ISO 9000

Quality Management System

Evsevios Hadjicostas

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

Definitions

ƒ The laboratory product

ƒ The laboratory process
ƒ The laboratory customer
ƒ The satisfaction
ƒ The improvement

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

1
 The Process Approach
Controls

Inputs Process Outputs

Resources

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

Model of a Process-based Quality Management System

Continual
Continualimprovement
improvementof
ofthe
thequality
qualitymanagement
managementsystem
system

Interested
Interested Interested
Interested
parties
parties Management
parties
parties
Management
Responsibility
Responsibility

Measurement
Measurement
Resource
Resource Analysis
Analysisand
and
Management
Management Improvement
Improvement

Requirements Product
Product Satisfaction
Requirements Product
Product Satisfaction
Input Realization
Realization
Output

Value-adding activities Information flow from ISO 9004:2000

3

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

2
 4 Quality Management System

ƒ 4.1 General requirements

ƒ 4.2 Documentation requirements
ƒ 4.2.1 General
ƒ 4.2.2 Quality manual
ƒ 4.2.3 Control of documents
ƒ 4.2.4 Control of records

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

4 QUALITY MANAGEMENT SYSTEM

4.1 General Requirements
ƒ Quality management system (QMS)
ƒ Continual improvement
ƒ Sequence and interaction of processes
ƒ Effective operation and control of processes
ƒ Availability of resources and information
ƒ Monitor, measure and analyze processes
ƒ Achieve planned results
ƒ Improve processes
ƒ Outsourcing of processes
5

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

3
 4 QUALITY MANAGEMENT SYSTEM
4.2 Documentation Requirements
4.2.1 General
ƒ Quality policy
ƒ Quality objectives
ƒ Quality manual
ƒ Procedures
ƒ Work instructions
ƒ Records
6

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

4 QUALITY MANAGEMENT SYSTEM

4.2 Documentation Requirements
4.2.2 Quality manual
ƒ The laboratory quality manual shall
include:
ƒ The scope of the quality management
system
ƒ Links to the laboratory procedures
ƒ Interactions between the processes of the
QMS
7

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

4
 4 QUALITY MANAGEMENT SYSTEM
4.2 Documentation Requirements
4.2.3 Control of documents
ƒ Approval of documents
ƒ Review, update and re-approval of documents
ƒ Identification of changes and current revisions
ƒ Availability of documents at points of use
ƒ Documents to be legible and readily
identifiable
ƒ Control of external documents
ƒ Control of obsolete documents
ƒ Archives
8

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

4 QUALITY MANAGEMENT SYSTEM

4.2 Documentation Requirements
4.2.4 Control of records
ƒ Objective evidence of conformity to
requirements
ƒ Legible, readily identifiable, retrievable
ƒ Documented procedure for the
identification, storage, protection,
retrieval, retention time and disposition
of records
9

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

5
 5 Management Responsibility
ƒ 5.1 Management ƒ 5.5 Responsibility, authority
commitment and communication
ƒ 5.2 Customer focus ƒ 5.5.1 Responsibility and
authority
ƒ 5.3 Quality policy
ƒ 5.5.2 Management
ƒ 5.4 Planning representative
ƒ 5.4.1 Quality objectives ƒ 5.5.3 Internal communication
ƒ 5.4.2 Quality ƒ 5.6 Management review
management system
ƒ 5.6.1 General
planning
ƒ 5.6.2 Review input
ƒ 5.6.3 Review output

10

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

5 MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
ƒ Addressing customer requirements
ƒ Establishing the quality policy
ƒ Ensuring that quality objectives are
established
ƒ Conducting management reviews
ƒ Ensuring the availability of resources

11

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

6
 5 MANAGEMENT RESPONSIBILITY
5.2 Customer Focus
ƒ Satisfaction of the needs and
expectation of the current and future
customers
ƒ Internal and external customers
ƒ The interested parties

12

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

5 MANAGEMENT RESPONSIBILITY
5.3 Quality Policy
ƒ Appropriate to the purpose of the laboratory
ƒ Commitment to compliance with requirements
ƒ How quality objectives are established and
reviewed
ƒ Communicated and understood within the
laboratory
ƒ Reviewed for continuing suitability

