revision: 8-feb-2003iso9000:2000 management overview 1 management overview of iso 9001 : 2000

Revision: 8-Feb-2003 ISO9000:2000 Management Overview

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Management Overview ofManagement Overview ofISO 9001 : 2000ISO 9001 : 2000


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Consolidation of the ISO 9000 Series

• ISO 9001, ISO 9002 and ISO 9003 are now integrated into one certification standard, ISO 9001:2000.

• All organizations will now be ISO 9001 certified. – The differentiation of design / no design will be done

through the scope statement on the ISO 9001 certificates.

• Exclusion of any activities (i.e. design) must be stipulated and justified in the Quality Manual.


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Consolidation of the ISO 9000 series

Previous 20 standards now replaced by four:

• ISO 9000: QMS Fundamentals & vocabulary

• ISO 9001: QMS Requirements

• ISO 9004: Guidance for QMS performance improvement

• ISO 19011: Guidelines for auditingTo be further supported by technical reports (ISO 9000-2, ISO 9000-3, etc.)


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The Use of ISO 9004 as a Management Tool

• ISO 9004 includes all of ISO 9001 plus additional items to consider for improvement ideas.

• ISO 9004 should be regularly used throughout the organization to lead beyond the basics of ISO 9001 and improve the QMS during:

– QMS Development, – Internal Audits,– Preventive Action,– Management Reviews.


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New Structure & Focus• The ISO 9001:1994 model for Quality Assurance and

the familiar 20 elements did not adequately achieve the intent to ADD VALUE.

• The ISO 9k2k Standards are now modelled for Quality Management with 5 Major clauses:

– Quality Management System (QMS)– Management Responsibility – Resource Management– Product Realization– Measurement, Analysis & Improvement


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New Structure & Focus

• Significantly less emphasis on procedures and records.

• Significantly more emphasis on management involvement and a system that works to achieve the goals of your business.


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Management Systems

QMS

BMSQuality

Management Systems vs.

Business Management

Systems:

Your BMS =

QMS+

FMS+

HS&EMS+

ERP+

HR


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Management Systems

QMS BMS

Quality Management Systems vs. Business Management Systems:

Your QMS is not something you do separately from your BMS “because ISO requires it”!


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• ISO 9001 & 9004 are based on the 8 Management System Principles:

– customer focus– leadership– involvement of people– process approach– system approach– continual improvement– factual approach to decision making– mutually beneficial supplier relationships


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Food for Thought:

– Your business is a set of interactive processes, not 20 elements of ISO 9000...

– Your QMS is the means of controlling these processes and ensuring that the desired output is effectively and efficiently achieved...

– Why would you define and manage your QMS based on 20 fragmented elements of a standard?


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““A desired result is A desired result is achieved more achieved more efficiently when efficiently when

activities and related activities and related resources are managed resources are managed

as a process.”as a process.”

The Process Approach


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ProcessProcessActivitiesActivities

++ResourcesResources

InputsInputs OutputsOutputs

ControlsControls(e.g. procedures, operators, gaging, tooling, maintenance, etc.)

The Process Approach


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““Identifying, Identifying, understanding and understanding and

managing interrelated managing interrelated processes as a system processes as a system

contributes to the contributes to the organization’s organization’s

effectiveness and effectiveness and efficiency in achieving its efficiency in achieving its

objectives.”objectives.”

The System Approach to Management


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The organization must identify the sequence & interactions of the QMS processes in the Quality Manual.

ProcessProcessAA

ProcessProcessDD

ProcessProcessBB

ProcessProcessCC

InputsInputsOutputsOutputsControlsControls

The System Approach


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CUSTOMERS

CUSTOMERS

Management responsibility

Resourcemanagement

Measurement, analysis,improvement

ProductProduct

Continual Improvement of theQuality Management System

RequIrements

SatIsfactIon

InputOutput

System Approach of ISO 9k2k


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Customer Focus

“Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.”


