FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.5.1

Revision #: 02

Revision Date:

06/06/2019

Title: 

Equipment Records Page 1 of 6

For the most current and official copy, check QMiS.

Sections in This Document

1. Purpose ....................................................................................................................................1

2. Scope .......................................................................................................................................1

3. Responsibility............................................................................................................................2

4. Background...............................................................................................................................2

5. References ...............................................................................................................................2

6. Procedure .................................................................................................................................2

6.1. Overview ........................................................................................................................2

6.2. Logbook Sections...........................................................................................................3

6.2.1. The following information may be included:.....................................................3

6.2.2. Operating Instructions......................................................................................3

6.2.3. Calibration and Verification ..............................................................................3

6.3. Maintenance...................................................................................................................4

6.4. Repair.............................................................................................................................5

6.5. Non-Conformances........................................................................................................5

6.6. Software Record and Calibration ...................................................................................5

6.7. Manufacturer's Instructions ............................................................................................5

7. Glossary/Definitions..................................................................................................................5

8. Records ....................................................................................................................................5

9. Supporting Documents .............................................................................................................6

10. Document History .....................................................................................................................6

11. Change History.........................................................................................................................6

12. Attachments..............................................................................................................................6

1. Purpose 

This procedure provides guidance for ISO/IEC 17025:2017 record 

requirements for laboratory testing equipment in the Office of Regulatory 

Science (ORS) laboratories.

2. Scope

These procedures apply to equipment maintenance, performance checks, 

calibration, and verification records of the ORS laboratories.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.5.1

Revision #: 02

Revision Date:

06/06/2019

Title: 

Equipment Records Page 2 of 6

For the most current and official copy, check QMiS.

3. Responsibility 

A. ORA laboratories ensure that laboratory testing equipment is 

maintained, monitored, calibrated, and verified properly before and/or 

during use.

B. Laboratory Management ensures that the equipment record 

requirements outlined in this procedure are adhered to.

4. Background 

ISO/IEC 17025:2017 requires records to be retained for equipment which can 

influence laboratory activities. ORS laboratories maintain equipment records 

electronically, in logbooks, or other kinds of record files for equipment 

calibration, verification, service, and other maintenance.

Records include equipment related information such as descriptions of 

operation, preventive maintenance, repairs, calibrations and verifications. 

Volume II, Section 2, ORA-LAB.5.5 Equipment provides guidelines on 

equipment performance measures and maintenance. 

Periodic review of equipment records, included as part of the laboratory’s audit 

procedure, is essential.

5. References 

A. ISO/IEC 17025:2017, General requirements for the competence of 

testing and calibration laboratories, Section 6.4.

B. AOAC International Guidelines for Laboratories Performing 

Microbiological and Chemical Analysis of Food, Dietary Supplements, 

and Pharmaceuticals – An Aid to Interpretation of ISO/IEC 17025:2017; 

August 2018

6. Procedure 

6.1. Overview 

A. The instrument or equipment records are compiled and required 

information maintained in a readily accessible manner. There is no 

requirement that the records be kept in a bound notebook or binder. 

Records may be kept electronically. For electronic records, local work 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.5.1

Revision #: 02

Revision Date:

06/06/2019

Title: 

Equipment Records Page 3 of 6

For the most current and official copy, check QMiS.

instructions state where these records are located and how they can be 

accessed.

B. The records are kept in a secure, accessible place in the laboratory.

C. The records for similar instruments may be kept together if they are 

clearly identified and separated. For example, records for multiple 

balances may share a single location.

D. The records are maintained for a period determined in each laboratory’s 

record and data management procedure and in accordance with agency 

record management policies.

6.2. Logbook Sections

6.2.1. The following information may be included:

A. description of the instrument critical accessories and software/firmware 

version;

B. manufacturer's name, type, serial number, and/or other unique 

identification (i.e. FDA number);

C. its current location, and

D. Evidence of verification that equipment conforms with specified 

requirements, including installation qualification (IQ), operational 

qualification (OQ) records; and

E. other related material such as instrument service and repair, warranty 

information, service contract conditions and specifications, and 

equipment manufacturer representatives’ names and telephone 

numbers.

6.2.2. Operating Instructions

Each piece of equipment has step-by-step operating instructions, including 

starting and shutting down the instrument. This may be addressed in 

manufacturer’s manuals or per laboratory procedure.