13

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

7
 5 MANAGEMENT RESPONSIBILITY
5.4 Planning
5.4.1 Quality objectives
ƒ The quality objectives of the various
functions and levels within the
laboratory shall be established and be
consistent with the quality policy and the
laboratory strategy

14

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

5 MANAGEMENT RESPONSIBILITY
5.4 Planning
5.4.2 Quality management system planning
ƒ Meet the general requirements for the
quality management system (4.1)
ƒ Management of change

15

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

8
 5 MANAGEMENT RESPONSIBILITY
5.5 Responsibility, Authority and
Communication
5.5.1 Responsibility and authority
ƒ Responsibilities and authorities of
laboratory personnel should be
defined and communicated within
the laboratory

16

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

5 MANAGEMENT RESPONSIBILITY
5.5 Responsibility, Authority and
Communication
5.5.2 Management representative
ƒ Member of the organization
ƒ Ensures the proper operation of the quality
management system
ƒ Reports to the top management
ƒ Promotes the awareness of customer
requirements throughout the organization

17

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

9
 5 MANAGEMENT RESPONSIBILITY
5.5 Responsibility, Authority and
Communication
5.5.3 Internal communication
ƒ Communication channels within the
laboratory
ƒ Communication as the stimulus for an
effective QMS

18

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

5 MANAGEMENT RESPONSIBILITY
5.6 Management Review
5.6.1 General
ƒ Review of the system at planned
intervals
ƒ Assessment of opportunities for
improvement
ƒ Needs for changes
ƒ Records of management reviews
19

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

10
 5 MANAGEMENT RESPONSIBILITY
5.6 Management Review
5.6.2 Review input
ƒ Results of audit and self-assessment
ƒ Feedback from customer and from
benchmarking activities
ƒ Performance of the laboratory activity
ƒ Any recommendations for improvement
(corrective and preventive actions,
suggestions from laboratory personnel)
20

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

5 MANAGEMENT RESPONSIBILITY
5.6 Management Review
5.6.3 Review output
ƒ Decisions and actions resulted from the
management review meetings that will
improve the effectiveness of the system
and the quality of the laboratory product

21

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

11
 6 Resource Management

ƒ 6.1 Provision of resources

ƒ 6.2 Human resources
ƒ 6.2.1 General
ƒ 6.2.2 Competence, awareness and training
ƒ 6.3 Infrastructure
ƒ 6.4 Work environment

22

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

6 RESOURCE MANAGEMENT
6.1 Provision of Resources
ƒ Provision of the resources needed for:
ƒ The implementation and maintenance of
the QMS
ƒ Realization of customer satisfaction

23

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

12
 6 RESOURCE MANAGEMENT
6.2 Human Resources
6.2.1 General
ƒ Appropriate education, training, skills
and experience of the laboratory
personnel

24

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

6 RESOURCE MANAGEMENT
6.2 Human Resources
6.2.2 Competence, awareness and training
ƒ Determination of necessary competence of
the laboratory personnel
ƒ Provision of training
ƒ Evaluation of the effectiveness of the action
taken
ƒ Awareness of personnel of the relevance and
importance of their activities
ƒ Maintenance of training records
25

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

13
 6 RESOURCE MANAGEMENT
6.3 Infrastructure
ƒ Building and workspace
ƒ Process equipment
ƒ Supporting services (transportation,
communication)
ƒ Information systems

26

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

6 RESOURCE MANAGEMENT
6.4 Work Environment
ƒ The work environment in the laboratory
shall be determined and managed in a
way to encourage people in achieving
conformity to product requirements

27

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

14
 7 Product Realization
ƒ 7.1 Planning of ƒ 7.3 Design and development
product realization ƒ 7.3.1 Design and development
ƒ 7.2 Customer- planning
related processes ƒ 7.3.2 Design and development inputs
ƒ 7.2.1 Determination ƒ 7.3.3 Design and development output
of requirements ƒ 7.3.4 Design and development review
related to product ƒ 7.3.5 Design and development
ƒ 7.2.2 Review of verification
requirements related ƒ 7.3.6 Design and development
to product validation
ƒ 7.2.3 Customer ƒ 7.3.7 Control of design and
communication development changes

