Quality Management Systems: the ISO 9000 Family of Standards

Quality Management Systems: the ISO 9000Family of Standards

Nicola Mezzetti, Ph.D.

Department of Information Engineering and Computer ScienceUniversity of Trento

[email protected]

A.A. 2014/2015

Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards

What is a Quality Management System?

Quality Management System

A set of coordinated activities to direct and control an organizationin order to continually improve the effectiveness and efficiency ofits performance

A Quality Management System (QMS):

enables an organization to achieve the goals and objectives setout in its policy and strategy

provides consistency and satisfaction in terms of methods,materials, equipment

interacts with all activities of the organization, beginning withthe identification of customer requirements and ending withtheir satisfaction


The ISO 9000 case study


The ISO 9000 Family of Standards

The ISO 9000 family addresses various aspects of qualitymanagement.

It aims at providing companies and organizations with guidanceand tools for ensuring that their product and services consistentlymeet customer’s requirements, and that quality is consistentlyimproved.

ISO 9000:2005 defines basic concepts and language

ISO 9001:2008 defines the requirement of a qualitymanagement system

ISO 9004:2009 focuses on how to make a qualitymanagement system more efficient and effective

ISO 19011:2011 sets out guidance on internal and externalaudits of quality management systems


The Scope of ISO 9000:2005

The ISO 9000 standard describes fundamentals of qualitymanagement systems and defines related terms. It applies to:

organizations seeking advantage through the implementationof a quality management system;

organizations seeking confidence from their suppliers thattheir product requirements will be satisfied;

users of the products;

those internal or external to the organization who assess thequality management system or audit it for conformity with therequirements of ISO 9001;

those internal or external to the organization who give adviceor training on the quality management system appropriate tothat organization;

developers of related standards.


The Scope of ISO 9001:2008

ISO 9001 specifies requirements for a quality management systemwhere an organization

needs to demonstrate its ability to consistently provideproduct that meets customer and applicable statutory andregulatory requirements, and

aims to enhance customer satisfaction through the effectiveapplication of the system, including processes for continualimprovement of the system and the assurance of conformityto customer and applicable statutory and regulatoryrequirements.

All requirements of this International Standard are generic and areintended to be applicable to all organizations, regardless of type,size and product provided.

Where any requirement(s) of this International Standardcannot be applied due to the nature of an organization and itsproduct, this can be considered for exclusion.


Rationale for QMSs (ISO 9000:2005)

Customers require products with characteristics that satisfy theirneeds and expectations, expressed in product specifications andcollectively referred to as customer requirements.

The QMS approach encourages organizations to analyzecustomer requirements, define the processes that contribute tothe achievement of a product which is acceptable to the customer,and keep these processes under control.

A QMS can provide the framework for continual improvement toincrease the probability of enhancing customer satisfaction and thesatisfaction of other interested parties.


Requirements for QMSs & for products (ISO 9000:2005)

The ISO 9000 family distinguishes between requirements forquality management systems and requirements for products.

Requirements for QMSs1 are generic and applicable toorganizations in any industry or economic sector regardless ofthe offered product category.

Requirements for products can be specified by customers or bythe organization in anticipation of customer requirements, orby regulation.

1see ISO 9001:2008Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards

Quality Management System Approach (ISO 9000:2005)

The quality management system approach encouragesorganizations to analyze customer requirements, define theprocesses that contribute to the achievement of a product whichis acceptable to the customer, and keep these processes undercontrol.

A quality management system can provide the framework forcontinual improvement to increase the probability of enhancingcustomer satisfaction and the satisfaction of other interestedparties.

It provides confidence to the organization and its customers that itis able to provide products that consistently fulfill requirements.


What is a Quality Management System? (ISO 9000:2005)

Quality Management System (ISO 9000:2005)

Management systema to direct and control an organization withregard to quality.

aSystem to establish policy and objectives and to achieve those objectives.

The QMS is that part of the organization’s management systemthat focuses on the achievement of results, in relation to thequality objectives, to satisfy the needs, expectations andrequirements of interested parties.

Quality objectives complement other objectives of theorganization (e.g., those related to growth, funding,profitability, the environment and occupational health andsafety).


Implications of Adopting a QMS (ISO 9000:2005)

Direction and control with regard to quality generally includesestablishment of:

quality policy,

quality objectives,

quality planning,

quality control,

quality assurance, and

quality improvement.


Quality Policies & Objectives (ISO 9000:2005)

Quality Policy

Overall intentions and direction of an organization related toquality as formally expressed by top management.

Quality Objective

Something sought, or aimed for, related to quality.

Policy and objectives are established to provide a focus todirect the organization2:

The quality policy provides a framework for establishing andreviewing quality objectives.

The quality objectives need to be consistent with the qualitypolicy and the commitment to continual improvement, andtheir achievement needs to be measurable.

2Both determine the desired results and assist the organization to apply itsresources to achieve the results


Quality Planning (ISO 9000:2005)

Quality Planning

Part of quality management focused on setting quality objectivesand specifying necessary operational processes and relatedresources to fulfill the quality objectives.

Quality Plan

Document specifying which proceduresa and associated resourcesshall be applied by whom and when to a specific project, product,process or contract.

atypically those referring to quality management processes and to productrealization processes.


Quality Control, Assurance & Improvement

Quality Control (ISO 9000:2005)

Part of quality management focused on fulfilling qualityrequirements.

Quality Assurance (ISO 9000:2005)

Part of quality management focused on providing confidence thatquality requirements will be fulfilled.

Quality Improvement (ISO 9000:2005)

Part of quality management focused on increasing the ability tofulfill quality requirements.


Quality Management’s Principles

Eight management principles that can be used by top managementin order to lead the organization towards improved performance:

Customer Focus

Leadership

Involvement of People

Process Approach

System Approach to Management

Continual Improvement

Factual Approach to Decision Making

Mutually Beneficial Supplier Relationships


Customer’s Focus

Customer’s Focus (ISO 9000:2005)

Organizations depend on their customers and therefore shouldunderstand current and future customer needs, should meetcustomer requirements and strive to exceed customer expectations.


Implications of Customer’s Focus

Researching and understanding customer needs andexpectations

Ensuring that the objectives of the organization are linked tocustomer needs and expectations

Communicating customer needs and expectations throughoutthe organization

Measuring customer satisfaction and acting on the result

Systematically managing customer relationships

Ensuring a balanced approach between satisfying customersand other interested parties (i.e., owners, employees, suppliers,financiers, local communities and society as a whole)


Benefits of Customer’s Focus

Increased revenue and marked share

Increased effectiveness in the use of organization’s resources

Improved customer loyalty


Leadership

Leadership (ISO 9000:2005)

Leaders establish unity of purpose and direction of theorganization. They should create and maintain the internalenvironment in which people can become fully involved inachieving the organization’s objectives.


Implications of Leadership

Considering the needs of all interested parties includingcustomers, owners, employees, suppliers, financiers, localcommunities and society as a whole

Establishing a clear vision of the organization’s future

Setting challenging goals and targets

Creating and sustaining shared values, fairness and ethical rolemodels at all levels of the organization

Proving people with the required resources, training andfreedom to act with responsibility and accountability

Inspiring, encouraging and recognizing people’s contribution


Benefits of Leadership

People will understand and be motivated towards theorganization’s goal and objectives

Activities are evaluated, aligned and implemented in a unifiedway

Miscommunication between levels of an organization will beminimized


Involvement of People

Involvement of People (ISO 9000:2005)

People at all levels are the essence of an organization and their fullinvolvement enables their abilities to be used for the organization’sbenefit.