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Customer Focus

• Information on Customer perception as to whether the organization has met their requirements must be collected, reviewed and appropriately acted upon (8.2.1).

• The methods of doing this are not prescribed by the standard but should be objective, representative of the customer base, and ADD VALUE.


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Customer Focus

• The most common methods of collecting Customer Satisfaction data are customer surveys and customer report cards (when provided).

• Other methods include measuring repeat orders, market share, industry benchmarking, capturing info. from sales visits, focus groups, and hiring consulting firms.

• A good system will use multiple methods and compare data from multiple sources to comprehensively understand customer perceptions and balance out any potential biases.


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Customer Focus

Additionally, the organization must demonstrate that effective arrangements for communicating with customers are in place in relation to:


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Customer FocusProduct Information (7.2.3-a):

– How well do you communicate your product information to your customers?

– Consider the experiences of using your favorite store Catalogue, or browsing Amazon.com or ebay...

– Were you satisfied with these experiences? – How do you know what your customers think about

your ability to communicate information that they are looking for?


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Customer Focus

Enquiries, contracts, and order handling, including changes (7.2.3-b):

– Now consider the “buying experience” with these same companies and ask the same questions…

– How do you think your customers feel about the ordering experience with your company? What about your quoting and order amendment processes?


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Customer Focus

Customer feedback, including complaints (7.2.3-c)

– Consider that a customer can be more loyal when you handle their problems to their satisfaction (or delight) vs. them never having a problem at all.

– Your want to know whether your customers are

satisfied with how you handle their feedback (even positive) and complaints.


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Factual Approach to Decision Making

“Effective decisions are based on the analysis of data and information.”


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Factual Approach to Decision Making

Plan

Do

Check

Act


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Analysis of Data & Measurement

More Food for Thought:

• Consider all the records and data that you collect and store in your company...

• How are each of these used for analysis, training, and improvement purposes?

• If you can’t answer this question for nearly every record you spend time and money collecting then why do you do it?


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Comprehensive Measurement & Improvement Model

Effect

ive

Com

mun

icat

ion

Planning & Resource Managem

ent

Quality Policy

Strategic QMS Objectives /

CSAT Metrics

QMS Process / Departmental Metrics and Objectives

Project / Product / Individual Metrics & Objectives

Factual & Logical Approach to Decision Making

Identification, Collection & Analysis of Records / Data


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• The Quality Policy must provide the framework for establishing strategic objectives (5.3).

• Measurable, documented, tactical objectives at relevant functions and levels of the organization must be established to support the strategic objectives (5.4.1).


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• The QMS Processes must be Monitored and/or Measured (8.2.3).

• Product specific objectives must be established (7.1-a).

• Customer Satisfaction must be measured (8.2.1).


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Continual Improvement

“Continual improvement of the organization’s overall performance should be a permanent objective of the organization.”


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• The organization shall implement actions necessary to achieve planned results and continual improvement of the QMS processes (4.1-f).

• Top management shall provide evidence of its commitment to the development and implementation of the QMS and continually improve its effectiveness (5.1).


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• (8.1) The organization shall continually improve the effectiveness of the QMS through the use of the…

–Quality Policy–quality objectives–internal audits–analysis of data–corrective and preventive actions–management reviews


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Analysis of Data, Measurement & Improvement

Plan

Do

Check

Act


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Strategic Quality Planning

Top Management shall ensure that:

• The planning of the QMS is carried out in order to meet the requirements in 4.1. - NOTE: Take some time to review 4.1!

• Plans are in place to achieve the quality objectives (5.4.2-a). • No requirement for plans to be documented - Caution:

verbal plans are only effective in certain situations.



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Tactical Quality Planning

Top Management shall ensure that:

• any changes to the business that affect the QMS are identified and that planning occurs to ensure that the integrity of the QMS is maintained (5.4.2-b).

• changes that could affect the QMS are identified in Management Reviews (5.6.2-f).