28

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

7 Product Realization
ƒ 7.4 Purchasing ƒ 7.5.2 Validation of
ƒ 7.4.1 Purchasing processes for production
processes and service provisions
ƒ 7.4.2 Purchasing ƒ 7.5.3 Identification and
information traceability
ƒ 7.4.3 Verification of ƒ 7.5.4 Customer property
purchased products
ƒ 7.5.5 Preservation of
ƒ 7.5 Product and service product
provision
ƒ 7.6 Control of
ƒ 7.5.1 Control of
production and service monitoring and
provisions measuring devices
29

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

15
 7 PRODUCT REALIZATION
7.1 Planning of Product Realization
ƒ Quality objectives and product specification
ƒ Establishment of processes and documents
and provision of resources specific to the
product
ƒ Verification, validation, monitoring, inspection,
and test activities specific to the product and
ƒ Criteria for product acceptance
ƒ Records
30

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

7 PRODUCT REALIZATION
7.2 Customer Related Processes
7.2.1 Determination of requirements related
to the product
ƒ Requirements specified by the customer
ƒ Requirements necessary for specified or
intended use
ƒ Statutory and regulatory requirements
ƒ Requirements determined by the
organization
31

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

16
 7 PRODUCT REALIZATION
7.2 Customer Related Processes
7.2.2 Review of requirements related to the
product
ƒ Definition of product requirements
ƒ Resolution of contract or order requirements
ƒ Ability to meet the defined requirements
ƒ Records of the results of the review and action
ƒ Confirmation of customer requirements and
re-confirmation in case of changes
ƒ Awareness of relevant personnel
32

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

7 PRODUCT REALIZATION
7.2 Customer Related Processes
7.2.3 Customer communication
ƒ The laboratory shall communicate
with its customers to get
information on the laboratory
products and feedback from
customers including customer
complaints
33

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

17
 7 PRODUCT REALIZATION
7.3 Design and Development
7.3.1 Design and development (D&D)
planning
ƒ Design and development stages
ƒ Review, verification and validation
ƒ Responsibilities and authorities
ƒ Effective communication between D&D
groups
ƒ Update of planning output
34

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

7 PRODUCT REALIZATION
7.3 Design and Development
7.3.2 Design and development inputs
ƒ Functional and performance
requirements
ƒ Statutory and regulatory requirements
ƒ Information from similar design
ƒ Other relevant information

35

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

18
 7 PRODUCT REALIZATION
7.3 Design and Development
7.3.3 Design and development output
ƒ Meeting the input requirements
ƒ Providing information for purchasing,
production and servicing
ƒ Defining acceptance criteria
ƒ Providing parameters for the safe and
proper use of the product
36

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

7 PRODUCT REALIZATION
7.3 Design and Development
7.3.4 Design and development review
ƒ Systematic reviews at suitable stages
ƒ Evaluation of D&D results
ƒ Identification of problems
ƒ Proposal of necessary action

37

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

19
 7 PRODUCT REALIZATION
7.3 Design and Development
ƒ 7.3.5 Design and development
verification
ƒ 7.3.6 Design and development
validation
ƒ 7.3.7 Control of design and
development changes

38

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

7 PRODUCT REALIZATION
7.4 Purchasing
7.4.1 Purchasing process
ƒ Definition of purchase requirements
ƒ Conformance of purchased product to
purchase requirements
ƒ Control to the supplier and the purchased
product
ƒ Criteria for selection, evaluation and re-
evaluation of suppliers
ƒ Evaluation results to be recorded
39

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

20
 7 PRODUCT REALIZATION
7.4 Purchasing
7.4.2 Purchasing information
ƒ Definition of the characteristics of the product
to be purchased
ƒ What is required for the approval of the
purchased product, procedures, processes
and equipment?
ƒ What are the necessary qualifications of
personnel?
ƒ What are the QMS requirements? 40

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

7 PRODUCT REALIZATION
7.4 Purchasing
7.4.3 Verification of purchased product
ƒ Inspection of purchased material
ƒ Purchased product to meet specified
purchase requirements
ƒ Verification at the supplier’s premises
ƒ Define verification arrangements
ƒ Define method of product release
41