Implication of Involvement of People

People understanding the importance of their contribution androle in the organization

People identifying constraints to their performance

People accepting ownership of problem and their responsibilityfor solving them

People evaluating their performance against their personalgoals and objectives

People actively seeking opportunities to enhance theircompetence, knowledge and experience

People freely sharing knowledge and experience

People openly discussing problems and issues


Benefits of Involvement of People

Motivated, committed and involved people within theorganization

Innovation and creativity in furthering the organization’sobjectives

People being accountable for their own performance

People eager to participate and contribute to continualimprovement


The Process Approach

Process Approach (ISO 9000:2005)

A desired result is achieved more efficiently when activities andrelated resources are managed as a process.

Process (ISO 9000:2005)

Set of interrelated or interacting activities which transforms inputsinto outputs.

The systematic identification and management of the processesemployed within an organization and particularly the interactionsbetween such processes is referred to as the ”process approach”.


Implications of the process approach

Systematically defining the activities necessary to obtaining adesired result

Establishing clear responsibility and accountability formanaging key activities

Analyzing and measuring of the capability of key activities

Identifying the interfaces of key activities within and betweenthe functions of the organization

Focusing on the factors - such as resources, methods andmaterials - that will improve key activities in the organization

Evaluating risks, consequences and impacts of activities oncustomers, suppliers and other interested parties


The Process Approach

The Process Approach (ISO 9000:2005)

Monitoring the satisfaction of interested parties requires the evaluation of

information relating to the perception of interested parties as to the

extent to which their needs and expectations have been met.Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards

Benefits of the process approach

Lower costs and shorter cycle times through effective use ofresources

Improved, consistent and predictable results

Focused and prioritized improvement opportunities


System Approach to Management

System Approach to Management (ISO 9000:2005)

Identifying, understanding and managing interrelated processes asa system contributes to the organization’s effectiveness andefficiency in achieving its objectives.


Implications of the system approach

Structuring a system to achieve the organization’s objectivesin the most effective and efficient way

Understanding the interdependencies between the processes ofthe system

Structured approaches that harmonize and integrate processes

Providing a better understanding of the roles andresponsibilities necessary for achieving common objectives andthereby reducing cross-functional barriers

Understanding organizational capabilities and establishingresource constraints prior to action

Targeting and defining how specific activities within a systemshould operate

Continually improving the system thorough measurement andevaluation


Benefits of the system approach

Integration and alignment of the processes that will bestachieve the desired results

Ability to focus effort on the key processes

Providing confidence to interested parties as to theconsistency, effectiveness and efficiency of the organization


Continual Improvement

Continual Improvement (ISO 9000:2005)

Continual Improvement of the organization’s overall performanceshould be a permanent objective of the organization.


Actions for Quality Improvement

analyzing and evaluating the existing situation to identifyareas for improvement;

establishing the objectives for improvement;

searching for possible solutions to achieve the objectives;

evaluating these solutions and making a selection;

implementing the selected solution;

measuring, verifying, analyzing and evaluating results of theimplementation to determine that the objectives have beenmet;

formalizing changes.

Results are reviewed to determine further opportunities forimprovement. Feedback from customers and other interestedparties, audits and review of the quality management system canalso be used to identify opportunities for improvement.


Implications of Continual Improvement

Employing a consistent organization-wide approach tocontinual improvement of the organization’s performance

Providing people with training in the methods and tools ofcontinual improvement

Making continual improvement of products, processes andsystems an objective for every individual in the organization

Establishing goals to guide, and measures to track, continualimprovement

Recognizing and acknowledging improvements


Benefits of Continual Improvement

Performance advantage through improved organizationcapabilities

Alignment of improvement activities at all levels to anorganization’s strategic intent

Flexibility to react quickly to opportunities


Factual Approach to Decision Making

Factual Approach to Decision Making (ISO 9000:2005)

Effective decisions are based on the analysis of data andinformation.


Implications of Factual Approach to Decision Making

Ensuring that data and information are sufficiently accurateand reliable

Making data accessible to those who need it

Analyzing data and information using valid methods

Making decisions and taking action based on factual analysis,balanced with experience and intuition


Benefits of Factual Approach to Decision Making

Informed decisions

Increased ability to demonstrate the effectiveness of pastdecisions through references to factual records

Increased ability to review, challenge and change opinions anddecisions


Mutually Beneficial Supplier Relationship

Mutually Beneficial Supplier Relationship (ISO 9000:2005)

An organization and its suppliers are interdependent and a mutuallybeneficial relationship enhances the ability of both to create value.


Implications of Mutually Beneficial Supplier Relationship

Establishing relationships that balance short-term gains withlong-term considerations

Pooling of expertise and resources with partners

Identifying and selecting key suppliers

Clear and open communication

Sharing information and future plans

Establishing joint development and improvement activities

Inspiring, encouraging and recognizing improvements andachievements by suppliers


Benefits of Mutually Beneficial Supplier Relationship

Increased ability to create value for both parties

Flexibility and speed of joint responses to changing market orcustomer needs and expectations

Optimization of costs and resources


Steps in Developing a QMS (ISO 9000:2005)

a) Determining the needs and expectations of customers andother interested parties;

b) Establishing the quality policy and quality objectives of theorganization;

c) Determining the processes and responsibilities necessary toattain the quality objectives;

d) Determining and providing the resources necessary to attainthe quality objectives;

e) Establishing methods to measure the effectiveness andefficiency of each process;

f) Applying these measures to determine the effectiveness andefficiency of each process;

g) Determining means of preventing non-conformities andeliminating their causes;

h) Establishing and applying a process for continual improvementof the quality management system.


Role of Top Management (ISO 9000:2005)

The quality management principles can be used by top management asthe basis of its role, which is as follows:

Establishing and maintaining the quality policy and objectives

Promoting the quality policy and objectives throughout theorganization to increase awareness, motivation and involvement

Ensuring focus on customer requirements throughout theorganization

Ensuring that appropriate processes are implemented to enablerequirements of customers to be fulfilled and quality objectives tobe achieved

Ensuring that an effective and efficient QMS is established,implemented and maintained

Ensuring the availability of necessary resources

Reviewing the quality management system periodically

Deciding on actions regarding the quality policy and objectives

Deciding on actions for improvement of the QMS


Value of Documentation (ISO 9000:2005)

Documentation enables communication of intent and consistencyof action.

Its use contributes to

achievement of conformity to customer requirements andquality improvement

provision of appropriate training

repeatability and traceability

provision of objective evidence

evaluation of the effectiveness and continuing suitability of thequality management system

Generation of documentation should not be an end in itself butshould be a value-adding activity.


Types of Documentation (ISO 9000:2005)

The following types of document are used in QMSs:

quality manuals, i.e. descriptions of the organization’s QMS

quality plans, i.e. descriptions of how the QMS is applied toa specific product, project or contract

specifications, i.e. documents stating requirements

guidelines, i.e. documents stating recommendations

documents that provide information about how to performactivities and processes consistently (e.g., procedures, workinstructions)

records, for providing objective evidence of activitiesperformed or results achieved

Each organization determines the extent of documentationrequired and the media to be used


Evaluating Quality Management Systems (ISO 9000:2005)

When evaluating QMSs, there are four basic questions that shouldbe asked in relation to every process being evaluated.

