Quality management systems - Politechnika Wrocł · PDF fileQuality management systems Robert...

Bioinformatics

Robert W. Góra

Quality management systems

Quality managementsystems

Robert W. Góra

Introduction andHistorical Outline

From StatisticalProcess Control toTotal QualityManagement

ISO 9000 standards

ConformityAssessment

QMS in Calibration andTesting Laboratories

Technical requirementsfor calibration andtesting laboratories

1.2

Chapter 1Introduction and Historical Outline

Robert W. GóraInstitute of Physical and Theoretical Chemistry

Wrocław University of Technology


Robert W. Góra



ISO 9000 standards




1.3

Medieval Guilds. Hallmarking as a certification?

Italian vambrace of an Italian armour c. 1440-45,Art Gallery and Museum, Kelvingrove, Glasgow,Inv. (Source: Tobias Capwell)

Figure 1: Armourer’s mark

The modern quality movementis usually associated with works ofShewhart, Deming, Juran or Ishikawa beforeand shortly after the Second World War.

However,its roots could be traced to medieval Europeand the unions of craftsmen called guilds.1

Guilds developed strict rules to maintain highstandards of product and flawless goods were marked with aspecial mark or symbol.2

1Robert P. Merges. “From Medieval Guilds to Open Source Software:Informal Norms, Appropriability Institutions, and Innovation”. In: Conference onthe Legal History of Intellectual Property. Madison, Wisconsin, 2004.

2Steven A. Epstein. Wage Labor and Guilds in Medieval Europe. TheUniversity of North Carolina Press, 1995, Andrew Walker. A Brief History ofQuality. 2008. URL: Availablefrom:http://www.cqc.co.za/.

Available from: http://www.cqc.co.za/


Robert W. Góra



ISO 9000 standards




1.4

Industrial Revolution.

January 1909. "A little spinner in GlobeCotton Mill. Augusta, Ga. The overseeradmitted she was regularly employed."(Source: shorpy.com)

Figure 2: A little spinner

The Industrial Revolutionin the early 1800s introduced the factorysystem and organized forms of production.

Quality in the factory system was ensuredby a foreman who supervised a group of lowqualified laborers. Further development of mass

production led to the formation of whole quality controldepartments in the production plants in USA in 1920s.

This process was accompanied by the increasing use ofscientific instruments in industry, e.g. the use of thermometersand hydrometers in brewing, which also led to improved qualitycontrol.3

3Patrick O’Brien and Roland Quinault. The Industrial Revolution and BritishSociety. Cambridge University Press, 1993.


Robert W. Góra



ISO 9000 standards




1.5

A pint of statistics at brewery.

Student in 1908, Wikimedia Commons

Figure 3: William SealyGosset, statistician,1876-1937

Actually,the first important application of statistics inthe industry occurred in the Guinness breweryin Dublin, Ireland, where W. S. Gosset appliedhis knowledge in mathematics and chemistryto control the quality of finished products.4

Gosset is the authorof the famous Student’s t-distribution commonlyused nowadays in statistical hypothesis testing.

4Zivorad R. Lazic. Design of Experiments in Chemical Engineering: APractical Guide. 2004, Wikipedia. URL:http://en.wikipedia.org/wiki/William_Sealy_Gosset.

http://en.wikipedia.org/wiki/William_Sealy_Gosset


Robert W. Góra


From StatisticalProcess Control toTotal QualityManagementShewart’s Control Charts

Statistical Control ofManagement Processes

Deming’s ProductionDiagram

Juran’s Trilogy

Pareto Principle

Deming’s 14 Points ofManagement

Total Quality Management

ISO 9000 standards




2.6

Chapter 2From Statistical Process Control toTotal Quality Management




Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.7

Between the Wars. The birth of Statistical Process Control.

(Source: www.york.ac.uk)Figure 4: Walter AndrewShewhart, physicist,engineer and statistician,1891-1967

The early industrialquality control was limited to inspectingfinished products and removing defectiveitems, which were then scraped or reworked.

In 1924 Dr. Shewhart,working for the Western Electric CompanyInspection Engineering Department at theHawthorne Works, realized that such a processis difficult to control and not very cost effective.

He posed a fundamental question: how much may the qualityof a product vary and yet be controlled and prepared a littlememorandum that featured a sketch of a modern control chart.


Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.8

Between the Wars. The birth of Statistical Process Control.

Shewhart continued his work at Bell Telephone Laboratoriesand summarized the results in his book “Economic Control ofQuality of Manufactured Product (1931)”.5 Based on hisobservations he proposed three postulates:

Shewhart postulates

• All chance systems of causes are not alike in the sensethat they enable us to predict future in terms of the past.

• Constant systems of causes do exist in nature. (e.g.Brownian motion)

• Assignable causes of variation may be found andeliminated.

5W. A. Shewhart. Economic Control of Quality of Manufactured Product.New York, Van Nostrand, 1931.


Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.9

Shewart’s control charts . . . in chemical laboratory.

Determination of SO2−4 reference material concentration.

−3σ

−2σ

−σ

3σ

2σ

σ

34%

34%

14%

14%

2%

2%

0.1%

0.1%

N

f(

x ;µ,σ2)

=1

σ√

2πe−

(x−µ)2

2σ2

σ2 =

1N

N

∑i=1

(xi −µ)2

µ =1N

N

∑i=1

xi

µ +σ

µ−σ

µ +2σ

µ−2σ

µ +3σ

µ−3σ


Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.9

Shewart’s control charts . . . in chemical laboratory.

Determination of SO2−4 reference material concentration.

−3σ

−2σ

−σ

3σ

2σ

σ34%

34%

14%

14%

2%

2%

0.1%

0.1%

N

f(

x ;µ,σ2)

=1

σ√

2πe−

(x−µ)2

2σ2

σ2 =

1N

N

∑i=1

(xi −µ)2

µ =1N

N

∑i=1

xi

µ +σ

µ−σ

µ +2σ

µ−2σ

µ +3σ

µ−3σ


Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.10

“The American Who Taught the Japanese About Quality”

Photo: The W. Edwards Deming Institute

Figure 5: W. EdwardsDeming, 1900-1993

At the time when Shewhart was beginningto apply his ideas of controlled variationto manufacturing processes, a Yale graduatestudent W. Edwards Deming6 had an internshipat Western Electric Hawthorne Plant in Chicago.

However, they were introduced to each otherlater, in 1927, when Deming joined the UnitedStates Department of Agriculture (his bossshared previously an apartment with Shewhart

in Brooklyn).

Deming quickly realized that the statistical process controlcould be applied also to the management processes. Later headopted Shewart’s ideas as the fundamental principles of hisquality philosophy.

6Jr. Robert B. Austenfeld. 2002.


Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.11


In late 1930s, Deming was responsible for courses in statisticsat the USDA’s graduate school. He invited Shewhart to givefour afternoon lectures. These were later published by theUSDA’s graduate school in 1939 as “Statistical Method fromthe Viewpoint of Quality Control”.7

In 1939 Deming joined the U.S. Census Bureau where headvocated the sampling and statistical process controltechniques. After the US entered World War II, Deming wasone of the lecturers for intensive courses to engineers andinspectors, which featured the statistical process controlcharting and the Shewhart Cycle.

Although this program resulted in the substantial reductions inscrap and rework costs, its message was almost completelyforgotten soon after the war ended. The quality control was nolonger considered a matter associated with testing and reworkbut efforts focused on quality prevention.

7W. A. Shewhart. Statistical Method from the Viewpoint of Quality. Ed. byW. Edwards Deming. Ontario, Dover, 1986.


Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.12

The Shewart’s cycle for Learning and Improvement.

The P D S A cycle.

PPlan

DDo

SStudy

AAct

Plan a testaimed atimprovement.

Do the teston a smallscale

Study the results.What did welearn?

Introduce orabandon thechange or runthrough the cycleagain.


Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.13


In 1947 Deming visited Japan as an adviser on samplingtechniques to General MacArthur’s Supreme Command ofAllied Powers. Around that time The Union of JapaneseScientists and Engineers (JUSE) became interested inAmerican quality control techniques. Few years later hereceived an invitation from the Union to give a series oflectures on the applications of statistics to quality improvement.

However, a turning point for Japan was Deming’s meeting with21 of Japan’s top managers in July of 1950. He advised themto think of manufacturing as a system that with consumerresearch, redesign of products and continuous improvementcan be brought under statistical control with ever-increasingquality.

He told them that if they followed his recommendations theywould capture the world markets within five years. . . whichwasn’t that far from truth.


Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.14

Deming’s diagram of production process viewed as asystem.