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

21
 7 PRODUCT REALIZATION
7.5 Production and Service Provision
7.5.1 Control of production and service
provision
ƒ Production and service provision under
controlled conditions such as
ƒ Availability of information relevant to
the characteristics of the products
ƒ Availability of work instructions
ƒ …
42

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

7 PRODUCT REALIZATION
7.5 Production and Service Provision
7.5.1 Control of production and service
provision (contd.)
ƒ Availability of suitable equipment
ƒ Availability and use of monitoring and
measuring devices
ƒ Monitoring and measurement
ƒ Release, delivery and post-delivery
activities
43

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

22
 7 PRODUCT REALIZATION
7.5 Production and Service Provision
7.5.2 Validation of processes for production and
service provision
ƒ Ability of processes to achieve planned
results
ƒ Verification of processes by monitoring
or measurement of the resulting output
ƒ Validation of processes for production
and service provision
ƒ … 44

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

7 PRODUCT REALIZATION
7.5 Production and Service Provision
7.5.2 Validation of processes for production and service
provision (contd.)
ƒ Arrangements for processes for production
and service provision
ƒ Criteria for review and approval of the processes
ƒ Approval of equipment and qualification of
personnel
ƒ Use of specific methods and procedures
ƒ Requirements for records
ƒ Re-validation
45

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

23
 7 PRODUCT REALIZATION
7.5 Production and Service Provision

7.5.3 Identification and traceability

ƒ Identification of the laboratory
product (i.e. the laboratory results)
ƒ Status of the laboratory product
ƒ Traceability of laboratory results
back to the raw data
46

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

7 PRODUCT REALIZATION
7.5 Production and Service Provision
7.5.4 Customer property
ƒ Protection of the customer’s property that is
under the control or is being used by the
laboratory
ƒ Customers to be informed if their product is
damaged or unsuitable
ƒ Records of any damaged or unsuitable
property
ƒ Intellectual property 47

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

24
 7 PRODUCT REALIZATION
7.5 Production and Service Provision
7.5.5 Preservation of product
ƒ Processes for handling, packaging,
storage, preservation and delivery of
product
ƒ Prevention of damage, deterioration or
misuse
ƒ Involvement of suppliers to effective
protection of purchased materials
48

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

7 PRODUCT REALIZATION
7.6 Control of Measuring and
Monitoring Devices

ƒ Determination of the necessary

monitoring and measurements
ƒ Processes to ensure that this activity is
carried out
ƒ Determination of the necessary
monitoring and measurement devices
…
49

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

25
 7 PRODUCT REALIZATION
7.6 Control of Measuring and
Monitoring Devices
ƒ Calibration or verification of devices
ƒ Adjustment of devices
ƒ Identification of calibration status
ƒ Protection from damage and deterioration
ƒ Assessment of the validity of previous results
ƒ Appropriate action to affected product or
equipment
ƒ Calibration records
50

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

8 Measurement, Analysis and

Improvement
ƒ 8.1 General ƒ 8.3 Control of non-
ƒ 8.2 Monitoring and conforming product
measurement ƒ 8.4 Analysis of data
ƒ 8.2.1 Customer ƒ 8.5 Improvement
satisfaction
ƒ 8.5.1 Continual
ƒ 8.2.2 Internal audit improvement
ƒ 8.2.3 Monitoring and ƒ 8.5.2 Corrective action
measurement of
ƒ 8.5.3 Preventive action
processes
ƒ 8.2.4 Monitoring and
measurement of product
51

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

26
 8 MEASUREMENT, ANALYSIS AND
IMPROVEMENT
8.1 General

ƒ Implementation of processes for

monitoring, measurement, analysis and
improvement of the laboratory activity
and the continual improvement of the
effectiveness of the Quality
Management System

52

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

8 MEASUREMENT, ANALYSIS AND

IMPROVEMENT
8.2 Monitoring and Measurement
8.2.1 Customer satisfaction
ƒ Meeting customer requirements
ƒ Processes to collect, analyze and use of
customer-related information
ƒ Customer surveys
ƒ Measurement of customer satisfaction
ƒ Customer complaints
53

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

27
 8 MEASUREMENT, ANALYSIS AND
IMPROVEMENT
8.2 Monitoring and Measurement
8.2.2 Internal audit
ƒ Internal Audit at planned intervals
ƒ System conformance to planned
arrangements and to the QMS
ƒ Effective implementation and
maintenance of the system
54