6.2.3. Calibration and Verification

A. All measuring equipment has an established schedule specifying 

performance checks, including the testing frequency and acceptable 

performance specifications. These performance checks ensure the 

equipment is operating properly and consistently prior to analysis.

B. Records will include calibration dates, results of calibrations, 

adjustments, acceptance criteria, and the due date of the next 

calibration or calibration interval.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.5.1

Revision #: 02

Revision Date:

06/06/2019

Title: 

Equipment Records Page 4 of 6

For the most current and official copy, check QMiS.

C. Laboratory equipment may have peripheral equipment that affects their 

performance. In these cases, systematic checks are also specified to 

ensure that the peripheral equipment is functioning properly. For 

example, tests of voltage regulators ensure voltage stability of 

automatic samplers for consistent sample delivery.

D. The performance check includes a description of the performance 

check, the date and analyst name, the determined value compared to a 

target value or specification, and any information to aid in equipment 

assessment.

E. Quality control procedures monitoring test validity and calibrations 

connected to a particular sample are generally recorded on the 

worksheet or electronically. For example, system suitability test results 

performed as part of sample analysis are submitted with the worksheet.

F. For equipment performance checks where traceability to primary 

standards is needed, a certificate or record establishing traceability or 

information about the properties or characteristics of the reference 

material is kept on file.

G. When contract calibration or verification services are used, the vendor 

should provide the following information (if not proprietary):

1. Description of work performed,

2. Test method,

3. Test data,

4. Traceability of standards used,

5. Date vendors test equipment or standards were last certified,

6. Performance versus the acceptance criteria, and

7. Certificate of conformance.

6.3. Maintenance 

A. Service contract or in-house preventive maintenance is recorded. This 

includes all maintenance, except for routine cleaning.

B. The records include:

1. description of the maintenance;

2. date it was done; and 

3. name of the service representative and company, or name of the 

analyst if maintenance provided internally.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.5.1

Revision #: 02

Revision Date:

06/06/2019

Title: 

Equipment Records Page 5 of 6

For the most current and official copy, check QMiS.

6.4. Repair

A. Equipment repairs are recorded.

B. The records include:

1. Initials of the analyst, and the date the problem was observed,

2. Description of the problem;

3. Date and initials of the analyst or service representative performing 

the repair;

4. Synopsis of the repair; and

5. Additional optional information like cost of repair, work order, copy of 

the invoice, etc.

6.5. Non-Conformances

Equipment non-conformances are recorded according to the procedures for 

Control of Nonconforming Work (ORA-LAB.4.9).

6.6. Software Record and Calibration

Software calibration certificates provided by the manufacturer are kept on file 

by the laboratory.

6.7. Manufacturer's Instructions

Manuals provided by the equipment manufacturer may be included in the 

logbook if they are very brief, significant, and readily accessible. Otherwise, 

logbooks should include references to the manuals’ location.

7. Glossary/Definitions 

None

8. Records 

A. Laboratory equipment records for maintenance, performance checks, 

calibration and verification

B. Laboratory equipment service and repair records

C. Records providing evidence of conformance to specifications

D. Primary standard certificates 

E. Software calibration and version records
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.5.1

Revision #: 02

Revision Date:

06/06/2019

Title: 

Equipment Records Page 6 of 6

For the most current and official copy, check QMiS.

9. Supporting Documents 

A. ORA Laboratory Manual, Volume II, ORA-LAB.5.5, Equipment

B. ORA Laboratory Manual, Volume II, ORA-LAB.4.13, Record and Data 

Management

C. ORA Laboratory Manual, Volume II, ORA-LAB.4.11, Corrective Action 

Procedure

D. ORA Laboratory Manual, Volume II, ORA-LAB.4.9 Control of 

Nonconforming Work

10. Document History

Revision

#

Status*

(D, I, R) Date Author Name and Title Approving Official Name and Title

1.2 R 11/16/05 LMEB LMEB

1.3 R 05/08/14 LMEB LMEB

02 R 06/06/2019 LMEB LMEB

* - D: Draft, I: Initial, R: Revision

11. Change History

Revision 

# Change

02 Revisions made as needed to align this procedure with new ISO/IEC 17025 and 

AOAC requirements. Revision to formatting and policy clarifications were also made.

12. Attachments

None