Production process viewed as a system.

Suppliers ofmaterials andequipement

A

B

C

D

Production Assembly Inspection Distribtion

Consumers

1

2

3

4

Consumer researchDesign and redesign

Receipt and testof materials


Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.15

Juran’s structured approach to managing for quality.

Photo: The New York Times

Figure 6: Joseph M.Juran, 1904-2008

In 1952 JUSE invited anotherquality guru Joseph M. Juran after publicationof his “Quality Control Handbook” in 1951.8

Whereas, Demingraised the significance of the statistical qualitycontrol of manufacturing processes, Juranoffered a structure for their implementation.

Juran stressed on the involvement of top andmiddle management in training, the idea that had found suchan resistance in the US. After Juran’s lectures JUSE startedthe regular courses for middle-management and workers.Since then quality control has become a concern ofmanagement and worker alike.

Interestingly, in Japan standardization and quality control werein fact legally enforced by institutions!

“The need for the development of quality tools wastaken up by the lectures of Juran in 1954. Whereas,Deming had raised the significance of the tools ofquality control, Juran “stressed that control charts,while necessary, were far from sufficient, and that useneeded to be made of the managerial tools, requiringthe understanding and co-operation of top and middlemanagement”. According to Juran, management’sresponsibility for quality covers the areas of policymaking, planning, control and measurement andreview. Thus, Juran offered a structure for theimplementation of quality control. According toNonaka he “provided a structured approach tomanaging for quality and to quality improvement”.After Juran’s visit, the JUSE set up courses formiddle-management spreading the key points ofJuran’s lectures. Indeed the course was extended totrain workers and foremen via 15 minute daily slots onthe radio later to be published by the nationalbroadcasting association as an accompanying textwhich sold 85.000 copies. Quality control became aconcern of management and worker alike. In additionto extending the training for quality, journals, such asTotal Quality Control or Quality Control for theForeman, continued to raise quality awareness.”9

8Joseph M. Juran. Quality Control Handbook. New York, McGraw-Hill, 1951.9Constanze Clarke. Automotive Production Systems and Standardisation.

From Ford to the Case of Mercedes-Benz. Physica-Verlag, Springer, 2005.


Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.16

The Juran Trilogy.

Chronic WasteOpportunity for Im-provement

SporadicSpike

Quality Control

Breakthrough

Quality Improvement

New Zoneof Quality Control

Quality Planning

LCL

UCL

UCL

LCL

Cos

tofP

oor

Qua

lity

Time0

5

10

15

20

25

30

35

40

45


Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.17

The Juran Trilogy: Quality Planning.

The essence of the Juran’s work is the so-called “JuranTrilogy”. It provides a strategic framework for theimplementation of quality management.

• Quality Planning. This is the first stage when the productsand processes that will be able to meet established goals(consumer needs) are designed.

• Identify the customers (use Pareto principle).• Determine the customers’ needs.• Develop a product whose features align with the customers’

needs.• Develop processes that are capable of producing such

products.• Establish quality controls.• Transfer these plans to the operating forces.


Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.18

The Juran Trilogy: Quality Control.

• Quality Control. Bringing a manufacturing process understatistical control provides a tool to deal with sporadicspikes in production, but does not generally allow toeliminate the intrinsic inefficiencies in the process. Jurancalls these inefficiencies a chronic waste.

• Evaluate actual operating performance.• Compare the performance to quality goals.• Act on the difference.


Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.19

The Juran Trilogy: Quality Improvement.

• Quality Improvement. It goes beyond control and dealswith the chronic waste that was built into the products andprocesses at the planning stage. According to Juran, itincludes the following steps:

• Establish the infrastructure needed to facilitate continuousquality improvement.

• Identify the improvement projects.• For each project, establish a team that is clearly charged

with the responsibility of bringing a successful resolution tothe project. Provide the teams with resources, training, andmotivation to: diagnose the causes, and stimulate remedies.

• Establish controls to hold the gains


Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.20

Pareto principle, 80-20 rule or as Juran wants it: “the vitalfew and the useful many”.

Juran popularized the so called “Pareto principle”. It’s sort of a rule ofa thumb based on an observation made by Vilfredo Pareto that often80% of an effect is caused by 20% of the causes. Juran began toapply this principle to quality issues.

It is based on a power law probability distribution (known also asBradford distribution) characteristic to various observable phenomena,ranging from Bose-Einstein condensation to the distribution of globalincome.

Pareto principle

80%

RESULT

20% EFFORT 0

20

40

60

80

100

Richest 20%

Second 20%

Third 20%

Fourth 20%

Poorest 20%

Qu

intil

e o

f in

com

e [

%]

Quintile of population

Distribution of world GDP, 1989

Figure 7: Pareto chart


Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.21

“If Japan can, why can’t we?” era

It was not until 1970s, that Americans began to realize thatbasically everything that had been made in Japan was muchbetter and cheaper than the domestic products.

This prompted NBC to produce a documentary that wouldattempt to answer the question: “If Japan can, why can’t we?” .The documentary aired in June 1980 showed that the key toJapanese success was in fact the implementation of Deming’sand Juran’s statistical approach to control the production andmanagement processes.

This event marks the dawn of what is commonly referred to as“Quality Revolution” in the Western Hemisphere. A few yearsbefore the end of his incredibly active life Deming publishes twoof his classic works: “Out of the Crisis” (1986)10 and “The NewEconomics” (1988)11 which summarize his ideas for qualityimprovement as they had gradually evolved over the years.

10W. Edwards Deming. Out of the Crisis. MIT Press, 1986.11W. Edwards Deming. The New Economics: For Industry, Government,

Education. MIT Press, 1988.


Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.22

Deming’s 14 points for transformation and management

In “Out of the Crisis” Deming enclosed his ideas in thefollowing fourteen points.[8]

1 Create constancy of purpose for improvement ofproduct and service. The point stresses the need for amission statement which must be understood by allemployees, suppliers, and customers. The strategicplan should look for the long-term payback.

2 Adopt the new philosophy. Management must learnthe responsibilities and take on leadership for change.Poor workmanship, defective products, or bad serviceare not acceptable.

3 Cease dependence on mass inspection. Eliminate theneed for inspection on a mass basis by building qualityinto the product in the first place. Statistical methods ofquality control are more efficient.


Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.23

Deming’s 14 points

4 End the practice of awarding business on the basis ofa price tag alone. Instead, minimize the total cost. Theaim in the purchase of new tools and other equipmentshould be to minimize the net cost per hour ofoperation or per piece produced. Move toward a singlesupplier for any one item, on a long-term relationshipof loyalty and trust.

5 Improve constantly and forever the system ofproduction and service. The improvement of theproduct and service is an ongoing process. TheDeming cycle involves the four-step process of plan,do, check, act. At the plan stage, the opportunities forimprovement are identified. The theory is tested on asmall scale at the do stage, the results of the test areanalyzed at the check stage, and the results areimplemented in the act stage.


Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.24


6 Institute training. On-the-job training must be providedfor all employees. Employees must be encouraged toimplement the knowledge developed through training.

7 Adopt and institute leadership. The aim of supervisionshould be to help people to do a better job usingmachines. Supervision must create an environmentwhere the workers take leadership roles inaccomplishing their work.

8 Drive out fear. Management must create anenvironment where workers are encouraged to askquestions and make suggestions. A climate ofinnovation leads to progress.

9 Break down barriers between departments. People inresearch, design, material procurement, sales, andproduction must work as a team. They mustunderstand the requirements and specifications.Teamwork leads to improvements in quality andproductivity.


Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.25


10 Eliminate slogans, exhortations, and targets for thework force. Exhortations such as asking for zerodefects and new levels of productivity only createadversarial relationships. The bulk of the causes of lowquality and low productivity belong to the system andthus lie beyond the power of the work force.

11 Eliminate numerical quotas for the work force andeliminate numerical goals for people in management.Quotas lead to the deterioration of quality. Learn thecapabilities of processes and methods to improvethem.

12 Remove barriers that rob people of pride ofworkmanship. Quality is achieved in the companywhen all employees are satisfied and motivated.Management must create an environment where theworkers take pride in their job.

13 Encourage education and self-improvement foreveryone. An organization needs people that areimproving with education.

14 Take action to accomplish the transformation. Thetransformation is everybody’s job.


Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.26

Deming’s system of profound knowledge I

In “The New Economics” Deming explains his system ofprofound knowledge.[9] It’s a management philosophy basedon the principle that each organization is a system ofinterrelated processes.

Deming believed that a system cannot understand itself andthe profound knowledge can only come from the outside of thesystem. It is a method that ties together all of his formerteachings and consisted of four elements that should be usedtogether to truly affect the transformation of management.


Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.27

Deming’s system of profound knowledge II

• Appreciation for a system. It must have an aim. Theperformance of each component must be judged onthe basis of its contribution to the aim. The systemmust be actively managed. Recognizing theimportance of the system to individual performance.

• Knowledge about variation. Variation is normal. Thereare two kinds of causes of variation: common andspecial. System should be stable in order to distinguishthe two. Managers should not blame their workers forpoor performance.

• Theory of knowledge. Theories need to be developedand tested to advance knowledge. Theplan-do-study-act (PDSA) cycle should be used todevelop theories (predictions) systematically and testthem. Learning should be continuous andorganization-wide.

• Psychology. People are born with intrinsic motivation.They have right to enjoy their work and to pride ofworkmanship. Elliminate fear, break down barriers.


Robert W. Góra





Juran’s Trilogy

Pareto Principle



ISO 9000 standards




2.28


In the early 1980s, Western companies introduced their own qualityprograms to counter the Japanese success. Deming’s 14 pointsbecame a core concept in the development of a new managementphilosophy the so-called “Total Quality Management” (TQM). The termwas first used by the Naval Air Systems Command in 1985 to describeits Japanese-style management approach.

TQM is a management approach to long-term success throughcustomer satisfaction in which all members of an organization must beinvolved in continuous improvement of their products, services andprocesses.

TQM, however, is more a philosophy than the actual guideline for animplementation. An emerging need for standards led to theestablishment of the Malcolm Baldrige National Quality Award by theUS Congress in 1987. The criteria used for the award incorporate allmajor elements of TQM and are in fact its definition.12

12C. P. Kharta. “TQM implementation. A comparison of ISO 9000:2000quality system standards, QS9000, ISO/TS 16949 and Baldrige criteria.” In:The TQM Magazine 16.5 (2004), pp. 331–340. DOI:10.1108/09544780410551269.

http://dx.doi.org/10.1108/09544780410551269


Robert W. Góra



ISO 9000 standardsBrief history of ISO 9000

Quality ManagementPrinciples

The ISO 9000Requirements

EnvironmentalManagement Systems




3.29

Chapter 3ISO 9000 Series of Standards forQuality Management




Robert W. Góra










3.30

ISO 9000 series of standards for quality management

In the same year that the Malcolm Baldrige award wasestablished, the International Organisation for Standardisation(ISO) publishes the standard ISO 9000 requirements forQuality Management Systems (QMS). The core standard isnamed ISO 9001.

The history of ISO 9001 standard can be traced to the USmilitary standard 105 for purchases of military goods. In 1963,this standard was used by the NATO as the US MIL-Q 9858. In1979 the British Standards Institute (BSI) published BS 5750,based on the NATO standard and adapting it for a non-militarycontext. The British Standard for quality systems was aprototype for the ISO 9000 series.13

In 1994 the ISO 9000 series was revised to focus more onquality assurance, commitment of executive management andto include service as a product.

13Constanze Clarke. Automotive Production Systems and Standardisation.From Ford to the Case of Mercedes-Benz. Physica-Verlag, Springer, 2005.


Robert W. Góra










3.31

ISO 9000 series of standards for quality management

In 2000 a new series was conglomerated into 4 maindocuments from around 20 of the previous revision with anintention to support process-oriented quality managementsystems and incorporate continuous improvement as anadditional demand.

The core of ISO 9000 standard series

• ISO 9000:2005 (PN-EN ISO 9000:2006) - QualityManagement Systems - Fundamentals and Vocabulary

• ISO 9001:2008 (PN-EN ISO 9001:2009) - QualityManagement Systems - Requirements

• ISO 9004:2009 (PN-EN ISO 9004:2009) - Managing forthe sustained success of an organization - A qualitymanagement approach

• ISO 19011:2002 (PN-EN ISO 19011:2003) - Guidelines onQuality and Environmental Management Systems Auditing


Robert W. Góra










3.32

The ISO 9000 Quality Management Principles

The ISO 9000 standard provides the fundamentals andvocabulary used in the entire family of standards. It introducesthe following eight Quality Management Principles that relate toDeming’s and Juran’s teachings:

1 Customer focus: organizations depend on their customersand therefore should understand current and futurecustomers’ needs, meet customers’ requirements, andstrive to exceed customer expectations.

2 Leadership: leaders establish unity of purpose and thedirection of the organization. They should create andmaintain an internal environment in which people canbecome fully involved in achieving the organization’sobjectives.

3 Involvement of people: people at all levels are the essenceof an organization, and their full involvement enables theirabilities to be used for the organization’s benefit.

4 Process approach: a desired result is achieved moreefficiently when related resources and activities aremanaged as a process.


Robert W. Góra










3.33

The ISO 9000 Quality Management Principles

The ISO 9000 standard provides the fundamentals andvocabulary used in the entire family of standards. It introducesthe folowing eight Quality Management Principles:

5 System approach to management: identifying,understanding, and managing a system of interrelatedprocesses for a given objective improve the organization’seffectiveness and efficiency.

6 Continual improvement: continual improvement should bea permanent objective of the organization.

7 Factual approach to decision-making: effective decisionsare based on the analysis of data and information.

8 Mutually beneficial relationships with suppliers: anorganization and its suppliers are interdependent, and amutually beneficial relationship enhances the ability ofboth to create value.


Robert W. Góra










3.34

ISO 9000 series key concepts, terms and definitions

Concepts relating to quality


Robert W. Góra










3.35


Concepts relating to management


Robert W. Góra










3.36


Concepts relating to organization


Robert W. Góra










3.37


Concepts relating to process and product


Robert W. Góra










3.38


Concepts relating to characteristics


Robert W. Góra










3.39


Concepts relating to conformity


Robert W. Góra










3.40


Concepts relating to documentation


Robert W. Góra










3.41


Concepts relating to examination


Robert W. Góra










3.42


Concepts relating to audit


Robert W. Góra










3.43


Concepts relating to quality assurance for measurementprocesses

QualityManagement

System

Management

Objectives

Customerfocus

Quality policy

Planning

Resourcemanagement

Product

Customerrequirements

Design &Development

Realization

Monitoring

Measurement& Analysis

Customersatisfaction

Internal AuditNonconforming

product

Managementreview

Documen-tation

QualityManual

Procedures &Instructions

Records

ContinualImprove-

ment

CorrectiveActions

PreventiveActions


Robert W. Góra










3.45

ISO 9001 Quality Management System - Requirements

4.1 General requirements

• To identify the QMS processes, their application and their mutualinteractions.

• To determine criteria and ensure resources for their effectiveoperation and monitoring.

• To maintain and continually improve these processes.

• To document the organization’s process-based QMS.

4.2 Documentation requirements

• To establish and maintain Quality Manual including: the scope ofthe QMS, the references to the documented procedures and adescription of the processes and their interactions.

• To establish procedures for:

• control of documents and records,• internal audits,• control of nonconforming product,• preventive and corrective actions.


Robert W. Góra










3.46

The ISO 9000 process approach for continual improvement

The ISO 9000 standard advocates the process approach tomanage an organization and to achieve continual improvementof QMS.

Managementresponsibility

Productrealization

Measurementanalysis andimprovement

ActCheck

Resourcemanagement

Do

Customers

Satisfaction

CustomersPlan

RequirementsInput

ProductOutput

Value-adding activities

Information flow


Robert W. Góra










3.47

5. Management responsibility

• To commit oneself to the development, implementationand continuous improvement of the organization’s QMS.

• To ensure customer focus in the organization.• To establish measurable quality objectives and quality

policy.• To appoint the management representative and systematic

management review of the QMS.

6. Resource Management

The organization should:• Determine and provide the resources sufficient to

implement, maintain and continually improve the QMS andto enhance customers’ satisfaction.

• Determine the necessary competence for personnel,provide training, and evaluate effectiveness of the actionstaken.

• Determine, provide and maintain the appropriateinfrastructure and work environment.


Robert W. Góra










3.48

7. Product realization

The organization should determine:

• The quality objectives and requirements for the product.

• The necessary processes, documentation, records, validation,monitoring and test activities specific to the product and thecriteria for product acceptance.

• The requirements specified by the customer, including service.

• All the relevant statutory and regulatory requirements.

• Customer communication including inquiries, contracts andcustomer feedback.

The organization should:

• Plan and control the design and development of the product.

• Evaluate and select suppliers based on their ability to meet theorganization’s requirements and specifications.

• Plan and carry out production and service provision undercontrolled conditions.

