization

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Key system components

• Documented procedures• Defined responsibilities

and authorities• Determination of

resources• Clear processes and

controls• Verification activities• Systematic improvement

processes

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What can we hope to gain from it?

• Consistency of methods

• Higher efficiency

• Fewer mistakes

• More involvement among personnel

• Recognition by all customers

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But won’t it slow us down or limit our creativity?

No, it actually encourages creativity and

efficiency by removing roadblocks

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What ISO 9001 is NOT

• NOT an absolute standard• NOT confined to the quality

department• NOT a “big honkin’ binder”

of procedures• NOT additional bureaucracy

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ISO establishes standards for a vast range of endeavors

• More than 13,000 standards for business, government, and society

• Military engineering• Agriculture• Image technology• You name it!

ISO = isos = Greek word for “equal” ISO acronym

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ISO 9000 Series ― What It Is

• Generic, baseline series• Widely applicable• Defines the basics• Identification varies among

countries• U.S. => ANSI/ISO/ASQ

Q9000 series

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ISO 9001:2008The Requirements

• Quality Management System• Management Responsibility• Resource Management• Product Realization• Measurement, Analysis, and Improvement

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Anywhere “shall” appears, the

organization must do something

“Shall” is the operative word in ISO 9001

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Materials outside of these sections are for guidance and

illustration purposes only

The “Shalls” of ISO 9001 start in Section 4 and continue through Section 8

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The standard repeats itself

numerous times

A confusing aspect of ISO 9001…

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The intent was to present the

requirements in an integrated fashion, not

in isolated buckets

The ISO 9001 standard is structured as a ‘process model’

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ResourceManagement

ManagementResponsibility

Measurement,Analysis,

Improvement

Product Realization

CONTINUAL IMPROVEMENT

Customer

Customer

Requirements

Satisfaction

ProductInput Output

The Process ModelQuality Management System

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So, what do I need to know?

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Quality PolicyThings to know

• Where it is

• What it means

• How you support it through your own activities

Georgia Power Forestry Quality Policy

• Target Zero – Every day, every job, safely

• Right of Way management that meets all customer, stakeholder, and regulatory requirements

• Establish and implement objectives that drive behavior and continual improvement

• Ensure a reliable transmission and distribution system

Manage company rights-of-way in a cost effective manner, ensuring high reliability of service. In order to realize this mission, we are dedicated to the following goals:

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Quality ObjectivesThings to know

• What are the objectives• What they indicate• The current status of objectives…are they

getting better or worse?• Specifically how YOU contribute to the

achievement of objectives

ACME Company – 2011 Business Objectives

1. Achieve a 98% on-time service rate

2. Reduce service re-work to 3% or less

3. Have 0 loss time safety incidents

4. Become ISO 9001 certified by December 2011

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Documentation & ProceduresThings to know

• How to access your documents• How you know documents are current • Understanding of contents• What to do if you had an idea for improvements• How documents are revised

Leading documentation problems

• Using an out-of-date document

• Not realizing a document existed

• Posting “bandit” documents, such as emails, memos, yellow sticky notes

• Everybody just develops their own private documentation

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Control of RecordsThings to know

• What records are you responsible for?• Where are they located?• How long are they maintained?• Can your access appropriate records?

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Management ResponsibilityThings for Top Management to know

• How do I communicate important topics to the organization?

• How do I reinforce a customer focus?• How do employees learn about objectives and how

they contribute?• How do I review our organizational effectiveness?• How do we receive customer feedback?• What actions are taken on customer feedback?

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• How do employees learn of their responsibilities and authorities?

• How was the management representative selected?

• How do I ensure appropriate resources are determined and provided?

• How do we address existing problems? (corrective action)

• How do we address potential problems? (preventive action)

• What is my leadership role with corrective and preventive actions?

Management ResponsibilityThings for Top Management to know

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Competency & TrainingThings to know

• What jobs am I competent to perform?

• What sorts of training events have I attended?

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Competency & TrainingThings for Human Resources to know

• How do we document competency requirements?• Is the required education, training, skills, and

experience addressed?• What training do we conduct to meet competency

requirements?• What is the frequency of the training?

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• How do we evaluate training effectiveness?• What records are kept?• Is there a written training procedure?• How do we work to improve the training process?

Competency & TrainingThings for Human Resources to know

Example competency requirements

Mail room specialist• Ability to demonstrate correct use of all mailroom

equipment• Working knowledge of parcel service (USPS, UPS, FedEx)

policies and pick-up times• Working knowledge of all internal mail room procedures;

pass procedures quiz at 90% or better• Completion of training course “Suspicious Materials

Handling” on a yearly basis• Completion of training course “Mail Privacy and Personal

Conduct” on a yearly basis

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Infrastructure & MaintenanceThings to know

• What maintenance tasks am I responsible for?• How often are these tasks performed?• What records are generated?• Where are these records kept?