– Examples: New IT/MRP systems, new / updated equipment, new or changed products / processes, organizational changes, etc.


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Leadership & Involvement of People

“Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.”

“People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.”


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• Top Management shall ensure that appropriate communication processes are established within the organization… (5.5.3)

• Specific requirements for communicating information regarding the effectiveness of the QMS and the importance of meeting customer and regulatory requirements (5.5.3 & 5.1-a).


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• The organization shall ensure that all personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives (6.2.2-d).


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• Management must determine and provide the resources needed to implement, maintain and continually improve the QMS, and to enhance customer satisfaction (6.1).

• Top Management shall provide evidence of its commitment by… ensuring the availability of resources (5.1-e).

Resource Management


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• Resource needs are a required Management Review item (5.6.3-c).

• Infrastructure (buildings, equipment, utilities, IT, communications, etc.) needs to ensure quality must also be determined and provided (6.3).

Resource Management


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• A system to determine competency needs and evaluate employee competencies must be established.

• The effectiveness of any actions taken to satisfy competency needs must be evaluated (6.2.2-c).

Resource Management


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Evaluation of Competence

Competency requirements must be determined for all positions / people that affect quality (6.2.2-a).

Examples – Qualification criteria in job descriptions, defined in QMS procedures, project plans, performance reviews…

Appropriate records to demonstrate that competency requirements have been met must be maintained (6.2.2-e).

Examples – Employment applications, resumes, degrees, professional certifications, training records, performance reviews...


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Evaluation of Competence

Organizational Competency considerations:

• Future demands (customer, technology, market)• Anticipated management and workforce succession

needs• Changes in the processes and equipment• Individual competencies needed• Statutory and regulatory requirements, standards,

directives, etc.(ISO 9004 :2000)


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Evaluation of Training Effectiveness

Consider Four Variables in the Training Equation:

1. The Trainee – Did they learn?Controls – Qualification criteria, pre/post testing, trainer / supervisor assessments, performance reviews…

2. The Trainer – Could they Teach?Controls – Qualification criteria / training for trainers, Trainee / management assessments of trainer performance, course evaluations…


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Evaluation of Training Effectiveness

3. The Material – Did it adequately convey the necessary information?

Controls – Trainee / Trainer assessments of materials, internal audits, course evaluations, benchmarking… Consider the ability of an interactive video to convey information vs. pictures only vs. a written procedure only vs. verbal instruction only vs. a combination of all?

4. The Environment – Was it conducive to learning the material?

Controls – Defined environmental requirements and monitoring (temperature, noise, lighting, distractions, etc.), trainee evaluations…


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Effect

ive

Com

mun

icat

ion

Planning & Resource Managem

ent

Quality Policy

Strategic QMS Objectives /

CSAT Metrics

QMS Process / Departmental Metrics and Objectives

Project / Product / Individual Metrics & Objectives

Factual & Logical Approach to Decision Making

Identification, Collection & Analysis of Records / Data


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In order to achieve any improvement in OTD you must first collect and analyze appropriate data in order to understand the primary causes of late deliveries and establish realistic improvement goals.

Metrics, improvement objectives, plans and resource needs will then be identified and communicated throughout the organization.

By engaging the entire organization in this process and using the PDCA cycle you will ultimately achieve your OTD goals and increased customer satisfaction and organizational efficiency.

On Time Delivery example


Production Planning & scheduling

Supplier OTDEquipment capacity &

Maintenance

InventoryManagement

ContractReview / Lead time

management

OTD


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Course Summary

Say what you do…

Do what you say…

And make sure that it works!


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Course Summary

The majority of the efforts needed to demonstrate

compliance to ISO 9001:2000lie with the management

team.


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Course Summary

Run properly, by management, your QMS

will help you achieve your business goals.

revision: 8-feb-2003iso9000:2000 management overview 1 management overview of iso 9001 : 2000

Documents

management reviews

management overviewidentifying

management involvement

management tooliso

business management

elements of iso

management system principles

basics of iso