QUALITY MANAGEMENT

PRINCIPLES OF QUALITY MANAGEMENT

Medical device reprocessing is a complex combination of interrelated manual and automated tasks that must constantly adapt to surgical demand without compromising patient safety.

The Quality Management System (QMS) structures, documents device reprocessing activities to improve efficiency, meet applicable regulatory
requirements while ensuring employee engagement and safety.

Quality Management System principles are defined by international standards. For the purpose of the present guide, ISO 134851 will serve as a reference.

ISO 13485 is a quality management standard specifically adapted for the medical device industry, originating from the broader ISO 9001 standard. Primarily designed for medical device manufacturing, ISO 13485 also extends to service activities, including device reprocessing in healthcare facilities. Some requirements tailored to device design and manufacturing are, however, not applicable to reprocessing activities. Extensive literature supports ISO 13485 implementation in sterilization departments, with resources such as AAMI ST90 serving as guidance.

Certification to ISO 13485 can affirm an organization’s QMS, offering assurance to customers and stakeholders that a Central Sterile Supply Department (CSSD) operates with a fully functional quality system. Certification is awarded following audits conducted by accredited external consultants. Achieving certification in standards such as ISO 13485, ISO 9001, or JCI requires consulting support and resources, which may not be feasible for all sterilization departments. departments.

ISO 13485 requirements are organized as follows:

Quality Management system describes QMS principles and describes documentation requirements
Management responsibility outlines the role of top management in QMS implementation, improvement and employee engagement.
Resources Management covers human and infrastructure/equipment needs.
Product Realization, renamed Device Reprocessing for the purpose of this guide, provides guidance to structure and perform activities.
Measurement, Analysis and Improvement describes measures to monitor and improve the quality of execution

In the following paragraphs of this chapter we will review how each of these 5 parts of ISO 13485 apply to reprocessing of medical devices in Healthcare facilities.

QMS and documentation requirements

The various levels of documents typically required by the qualiy management system are, the quality manual, procedures, work instruction, form and records

The quality manual:

Defines quality policy statement, assign responsibilities and quality objectives for each function of the sterilization department
Identify the scope of the QMS, i.e. the various activities (processes) covered by the QMS and how these activities interact
Identifies the applicable regulation or governmental instructions and reference best practices
List the procedures, work instructions and forms used to execute and record activities and include a control procedure to ensure that QMS documentation is always up to date

The quality policy statement is a formal, concise document signed by management that outlines the facilities commitment to meeting customer needs and enhancing the Quality Management System (QMS). This policy serves as a foundation for quality objectives and continuous improvement.

An example of a “minimal” policy statement could be: “Our department is committed to the reliable, on-time delivery of safe, fully functional medical devices to the surgical department, in compliance with applicable regulations and industry best practices. This is achieved through the precise execution of each step in the device reprocessing workflow by skilled personnel, who actively contribute to the continuous improvement of our Quality Management System.”

The quality policy serves as a basis to establish the quality objectives assigned to each function of the sterilization department.

The Quality Policy and objectives are communicated and explained throughout the department and reviewed for continuing suitability and applicability (see also Management responsibilities paragraph).

A prerequisite to the implementation of the Quality Management System is a clear definition of the scope of the QMS, i.e. the processes (activities) covered by the QMS.

The ISO definition for processes is “a set of interrelated or interacting activities that use inputs to deliver an intended result”. For example, the input to the cleaning process is a soiled device and the intended results is a clean and dry device (assuming that drying is part of the cleaning process).

Reprocessing of medical devices by health care facilities is typically described as a sequence of operational processes (point of use processing, cleaning, control & assembly, packaging, sterilization, transport and storage), execution of which require support processes (such as human resources, management, maintenance or qualification of equipment).

The scope of the sterilization department QMS may vary between institutions. For example, part of sterilization activities may also be subcontracted to an external organization. The healthcare facility must however check that the QMS of the external service provider is adequate.

Once the processes are defined, procedures and related work instructions are developed.

Procedures relate to the process and define input, output, responsibilities, effectiveness criteria, measures or records and applicable laws and/or standards. Work instructions detail how to accomplish a specific job or task. It takes into account the instructions for reprocessing provided by the manufacturer of the medical device and applicable best practices.

Activities are monitored and recorded for traceability and future analysis. The data to be recorded, forms to be used and rules for conservation are defined by best practices and/or applicable local regulation.