• Determine the monitoring and measurement activities to providethe evidence of conformity of the product to the requirements.


Robert W. Góra










3.49

8. Measurement, analysis and continual improvement

The organization should:

• Plan and implement the monitoring, measurement, analysis andimprovement processes needed to demonstrate conformity of theproduct and to continually improve and ensure conformity of theQMS.

• Monitor customers’ satisfaction.

• Conduct internal audit at planned intervals.

• Perform monitoring and measurement of the products andprocesses.

• Ensure that the nonconforming product is identified andcontrolled

• Collect and analyze appropriate data to demonstrateeffectiveness of QMS and its continual improvement.

• Undertake corrective actions to eliminate the causes ofencountered nonconformities.

• Determine preventive actions to eliminate the causes of potentialnonconformities.


Robert W. Góra










3.50

Concluding remarks

Although there is a common opinion that the ISO 9001systems appear to be very bureaucratic, it depends heavily onthe particular implementation. The ISO 9001 standard isdesigned to be applicable for any company of any size, and ofany profile of business activity. This makes the requirementsvery broad and general.

An organization implementing ISO 9000 QMS usually createsmany different documents and procedures in order to meetrequirements of the standard (and registrar) instead ofdocumenting its factual practices. This often leads to acumbersome and bureaucratic system.

ISO 9001 is meant to be a very flexible standard and there arecountless ways of implementing its requirements. Although theauditors of registrars should be equally flexible, this is notalways the case.


Robert W. Góra










3.51

Concluding remarks

Ultimately, ISO 9001 is meant to provide a structural approachfor an organization to:

• meet their customers’ and any applicable regulatoryrequirements,

• enhance their customers’ satisfaction, and• achieve continual improvement of its performance

Only so much and so many.


Robert W. Góra










3.52

Environmental Management Systems

Industrial development comes with a price.

Although there is an ongoing dispute about the extent of theeffects of human activity on global climate, the observeddepletion of the ozone layer, air, water and soil pollution, globalwarming, and deforestation are nowadays widelyacknowledged as the major environmental issues.

An increased ecological awareness of general public,governments and interest groups affects strongly the policies ofmany companies.

This is particularly true for a large international corporationswhich, in order to gain competitive advantage, want to provideenvironment-friendly products and services.


Robert W. Góra










3.53

Environmental Management Systems

To meet these expectations, in 1996 the ISO 14000 family ofstandards was established. The standards were revised in2004. The core standard, ISO 14001, provides a framework oftools for managing environmental issues and is the mostrecognized Environmental Management System (EMS).

Generally, ISO 14001 is a documented management systemfor environment-related functions of an organization, includingcollection of environmental policies and procedures.


Robert W. Góra



ISO 9000 standards

ConformityAssessmentCertification

Accreditation

Standards for Accreditation

Polish Center forAccreditation



4.54

Chapter 4Conformity Assessment Systems




Robert W. Góra



ISO 9000 standards


Accreditation





4.55

Conformity Assessment, Certification and Accreditation

Certification against ISO 9001:2008 is a process in which thesystem is audited against the requirements of the standard byan independent third-party certification or registration bodywhich, if the requirements have been met, issues a certificateof conformity.

Certification is not a requirement of any of the standards in theISO 9000 family. An organization can implement the standardswithout seeking certification.

However, up to the end of December 2008, at least 982 832ISO 9001:2000 certificates had been issued in 176 countries(10 965 in Poland).14

So what are the certification pros and cons?

14The ISO Survey of Certifications. 2008.


Robert W. Góra



ISO 9000 standards


Accreditation





4.56

Certification pros and cons

• Customer or regulatoryrequirements.

• An independentconfirmation ofconformity adds value.

• Conformity to ISO 9000is a major criteria forthe selection ofsuppliers.

• Marketing.• International

recognition.

• Greater degree ofbureaucracy?

• Expensive quality?• Discrepancies between

the intention of ISOstandards and theirpractical application?

“Of 325 quality managers questioned in a study byKamiske et. al (1984), around 60% stated that theintroduction of the ISO 9000 series had either led toinsignificant or no reduction in the number of defectparts. A second study, intended to evaluate thebenefits of introducing general standards andtechnical rules of 4.000 companies in Germany,Austria and Switzerland, conducted for the DINbetween 1997 and 2000 adds that 61% of companiesaffirmed that costs actually occurred through theintroduction of standards (DIN 2000:12). 37% ofcompanies linked this increase to the necessity ofmaking additional staff available. Regarding thebenefits, 62% of companies stated a reduction intrading costs caused by the “simplification ofcontractual agreements”. Only 9.3% of companiesprovided actual figures of monetary savings resultingfrom standardisation. [. . . ]”“Conformity to standard quality management systems,particularly the ISO 9000, has been a major criteriafor the selection of suppliers. According to Franke, formany customers and clients product quality alone nolonger counts, they are increasingly interested in theproduct and process quality of manufacturers andsuppliers. The ISO 9000 certificate is seen as proof(or mark !) of the existence of an efficient qualitymanagement system and it is assumed that thosecompanies which do not have a quality managementsystem are not seriously concerned about qualityissues.”15

15Constanze Clarke. Automotive Production Systems and Standardisation.From Ford to the Case of Mercedes-Benz. Physica-Verlag, Springer, 2005.


Robert W. Góra



ISO 9000 standards


Accreditation





4.57

Conformity assessment, Certification and Accreditation

ISO itself does not perform certification to its standards, issuecertificates or control certification performed by otherorganizations.

So who does all those things? The so called accreditationbodies and the registrars and certifiers accredited by them.16

Accreditation

“Accreditation is third-party attestation related to aconformity assessment body – CAB (laboratory,certification body or inspection body) conveyingformal demonstration of its competence to carry outspecific conformity assessment tasks.”a

aEN ISO-IEC-17021:2006

16APEC SCSC Education Guideline 3. Standardization: Fundamentals,Impact, and Business Strategy. Textbook for Higher Education. Asia PacificEconomic Cooperation Secretariat, 2010.


Robert W. Góra



ISO 9000 standards


Accreditation





4.58

Accreditation – The International Picture

The accreditation bodies are usually recognized by, theirnational government and are authorized to accredit registrarsof QMS or EMS, inspection bodies, testing laboratories andcertifiers of products.

In Europe, most countries have a single accreditation bodydealing with all these activities.

Official IAF logo

In 1993, a group ofaccreditation bodies met in Houston for the firstmeeting of “Organizations Accrediting QualitySystem Registrars and Certification programs”and began an organization that is now namedthe International Accreditation Forum (IAF).17

17www.iaf.nu


Robert W. Góra



ISO 9000 standards


Accreditation





4.59


IAF has developed a peer evaluation process for signatories ofthe so-called Multilateral Recognition Agreement (MLA), inorder to ensure continuing compliance with the internationalstandard for accreditation bodies (currently EN ISO/IEC17011:200618).

MLA signatories are obliged to recognize on an equal basiswith their own the certificates and reports from theorganizations accredited by the signatories and to recommendand promote such an acceptance in their countries.

18PN-EN ISO/IEC 17021:2007. Conformity assessment – Requirements forbodies providing audit and certification of management systems. 2007.


Robert W. Góra



ISO 9000 standards


Accreditation





4.60


Official ILAC-MRA logo

In 1997, theInternational Laboratory Accreditation Cooperation(ILAC) was established and assumed a similarto IAF peer evaluation process of its members.19

IAF and ILAC now work closelytogether and have a Joint Executive Committee.

Source: www.conformity.com

19www.ilac.org


Robert W. Góra



ISO 9000 standards


Accreditation





4.61


Official EA logo

In Europe, the European co-operationfor Accreditation (EA) was established in1997 and it is an active member of ILAC and IAF.20

EA is the Association of the national accreditation bodies (EAMLA signatories) that provide accreditation for the followingconformity assessment activities:

• Calibration and Testing• Inspection• Certification of quality and environmental management

systems (QMS and EMS)• Certification of products• Certification of persons• EMAS verifiers

20www.european-accreditation.org

Standards for accreditation21

AccreditationBodies(AB)

ISO/IEC 17011

CertificationBodies(CAB)

EMAS VerifiersCouncil

Regulation761/2001

ISO/IEC 17021ISO Guide 65(EN 45011) ISO/IEC 17021 ISO/IEC 17024

Eco-Managementand AuditScheme

EnvironmentalManagement

SystemsProducts

QualityManagement

SystemsPersons

21Source: EA

Standards for accreditation

AccreditationBodies(AB)

ISO/IEC 17011

LaboratoriesCertification

Bodies(CAB)

InspectionBodies

ISO/IEC 17025ISO/IEC 15189 ISO/IEC 17020

Testing andCalibration

Inspection


Robert W. Góra



ISO 9000 standards


Accreditation





4.64

International recognition of accreditation

• All signatories of IAF Multilateral Recognition Arrangement(MLA) and ILAC Mutual Recognition Arrangement (MRA) werepositively verified in a peer review process which evaluated:

• their compliance with ISO/IEC 17011 standard,• the performance of their assessors during actual

assessments/reassessments in order to determine if theaccredited laboratories are in compliance with ISO/IEC17025 or ISO 15189.

