4.0 - Management Requirements

4.1.1

Legal Entity:

Faraday Test Laboratory

15091 Northville Rd

Plymouth, MI 48170

4.1.2

All FTL personnel are responsible for the laboratory performing its' duties objectively without regard for customer pressures.

4.1.3

The policies and procedures found in this quality system, along with this quality manual, covers work carried out in this laboratory as well as subcontracting oflaboratories under FTL's supervision.

Corporate Organization

<<<Refer to ISO 17025, clause 4.1.4. >>>

This laboratory is not part of a larger corporate organization. As such, the following is non-applicable:

The corporate organization of which this laboratory is a part has detailed the responsibilities of key personnel overseeing the laboratory to identify any potential conflicts of interest.

no potential conflicts of interest between laboratory and corporate.

This laboratory is a third-party, independent, and impartial entity. Personnel are free from undue commercial and financial pressures and are expected to exercise good technical judgment.

4.1.4

The corporate organization, of which this laboratory is a part of, has detailed the responsibilities of key personnel overseeing the laboratory to identify any potential conflicts of interest.

4.1.5

The General Manager, Technical Manager, and Quality Manager implement and maintain the quality system. They also identify departures from the quality or technical requirements and initiate actions to minimize any departures.

Arrangements have been made to ensure that the laboratory management and personnel are free from any undue internal or external commercial, financial, and other pressures that may affect the quality of their work.

The protection of the confidential information and proprietary rights of the laboratory's customers are handled through a policy and procedure. The procedure for the electronic storage and transmission of results provides further protections.

A policy and procedure are in place to avoid any activity that would jeopardize the competence, impartiality, judgment, or operational integrity of the laboratory.

The organizational chart shows the management and personnel reporting structure of the laboratory and its relationship to any parent organization.

The responsibilities and authority granted to the various roles within the laboratory can be found in the Job Descriptions. Their interrelationship between them and other personnel are shown in the the organizational chart.

The Technical Manager is responsible for supervising testing (calibration) staff.

The Technical Manager has the overall responsibility for the technical operations and the associated staff.

The individual appointed as the Quality Manager is identified in the organizational chart. Irrespective of other duties, the quality manager has direct access to the General Manager and Technical Manager.

Deputies for the key managerial personnel are listed on the organizational chart.

The General Manager, Technical Manager, and Quality Manager are responsible for ensuring that staff are aware of the relevance and importance of their activities in achieving the management system objectives.

4.1.6

The General Manager, Technical Manager, and Quality Manager ensure that the effectiveness of the management system is appropriately communicated within the laboratory.

4.2.1

This website includes the overview of laboratory and and services we provide. The documentations follow ISO 19075 rules and regulation which located under our Quality Manual, and it is password protected. The website can be accessed on computer or a mobile phone

4.2.2

The Quality Manager has issued the quality policy statement.

4.2.3

This website, being the implementation of the quality system, is evidence of the commitment of the Quality Manager to continuously improving its effectiveness.

4.2.4

The General Manager requires that all staff members understand the importance of meeting customer, statutory, and regulatory requirements.

4.2.5

The policies and procedures (quality & technical) of the laboratory are provided as links in the Navigation Menu of this website. The structure of the quality system is centered on this website with a Main Menu link to the Quality Manual. Written documents are replaced with "Content Types" of:

Policies

Procedures

Supplements

Supplements are web pages (documents) referenced by the Quality Manual but are separate web pages (documents) as are the policies and procedures.

4.2.6

The roles and responsibilities are defined in the job descriptions for the Technical Manager and Quality Manager.

4.2.7

The General Manager, Quality Manager, and Technical Manager have the responsibility for ensuring that the integrity of the quality system is maintained during any changes.

4.3.1 General

A document control procedure has been implemented.

4.3.2 Document approval and issue

Quality documents are approved, as appropriate, by the General Manager, Technical Manager, and/or the Quality Manager.

4.3.3 Document changes

Documents will be changed in accordance with the document control procedure.

4.4.1

The Quality Manager has issued a policy and procedure for the review of requests, tenders, and contracts.

4.4.2

Appropriate records of the request/tender review along with changes, both verbal and written, are maintained according to the procedure above.

4.4.3

Subcontracted work is also covered by the procedure above.

4.4.4

The procedure above requires the customer to be notified of any deviation from the contract.

4.4.5

Changes made to the contract will undergo the same procedure as the original contract.

