ISO 9001 and ISO 9004 Workshop

by Charles Corrie, BSI Secretary to ISO/TC 176/SC 2

Workshop Plan
Introductions Background to ISO 9000 Quality principles ISO 9001 ISO 9004 Self Assessment

Background to the ISO 9000 standards

History
The International Organization for Standardization (ISO) established in 1947 ISO/TC 176 established in 1979 First ISO 9000 standards published in 1987 2nd editions in 1994 3rd editions in 2000 Major changes in 2000 editions, with - the adoption of the process approach, and the merger of ISO 9001, ISO 9002, ISO 9003

ISO 9000 is not a single standard,

but a family of standards

The core standards in the family:

ISO 9000:2005 Quality management systems -- Fundamentals and vocabulary ISO 9001:2000 Quality management systems -- Requirements
ISO 9004:2000 Quality management systems -- Guidelines for performance improvements ISO 19011:2002 Guidelines for quality and/or environmental management systems auditing

The supporting standards:

ISO 10002:2004 Quality management -- Customer satisfaction -- Guidelines for complaints handling in organizations ISO 10005:2005 Quality management -- Guidelines for quality plans ISO 10006:2003 Quality management systems -- Guidelines for quality management in projects ISO 10007:2003 Quality management systems -- Guidelines for configuration management

The supporting standards continued ISO 10012:2003 Measurement management systems -- Requirements for measurement processes and measuring equipment ISO/TR 10013:2001 Guidelines for quality management system documentation ISO/TR 10014:2006 Quality management systems -- Guidelines for realizing financial and economic benefits

ISO 10015:1999 Quality management -- Guidelines for training

The supporting standards continued

ISO/TR 10017:2003 Guidance on statistical techniques for ISO 9001:2000 ISO 10019:2005 Guidelines for the selection of quality management system consultants and use of their services

ISO/TC 176 Other guidance

Selection and Use of ISO 9000 brochure
Quality Management Principles ISO 9000 Introduction and Support Package:
N524 - Guidance on ISO 9001:2000 clause 1.2 'Application' N525 - Guidance on the Documentation Requirements of ISO 9001 N526 - Guide to the Terminology used in ISO 9001:2000 and ISO 9004

N544 - Guidance on the Concept and Use of the Process Approach for management systems
N630 - Guidance on Outsourced Processes

Interpretations
ISO Handbook: ISO 9001 for Small Businesses

ISO 9001 Auditing Practices Group

Joint ISO/TC 176, ISO/CASCO and IAF team that produces guidance notes focussed on 3rd party management system auditors, but useful to 1st party auditors.

More than 20 papers posted on the web, e.g.:

The need for a 2-stage approach to auditing Measuring QMS effectiveness and improvements Identification of processes Understanding the process approach

Determination of the where appropriate processes

Now also Accreditation Auditing guidance

Web sites

www.iso.org (general guidance)

www.tc176.org
(interpretations)

www.iso.org/tc176/sc2
(ISO 9000 Introduction and Support package)

www.iso.org/tc176/ISO9001AuditingPracticesGroup (auditing guidance)

Key to standards development stages: NWIP New Work Item proposal AWI WD CD DIS Approved Work item Working Draft Committee draft Draft International Standard

FDIS Final Draft International Standard

ISO/TC 176 Work in Progress

TC 176 Interpretations TC 176/SC 1

ISO/AWI 9000
Quality management systems -- Fundamentals and vocabulary

TC 176/SC 2
ISO/DIS 9001 ISO/CD2 9004

ISO/TC 176 Work in Progress

TC176/SC 3 ISO/FDIS 10001 Quality management -- Customer satisfaction -- Guidelines for codes of conduct ISO/FDIS 10003 Quality management -- Customer satisfaction -- Guidelines for external customer disputes resolution ISO/CD 10004 Guidelines for monitoring and measuring customer satisfaction ISO/WD 10018 Quality management Guidelines on people involvement and competences

What does having ISO 9000 mean ?

