Embed Size (px)
Citation preview
ISO 9001 and ISO 9004Workshop
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 Background to the ISO 9000 standardsISO 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 9000:2005Quality management systems -- Fundamentals and vocabulary
ISO 9001:2000Quality management systems -- Requirements
ISO 9004:2000Quality management systems -- Guidelines for performance improvements
ISO 19011:2002Guidelines for quality and/or environmental management systems auditing
The supporting standards:
ISO 10002:2004Quality management -- Customer satisfaction -- Guidelines for complaints handling in organizations
ISO 10005:2005Quality management -- Guidelines for quality plans
ISO 10006:2003Quality management systems -- Guidelines for quality management in projects
ISO 10007:2003Quality management systems -- Guidelines for configuration management
The supporting standards – continued
ISO 10012:2003Measurement management systems -- Requirements for measurement processes and measuring equipment
ISO/TR 10013:2001Guidelines for quality management system documentation
ISO/TR 10014:2006Quality management systems -- Guidelines for realizing financial and economic benefits
ISO 10015:1999Quality management -- Guidelines for training
The supporting standards – continued
ISO/TR 10017:2003Guidance on statistical techniques for ISO 9001:2000
ISO 10019:2005Guidelines 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 Approved Work item
WD Working Draft
CD Committee draft
DIS Draft International Standard
FDIS Final Draft International Standard
ISO/TC 176 Work in ProgressTC 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 principlesQuality principles
Question:What is quality ?
Callejón del Beso,
Guanjuato
ISO 9000:2005
3.1.1qualitydegree 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
3.1.4customer satisfactioncustomer'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 necessarilyimply 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
ACTIVITIES
ENABLERS
CUSTOMERSATISFACTION
DESIRED
OUTPUTS
CUSTOMER
INPUTS
EFFECTIVENESSOF PROCESS =Ability to achievedesired results
Interrelated or interactingactivities and control
methods
Monitoring and Measuring
InputRequirements Specified
(Includes resources)
OutputRequirements Satisfied(Result of a process)
EFFICIENCY OFPROCESS =
Results achievedvs. resources used
Basic process, with monitoring and measuring
ISO 9000:2005
3.2.1systemset of interrelated or interacting elements
3.2.2management systemsystem (3.2.1) to establish policy and objectives and to achieve those objectives
3.2.3quality management systemmanagement system (3.2.2) to direct and control an organization (3.3.1) with regard to quality (3.1.1)
PROCESS A
PROCESS C
PROCESS B PROCESS D
Inputs to A
Inputs to B Outputs from A
Inputs to C Outputs from C
Outputs from B Inputs to D
Outputs from D
Outputs from other processes Outputs from
other processes
A system of processes
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.
Resource Processes
Product Design
Process Design
Project Planning
Production
Management Processes
Mea
surem
ent, A
nalysis, a
nd Im
provem
ent
OI
IO
I O
I O
I O
I O
I O
I O
Resource Processes
Product Design
Process Design
Project Planning
Production
Management Processes
Mea
surem
ent, A
nalysis, a
nd Im
provem
ent
OI
IO
IO
I OI O
I OI O
I OI O
I OI O
I OI O
I OI O
Example of processes and their sequencing
A1, A2, A3, A4
95%, 95%, 95%, 95% Efficiency
Overall = 81%
P-D-C-A, or Deming, cycle
Plan•What to do?•How to do it?
Do•Do what wasplanned
Check• Did things happenaccording to plan?
Act•How to improvenext time?
ISO 14001 PDCA type structure
Continual Improvement
Management Review
Checking and Corrective Action
Environmental Policy
Planning
Implementation and Operation
ISO 9000 Process Approach structure
Managementresponsibility
Measurement,analysis andimprovement
Resourcemanagement
Product realizationInput Output
Customers
Customers
Requirements
Satisfaction
Product
Continual improvement ofthe quality management system
Continual Improvement
Plan
DoCheck
Act
Regulations
Continual Improvement
ISO 9001:2008ISO 9001:2008
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.
Scope of ISO 9001
It is comprised of a number of “introductory” sections:
ForewordIntroduction1. Scope2. Normative reference3. Terms and definitions
ISO 9001 is an ‘assessment specification’ for Quality Management Systems.
Followed by 5 main clauses, and 62 sub-clauses: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 7clause 7 may be excluded (see clause 1.2).
The standard requires only 6 documented procedures6 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 organization’s own additional procedures.
ISO 9001 schedule
• Draft International Standard, Sept 07
• Final Draft International Standard, July 08
• Publication, Oct 08
ISO 9004:2009ISO 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 forISO 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 notnot 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 organization’s 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 – Why we exist
• Vision – What we want to be
• Strategy – Ways to achieve our vision
• Policy – How are we acting
• Objectives – What we need to achieve
ISO 9004:2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
ISO 9004:2009
4 Managing for sustainable success4.1 Interested parties focus4.2 Approaches of managing for sustainable
success4.2.1 General4.2.2 Focus on Strategy4.2.3 Process approach4.2.4 Continual Improvement4.3 Management Responsibility4.4 Assessing sustainable success
ISO 9004:2009
5 The organization's environment
5.1 Changing environment
5.2 Monitoring
5.3 Analyzing
ISO 9004:2009
6 Policy and strategy formulation, planning & deployment
6.1 Policy and Strategy formulation6.2 Policy and strategy planning and
deployment6.2.1 Planning6.2.2 Scenarios and strategic risks6.2.3 Deployment into processes and
structures of an organization
ISO 9004:2009
7 Resources7.1 Management of resources7.2 Financial resources7.3 Human resources7.3.1 General7.3.2 Management of Human Resources7.3.3 Competence of people7.3.4 Involvement and motivation of people in
the organization
ISO 9004:2009
7.4 Partners
7.4.1 Partners and partnership
7.4.2 Selection of partners
7.4.3 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 Infrastructure
7.6 Work environment
7.7 Knowledge, information and technology
7.8 Natural resources
ISO 9004:2009
8 Process management
8.1 Types of processes
8.2 Managing the organization’s processes
8.3 Process responsibility and authority
ISO 9004:2009
9 Measurement and analysis9.1 Purpose9.2 Key performance indicators9.3 Gathering data and information9.3.1 General9.3.2 Data in relation to key performance indicators9.3.3 Internal audit9.3.4 Self-assessment9.4 Review of data and monitoring the achievement
of objectives9.5 Decisions
ISO 9004:2009
10 Improvement, innovation and learning
10.1 Aiming for sustainable success requires improvement and innovation
10.2 Improvement
10.3 Innovation
10.4 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 organization’s environment
2. Strategy
4. Resources
1. Analysis
6. Measurements
5. Implementation
3. Processes & structure
2. Strategy
4. Resources
1. Analysis
6. Measurement& improvement
5. Implementation
3. Processes & structure
2. Strategy
4. Resources
1. Analysis
6. Measurements
5. Implementation
3. Processes & structure
2. Strategy
4. Resources
1. Analysis
6. Measurements
5. Implementation
3. Processes & structure
2. Strategy
4. Resources
1. Analysis
6. Measurement& improvement
5. Implementation
3. Processes & structure
2. Strategy
4. Resources
1. Analysis
6. Measurement& improvement
5. Implementation
3. Processes & structure
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 identicalidentical:
• 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 organizationConsideration of the needs and expectations of interested parties (including customers and stakeholders)
• Leadership - Commitment and actions by management
• SupportResources and other needs that enable the organization to function
• OperationsActivities/processes that make the organization achieve its purpose
• Performance evaluationMeasurement and data gathering, analysis and use
• Improvement - Action to enhance the organization's performance