• MLA/MRA signatories are obliged to recognize on an equal basiswith their own the certificates, calibration and testing reports fromthe organizations accredited by the signatories.

• Ultimately, MLA/MRA help to reduce some of the technicalbarriers to trade – products “tested once and acceptedeverywhere”.

• MLA/MRA signatories can enter into a licensing agreement withILAC and IAF to use the ILAC-MRA and IAF-MLA marks incombination with their own accreditation body symbol.


Robert W. Góra



ISO 9000 standards


Accreditation





4.65

Accreditation system in Poland

Official PCA logo

In Poland the accreditation system is administeredby the Polish Center for Accreditation (PCA).

PCA is the national accreditation body authorizedto accreditation of certification and inspection bodies,testing and calibration laboratories and other entities

conducting conformity assessments and verifications on the basis ofthe Act of Parliament of 30 August 2002 on Conformity AssessmentSystem (the consolidated text Dz.U. of 2004, No 204, item 2087 withfurther changes).22

PCA is signatory of EA MLA, IAF MLA and ILAC MRA

• On 24 November 2004, PCA signed EA Multilateral Agreement withinQMS, EMS, products and persons certification bodies, and testing andcalibration laboratories.

• On 19 January 2005 PCA signed ILAC Mutual Recognition Arrangementin the scope of testing and calibration laboratories

• On 16 February 2005 PCA signed IAF Multilateral RecognitionArrangement in the scope of QMS, EMS and products certificationbodies.

22Source: www.pca.gov.pl


Robert W. Góra



ISO 9000 standards


Accreditation





4.66

World Accreditation Day 2010 – “Global Acceptance”

World Accreditation Day9 June 2010

Global Acceptance

10th Anniversary ILAC MRA | 12th Anniversary IAF MLA

Official WAD 2010 poster


Robert W. Góra



ISO 9000 standards


QMS in Calibration andTesting LaboratoriesAccreditation vs.Certification

Organization andmanagement requirements

Monitoring of the qualitysystem


5.67

Chapter 5Quality management systems incalibration and testing laboratoriesTechnical competence underpinned by a quality system




Robert W. Góra



ISO 9000 standards






5.68

Laboratory Accreditation vs. ISO 9001 Certification?

Laboratories are organizations that produce test and/orcalibration results. They can implement, be audited, andcertified to ISO 9001 international standard.

However, ISO 9001 does not address the technicalcompetence of the laboratory. Therefore, it does not assurethat the produced test or calibration results are accurate andreliable.

Most economies now rely on a process called LaboratoryAccreditation to evaluate laboratory competence.

Accreditation vs. Conformity Certification

Accreditation is a procedure by which an authoritative bodygives formal recognition that a body or person is competent tocarry out specific tasks.

Conformity is a fulfillment by a product, process or service ofspecified requirements.


Robert W. Góra



ISO 9000 standards






5.69

ISO/IEC 17025 – General Requirements for the Competenceof Testing and Calibration Laboratories

Accreditation bodies now use ISO/IEC 1702523 international standardas the basis for their accreditation of testing and calibrationlaboratories.24

Prior to issuing of ISO/IEC 17025:1999 there was no internationallyaccepted standard for laboratory accreditation. However, ISO/IECGuide 25 provided a considerable level of uniformity.

The first edition (1999) of ISO/IEC 17025 standard was in fact arevision of the third edition of ISO Guide 25 and EN 45001standard.25 There was a minor revision of the standard in 2005, toensure compliance with the new revision of ISO 9001:2000 standard.

23PN-EN ISO/IEC 17025:2005. General requirements for the competence oftesting and calibration laboratories. 2005.

24C. D. Faison et al., eds. NIST Handbook 150, Procedures and GeneralRequirements. National Institute of Standards and Technology, 2006,Complying with ISO 17025. A practical guidebook. United Nations IndustrialDevelopment Organization, Vienna, 2009.

25PN-EN 45001:1993. General criteria for the operation of testinglaboratories. (Superseded, Withdrawn).


Robert W. Góra



ISO 9000 standards






5.70

Brief History of Accreditation in Poland

The first certificate of accreditation in Poland, was issued fortesting laboratory in 1992, for certification body in 1993 and forcalibration laboratory in 1997. All accreditations were carriedout in accordance with the requirements of EN 45000standards series.


Robert W. Góra



ISO 9000 standards






5.71

Is accreditation truly voluntary?

Although, it was the original intention, the accreditation is nolonger voluntary! Currently in Poland there are at least 96regulatory acts referring to or requiring the test and/orcalibrations to be performed by the accredited laboratories:

• The Law on Construction Products (Dz.U. No 92 item 881 from16.04.2004).

• The Law on Prevention and Suppression of Infections and InfectiousDiseases in Humans (Dz.U. No 234 item 1570 from 05.12.2008).

• The Ministry of Health Regulation on the Sampling and Testing ofChemical Substances and Chemical Preparations and Products Underthe Supervision Exercised by the Chief Sanitary Inspectorate (Dz.U. No165 item 1122 from 01.09.2010).

• The Cosmetics Act (Dz.U. No 42 item 473 from 30.03.2001).• The Law on monitoring and controlling the quality of fuels (Dz.U. No 169

item 1200 from 25.08.2006).• The Law on Fertilizers and Fertilization (Dz.U. No 147 item 1033 from

10.07.2007).• The Law on the Prevention and Remedying of Environmental Damage

(Dz.U. No 75 item 493 from 13.04.2007).• The Veterinary Inspection Act (Dz.U. No 112 item 744 from 29.01.2004)


Robert W. Góra



ISO 9000 standards






5.72

The Scope of ISO/IEC 17025 standardISO/IEC 17025 standard is applicable to all organizations performingtests and/or calibrations.

Laboratories that comply with ISO/IEC 17025 standard also operate inaccordance with the requirements of ISO 9001 that are relevant tocalibration and testing activities. This is particularly important for ISO9001 certified clients searching for a laboratory acting as asub-contractor.

ISO/IEC 17025 standard specifies the general requirements for thecompetence to carry out tests and/or calibrations, including sampling.In addition to the requirements regarding the QMS, it addresses thefollowing relevant factors:

• technical competency of personnel,

• validation of the methods,

• traceability of measurements,

• estimation of measurement uncertainty,

• calibration and maintenance of test equipment,

• sampling and handling of test items,

• quality assurance and environmental conditions.


Robert W. Góra



ISO 9000 standards






5.73

General Requirements

• It is unlikely that any properly organized laboratory shouldneed to change its structure in any fundamental way inorder to comply with the ISO 17025 standard. Usually all itneeds to be done is to identify and document itsmanagement system and procedures.

• The QMS should be appropriate to the size of thelaboratory and to the scope of its activities. It should besufficiently simple – otherwise it will not be used!

• Laboratories are required to continually improve theeffectiveness of its management system through the useof the quality policy, quality objectives, audit results,analysis of data, corrective and preventive actions andmanagement review.

• Laboratory personnel should be involved in documentingthe QMS as much as possible.


Robert W. Góra



ISO 9000 standards






5.74

Organization

Laboratory should:• Describe the legal identity of the laboratory (it must be an entity

that can be held legally responsible) and define its organizationand management structure,

• Identify any potential conflicts of interest if laboratory is a part ofan organization performing other activities,

• Identify managerial and technical personnel making decisions onpolicy and allocating resources. Appoint deputies for keymanagerial personnel,

• Specify a technical management structure for quality assuranceof technical activities such as: selection and/or development ofmethods, monitoring the validity of tests and calibrations andauthorizing the reports,

• Appoint a Quality Manager responsible for implementing,operating and auditing the quality management system as wellas organization and scheduling of its reviews,

• Ensure that its management and personnel are free from anyundue internal and external pressures and influences that mayadversely affect the quality of their work.


Robert W. Góra



ISO 9000 standards






5.75

Quality System

• Quality control is simply a good laboratory practice. Anylaboratory takes precautions to secure the integrity of thedata it produces and has some kind of arrangements todetect the potential problems.