Your organization will have: - Examined the ISO 9001 standard - Implemented a quality management system that complies with the requirements of the standard - Been independently assessed as to having a system that complies - Been awarded a certificate to show external parties that you have achieved compliance

How long does it take to achieve ISO 9001 certification ?

Allowing for: - Communication, training and consultation - The updating of existing systems and documentation - The availability of management - Initial reviews and internal audits - The certification audit and achievement of corrective actions Approximately 18 months

How is certification performed ?

An initial consultation with a certification body, and agreement of scope Contract agreement Performance of an audit of your complete management system Correction of nonconformities Award of certification (6 monthly) surveillance audits After 3 years, a re-audit of your full QMS

Quality principles

Question: What is quality ?

Callejn del Beso,

Guanjuato

ISO 9000:2005 3.1.1 quality degree to which a set of inherent characteristics (3.5.1) fulfils requirements (3.1.2) NOTE 1 The term quality can be used with adjectives such as poor, good or excellent. NOTE 2 Inherent, as opposed to assigned, means existing in something, especially as a permanent characteristic.

Fitness for Purpose ?

Mexico

The 8 Quality management principles that are the basis of the standards
Customer - focused organisation Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationship

ISO 9000:2005
3.1.4 customer satisfaction customer's perception of the degree to which the customer's requirements (3.1.2) have been fulfilled NOTE 1 Customer complaints are a common indicator of low customer satisfaction but their absence does not necessarily imply high customer satisfaction.

NOTE 2 Even when customer requirements have been agreed with the customer and fulfilled, this does not necessarily ensure high customer satisfaction.

Basic process
Controls (e.g. management)

Inputs

Activity

Outputs

Resources

Basic process model

MANAGEMENT

CUSTOMER

DESIRED
ACTIVITIES ENABLERS

INPUTS

OUTPUTS

CUSTOMER SATISFACTION

Basic process, with monitoring and measuring

EFFECTIVENESS OF PROCESS = Ability to achieve desired results

Input Requirements Specified (Includes resources)

Interrelated or interacting activities and control methods

Output Requirements Satisfied (Result of a process)

Monitoring and Measuring

EFFICIENCY OF PROCESS = Results achieved vs. resources used

ISO 9000:2005 3.2.1 system set of interrelated or interacting elements 3.2.2 management system system (3.2.1) to establish policy and objectives and to achieve those objectives 3.2.3 quality management system management system (3.2.2) to direct and control an organization (3.3.1) with regard to quality (3.1.1)

A system of processes

Outputs from other processes

Outputs from other processes

Inputs to A

PROCESS A

Inputs to B Outputs from A

PROCESS B

Outputs from B Inputs to D

Outputs from D

PROCESS D

Inputs to C

Outputs from C

PROCESS C

Question:
What general types of processes can be identified in an organization ?

Types of process
Processes for management of an organization. Processes for managing resources. Realization processes. Measurement, analysis and improvement processes

Types of process
Processes for management of an organization. These include processes relating to strategic planning, establishing policies, setting objectives, providing communication, ensuring availability of resources needed and management reviews.

Types of process
Processes for managing resources. These include all those processes for the provision of the resources that are needed for the processes for managing an organization, for realization, and for measurement.

Types of process
Realization processes. These include all processes that provide the intended output of the organization.

Types of process
Measurement, analysis and improvement processes. These include those processes needed to measure and gather data for performance analysis and improvement of effectiveness and efficiency. They include measuring, monitoring and auditing processes, corrective and preventive actions and are an integral part of the management, resource management and realization processes.

Example of processes and their sequencing

Management Processes
I O

Measurement, Analysis, and Improvement Measurement, Analysis, and Improvement

Process Design I O Production I Project Planning I O O

Product Design I O

O
O

Resource Processes

A1, A2, A3, A4

95%, 95%, 95%, 95% Efficiency

Overall = 81%

P-D-C-A, or Deming, cycle

Act
How to improve next time?

Plan
What to do? How to do it?

Check
Did things happen according to plan?