Is the process identified and appropriately defined?

Are responsibilities assigned?

Are the procedures implemented and maintained?

Is the process effective in achieving the required results?

The collective answers to the above questions can determine theresult of the evaluation. Evaluation of a quality managementsystem can vary in scope and encompass a range of activities, suchas auditing and reviewing the quality management system, andself-assessments.


Auditing the Quality Management System (ISO 9000:2005)

Audits are used to determine the extent to which the qualitymanagement system requirements (ISO 9001) are fulfilled.

Audit findings are used to assess the effectiveness of the QMSand to identify opportunities for improvement

First-party audits are conducted by, or on behalf of, theorganization itself for internal purposes and can form the basisfor an organization’s self-declaration of conformity

Second-party audits are conducted by customers of theorganization or by other persons on behalf of the customer

Third-party audits are conducted by external independentorganizations

ISO 19011 provides guidance on auditing.


Reviewing Quality Management Systems (ISO 9000:2005)

One role of top management is to carry out regular systematicevaluations of the suitability, adequacy, effectiveness and efficiencyof the quality management system with respect to the qualitypolicy and quality objectives.

This review can include consideration of the need to adapt thequality policy and objectives in response to changing needsand expectations of interested parties

The review includes determination of the need for actions

Amongst other sources of information, audit reports are used forreview of the quality management system.


Reviewing Quality Management Systems (ISO 9000:2005)

An organization’s self-assessment is a comprehensive andsystematic review of the organization’s activities and resultsreferenced against the quality management system or a model ofexcellence.

Self-assessment can provide an overall view of the performance ofthe organization and the degree of maturity of the qualitymanagement system.

It can also help to identify areas requiring improvement in theorganization and to determine priorities.


ISO 9001: Requirements of a QualityManagement System


General Requirements for a QMS (9001:2008)

The organization shall establish, document, implement andmaintain a quality management system and continually improve itseffectiveness in accordance with the requirements of thisInternational Standard.

The organization shall

determine the processes needed for the quality managementsystem and their application throughout the organization,

determine the sequence and interaction of these processes,

determine criteria and methods needed to ensure that boththe operation and control of these processes are effective,

ensure the availability of resources and information necessaryto support the operation and monitoring of these processes,

monitor, measure where applicable, and analyse theseprocesses, and

implement actions necessary to achieve planned results andcontinual improvement of these processes.


General Requirements: Outsourcing

Where an organization chooses to outsource any process thataffects product conformity to requirements, the organization shallensure control over such processes.

The type and extent of control to be applied to these outsourcedprocesses shall be defined within the quality management system.


Document Requirements (9001:2008)

The quality management system documentation shall include

documented statements of a quality policy and qualityobjectives,

a quality manual,

documented procedures and records required by thisInternational Standard, and

documents, including records, determined by the organizationto be necessary to ensure the effective planning, operation andcontrol of its processes.

The quality manual that includes:

the scope of the quality management system, including detailsof and justification for any exclusions,

the documented procedures established for the qualitymanagement system, or reference to them, and

a description of the interaction between the processes of thequality management system.


Control of Documents (ISO 9001:2008)

Documents required by the QMS shall be controlled. A documentedprocedure shall be established to define the controls needed:

to approve documents for adequacy prior to issue,

to review and update as necessary and reapprove documents,

to ensure that changes and the current revision status of documentsare identified,

to ensure that relevant versions of applicable documents areavailable at points of use,

to ensure that documents remain legible and readily identifiable,

to ensure that documents of external origin determined by theorganization to be necessary for the planning and operation of theQMS are identified and their distribution controlled, and

to prevent the unintended use of obsolete documents, and to applysuitable identification to them if they are retained for any purpose.

Records are a special type of document and shall be controlled according

to different requirements.Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards

Control of Records (ISO 9001:2008)

Records established to provide evidence of conformity torequirements and of the effective operation of the qualitymanagement system shall be controlled.

The organization shall establish a documented procedure to definethe controls needed for the identification, storage, protection,retrieval, retention and disposition of records.

Records shall remain legible, readily identifiable and retrievable.


ISO 9001: Management Responsibility


Management Commitment & Customer Focus

Top management shall provide evidence of its commitment to thedevelopment and implementation of the quality managementsystem and continually improving its effectiveness by

communicating to the organization the importance of meetingcustomer as well as statutory and regulatory requirements

establishing the quality policy

ensuring that quality objectives are established

conducting management reviews

ensuring the availability of resources

Top management shall ensure that customer requirements aredetermined and are met with the aim of enhancing customersatisfaction.


Management & Quality Policy

Top management shall ensure that the quality policy

is appropriate to the purpose of the organization

includes a commitment to comply with requirements andcontinually improve the effectiveness of the qualitymanagement system

provides a framework for establishing and reviewing qualityobjectives

is communicated and understood within the organization

is reviewed for continuing suitability


Management Responsibility on Planning

Quality ObjectivesTop management shall ensure that quality objectives, includingthose needed to meet requirements for product, are established atrelevant functions and levels within the organization. The qualityobjectives shall be measurable and consistent with the qualitypolicy.

Quality Management System PlanningTop management shall ensure that

the planning of the quality management system is carried outin order to meet the general requirements, as well as thequality objectives

the integrity of the quality management system is maintainedwhen changes to the quality management system are plannedand implemented.


Responsibility, Authority and Communication

Top management shall ensure that responsibilities and authoritiesare defined and communicated within the organization.

Top management shall appoint a member of the organization’smanagement who, irrespective of other responsibilities, shall haveresponsibility and authority that includes

ensuring that processes needed for the quality managementsystem are established, implemented and maintained

reporting to top management on the performance of thequality management system and any need for improvement

ensuring the promotion of awareness of customer requirementsthroughout the organization

Top management shall ensure that appropriate communicationprocesses are established within the organization and thatcommunication takes place regarding the effectiveness of thequality management system.


Management Review

Top management shall review the organization’s QMS, at plannedintervals, to ensure its continuing suitability, adequacy and effectiveness.This review shall include assessing opportunities for improvement and theneed for changes to the QMS, including the quality policy and qualityobjectives. Records from management reviews shall be maintained.

Review Input:

results of audits

customer feedback

process performance and productconformity

status of preventive and correctiveactions

follow-up actions from previousmanagement reviews

changes that could affect the QMS

recommendations for improvement

Review Output:

improvement of theeffectiveness of theQMS and its processes

improvement of productrelated to customerrequirements

resource needs


ISO 9001: Resource Management


Resource Management

The organization shall determine and provide the resources needed

to implement and maintain the quality management systemand continually improve its effectiveness

to enhance customer satisfaction by meeting customerrequirements

Three kinds of resources:

Human resources: personnel performing work affectingconformity to product requirements shall be competent on thebasis of appropriate education, training, skills and experience

Infrastructure: the organization shall determine, provide andmaintain the infrastructure3 needed to achieve conformity toproduct requirements

Work Environment: the organization shall determine andmanage the work environment needed to achieve conformityto product requirements

3e.g., buildings, workspace, process equipment, and supporting servicesNicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards

Competence, training and awareness

The organization shall

determine the necessary competence for personnel performingwork affecting conformity to product requirements

where applicable, provide training or take other actions toachieve the necessary competence

evaluate the effectiveness of the actions taken

ensure that its personnel are aware of the relevance andimportance of their activities and how they contribute to theachievement of the quality objectives

maintain appropriate records of education, training, skills andexperience


ISO 9001: Product Realization


Planning of Product Realization

The organization shall plan4 and develop the processes needed forproduct realization.