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Sales & ContractThings for Sales to know

• How are orders and contracts received?• How are they reviewed? What is the record?• What happens if we don’t agree with order

requirements?• What happens if problems arise after an order

is accepted?

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• How do we keep the customer apprised of progress on orders?

• How is product information (brochures, website, etc.) kept up to date?

• How do customers provide feedback?• How are complaints handled?• How is this information shared with the rest of the

organization?

Sales & ContractThings for Sales to know

Leading contracting problems

• Customer changed requirements, but we didn’t communicate changes internally

• Not formally reviewing requirements at the time of acceptance

• Informal documentation of customer requirements

• Accepting requirements we know we can’t meet

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Design & DevelopmentThings for Engineers to know

• What constitutes the record of design planning?• How do we capture design inputs?• How do we generate design outputs?• What sorts of design review are performed?

What are the records?

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• What design verifications are performed? What are the records?

• What design validations are performed? What are the records?

• How do we change existing designs? What are the records?

Design & DevelopmentThings for Engineers to know

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Purchasing & Supplier ManagementThings for Purchasing to know

• What is our criteria for selecting, evaluating, and re-evaluating suppliers?

• What records do we have of evaluating suppliers?• Are ALL critical suppliers included within the

system? • What happens to suppliers who fail to perform?• How do we communicate requirements to

suppliers?• How is purchased product verified when it

arrives?

Leading purchasing problems

• Evaluating suppliers with meaningless criteria

• Not clearly documenting purchase requirements

• Not requiring suppliers to take corrective action when they fail

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Process Control Things to know

• How you monitor your process• What specifications or standards are in place• What written procedures apply to your

process?• What tools and equipment are required for

your process?

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• What are the acceptable limits of your process?• What do you do if the process exceeds these

limits?• How would you propose improvements to your

process?• Who are the customers of your process and what

are their requirements?

Process Control Things to know

Leading problems with process control

• No oversight or supervision• Putting people on the job

before they understand the tasks

• No clear guidelines for acceptable versus unacceptable process results

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Material control & product PreservationThings to know

• How products are coded and labeled• Correct locations for products, based on their

status• Preservation requirements• What to do when products lack identification• Special handing and storage requirements, if any

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Repair & customer propertyThings to know

• How is customer property identified?• How is it protected and safeguarded?• How do we know what to do with it?• Who do we notify if customer property is

unsuitable or can’t be repaired?• What records are kept?

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Calibration Things to know

• The measuring instruments under your control• Correct method for using measuring instruments • Who do I notify when calibration is due?• Status of calibration• What you would do if measuring instruments

malfunction

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Customer Satisfaction Things to know

• Your customers and their requirements• How we capture feedback• How feedback is analyzed• What actions are taken

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Monitoring & measurement of productThings to know

• What is the criteria for product inspection and test?

• What is the frequency?• What records must be generated?• Are you required to record any special data about

inspections and tests?• What happens if product does not meet

requirements?

Leading inspection problems

• Getting into a hurry and skipping it

• Using the wrong inspection criteria

• Not keeping records• Tying inspection results to

disciplinary action• Separating the making

from the checking

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Control of Nonconforming ProductsThings to know

• How nonconforming products are identified• Where they are stored• Who dispositions them• Your role in carrying out the disposition• What records must be kept

Leading problems with nonconforming products

• Assuming that people know what nonconforming looks like

• Removing nonconforming identification before disposition is complete

• Allowing nonconforming products to get out the door

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Internal Auditing Things for auditors to know

• Do you have a procedure for internal auditing?• Where is our schedule for internal audits?• How are audits planned?• How are auditees notified?• How do you plan your interview questions and

audit trails?• Do you look for positives?

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• How do you handle audit nonconformities?• How do you sample evidence?• What do you do when disagreements arise?• What records are created by the audit process?• What is your role in verifying corrective actions?• What sort of training qualifies you to be an

internal auditor?

Internal Auditing Things for auditors to know

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Continual ImprovementThings to know

• What are some of our key tools for driving improvement?

• How can I get involved?• What do I do if I have ideas for improvement?

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Corrective / Preventive Action Things to know

• Method for initiating corrective or preventive action

• What sorts of issues can trigger corrective or preventive actions

• How are causes determined?• How do we ensure actions are taken?• Status of corrective and preventive actions in

your area

Leading problems with corrective actions

• “Pencil whipping” corrective actions

• Taking action on symptoms instead of causes

• Not digging deep enough to identify real causes

• Closing corrective actions before there is evidence of effectiveness

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The ImplementationProcess

ISO 9001 implementation success factors

• Getting some expert assistance right at the beginning

• ISO 9001 Gap Analysis• ISO 9001 Project Planning,

with clear action items• Visibility of progress against

action items• Broad involvement of many

personnel – not a single person’s project

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ISO 9001 implementation success factors

• Top management closely involved

• Not having a “Let’s get a certificate on the wall” philosophy

• Training a diverse team of internal auditors

• All focusing failures on the process, not on people

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The Certification Process

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What do we need to do to become ISO certified?