Do
Do what was planned

ISO 14001 PDCA type structure

Continual Improvement

Environmental Policy

Management Review

Planning

Checking and Corrective Action

Implementation and Operation

ISO 9000 Process Approach structure

Continual improvement of the quality management system

Management responsibility

Customers Customers
Resource management Measurement, analysis and improvement

Satisfaction

Requirements

Input

Product realization Product

Output

Continual Improvement

ISO 9001:2008

Scope of ISO 9001

ISO 9001 specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

ISO 9001 is an assessment specification for Quality Management Systems.

It is comprised of a number of introductory sections:

Foreword Introduction 1. Scope 2. Normative reference 3. Terms and definitions

Followed by 5 main clauses, and 62 subclauses:

4.Quality management system
5.Management responsibility 6.Resource management

7.Product Realization
8.Measurement, analysis and improvement Annex A Correspondence to ISO 14001:2004 Bibliography

All the requirements of clauses 4, 5, 6 and 8 are required to be complied with. However, where there is sufficient justification to do so, some of the requirements of clause 7 may be excluded (see clause 1.2).

The standard requires only 6 documented procedures

4.2.3 Control of documents 4.2.4 Control of records 8.2.2 Internal audit 8.3 Control of nonconforming product 8.5.2 Corrective action 8.5.3 Preventive action

However, it is likely that these will need to be supplemented by your organizations own additional procedures.

ISO 9001 schedule

Draft International Standard, Sept 07 Final Draft International Standard, July 08 Publication, Oct 08

ISO 9004:2009

A new direction for quality

Inspection Quality assurance Quality management (including customer satisfaction) Sustainable success

Change in the standards

1987/1994, Focus for customer benefit 2000, Focus on customers, plus benefits to the organization 2009, Focus mainly on benefits for the organization

ISO 9004:2009 new title

Managing for sustainable success a quality management approach

Sustainable success ?
4 companies incorporated for over 700 years A few hundred companies for over 350 years Several thousand for over 100 years Hundreds of thousands of organizations less than ten years old

So how do you go from being a start-up business to being 10 years old, to being 100 years old, to 350, to 750 ???

Questions: How do you think sustainable success could be achieved ? What are the critical factors ?

ISO 9004:2009
3.1 Sustainable success <of an organization> ability of an organization or activity to maintain or develop its performance in the long term. Note 1 Sustainable success emphasizes the need for a balance between the economic/financial interests of an organization and those of its social and ecological environment. Note 2 Sustainable success relates to interested parties of an organization (such as shareholders, employees, customers, users, interest groups and communities).

Purpose of ISO 9004:2009

To help organizations who are users of ISO 9001 obtain sustained benefit from the implementation of a more broad-based and in-depth quality management system.

Objectives for ISO 9004:2009

Facilitate improvement in users quality management systems Provide guidance to an organization for the creation of a quality management system that:
creates value for its customers, via the products it provides creates value for all other interested parties, balances all interested-party viewpoints.

Provide guidance for managers on leading their organization towards sustainable success. Forward compatibility to allow organizations to build on existing quality management systems.

Target customers for ISO 9004:2009

First Priority
Current users of ISO 9001: Organizations just getting started on ISO 9001

Second Priority
Organizations who are not users of ISO 9001 who want to go farther in QMS implementation than 9001

ISO 9004:2009 is not intended to be:

An implementation guide to ISO 9001 A business excellence model A set of requirements A textbook on Total Quality Management A source of untried approaches and methods

ISO 9004:2009 approach to sustainable success

Understand the organizations environment Establish a mission & vision Deploy strategies to achieve mission & vision Establish policies and objectives Manage resources and processes Monitor, measure and review performance Improve, innovate, and learn Use of self-assessment tools

Mission Vision Strategy Policy Objectives

Why we exist What we want to be Ways to achieve our vision How are we acting What we need to achieve

ISO 9004:2009
Foreword Introduction 1 Scope 2 Normative references 3 Terms and definitions