The organization shall determine:

quality objectives and requirements for the product

the need to establish processes and documents, and to provideresources specific to the product

required verification, validation, monitoring, measurement,inspection and test activities specific to the product and thecriteria for product acceptance

records needed to provide evidence that the realizationprocesses and resulting product meet requirements

The output of this planning shall be in a form suitable for theorganization’s method of operations.

4Planning of product realization shall be consistent with the requirements ofthe other processes of the QMS.


Determination of requirements related to the product

The organization shall determine

requirements specified by the customer, including therequirements for delivery and post-delivery5 activities

requirements not stated by the customer but necessary forspecified or intended use, where known

statutory and regulatory requirements applicable to theproduct

any additional requirements considered necessary by theorganization

5e.g., actions under warranty provisions, contractual obligations such asmaintenance services, and supplementary services such as recycling or finaldisposal


Determination of requirements related to the product (cont.)

Prior to the organization’s commitment to supply a product to thecustomer, the organization shall review the requirements related tothe product. The review shall ensure that:

product requirements are definedcontract or order requirements differing from those previouslyexpressed are resolvedthe organization has the ability to meet fie definedrequirements.

Records of the results of the review and actions arising from thereview shall be maintained.

It is worth noting that:

where the customer provides no documented statement ofrequirement, the customer requirements shall be confirmed by theorganization before acceptance

where product requirements are changed, the organization shallensure that relevant documents are amended and that relevantpersonnel are made aware of the changed requirements.


Customer communication

The organization shall determine and implement effectivearrangements for communicating with customers in relation to

product information

enquiries, contracts or order handling, including amendments

customer feedback, including customer complaints


Design and development planning

The organization shall plan and control the design anddevelopment of product. During this activity the organization shalldetermine

the design and development stages

the review, verification and validation that are appropriate toeach design and development stage

the responsibilities and authorities for design and development

The organization shall manage the interfaces between differentgroups involved in design and development to ensure effectivecommunication and clear assignment of responsibility.

Planning output shall be updated, as appropriate, as the designand development progresses.


Design and Development Inputs

Inputs relating to product requirements shall be determined andrecords maintained. These inputs shall include:

functional and performance requirements

applicable statutory and regulatory requirements

where applicable, information derived from previous similardesigns

other requirements essential for design and development

The inputs shall be reviewed for adequacy. Requirements shall becomplete, unambiguous and not in conflict with each other.


Design and Development Outputs

The outputs of design and development shall be in a form suitablefor verification against the design and development input and shallbe approved prior to release. They shall

meet the input requirements for design and development

provide appropriate information for purchasing, productionand service provision

contain or reference product acceptance criteria

specify the characteristics of the product that are essential forits safe and proper use


Design and development review

At suitable stages, systematic reviews of design and developmentshall be performed in accordance with planned arrangements

to evaluate the ability of the results of design anddevelopment to meet requirements

to identify any problems and propose necessary actions..

Participants in such reviews shall include representatives offunctions concerned with the design and development stage beingreviewed.

Records of the results of the reviews and any necessary actionsshall be maintained.


Design and development verification and validation

In accordance with planned arrangements:

Verification shall be performed to ensure that the design anddevelopment outputs have met the design and developmentinput requirements

Validation shall be performed to ensure that the resultingproduct is capable of meeting the requirements for thespecified application or intended6

Records of the results of verification and validation, and anynecessary actions, shall be maintained.

6Wherever practicable, validation shall be completed prior to the delivery orimplementation of the product.


Control of design and development changes

Design and development changes shall be identified and recordsmaintained.

The changes shall be reviewed, verified and validated, asappropriate, and approved before implementation.

The review of design and development changes shall includeevaluation of the effect of the changes on constituent parts andproduct already delivered.

Records of the results of the review of changes and any necessaryactions shall be maintained.


Purchasing process

The organization shall ensure that purchased product conforms tospecified purchase requirements.

the type and extent of control applied to the supplier and thepurchased product shall depend on the effect of the purchasedproduct on subsequent product realization or the final product

The organization shall evaluate and select suppliers based on theirability to supply product in accordance with the organization’srequirements.

Criteria for selection, evaluation and re-evaluation shall beestablished

Records of the results of evaluations and any necessary actionsarising from the evaluation shall be maintained.


Purchasing information

Purchasing information shall describe the product to be purchased,including, where appropriate:

requirements for approval of product, procedures, processesand equipment

requirements for qualification of personnel

quality management system requirements

The organization shall ensure the adequacy of specified purchaserequirements prior to their communication to the supplier.


Verification of purchased product

The organization shall establish and implement the inspection orother activities necessary for ensuring that purchased productmeets specified purchase requirements.

Where the organization or its customer intends to performverification at the supplier’s premises, the organization shall statethe intended verification arrangements and method of productrelease in the purchasing information.


Control of production and service provision

The organization shall plan and carry out production and serviceprovision under controlled conditions which shall include, asapplicable

the availability of information that describes thecharacteristics of the product

the availability of work instructions, as necessary

the use of suitable equipment

the availability and use of monitoring and measuringequipment

the implementation of monitoring and measurement

the implementation of product release, delivery andpost-delivery activities


Validation of processes for production and service provision

The organization shall validate any processes for production andservice provision where the resulting output cannot be verified bysubsequent monitoring or measurement.

Validation shall demonstrate the ability of these processes toachieve planned results.

The organization shall establish arrangements for these processesincluding, as applicable,

defined criteria for review and approval of the processes

approval of equipment and qualification of personnel

use of specific methods and procedures

requirements for records

revalidation


Identification and traceability

Where appropriate, the organization shall identify the product bysuitable means throughout product realization.

The organization shall identify the product status with respect tomonitoring and measurement requirements throughout productrealization.

Where traceability is a requirement, the organization shall controlthe unique identification of the product and maintain records.


Customer property

The organization shall exercise care with customer property7 whileit is under the organization’s control or being used by theorganization.

The organization shall identify, verify, protect and safeguardcustomer property provided for use or incorporation into theproduct.

If any customer property is lost, damaged or otherwise found to beunsuitable for use, the organization shall report this to thecustomer and maintain records.

7Customer property can include intellectual property and personal data.Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards

Preservation of product

The organization shall preserve the product during internalprocessing and delivery to the intended destination in order tomaintain conformity to requirements.As applicable, preservation shall include:

identification

handling

packaging

storage

protection

Preservation shall also apply to the constituent parts of a product.


Control of monitoring and measuring equipment

The organization shall determine the monitoring and measurementto be undertaken and the monitoring and measuring equipmentneeded to provide evidence of conformity of product to determinedrequirements.

The organization shall establish processes to ensure thatmonitoring and measurement can be carried out and are carriedout in a manner that is consistent with the monitoring andmeasurement requirements.


Control of monitoring and measuring equipment (cont.)