• On the other hand, the quality management system ismuch more orientated towards quality assurance. Theemphasis is on error prevention rather than on errordetection.

• Quality system must be documented and the laboratoryshould establish and maintain procedures to control alldocuments.


Robert W. Góra



ISO 9000 standards






5.76

Quality System Documentation

• The key element of QMS documentation is the qualitymanual including defined quality policies, qualityobjectives, responsibilities of technical management andquality manager, as well as the supporting procedures (orreferences to them) including technical procedures.

• Other documents that form QMS include: regulations,standards, normative documents, test or calibrationmethods, software, specifications, instructions andmanuals.

• It is not necessary for the laboratory to write up allmethods and operating procedures. As long as thestandard, adequately documented methods are used,and/or equipment operating instructions provided by themanufacturer, a copy is enough.


Robert W. Góra



ISO 9000 standards






5.77

Control of documents

• All documents issued to the personnel in the laboratory aspart of the QMS should be uniquely identified, reviewedand approved for use by the authorized personnel. Thisapplies also to any changes to documents.

• All documents should be periodically reviewed and, wherenecessary, revised. Obsolete documents should beremoved or otherwise assured against unintended use.


Robert W. Góra



ISO 9000 standards






5.78

Review of requests, tenders and contracts

• The laboratory should establish and maintain proceduresfor the review of requests, tenders and contracts. Theseshould ensure that:

• The requirements, including the methods to be used, areadequately defined, documented and understood,

• The appropriate test and/or calibration method is selectedand is capable of meeting the customers’ requirements.

• Records of reviews, including any significant changes,should be kept.

• The customer must be informed of any deviation from thecontract and any work that is subcontracted.


Robert W. Góra



ISO 9000 standards






5.79

Subcontracting of tests and calibrations

• The laboratory’s subcontractor must be competent (i.e.complying with ISO/IEC 17025 standard for the work inquestion).

• The laboratory is always responsible for the workperformed by subcontractor, unless the client insists on aparticular subcontractor.

• The laboratory must keep a list of approvedsub-contractors and a record of the evidence ofcompliance.


Robert W. Góra



ISO 9000 standards






5.80

Purchasing services and supplies

• The laboratory should have a policy and procedures forthe selection and purchasing of services and supplies ituses that affect the quality of the tests and/or calibrations

• The purchasing documents should be reviewed andapproved for the technical content prior to release.

• The laboratory should be able to demonstrate that itcontrols the quality of any input, service or supply whichcould impact the quality of the produced results.

• The laboratory should evaluate its suppliers and maintainrecords of these evaluations and list those approved.


Robert W. Góra



ISO 9000 standards






5.81

Service to the client

• Laboratories are encouraged to allow clients the access tomonitor the laboratory’s performance, provided thatconfidentiality of other clients is not compromised.

• The laboratory should seek feedback from its customers inorder to to improve the management system, testing andcalibration activities and customer service.

• Laboratories are required to have a policy and proceduresfor the resolution of customers’ complaints (records of allcomplaints, investigations and corrective actions takenmust be kept).


Robert W. Góra



ISO 9000 standards






5.82

Control of nonconforming testing and/or calibration work

• Laboratories should have a procedure for ensuring thatwork, or release of data, is stopped immediately whennonconforming work is identified.

• The responsibilities and authorities for the management ofnonconforming work must be designated.

• The laboratory should promptly evaluate the significanceof the nonconforming work, analyze the cause, takecorrection, and if necessary implement appropriatecorrective actions.


Robert W. Góra



ISO 9000 standards






5.83

Control of records

• The laboratory should establish and maintain procedures foridentification, collection, indexing, access, filing, storage,maintenance and disposal of quality and technical records.

• Quality records include reports from internal audits andmanagement reviews as well as records of corrective andpreventive actions.

• Technical records consist of observations, raw data, calculationsand derived data, individual equipment logs for each major itemof equipment, copies of all reports, staff records, and anysufficient information to establish an audit trail.

• Technical records should enable the test or calibration to berepeated under conditions as close as possible to the original.

• Observations, data and calculations should be recorded at thetime they are made and should be identifiable to the specifictask. When mistakes occur in records, each mistake should becrossed out, not erased.

• All records should be held secure and confidential. Thelaboratory should establish procedures to protect, back up andprevent an unauthorized access to or amendment of recordsstored electronically.


Robert W. Góra



ISO 9000 standards






5.84

Monitoring and maintenance of the quality system

ISO 17025 requires audit, review and monitoring of the QMS inorder to detect actual or potential non-conformities before theyimpact on the quality of the results.

Organization and planing of internal audits and managementreviews is the responsibility of the quality manager.

An audit allows management to determine if the quality systemas specified in the quality manual has been effectivelyimplemented.

A management review, on the other hand, allows thelaboratory top management to examine the performance of thequality system as a whole and to introduce necessary changesor improvements.


Robert W. Góra



ISO 9000 standards






5.85

Internal audits

• The laboratory should conduct internal audits of itsactivities on a planned and regular basis and according toa documented procedure, to verify that its operationscontinue to comply with the ISO/IEC 17025 QMSrequirements.

• The program of internal audits should address allelements of the management system, including the testingand/or calibration activities.

• Such audits should be carried out by trained and qualifiedpersonnel who are, if possible, independent of the activityto be audited.

• When audit findings cast doubt on the effectiveness of theoperations or on the correctness or validity of the results,the corrective actions should be taken. Theirimplementation and effectiveness should be verified infollow-up audit activities.

• The auditor must make a written report on every audit.Other documents can be appended if necessary.


Robert W. Góra



ISO 9000 standards






5.86

Management reviews

The laboratory top management should periodically conduct areview of the QMS and testing and/or calibration activities toensure their continuing suitability and effectiveness. The reviewshall take account of:

• suitability of policies and procedures,• reports from managerial and supervisory personnel,• the outcome of recent internal audits and corrective and

preventive actions,• assessments by external bodies;• the results of interlaboratory comparisons or proficiency

tests,• changes in the volume and type of the work,• customers’ feedback and complaints,• recommendations for improvement and other relevant

factors, such as quality control activities, resources andstaff training.


Robert W. Góra



ISO 9000 standards



Technical requirementsfor calibration andtesting laboratoriesPersonnel andEnvironmental Conditions

Test and CalibrationMethods

Equipment andMeasurement Traceability

Sampling and Handling ofTest and Calibration Items

Quality Assurance of testsand calibrations.

Reporting the results

6.87

Chapter 6Technical requirements foraccreditation of calibration andtesting laboratories




Robert W. Góra



ISO 9000 standards









6.88

Key factors determining correctness and reliability of theresults

ISO/IEC 17025 standard identifies the key factors thatdetermine the correctness and reliability of the tests and/orcalibrations performed by a laboratory. These include:

• technical competence of personnel,• accommodation and environmental conditions,• validation of the methods,• traceability of measurements,• calibration and maintenance of the test equipment,• sampling and handling of the test items.


Robert W. Góra



ISO 9000 standards









6.89

Personnel

• The laboratory management should ensure the competence ofall its personnel performing specific tasks. Competence of staffshould be reviewed and re-assessed on a regular basis.

• The laboratory should have a policy and procedures foridentifying training needs and providing training of personnel.The goals in this respect should be clearly formulated.

• The laboratory should use personnel who are employed by, orunder contract to, the laboratory and maintain current jobdescriptions for managerial, technical and key support personnelinvolved in tests and/or calibrations.

• Staff should be qualified on the basis of appropriate education,training, experience and/or demonstrated skills, as required.

• Personnel should be authorized to perform particular types ofsampling, test and/or calibration, to issue test reports andcalibration certificates, to give opinions and interpretations and tooperate particular types of equipment.

• When using staff who are undergoing training or are contracted,appropriate supervision must be provided.


Robert W. Góra



ISO 9000 standards









6.90

Accommodation and environmental conditions

• The laboratory should ensure that the environmentalconditions do not invalidate the results or adversely affectthe required quality of any measurement.

• The laboratory should monitor, control and recordenvironmental conditions as required by the relevantspecifications, methods and procedures or where theyinfluence the quality of the results.

• Depending on the technical activities concerned, dueattention should be paid, for instance, to:

• biological sterility,• dust,• electromagnetic disturbances and electrical supply,• radiation,• humidity and temperature,• sound and vibration levels.

• There must be effective separation between neighboringareas in which there are incompatible activities to preventcross-contamination.

• Access to areas affecting the quality of the tests and/orcalibrations must be restricted and controlled.