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

8 MEASUREMENT, ANALYSIS AND

IMPROVEMENT
8.2 Monitoring and Measurement
8.2.2 Internal audit
ƒ Audit program
ƒ Status and importance of processes
ƒ Areas to be audited
ƒ Results of previous audit
ƒ Selection of auditors
ƒ Objectivity and impartiality
ƒ Not to audit their own work
55

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

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 8 MEASUREMENT, ANALYSIS AND
IMPROVEMENT
8.2 Monitoring and Measurement
8.2.2 Internal audit
ƒ Internal audit procedure
ƒ Elimination of non conformities and
their causes
ƒ Follow up activities

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Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

8 MEASUREMENT, ANALYSIS AND

IMPROVEMENT
8.2 Monitoring and Measurement
8.2.3 Monitoring and measurement
of processes
ƒ Ability of processes to achieve
planned results
ƒ Evaluation of process performance

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Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

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 8 MEASUREMENT, ANALYSIS AND
IMPROVEMENT
8.2 Monitoring and Measurement
8.2.4 Monitoring and measurement of
product
ƒ Ability of product to satisfy the purpose
ƒ Conformity to the acceptance criteria
ƒ Qualified persons to release products

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Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

8 MEASUREMENT, ANALYSIS AND

IMPROVEMENT
8.3 Control of non-conforming products
ƒ Identification of non-conforming products
ƒ Procedure for non-conforming products
ƒ Elimination of non-conformity
ƒ Release under concession by a relevant
authority or by the customer
ƒ Records for non-conformities and concession
ƒ Re-verification of corrected products
ƒ Completion of planned arrangements before
release
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Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

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 8 MEASUREMENT, ANALYSIS AND
IMPROVEMENT
8.4 Analysis of Data
ƒ Analysis of data
ƒ Suitability and effectiveness of the QMS
ƒ Continual improvement
ƒ Customer satisfaction
ƒ Conformity to product requirements
ƒ Trends of processes
ƒ Opportunities for preventive action
ƒ Performance of suppliers
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Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

8 MEASUREMENT, ANALYSIS AND

IMPROVEMENT
8.5 Improvement
8.5.1 Continual improvement
ƒ Improvement of the effectiveness of the
QMS through the use of the quality policy,
quality objectives, audit results, analysis of
data, corrective and preventive action and
management review
ƒ Small-step improvements
ƒ Strategic breakthrough improvements
ƒ Process for the identification and
management of improvement activities 61

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

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 8 MEASUREMENT, ANALYSIS AND
IMPROVEMENT
8.5 Improvement
8.5.2 Corrective action
ƒ Elimination of causes of non-conformity
ƒ Prevention of recurrence
ƒ Documented procedure
ƒ Review of non-conformities and customer
complaints
ƒ Causes of non-conformities
ƒ Need for action
ƒ Records of the results of action taken
ƒ Reviewing the effectiveness of the corrective
action taken 62

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

8 MEASUREMENT, ANALYSIS AND

IMPROVEMENT
8.5 Improvement
8.5.3 Preventive action
ƒ Elimination of causes of potential non-conformity
ƒ Prevention of occurrences
ƒ Documented procedure
ƒ Determination of potential non-conformities and
their causes
ƒ Evaluation of the need for action
ƒ Implementation of action
ƒ Records of the results of action taken
ƒ Reviewing the effectiveness of the preventive
action taken 63

Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

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 Summary
ƒ ISO 9000 basic requirements
ƒ Quality management system
ƒ Management responsibility
ƒ Resource management
ƒ Product realization
ƒ Measurement, analysis and improvement
ƒ The process approach
ƒ Documented quality management system
ƒ Objective evidence of the conformance of the
laboratory activities to the requirements
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Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

Where to Get More Information

ƒ Quality Management Systems –

Requirements
ISO 9001:2008
ƒ Quality Management Systems -
Guidelines for performance
improvements
ISO 9004:2000
ƒ http://www.iso.org
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Hadjicostas, E. : ISO 9000 Quality Management System © Springer-Verlag, Berlin Heidelberg 2010
In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching (2nd ed.)

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