Where necessary to ensure valid results, measuring equipment shall

be calibrated or verified, or both, at specified intervals, orprior to use, against measurement standards traceable tointernational or national measurement standards; where nosuch standards exist, the basis used for calibration orverification shall be recorded

be adjusted or re-adjusted as necessary

have identification in order to determine its calibration status

be safeguarded from adjustments that would invalidate themeasurement result

be protected from damage and deterioration during handling,maintenance and storage


Control of monitoring and measuring equipment (cont.)

In addition, the organization shall assess and record the validity ofthe previous measuring results when the equipment is found not toconform to requirements.

The organization shall take appropriate action on the equipmentand any product affected. Records of the results of calibration andverification shall be maintained.

When used in the monitoring and measurement of specifiedrequirements, the ability of computer software to satisfy theintended application shall be confirmed. This shall be undertakenprior to initial use and reconfirmed as necessary.


ISO 9001: Measurement, analysis andimprovement


Measurement, analysis and improvement

The organization shall plan and implement the monitoring,measurement, analysis and improvement processes needed:

to demonstrate conformity to product requirements

to ensure conformity of the quality management system

to continually improve the effectiveness of the qualitymanagement system.

This shall include determination of applicable methods, includingstatistical techniques, and the extent of their use.


Monitoring and measurement: Customer Satisfaction

As one of the measurements of the performance of the qualitymanagement system, the organization shall monitor informationrelating to customer perception as to whether the organization hasmet customer requirements. The methods for obtaining and usingthis information shall be determined.


Monitoring and measurement: Internal Audit

The organization shall conduct internal audits at planned intervalsto determine whether the QMS

conforms to the planned arrangements, to the requirements ofthis International Standard and to the quality managementsystem requirements established by the organization

is effectively implemented and maintained.

An audit programme shall be planned, taking into considerationthe status and importance of the processes and areas to beaudited, as well as the results of previous audits.

The selection of auditors and conduct of audits shall ensureobjectivity and impartiality of the audit process.


Monitoring and measurement: Internal Audit (cont.)

A documented procedure shall be established to define theresponsibilities and requirements for planning and conductingaudits, establishing records and reporting results.

Records of the audits and their results shall be maintained.

The management, responsible for the area being audited shallensure that any necessary corrections and corrective actions aretaken without undue delay to eliminate detected nonconformitiesand their causes.

Follow-up activities shall include the verification of the actionstaken and the reporting of verification results


Monitoring and measurement of processes

The organization shall apply suitable methods for monitoring and,where applicable, measurement of the quality management systemprocesses. These methods shall demonstrate the ability of theprocesses to achieve planned results. When planned results are notachieved, correction and corrective action shall be taken, asappropriate.

When determining suitable methods, it is advisable that theorganization consider the type and extent of monitoring ormeasurement appropriate to each of its processes in relationto their impact on the conformity to product requirementsand on the effectiveness of the quality management system.


Monitoring and measurement of product

The organization shall monitor and measure the characteristics ofthe product to verify that product requirements have been met.This shall be carried out at appropriate stages of the productrealization process in accordance with the planned arrangements.Evidence of conformity with the acceptance criteria shall bemaintained.

Records shall indicate the person(s) authorizing release of productfor delivery to the customer.

The release of product and delivery of service to the customer shallnot proceed until the planned arrangements have beensatisfactorily completed, unless otherwise approved by a relevantauthority and, where applicable, by the customer.


Control of nonconforming product

The organization shall ensure that product which does not conformto product requirements is identified and controlled to prevent itsunintended use or delivery.

A documented procedure shall be established to define the controlsand related responsibilities and authorities for dealing withnonconforming product.


Dealing with nonconforming product

Where applicable, the organization shall deal with nonconformingproduct by one or more of the following ways:

by taking action to eliminate the detected nonconformity

by authorizing its use, release or acceptance under concessionby a relevant authority and, where applicable, by the customer

by taking action to preclude its original intended use orapplication

by taking action appropriate to the effects, or potentialeffects, of the nonconformity when nonconforming product isdetected after delivery or use has started

When nonconforming product is corrected it shall be subject tore-verification to demonstrate conformity to the requirements.

Records of the nature of nonconformities and any subsequentactions taken, including concessions obtained, shall be maintained.


Analysis of data

The organization shall determine, collect and analyze appropriatedata to demonstrate the suitability and effectiveness of the qualitymanagement system and to evaluate where continual improvementof the effectiveness of the quality management system can bemade.The analysis of data shall provide information relating to

customer satisfaction

conformity to product requirements

characteristics and trends of processes and products, includingopportunities for preventive action

suppliers


Improvement

The organization shall continually improve the effectiveness of theQMS through he use of the quality policy, quality objectives, auditresults, analysis of data, corrective and preventive actions andmanagement review.

Corrective ActionsThe organization shall take appropriate action to eliminate thecauses of nonconformities in order to prevent recurrence.

A documented procedure shall be established to definerequirements for

reviewing nonconformities (including customer complaints)determining the causes of nonconformitiesevaluating the need for action to ensure that nonconformitiesdo not recurdetermining and implementing action neededrecords of the results of action takenreviewing the effectiveness of the corrective action taken


Improvement (cont.)

Preventive ActionsThe organization shall determine action to eliminate the causes ofpotential nonconformities in order to prevent their occurrence.

Preventive actions shall be appropriate to the effects of thepotential problems.

A documented procedure shall be established to definerequirements for

determining potential nonconformities and their causes,

evaluating the need for action to prevent occurrence ofnonconformities

determining and implementing action needed

records of results of action taken

reviewing the effectiveness of the preventive action taken


The Role of Statistical Techniques (ISO 9000:2005)

The use of statistical techniques can help in understandingvariability, and thereby can help organizations to solve problemsand improve effectiveness and efficiency. These techniques alsofacilitate better use of available data to assist in decision making.

Statistical techniques can help to measure, describe, analyze,interpret and model such variability, even with a relatively limitedamount of data.

Statistical analysis of such data can help to provide a betterunderstanding of the nature, extent and causes of variability, thushelping to solve and even prevent problems that may result fromsuch variability, and to promote continual improvement.

Guidance on statistical techniques in a quality management systemis given in ISO/TR 10017.


ISO 9004: Managing for the sustained successof an organization - A quality management

approach


Extended model of a process-based QMS


Sustained Success

The organization can achieve sustained success by consistentlymeeting the needs and expectations of its interested parties, in abalanced way, over the long term.

An organization’s environment is ever-changing and uncertain, andto achieve sustained success its top management should:

have a long-term planning perspective

constantly monitor and regularly analyze the organization’senvironment

identify relevant interested parties, assess their individualpotential impacts on the organization’s performance, as wellas determining how to meet their needs and expectations in abalanced way

continually engage interested parties and keep them informedof the organization’s activities and plans


Sustained Success (cont.)

establish mutually beneficial relationships with suppliers,partners and other interested parties

make use of a wide variety of approaches, includingnegotiation and mediation, to balance the often competingneeds and expectations of interested parties

identify associated short and long-term risks and deploy anoverall strategy for the organization to mitigate them8

anticipate future resource needs (including competences)

8For more information on risk management, see ISO 31000Nicola Mezzetti, Ph.D. Quality Management Systems: the ISO 9000 Family of Standards

Sustained Success (cont.)

establish processes appropriate to achieving the organization’sstrategy, ensuring that they are capable of responding quicklyto changing circumstances

regularly assess compliance with current plans and procedures,and take appropriate corrective and preventive actions

ensure that people in the organization have opportunities forlearning for their own benefit, as well as for maintaining thevitality of the organization

establish and maintain processes for innovation and continualimprovement


The Organization’s Environment

An organization’s environment will be undergoing changecontinually, regardless of its size (large or small), its activities andproducts, or its type (for profit or not-for-profit); consequently thisshould be monitored constantly by the organization.