Robert W. Góra



ISO 9000 standards









6.91

Some Specific Considerations for Chemical andMicrobiological Testing26

In the case of chemical analysis, the cross contaminationbetween samples and possible environmental contamination ofsamples are likely to be the key concern – particularly for thesubstances which are being tested for at trace levels.

Although, it is quite common to monitor the temperature ofchemistry laboratories, this is rarely necessary. In practice, thevariations in modern borosilicate volumetric glassware over atemperature range in which personnel will be comfortable isnegligible relative to other sources of uncertainty ofmeasurements.

The only reason for monitoring the temperature is that data will beaffected if a specific range of temperature is not observed. Thismight be the case for some precision scientific instruments. Forinstance the ICP-MS environment must be free of dust, corrosivevapors and vibration, and maintained at a cool and stabletemperature (typically 18-23◦C with less than 2◦C drift per hour).

26Complying with ISO 17025. A practical guidebook. United NationsIndustrial Development Organization, Vienna, 2009.


Robert W. Góra



ISO 9000 standards









6.92


The following general rules should be observed for goodpractice in general chemical testing work:

• Only very diluted solutions of standards necessary for theequipment calibration should be ever introduced into areaswhere the samples are being handled and processed.

• Precautions should be taken to avoid spillage of standards.

• The preparations (and possibly testing) of samples containinghigh levels and low levels of the same targets should be carriedout in well separated rooms with their own glassware.

• Enforce good housekeeping and tidiness by generalmanagement pressure.



Robert W. Góra



ISO 9000 standards









6.93


In the case of microbiological laboratories, the potential spillageshould also be easily contained and thoroughly cleaned up.

Impervious bench tops with good seals against walls and floorand around fittings such as sinks are expected and floorsshould be continuous sealed surfaces.

Microbiology laboratories will often need to be air-conditionedwith split type units and all windows sealed to prevent opening.Entry to the laboratory should always be double doored with avestibule and changing/washing area.



Robert W. Góra



ISO 9000 standards









6.94


The laboratory must keep the reference cultures of organismsfor control purposes. The following precautions help to avoidcontamination:

• Clear segregation of samples, references and media storage.

• Segregated area for handling the references, ideally with alaminar flow cabinet.

• Dedicated laboratory coats and footwear with a changing areawhere staff can wash.

• A planned cleaning regime for the laboratory, covering benches,floors, windows, light fittings, ventilation grills, air conditioners,water baths and autoclaves.

• Documented procedures for dealing with spillages and records ofspillages and action taken.

• Monitoring temperature and humidity: limits need not bestringent but humidity above 50% and temperatures above 25◦Ccan lead to problems of mould growth.



Robert W. Góra



ISO 9000 standards









6.95

Test and calibration methods and method validation

Selection of Methods

• The laboratory should use appropriate test or calibrationmethods (including methods for sampling) which meet therequirements of the client and, where possible, methodspublished as national, regional or international standards,by reputable technical organizations or in relevantscientific texts or journals.

• If it is necessary to employ non-standard methods, theseshould be fully validated and documented to show thatthey are appropriate and fit for purpose. These must bealso agreed with the client.


Robert W. Góra



ISO 9000 standards









6.96

Laboratory-Developed and Non-Standard Methods

For new methods, procedures should be developed containingat least the following information:

• appropriate identification and scope,

• description of the type of item to be tested or calibrated,

• parameters or quantities and ranges to be determined,

• apparatus and equipment, including technical performancerequirements,

• reference standards and reference materials required,

• environmental conditions required and any stabilization periodneeded,

• description of the procedure, including preparation of items,calibration and adjustment of the equipment before the use andthe methods of recording the results,

• criteria and/or requirements for approval/rejection, data to berecorded and the method of analysis and presentation,

• the uncertainty or the procedure for estimating uncertainty.


Robert W. Góra



ISO 9000 standards









6.97

Validation of methods

• Validation is the confirmation by examination and theprovision of objective evidence that the particularrequirements for a specific intended use are fulfilled.

• In order to confirm that the methods are fit for the intendeduse, the laboratory must validate:

• non-standard methods,• laboratory-designed/developed methods,• standard methods used outside their intended scope, and

amplifications and modifications of standard methods

• Although it is not necessary for the laboratory to validatestandard methods used within their intended scope, thelaboratory must confirm that it can properly operatestandard methods before introducing the tests orcalibrations. If the standard method changes, theconfirmation should be repeated.


Robert W. Góra



ISO 9000 standards









6.98

Validation of methods

• The validation should be as extensive as it is necessary tomeet the intended requirements. Generally it shoulddemonstrate:

• the scope of applicability in terms of samples and numericalrange,

• selectivity,• robustness in use,• accuracy, precision and bias,• linearity, detection limit (LOD), and limit of quantitation

(LOQ)• limit of repeatability and/or reproducibility,• the expanded uncertainty for a specified level of confidence.

• The laboratory should record the results and theprocedure used for the validation, and a statement as towhether the method is fit for the intended use.


Robert W. Góra



ISO 9000 standards









6.99

Estimation of measurement uncertainty

• Calibration and testing laboratories should have and applyprocedures for estimating uncertainty of measurements.

• However, in certain cases the nature of the test method maypreclude rigorous, metrologically and statistically valid,calculation of measurement uncertainty. In these cases thetesting laboratory should at least attempt to identify all thecomponents of uncertainty and make a reasonable estimation.

• When estimating the uncertainty of measurement, all uncertaintycomponents which are of importance in a given situation shouldbe taken into account using appropriate methods of analysis.

The Guide to the Expression of Uncertainty in Measurement(GUM)30 is recognized by EA as the master document onmeasurement uncertainty.31.

30Guide to the Expression of Uncertainty in Measurement. BIPM, IEC, IFCC,ISO, IUPAC, IUPAP, OIML. International Organization for Standardization,1995.

31EA-4/16 (rev.00), EA Guidelines on the Expression of Uncertainty inQuantitative testing. European co-operation for Accreditation, 2003.


Robert W. Góra



ISO 9000 standards









6.100

Control of Technical Records . . . Again

• All calculations and data transfers in the laboratory must besubject to appropriate checks in a systematic manner.

• Any in-house software for acquisition and processing of data(including spreadsheets) must be documented and validated forthe intended use.

• Procedures for protecting the data should be established andimplemented.


Robert W. Góra



ISO 9000 standards









6.101

Equipment

ISO 17025 requires a complete history of each piece of equipment,understood to encompass any items which may affect the validity ofmeasurements or calibrations. This includes the detailed records ofthe following activities required by this standard:

• Checks and calibrations carried out before the equipment is placed inservice and its unique identification.

• Checks carried out to maintain confidence in the calibration status of theequipment, according to a defined procedure.

• Authorization of personnel and provision of any relevant instructions andmanuals which should be readily available for use.

• Documentation and implementation of the procedures for handling, useand maintenance of the measuring equipment.

• Service of the equipment that has been shown to be defective or outsidethe specified limits and analysis of the potential influence on previoustests and/or calibrations (control of nonconforming work).

• Indication of the status of calibration.

• The equipment should be under permanent control of the laboratory.When, for whatever reason, it goes outside its direct control it must bechecked and shown to be satisfactory before it is returned to service.


Robert W. Góra



ISO 9000 standards









6.102

Equipment records

ISO 17025 specifically requires maintenance of the following recordsfor each item of the equipment and its software:

• the identity of the item of equipment and its software,

• the manufacturer’s name, type identification, and serial numberor other unique identification,

• checks that the equipment complies with the specification,

• the current location, where appropriate,

• the manufacturer’s instructions, if available, or reference to theirlocation,

• dates, results and copies of the reports and certificates of allcalibrations, adjustments, acceptance criteria, and the due dateof the next calibration,

• the maintenance plan, where appropriate, and maintenancecarried out to date,

• any damage, malfunction, modification or repair to theequipment.


Robert W. Góra



ISO 9000 standards









6.103

Metrological Traceability

“Metrological traceability is property of ameasurement result whereby the result can be relatedto a reference through a documented unbroken chainof calibrations, each contributing to the measurementuncertainty.”a

aVIM, International vocabulary of metrology — Basic and general conceptsand associated terms. Joint Committee for Guides in Metrology (JCGM).

Measurement traceability in Testing and Calibration Laboratories

Laboratories are required to implement a calibration systemwhich ensures that the results of any tests or calibrationsperformed are comparable with those of any other laboratory.

The key element of such a system is the metrologicaltraceability of any measurement through an unbroken chain ofcomparisons to a recognized international standard for themeasurand in question which, wherever possible, is required tobe the corresponding SI unit of measurement.


