Preface

v

Introduction

ix

1.0

Organization

1

1.0

Organization

1

1.1

Executive Management

1

1.2

Laboratory Director Qualifications and Responsibilities

2

1.3

Laboratory Supervisor Qualifications and Responsibilities

2

1.4

Staffing Changes

2

2.0

Resources

3

2.0

Resources

3

2.1

Human Resources

3

3.0

Equipment

5

3.0

Equipment

5

3.1

Selection of Equipment

5

3.2

Qualification of Equipment

5

3.3

Unique Identification of Equipment

5

3.4

Control of Equipment

5

3.5

Computer Systems

6

4.0

Supplier and Customer Issues

8

4.0

Supplier and Customer Issues

8

4.1

Supplier Qualification

8

4.2

Agreements

8

4.3

Incoming Receipt, Inspection, and Testing

9

4.4

Promotional Materials

9

5.0

Process Control

10

5.0

Process Control

10

5.1

General Elements

10

5.2

Sample Collection

14

5.3

Testing and Results

17

5.4

Specific Testing Methods

20

5.5

Calculations

22

6.0

Documents and Records

24

6.0

Documents and Records

24

6.1

Documents

24

6.2

Records

25

6.3

Relationship Test Reports

26

6.2.1A

Retention of Records

28

6.3A

Requirements for Test Reports

32

7.0

Deviations and Nonconforming Products and Services

34

7.0

Deviations and Nonconforming Products and Services

34

7.1

Nonconforming Materials, Samples, and Services

34

7.2

Nonconforming Proficiency Test Results

34

7.3

Nonconforming Competency Assessments

35

8.0

Assessments: Internal and External

36

8.0

Assessments: Internal and External

36

8.1

Management of Assessment Results

36

9.0

Process Improvement through Corrective and Preventive Action

37

9.0

Process Improvement through Corrective and Preventive Action

37

9.1

Corrective Action

37

9.2

Preventive Action

38

9.3

Quality Monitoring

38

10.0

Facilities, Work Environment, And Safety

39

10.0

Facilities and Safety

39

10.1

Facilities and Work Environment

39

10.2

Health and Safety

40

10.3

Environmental Monitoring

40

10.4

Emergency Management

40

Glossary

41

“Crosswalk” between the 8th and 9th Editions of Standards for Relationship Testing Laboratories

49

Index

53