Such monitoring should enable the organization to identify, assessand manage the risks related to interested parties, and theirchanging needs and expectations.

Top management should make decisions for organizational changeand innovation in a timely manner in order to maintain andimprove the organization’s performance.


Interested Parties, Needs and Expectations

Interested parties are individuals and other entities that add valueto the organization, or are otherwise interested in, or affected by,the activities of the organization.

Meeting the needs and expectations of interested partiescontributes to the achievement of sustained success by theorganization.

needs and expectations of individual interested parties aredifferent, can be in conflict with those of other interestedparties, or can change very quickly

The means by which the needs and expectations of interestedparties are expressed and met can take a wide variety of forms,including collaboration, cooperation, negotiation, outsourcing, orby terminating an activity.


Strategy and Policy

To achieve sustained success, top management should establishand maintain a mission, a vision and values for the organization.

a mission is a description of why the organization exists

a vision describes its desired state, i.e. what the organizationwants to be and how it wants to be seen by its interestedparties

These should be clearly understood, accepted and supported bypeople in the organization and, as appropriate, by other interestedparties.


Strategy and Policy Formulation

In order to establish, adopt and sustain an effective strategy andpolicy, the organization should have processes to

continually monitor and regularly analyze the organization’senvironment, including its customers’ needs and expectations,the competitive situation, new technologies, political changes,economic forecasts, or sociological factors

identify and determine the needs and expectations of otherinterested parties

assess its current process capabilities and resources

identify future resource and technology needs

update its strategy and policies

identify the outputs necessary to meet the needs andexpectations of the interested parties


Strategy and Policy Formulation (cont.)

These processes should be established in a timely manner, with anynecessary plans and resources being provided to support them.

The formulation of an organization’s strategy should also consideractivities such as analyses of customer or regulatory demands, itsproducts, its strengths, weaknesses, opportunities, and threats.

A defined process should exist for the formulation and review ofthe organization’s strategy.


Strategy and Policy Deployment

To implement a strategy and policies for sustained success, theorganization should establish and maintain processes and practicesthat

translate its strategy and policies into measurable objectivesfor all relevant levels of the organization appropriate

establish timelines for each objective and assign responsibilityand authority for achieving the objective

evaluate strategic risks and define adequate counter measures

provide the resources required to deploy needed activities

execute the activities needed to achieve these objectives


Strategy and Policy Deployment: Processes & Practices

In order to ensure that its processes and practices are effective andefficient, the organization should perform activities for

anticipating any potential conflicts arising from the differentneeds and expectations of its interested parties

assessing and understanding the organization’s currentperformance and the root-causes of problems in the past

keeping interested parties informed, gaining theircommitment, keeping them aware of progress against plans,and obtaining feedback and ideas for improvement from them

reviewing the management system and its processes, andupdating them as necessary

monitoring, measuring, analyzing, reviewing and reporting

providing any required resources, including those forimprovement, innovation and learning

the development, updating and accomplishment of objectives

ensuring that the results are consistent with the strategy


Strategy and Policy Deployment: Deployment

To deploy its strategy and policies, the organization should identifythe relationships between its processes.

A description of the sequence and interaction of the processes canassist review activities by

showing the relationship between organizational structures,systems and processes

identifying potential problems in the interactions betweenprocesses

providing a means for prioritizing improvement and otherchange initiatives

providing a framework for setting, aligning and deployingobjectives to all relevant levels of the organization


Strategy and Policy Communication

The effective communication of the strategy and policies isessential to the sustained success of the organization. Suchcommunication should be meaningful, timely and continual.

Communication should also include a feedback mechanism, areview cycle and should incorporate provisions to proactivelyaddress changes in the organization’s environment.

The organization’s communication process should operate bothvertically and horizontally and should be tailored to the differingneeds of its recipients.


Resource Management

The organization should identify the internal and external resources thatare needed for the achievement of the organization’s objectives in theshort and long term.

the organization’s policies and methods for resource managementshould be consistent with its strategy.

To ensure that resources are used effectively and efficiently, it is necessaryto have processes in place to provide, allocate, monitor, evaluate,optimize, maintain and protect those resources.

In parallel, research for new resources, optimized processes and newtechnologies should take place.

The organization should periodically review the availability and suitabilityof the identified resources, including outsourced resources, and takeaction as necessary.

The results of these reviews should also be used as inputs into theorganization’s reviews of its strategy, objectives and plans.


Financial Resources

Top management should determine the organization’s financial needs andestablish the necessary financial resources for current and futureoperations.

The organization should establish and maintain processes for monitoring,controlling and reporting the effective allocation and efficient usage offinancial resources related to the organization’s objectives.

Improving the effectiveness and efficiency of the management system canpositively influence the financial results of the organization in many ways.Examples include

internally, by reducing process and product failures and eliminatingthe waste of materials or time, and

externally, by reducing product failures, costs of compensation underguarantees and warranties, product liabilities and other legalexposure, costs of lost customers and markets.


People in the Organization

People are a significant resource of an organization and theirfull involvement enhances their ability to create value for interestedparties.

Top management should, through its leadership, create andmaintain a shared vision, shared values and an internalenvironment in which people can become fully involved inachieving the organization’s objectives.

As people are a most valuable and critical resource, it is necessaryto ensure that their work environment encourages personalgrowth, learning, knowledge transfer and teamwork.

People management should be performed through a planned,transparent, ethical and socially responsible approach.

The organization should ensure that the people understand theimportance of their contribution and roles.


People in the Organization: Management

The organization should establish processes that empower peopleto:

translate the organization’s strategic and process objectivesinto individual job objectives, and to establish plans for theirachievement

identify constraints to their performance

take ownership and responsibility to solve problems

assess personal performance against individual job objectives

actively seek opportunities to enhance their competence andexperience

promote teamwork and encourage synergy between people

share information, knowledge and experience within theorganization


People in the Organization: Competences

The organization should establish and maintain a peopledevelopment plan and associated processes, to assist theorganization in identifying, developing and improving thecompetence of its people.

Identifying the professional and personal competences theorganization could need in the short and long term, inaccordance with its mission, vision, strategy, policies, andobjectives

Identifying the competences currently available in theorganization and the gaps between what is available and whatis currently needed and could be needed in the future

Implementing actions to improve and or acquire competencesto close the gaps

Reviewing and evaluating the effectiveness of actions taken toensure that the necessary competences have been acquired

Maintaining competences that have been acquired


People in the Organization: Involvement & Motivation

To enhance the involvement and motivation of its people, theorganization should consider activities such as:

developing a process to share knowledge and use thecompetence of people, e.g. a scheme for collecting ideas forimprovement

introducing an appropriate recognition and reward system,that is based on individual evaluations of the accomplishmentsof the people

establishing a skills qualification system and career planning,to promote personal development

continually reviewing the level of satisfaction and needs andexpectations of people

providing opportunities for mentoring and coaching


Suppliers and Partners

Partners can be suppliers of products, service providers,technological and financial institutions, governmental andnon-governmental organizations or other interested parties.

Partners can contribute with any type of resource, as agreed anddefined in a partnership agreement.