Robert W. Góra



ISO 9000 standards









6.104

Calibration Hierarchy.

There is an established calibration hierarchy.32

At the international level, decisions concerning the InternationalSystem of Units (SI) and the realization of the primary standards aretaken by the Conférence Générale des Poids et Mesures (CGPM).The Bureau International des Poids et Mesures (BIPM) is in charge ofcoordinating the development and maintenance of primary standardsand organizes intercomparisons on the highest level.

The National Metrology Institutes (NMI) are the highest authorities inmetrology in almost all countries (in Poland GUM). In most cases theymaintain the national standards of the country which are the sourcesof traceability for the associated physical quantity in that country.

The Accredited Calibration Laboratories provide calibration servicesaccording to their scope of accreditation, identifying the specifiedmeasurands and their best measurement capability i.e. the smallestuncertainties that can be achieved with the suitable measuringdevices. Their reference standards are compared, at appropriateintervals, with reference standards of NMI.

32EA-4/07 (rev.01), Traceability of Measuring and Test Equipment to NationalStandards. European co-operation for Accreditation, 1995.


Robert W. Góra



ISO 9000 standards









6.105

Calibration Hierarchy.

According to EA 4/07

Figure 8: The figure illustrates how an in-house calibration system (right hand side of the diagram) may interact with theexisting metrological infrastructure (left hand side of the diagram).


Robert W. Góra



ISO 9000 standards









6.106

Measurement Traceability

• All the equipment used for tests and/or calibrations, havinga significant effect on the accuracy or validity of the testresult, calibration or sampling should be calibrated beforebeing put into service according to an established programand procedure.

• The established program for calibration of the equipmentmust ensure traceability of measurements made by thelaboratory to the International System of Units (SI).

• There are certain calibrations that currently cannot bestrictly made in SI units. In these cases the traceability toappropriate measurement standards should bedetermined by the use of certified reference materials(CRM), agreed methods and/or consensus standards. .

• For testing laboratories, there is no need for calibration ofthe equipment if the associated contribution to the totaluncertainty of the test result is small.


Robert W. Góra



ISO 9000 standards









6.107

Reference Standards and Reference Materials

• The laboratory should have a program and procedure forthe calibration of its reference standards which should beused for calibration only.

• Reference materials should, where possible, be traceableto SI units of measurement, or to certified referencematerials.

• Checks needed to maintain confidence in the calibrationstatus of reference, primary, transfer or working standardsand reference materials should be carried out according todefined procedures and schedules.

• The laboratory should have procedures for safe handling,transport, storage and use of reference standards andreference materials in order to prevent contamination ordeterioration and in order to protect their integrity.


Robert W. Góra



ISO 9000 standards









6.108

Sampling

• When the laboratory carries out sampling of substances,materials or products for subsequent testing, it shouldestablish a sampling plan and procedures. Sampling plansshould, whenever reasonable, be based on appropriatestatistical methods.

• Any deviations, additions or exclusions from thedocumented sampling procedures, must be recorded,included in all documents containing test and/or calibrationresults, and communicated to the appropriate personnel.

• The laboratory should have procedures for recordingrelevant data and operations relating to sampling thatforms a part of the testing or calibration that is undertaken.


Robert W. Góra



ISO 9000 standards









6.109

Handling of test and calibration items

• The laboratory should have procedures for thetransportation, receipt and handling of the test and/orcalibration items.

• The laboratory should develop and implement a system forunique identification of the test and/or calibration items.This identification should be retained throughout the life ofthe item in the laboratory. The system should ensure thatthe items cannot be confused physically or when referredto in records or other documents. Upon receipt of the testor calibration item should be examined for abnormalities ordepartures from normal or specified conditions.

• The laboratory should establish and implementprocedures and have appropriate facilities for avoidingdeterioration, loss or damage to the test or calibration itemduring storage, handling and preparation.


Robert W. Góra



ISO 9000 standards









6.110

Assuring the quality of test and calibration results

• The laboratory should implement quality controlprocedures for monitoring the validity of tests andcalibrations undertaken. This monitoring should beplanned and regularly reviewed.

• The resulting data shall be recorded in such a way thattrends are detectable and, where practicable, statisticaltechniques should be applied to the reviewing of theresults.

• Quality control data should be analyzed and, where theyare found to be outside predefined criteria, a plannedaction should be taken to correct the problem and toprevent incorrect results from being reported.


Robert W. Góra



ISO 9000 standards









6.111

Quality Control Tools

The following techniques can be applied for continuousmonitoring of the validity of tests and calibrations.

• Regular use of certified reference materials and/or internalquality control using secondary reference materials.

• Participation in interlaboratory comparisons (ILC) orproficiency-testing (PT) programs.

• Replication of tests or calibrations using the same ordifferent methods.

• Retesting or recalibration of retained items.• Correlation of results for different characteristics of an

item.


Robert W. Góra



ISO 9000 standards









6.112

General Reporting Requirements

ISO 17025 is very specific about the information that shouldappear in reports. The general requirement and intention isthat the data should be reported accurately, clearly,unambiguously and objectively.

The results should be reported, usually as a “Test Report” or a“Calibration Certificate” and should include all the informationrequested by the customer or required by the method used,and necessary for the interpretation of the results.

The results may be reported in a simplified way, if tests orcalibrations are performed for the internal customers or if thereare written agreements with the client.


Robert W. Góra



ISO 9000 standards









6.113

Test Reports and Calibration Certificates

Each test report or calibration certificate should include thefollowing information:

• a title (e.g., “Test Report” or “Calibration Certificate”),• the name and address of the laboratory and

testing/calibration facilities if different from the address ofthe laboratory,

• unique identification of the test report or calibrationcertificate (such as the serial number), including anidentification on each page of the report and its end,

• the name and address of the customer,• identification of the method used,• a description of, the condition and unique identification of

the item(s) tested or calibrated,• the date of receipt and the date(s) of performance of the

test or calibration,


Robert W. Góra



ISO 9000 standards









6.114

Test Reports and Calibration Certificates

Each test report or calibration certificate should include thefollowing information:

• reference to the sampling plan and procedures used, ifthese are relevant to the validity or application of theresults,

• the test or calibration results with, where appropriate, theunits of measurement and its uncertainty,

• the name(s), function(s) and signature(s) or equivalentidentification of person(s) authorizing the test report orcalibration certificate,

• where relevant, a statement to the effect that the resultsrelate only to the items tested or calibrated.

Results of the tests performed by the subcontractors should beclearly identified and in the case of calibrations thesubcontracted laboratory should issue the calibrationcertificate.

Material amendments to a test report or calibration certificateafter its issuing should be made only in the form of a separatedocument.


Robert W. Góra



ISO 9000 standards









6.115

Additional requirements for Test Reports

Test reports should, when necessary for the interpretation ofthe results, include the following:

• Any deviations from the test method, and information onspecific test conditions, such as environmental conditions,

• where relevant, a statement ofcompliance/non-compliance with requirements and/orspecifications,

• a statement on the estimated uncertainty of measurement,if it is relevant to the validity or application of the testresults, if it is requested by a customer, or when theuncertainty affects compliance with a specification limit,

• opinions and interpretations where appropriate andneeded (these should be clearly marked as such in a testreport, and their basis should be documented).


Robert W. Góra



ISO 9000 standards









6.116

Additional Requirements for Reports Containing the Results ofSampling

Test reports containing the results of sampling should includethe following, when necessary for the interpretation of testresults:

• the date of sampling,• unambiguous identification of the substance, material or

product sampled (including the name of the manufacturer,the model or type of designation and serial numbers asappropriate),

• the location of sampling, including any diagrams, sketchesor photographs,

• a reference to the sampling plan and procedures used,• details of any environmental conditions during sampling

that may affect the interpretation of the test results,• any standard or other specification for the sampling

method or procedure, and deviations from thespecification concerned.


Robert W. Góra



ISO 9000 standards









6.117

Additional Requirements for Calibration Certificates

Calibration certificates should include the following, whennecessary for the interpretation of calibration results:

• the conditions (e.g., environmental) under which thecalibrations were made that have an influence on themeasurement results,

• the uncertainty of measurement and/or a statement ofcompliance with an identified metrological specification

• evidence that the measurements are traceable,• if an instrument for calibration has been adjusted or

repaired, the calibration results before and after theadjustment or repair,

A calibration certificate should not contain anyrecommendations on the calibration interval except where thishas been agreed with the customer.

Quality management systems - Politechnika Wrocł · PDF fileQuality management systems Robert...

Documents

Transcript of Quality management systems - Politechnika Wrocł · PDF fileQuality management systems Robert...