4.5.1

The laboratory uses ISO 17025 accredited subcontractors whenever applicable. Non-accredited subcontractors are used when requested by clients or the work to be done does not require performance in accordance with ISO 17025. If a subcontractor is not accredited, then they are evaluated to ISO 17025 prior to subcontracting any work to them.

4.5.2

When applicable, the customer is notified of the use of a subcontractor per the procedure on the review of requests, tenders, and contracts.

4.5.3

The laboratory accepts full responsibility for subcontracted work except in the event that the subcontractor is selected by the customer or designated by a regulating authority, in which case, clause 4.7, service to the customer, remains in effect.

4.5.4

A list of approved suppliers is maintained on this website.

4.6.1

The selection and purchasing of services and supplies are governed by a policy and procedure. Another procedure is used for the reception and storage of consumable materials.

4.6.2

Purchased consumable materials, reagents, and supplies that can affect the quality of the test results must be inspected according to the consumable inspection instructions.

4.6.3

A purchase order for any consumable material, reagent, supplies, or services shall be reviewed by the Technical Manager prior to release.

4.6.4

A record of the supplier evaluation shall be entered, and the approved suppliers list shall be maintained.

4.7.1

The laboratory cooperates with all customers (and their representatives) to the maximum extent possible. Access to the laboratory is granted while ensuring that the confidentiality of other customers is maintained.

4.7.2

Each Sales Representative is responsible for obtaining customer feedback, both positive and negative. This information is provided to the Quality Manager for improving the management system, Testing (calibration) services, and customer service.

The laboratory has a policy and procedure for handling complaints. Records of all complaints, investigations and corrective actions are maintained.

4.9.1

The laboratory has a policy and procedure for handling work that does not conform to lab procedures or customer requirements. All personnel are required to report any anomalies regarding testing (calibration) work to the Quality Manager. The Technical Manager is responsible for the control of non-conforming work and the Test (Calibration) Specialist can halt work.

4.9.2

If the non-conforming work may recur or that personnel are not following the laboratory policies and procedures, then a corrective action is implemented.

The effectiveness of the quality system is improved by:

Implementing the objectives of the quality system through the quality policy.

Analyzing the results of internal audits.

Implementing corrective and preventive actions.

Performance of management reviews.

4.11.1 General

The laboratory has a policy and procedure for implementing corrective action. The Quality Manager, General Manager, and Technical Manager are the designated authorities.

4.11.2 Cause analysis

The corrective action procedure includes a root cause analysis of the problem.

4.11.3 Selection and implementation of corrective actions

The laboratory maintains a record of the corrective actions.

4.11.4 Monitoring of corrective actions

Corrective actions shall have a status of "Open" until their effectiveness is confirmed. Once corrective action has been deemed effective by correcting the problem, it is marked "Closed".

4.11.5 Additional audits

If the corrective action has the potential of affecting other tests (calibrations) performed, then an internal audit is scheduled to determine any serious risks to the laboratory.

4.12.1

The laboratory shall identify needed improvements and potential sources of non-conformities. A preventive action will be created so that action plans can be developed, implemented, and monitored.

4.12.2

The laboratory uses the corrective action procedure for implementing preventive actions.

4.13.1 General

The laboratory has a procedure for identification, collection, indexing, access, filing, storage, maintenance, and disposal of quality and technical records. Record retention times are defined for various documents.

A procedure is used for the backup of electronic records and a security procedure has been implemented to prevent unauthorized access or amendment to those electronic records and other records.

4.13.2 Technical Records

Technical records are stored in the job folder for which they were derived. Calibration records for equipment (assets) used for testing (calibrations) are uploaded to their appropriate asset page. Where practicable, mistakes on hand-written records are crossed out and not erased, made illegible, or deleted and the correct value marked alongside. The document control procedure covers equivalent measures for electronic records.

4.14.1

The laboratory has a procedure for performing internal audits according to a schedule. The Quality Manager is responsible for planning and organizing internal audits.

4.14.2

If audit results show that the effectiveness of the quality system or technical operations is compromised, a corrective action shall be implemented. If any test (calibration) results may be affected, then the procedure for controlling non-conforming work will be followed.

4.14.3

Records of internal audit findings and their related corrective actions are maintained.

4.14.4

Internal audit records will remain open until the effectiveness of any corrective actions are validated, at which time the record will be marked closed, and a close date entered.

4.15.1

A management review shall take place according to the schedule.

4.15.2

A record of the management review is kept.