The organization and its partners are interdependent and amutually beneficial relationship enhances their capabilities tocreate value.


Suppliers and Partners (cont.)

When an organization is developing partnerships, the organizationshould give consideration to issues such as:

the provision of information to partners, as appropriate, tomaximize their contributions

supporting partners, in terms of providing them with resources(e.g. information, knowledge, expertise, technology, processes,and shared training)

the sharing of profits and losses with partners

improving the performance of partners


Suppliers and Partners: Selection & Evaluation

The organization should establish and maintain processes toidentify, select, and evaluate its suppliers and partners, in order tocontinually improve their capabilities and to ensure that theproducts or other resources they provide meet the needs andexpectations of the organization.

In selecting and evaluating suppliers and partners, the organizationshould consider:

their contribution to the organization’s activities and ability tocreate value for the organization and its interested parties

the potential for continually improving their capabilities

the enhancement of its own capabilities that can be achievedthrough co-operation with the suppliers and partners

the risks associated in the relationships with the suppliers andpartners


Suppliers and Partners: Performance Improvement

Together with its suppliers and partners, the organization shouldseek to continually improve the quality, price and delivery ofproducts provided by the suppliers and partners, and theeffectiveness of their management systems, based on periodicevaluation and feedback of their performance.

The organization should continually review and strengthen itsrelationships with its suppliers and partners, while considering thebalance between its short and long term objectives.


Infrastructure

The organization should plan, provide and manage itsinfrastructure effectively and efficiently. It should periodicallyassess the suitability of the infrastructure to meet organizationalobjectives.

Appropriate consideration should be given to:

the dependability of the infrastructure (including considerationof availability, reliability, maintainability, and maintenancesupport)

safety and security

infrastructure elements related to products and processes

the efficiency, cost, capacity and work environment

the impact of the infrastructure on the work environment

The organization should identify and assess the risks associatedwith the infrastructure and take action to mitigate the risks,including the establishment of adequate contingency plans.


Work Environment

The organization should provide and manage a suitable workenvironment to achieve and maintain the sustained success of theorganization and the competitiveness of its products.

A suitable work environment, as a combination of human andphysical factors, should include consideration of

creative work methods and opportunities for greaterinvolvement to realize the potential of people in theorganization

safety rules and guidance and the use of protective equipment

ergonomics

psychological factors, including workload and stress

workplace location

facilities for people in the organization

maximization of efficiency and minimization of waste

heat, humidity, light, airflow

hygiene, cleanliness, noise, vibration and pollution


Knowledge

Top management should

assess how the organization’s current knowledge base isidentified and protectedconsider how to obtain the knowledge required to meet thepresent and future needs of the organization

.There are many issues to consider when defining how to identify,maintain and protect knowledge:

learning from failures, near miss situations and successescapturing the knowledge and experience of people in theorganizationgathering knowledge from customers, suppliers and partnerscapturing undocumented knowledge that exists within theorganizationensuring the effective communication of importantinformation contentmanaging data and records


Information

The organization should establish and maintain processes to gatherreliable and useful data and for converting such data into theinformation necessary for decision making.

This includes the processes needed for the storage, security,protection, communication and distribution of data andinformation to all relevant parties.

The organization’s information and communication systems needto be robust and accessible, to ensure their capabilities.

The organization should ensure the integrity, confidentiality andavailability of information relating to its performance, processimprovements, and on progress towards the achievement ofsustained success.


Technology

Top management should consider technological options to enhancethe organization’s performance in areas such as product realization,marketing, benchmarking, customer interaction, supplier relationsand outsourced processes.

The organization should establish processes for the assessment of

the current levels of technology inside and outside theorganization, including emerging trends

economic costs and benefits

the evaluation of risks related to changes in technology

the competitive environment

its speed and ability to react to customer requirementspromptly, to ensure that it remains competitive


Natural Resources

The availability of natural resources is one of the factors that caninfluence an organization’s sustained success and ability to meetthe requirements of its customers and other interested parties.The organization should

consider the risks and opportunities related to the availabilityand use of energy and natural resources in the short and longterm

give appropriate consideration to the integration ofenvironmental protection aspects into product design anddevelopment, as well as to the development of its processes tomitigate identified risks

seek to minimize environmental impacts over the full life cycleof its products and its infrastructure, from design, throughmanufacturing or service delivery, to product distribution, useand disposal


Process Management

Processes are specific to an organization and vary depending onthe type, size and level of maturity of the organization.

The organization should ensure the proactive management of allprocesses, including outsourced processes, to ensure that they areeffective and efficient, in order to achieve its objectives.

This can be facilitated by adopting a process approach thatincludes establishing processes, interdependencies, constraints andshared resources.

Processes and their interrelationships should be reviewed ona regular basis and suitable actions should be taken for theirimprovement.

Processes should be managed as a system by creating andunderstanding the networks of processes, their sequences andinteractions. The consistent operation of this system is oftenreferred to as the systems approach to management.


Process Planning and Control

The organization should determine and plan its processes anddefine the functions that are necessary for providing products thatcan continue to meet the needs and expectations of customers andother interested parties, on an ongoing basis.

Processes should be planned and controlled to be in accordancewith the organization’s strategy and should address managementactivities, provision of resources, product realization, monitoring,measurement and reviewing activities.


Process Planning and Control (cont.)

In the planning and control of processes, consideration should begiven to

analyses of the organization’s environment

short and long term forecasts of market developments

the needs and expectations of the interested parties

objectives to be achieved

statutory and regulatory requirements

potential financial and other risks

process inputs and outputs

interactions with other processes

resources and information

activities and methods

records that are required or desired

measurement, monitoring and analysis

corrective and preventive actions

improvement and/or innovation activities


Process Responsibility and Authority

For each process, the organization should appoint a processmanager (often referred to as the process owner) with definedresponsibilities and authorities to establish, maintain, control andimprove the process and its interaction with other processes.

The process manager could be a person or a team, depending onthe nature of the process and the organization’s culture.

The organization should ensure that the responsibilities, authoritiesand roles of process managers are recognized throughout theorganization, and that the people associated with the individualprocesses have the competences needed for the tasks and activitiesinvolved.


Monitoring

Top management should establish and maintain processes formonitoring the organization’s environment, and for collecting andmanaging the information that is necessary for

identifying and understanding the present and future needsand expectations of all relevant interested parties

assessing strengths, weaknesses, opportunities and threats

determining the need for alternative, competitive or newproduct offerings

evaluating current and emerging markets and technologies

anticipating current and expected changes in statutory andregulatory requirements


Monitoring (cont.)

understanding the labor market and its effect on the loyalty ofpeople in the organization

understanding the social, economic, ecological trends andlocal cultural aspects relevant to the organization’s activities

determining the need for natural resources, and theirprotection over the long term

assessing current organizational and process capabilities


Measurement

Top management should assess progress in achieving plannedresults against the mission, vision, policies strategies andobjectives, at all levels and in all relevant processes and functionsin the organization.

A measurement and analysis process should be used to monitorthis progress, to gather and provide the information necessary forperformance evaluations and effective decision making.

The selection of appropriate key performance indicators andmonitoring methodology is critical for success of the measurementand analysis process.

The methods used for collecting information regarding keyperformance indicators should be practicable and appropriate tothe organization.