ISO 9004:2009
4 4.1 4.2 4.2.1 4.2.2 4.2.3 4.2.4 4.3 4.4 Managing for sustainable success Interested parties focus Approaches of managing for sustainable success General Focus on Strategy Process approach Continual Improvement Management Responsibility Assessing sustainable success

ISO 9004:2009
5 5.1 5.2 5.3 The organization's environment Changing environment Monitoring Analyzing

ISO 9004:2009
6 Policy and strategy formulation, planning & deployment 6.1 Policy and Strategy formulation 6.2 Policy and strategy planning and deployment 6.2.1 Planning 6.2.2 Scenarios and strategic risks 6.2.3 Deployment into processes and structures of an organization

ISO 9004:2009
7 7.1 7.2 7.3 7.3.1 7.3.2 7.3.3 7.3.4 Resources Management of resources Financial resources Human resources General Management of Human Resources Competence of people Involvement and motivation of people in the organization

ISO 9004:2009
7.4 7.4.1 7.4.2 7.4.3 Partners Partners and partnership Selection of partners Issues to be considered concerning partners 7.4.4 Evaluation of relationships with partners 7.4.5 Improvement of the partners capability 7.4.6 Review of relationships

ISO 9004:2009
7.5 7.6 7.7 7.8 Infrastructure Work environment Knowledge, information and technology Natural resources

ISO 9004:2009
8 8.1 8.2 8.3 Process management Types of processes Managing the organizations processes Process responsibility and authority

ISO 9004:2009
9 9.1 9.2 9.3 9.3.1 9.3.2 9.3.3 9.3.4 9.4 9.5 Measurement and analysis Purpose Key performance indicators Gathering data and information General Data in relation to key performance indicators Internal audit Self-assessment Review of data and monitoring the achievement of objectives Decisions

ISO 9004:2009
10 10.1 10.2 10.3 10.4 Improvement, innovation and learning Aiming for sustainable success requires improvement and innovation Improvement Innovation Learning

ISO 9004:2009
Annex A (Informative) Managing for sustainable success The self-assessment tools Annex B (Informative) Managing for sustainable success Self-assessment sheets Bibliography

ISO 9004 Schedule

2nd Committee Draft, for comment, Aug 07 3rd Committee Draft, for ballot, Jan 08 Draft International Standard, Aug 08 Final Draft International Standard, May 09 Publication, Aug 09

Question: What could be the business environment of - A large organization ? - A medium sized organization ? - A small business ?

An organizations environment

1. Analysis
1. Analysis 2. Strategy 6.6. Measurement Measurements

2. Strategy

& improvement
5. Implementation

5. Implementation

3.3. Processes Processes & structure

& structure

4. Resources

4. Resources

Question:
Who are the interested parties ?

Examples of Interested parties

Customers Shareholders/Investors/Owners Employees Partners/Suppliers Society Regulators Competitors

Question: What will the interested parties be looking for from the organization ?

Self -Assessment

What is it ?
A structured methodology Used by an organization To assess the maturity of its systems and processes To identify areas for improvement

How does it work ?

ISO CD2 9004 offers a two stage model Assessing the strategic and the operational performance levels By the use of a series of questions in a matrix, that enables the organization to identify its maturity levels Based on the guidance from the body of the standard

The Future ?

Integrated management system standards ?

TC176/SC2 & TC207/SC1 proposed Joint Vision for ISO 9001 and ISO 14001
(being considered)

The future revisions of ISO 9001 and ISO 14001 will be aligned and will seek to enhance further the current levels of compatibility between the two standards, through the promotion of identical:

titles, sequence of titles, text and definitions that are permitted to diverge only where necessitated by specific differences in managing environment or quality.

TC176/SC2 & TC207/SC1 proposed generic systems structure (being considered)

Context of the organization Consideration of the needs and expectations of interested parties (including customers and stakeholders) Leadership - Commitment and actions by management Support Resources and other needs that enable the organization to function Operations Activities/processes that make the organization achieve its purpose Performance evaluation Measurement and data gathering, analysis and use Improvement - Action to enhance the organization's performance