• Successfully complete an audit by a registrar• The audit will occur after we have set up

processes to meet all the requirements of the standard

• Auditors will determine if the processes meet the requirements of the standard, and see if we are following them

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About the audit

• It is important to remember that no one is being audited on their individual performance!

• The audit will evaluate the performance of the organization as a whole

• The intent of auditing is not to nit-pick, but to drive meaningful improvements

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What role will you have in ISO?

• Our processes will be controlled by the use of work instructions, training employees, and other methods

• Employees will be required to follow work instructions for certain jobs

• Employees also need to be aware of how their job affects the plant’s objectives

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NOTE: Systems vary among registrars.

ISO 9001:2008How Do You Maintain Certification?

• Pass surveillance audits, usually a partial audit every 6 months

• Pass re-registration audits, usually a full audit every 3 years

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Don’t miss this Course!

• “Attaining Customer Loyalty”September 13-14, 2011Las Vegas, NV

• Fun, interactive, and practical• Offered at NO COST to NISH affiliate

organizations• Register: https://www.nishacademy.org• Or contact Cora Chaply at: 571-226-4534

For more information:

Presenter:

Craig Cochran

678-699-1690

craig.cochran@innovate.gatech.edu

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Smart and practical books :

www.patonprofessional.com

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Richie Ybarra - ISO Coordinator ReadyOne Industries

rybarra@readyone.org

Management ReviewsMeasuring the Effectiveness of an Organization

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Management ReviewsPerformance Inputs – Measuring Objectives

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Management ReviewsPerformance Outputs – Establishing Improvements

Management ReviewsValidation of Improvement Efforts – Added Value?

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Management ReviewsPerformance Management – Business Goals for ROI

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Management ReviewsControl of Records – Power of Documentation

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Ed Boerst - Corporate Quality Director Professional Contract Services, Inc.

INTRODUCING PCSIINTRODUCING PCSI

At PCSI, we take pride in the quality and performance of the service we give to our customers and the diverse employment opportunities we provide for people with disabilities.

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PCSI started in a one room office with 2 employees. When: Founded 1996, with 2 employees Why: To provide employment opportunities for people with

disabilities through performance of state and federal contracts What: Ability One; formally Javits-Wagner-O’Day (JWOD)

Program, Texas State Use Program (TIBH) – turnkey contract management solution

How: Operates as a business, completely self-sufficient contractor Where: Corporate Headquarters – Austin; contracts located in 6

states – TX, OK, CO, UT, VA and WA

HISTORYHISTORY

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Average annual growth since 1996 = 20%

Strongest growth potential – Hospital Housekeeping, Facilities Maintenance, Vehicle Maintenance, Warehouse Operations and Data Entry

Currently have approx. 40 contracts with over 1250 employees

ISO Certification received in December 2007

Recertification received in December 2010

Currently have 10 contracts certified at 6 sites plus corporate.

Will add 2 contracts at 2 sites in May and June of this year.

PCSI HIGHLIGHTSPCSI HIGHLIGHTS

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ISO implementation and certification brought consistency among sites:• Concept that all provided services are process based• Processes were captured and documentation developed to

standardize processes among sites• Resulted in common formats for procedures, records, and

forms• Standardization of documentation numbering at the site and

corporate levels• Document Control (all documents recorded on a Master

Document List)

• Developed universal methods for sites to perform audit inspections and report quality performance, on a monthly basis, to PCSI Corporate Management

WHAT ISO BROUGHT TO PCSIWHAT ISO BROUGHT TO PCSI

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WHAT ISO BROUGHT TO PCSIWHAT ISO BROUGHT TO PCSI

ISO fostered a continuous improvement cycle:• Improvement of Input + process improvement =

• Reduction in customer complaints• Significant reduction in deficiencies per site• Improved site AQLs• Reduction in cost• Total customer satisfaction

Praeto analysis was implemented to analyze and trenddeficiencies to provide correction and eliminate recurrence.

Formal “closed loop” Corrective Action and PreventiveAction processes were implemented at all sites.

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Discussion & QuestionsWhat should I know about ISO 9001?

POLLY WESSELSenior Quality Manager

NISH - Products8401 Old Courthouse Rd.

Vienna, VA. 22182office: 703-584-3956pwessel@nish.org

Session Evaluation Information

SESSION TITLE: Tools1

SESSION CODE: Q-T900