Measurement: Key Performance Indicators

Factors that are within the control of the organization and criticalto its sustained success should be subject to performancemeasurement and identified as key performance indicators (KPIs).

KPIs should be quantifiable and should enable theorganization to set measurable objectives, identify, monitorand predict trends and take corrective, preventive andimprovement actions when necessary.

Top management should select KPIs as a basis for makingstrategic and tactical decisions.

KPIs should be suitably cascaded as performance indicators atrelevant functions and levels within the organization to supportthe achievement of top level objectives.KPIs should be appropriate to the nature and size of theorganization and to its products, processes and activities.KPIs need to be consistent with the objectives of theorganization.


Measurement: Key Performance Indicators (cont.)

In selecting the KPIs, the organization should ensure that theyprovide information that is measurable, accurate and reliable, andusable to implement corrective actions when performance is not inconformity with objectives or to improve process efficiency andeffectiveness.

Such information should take into account

the needs and expectations of customers and other interestedparties,

the importance of individual products to the organization,both at the present time and in the future,

the effectiveness and efficiency of processes,

the effective and efficient use of resources,

profitability and financial performance, and

statutory and regulatory requirements, where applicable.


Measurement: Internal Audit

Internal auditing is an effective tool for identifying problems, risksand nonconformities, as well as for monitoring progress in closingpreviously identified nonconformities.

Internal audits should assess the implementation and effectivenessof the management system. To be effective, internal audits shouldbe conducted in a consistent manner, by competent personnel, inaccordance with an audit plan.

The outputs of internal audits provide a useful source ofinformation for

addressing problems and nonconformities

benchmarking

promoting good practices within the organization

increasing understanding of the interactions between processes

The results of internal audits are usually presented in the form ofreports.


Measurement: Self-Assessment

Self-assessment is a comprehensive and systematic review of theorganization’s activities and its performance in relation to itsdegree of maturity.

should be used to determine the strengths and weaknesses ofthe organization in terms of its performance as well as its bestpractices.

The results of self-assessments support

continual improvement of the organization’s overallperformanceprogress towards achieving and maintaining sustained successfor the organizationinnovation in the organization’s processes, products andstructure, when appropriaterecognition of best practicesthe identification of further opportunities for improvement

The results of self-assessments should be communicated torelevant people in the organization.


Measurement: Benchmarking

Benchmarking is a measurement and analysis methodology that anorganization can use to search for the best practices inside andoutside the organization, with the aim of improving its ownperformance.

There are several types of benchmarking, such as

internal benchmarking, competitive benchmarking, and genericbenchmarking

Successful benchmarking depends on factors such as

support by top management, the employed methodology,estimation of benefits vs. costs, understanding of the subjectbeing investigated

The organization should establish and maintain amethodology for benchmarking that defines rules for itemssuch as, for instance

the definition of the scope of the subject, the determination ofindicators, the collection and analysis of data


Analysis

Top management should analyze information gathered frommonitoring the organization’s environment, identify risks andopportunities, and establish plans to manage them.

The analysis of the information gathered should enable factualdecisions to be made on strategy and policy issues such as

potential changes in needs and expectations of interested parties

products and activities providing the most value for its interestedparties

new products and processes needed to meet the changing needs andexpectations of its interested parties

the evolving demands for the organizations’ products in the longterm

the influence of emerging technologies on the organization

new competences that could be needed

changes that can be expected in statutory and regulatoryrequirements which would affect the organization.


Review of Information

Top management should use a systematic approach to reviewingavailable information and for ensuring that the information is usedfor decision making.

Data can be collected from many sources, such as

monitoring of the organization’s environment

measurements of the organization’s performance, including keyperformance indicators

assessments of the integrity and validity of the measurementprocesses

results of internal audit, self-assessment and benchmarking activities

risk assessment

feedback from customers and other interested parties

The reviews should be used to evaluate the results achievedagainst applicable objectives such as, for instance, opportunities forimprovement, innovation and learning.


Improvement, Innovation & Learning

Improvement and innovation could be necessary for sustainedsuccess. Learning provides the basis for effective and efficientimprovement and innovation.

Improvement, innovation and learning can be applied to

products,

processes and their interfaces,

organizational structures,

management systems,

human aspects and culture,

infrastructure, work environment and technology, and

relations with relevant interested parties.

Fundamental to effective and efficient improvement, innovationand learning is the ability and enablement of the people in theorganization to make informed judgments on the basis of dataanalyses and the incorporation of lessons learned.


Improvement

The organization should define objectives for the improvement ofits products, processes, organizational structures and itsmanagement system through the analysis of data.

The improvement processes should follow a structured approach,such as the Plan-Do-Check-Act (PDCA) methodology.

The organization should ensure that continual improvementbecomes established as a part of the organizational culture by

providing the opportunities for people in the organization toparticipate in improvement activities, through theirempowerment

providing the necessary resources

establishing recognition and reward systems for improvement

continual improvement of the effectiveness and efficiency ofthe improvement process itself


Innovation

Innovation could be required in order to meet the needs andexpectations of interested parties. The organization should

identify the need for innovation

establish and maintain an effective and efficient innovationprocess

provide the related resources

Innovation can be applied to issues at all levels, through changes intechnology or products, in processes, in the organization, or in theorganization management system.

The timing for innovation is usually a balance between urgencyversus resources available for its development.


Innovation (cont.)

The establishment, maintenance and management of processes forinnovation within the organization can be influenced by

the urgency of the need for innovation

innovation objectives and their impact on products, processesand the organizational structures

the organization’s commitment to innovation

people’s willingness to challenge and change the status quo

the availability or emergence of new technologies

The organization should assess the risks related to plannedinnovation activities, including giving consideration to the potentialimpact on the organization of changes, and prepare preventiveactions to mitigate those risks, including contingency plans, wherenecessary.


Learning

The organization should encourage improvement and innovationthrough learning. It is necessary to adopt

Learning as an organization involves consideration ofcollecting information from various internal and external eventsand sources, including success stories and failuresgaining insights through in-depth analyses of the informationthat has been collected

Learning that integrates the capabilities of individualswith those of the organization involves consideration of

organization’s values, based on its mission, vision andstrategiesdemonstrating leadership through the behavior of topmanagementstimulation of networking, connectivity, interactivity andsharing of knowledge both inside and outside the organizationmaintaining systems for learning and sharing of knowledgerecognizing, supporting and rewarding the improvement ofpeople’s competenceappreciation


Quality Management Systems and ExcellenceModels


QMSs and Excellence Models

The approaches of quality management systems given in the ISO9000 family of standards and in organizational excellence modelsare based on common principles. Both approaches

enable an organization to identify its strengths andweaknesses,

contain provision for evaluation against generic models,

provide a basis for continual improvement, and

contain provision for external recognition.


QMSs and Excellence Models (cont.)

The difference between the approaches of the quality managementsystems in the ISO 9000 family and the excellence models lies intheir scope of application. The ISO 9000 family of standardsprovides requirements for quality management systems andguidance for performance improvement; evaluation of qualitymanagement systems determines fulfillment of those requirements.

The excellence models contain criteria that enablecomparative evaluation of organizational performance and thisis applicable to all activities and all interested parties of anorganization.

Assessment criteria in excellence models provide a basis for anorganization to compare its performance with the performanceof other organizations.


References

ISO 9000:2005 Standard




Leadership & Management

Quality Management Systems: the ISO 9000 Family of Standards