Traceability is the ability to verify the history, location, or application of a medical device by means of recorded identification. Identification of each surgical set, individual instrument can be obtained by bar code, direct marking on devices or color coding. Traceability allows the identification of loaned devices. It is used to determined the useful life

Common documentation structure and hierarchy:

The quality manual describes the QMS (quality policy, processes in the scope of the QMS and how they interact, responsibilities, applicable rules and best practices, documentation structure and control)
For each process as defined in the quality manual, the procedures define the input and expected outputs, when, where and by whom the process is executed
Work instructions are detailed step by step description of tasks to be performed. Work instructions are often illustrated by graph or photos.
Predefined measures and observations are entered in forms to confirm that the tasks were appropriately executed. Records kept for future analysis

Procedures and instructions are developed according to a risk based approach. Risk is a combination of the probability of occurrence of harm and the severity of that harm. Anticipation minimizes the risk of negative events and time consuming corrective measures.

The risk associated to each process may be summarized in a matrix that describes the risk and their consequences, rate their severity on a scale from 1 to 5. The two are multiplied to obtained a criticality grade which will determine the priority of actions to be taken by the facility. For example, a risk with minor consequences but very likely to occur might deserve more attention and investment than a risk with deadly consequences but that is very unlikely. This structured risk assessment provides a clear, quantitative basis for prioritizing resources and actions, ensuring that risks with high likelihood or severe consequences are addressed systematically.

Management responsibilities

The implementation of a QMS is a strategic decision that must be actively supported by top management.

While quality management may be delegated to a Quality Manager, active management oversight is essential to foster engagement among staff and partners at all levels of the organization. Direct involvement from senior management not only reinforces the importance of quality objectives but also drives a culture of accountability and continuous improvement throughout the organization. This oversight ensures alignment with quality goals, encourages collaboration, and motivates every team member to prioritize quality in their work.

Management:

establishes quality policystatement and objectives (see Quality management system & documentation requirements),
ensures that resources (human and equipments) are available (see Resources Management),
defines, document and communicates responsibilitiesand authorities,
organizes periodic management reviews and internal and external feedbacks via auditsto adapt to changes and improve performances. (see Measurement, Analysis and Improvement)

Resource management

For ISO 13485, resources include human resources and infrastructure, i.e. equipment as well as facilities, air and water

Needs are evaluated, defined and adapted by management (see Management responsibilities), It includes

Adequate staffing with appropriate skills and training. Competences are checked on scheduled basis and recorded. Personel is made aware of their contribution to quality.
Ensuring a safe work environment (g., lighting, temperature control, ergonomic workstations, availability of protective equipment) and clearly defined contamination control measures for each area of the sterilization department (e.g., air quality, dress code, circulation of devices and staff)
Equipment with adequate performance and preventive maintenance plan

Medical device reprocessing

Reprocessing activities are organized according to user needs (for example composition of surgical sets, turnaround) and in accordance with applicable Regulation & Standard and best practices.

Procedures for each reprocessing stage (point of use reprocessing, cleaning & disinfection, control & assembly, packaging, sterilization, transport and storage) are defined according to a risk based approach. Any change to procedure is evaluated before implementation.

Work Instructions are as detailed and illustrated as needed and in accordance with instructions for reprocessing provided by the manufacturer of the reusable medical device and Spaulding classification. Exceptions must be justified.

When a new device is acquired or received on loan, existing procedures and work instructions must be reviewed to ensure they can be used as is or if adaptation or new instructions are needed. This review ensures that all processes are tailored to the device’s specific requirements, supporting safe and effective integration into existing workflows.

All processes must be validated. All equipment must be qualified and maintained per manufactures instructions for use (see process validation).

Human resources in charge of each reprocessing tasks are clearly identified, adequately trained (see resources management).

Manual and automated operations are monitored. Measures are benchmarked against pre-determined efficiency criteria. Records are kept and traceability of device and surgical sets is operational.

Measurement, Analysis and Improvement

Procedures are defined to:

Collect and analyze feedback from customers satisfaction questionaires, perform internal audit and management reviews, monitor processes via routine controls and process validations.
Manage non conformities, collect and handle complaints, and when required by local regulation, report adverse events to health authorities
Continuously maintain and improve the effectiveness of the Quality Systems with corrective and preventive measures.

The continuous improvement principle commonly illustrated by the Deming circle or PDCA (Plan – Do – Check – Act)

Recommendations of WFHSS for quality management

The implementation of a quality management system is essential to overcome the complexity of medical device reprocessing activities and constantly adapts to needs of surgical and medical users. International standard ISO 13485 can be used as a reference. It describes the documentation requirements and reminds principles for management responsibilities, resource management, product realization (i.e. device processing activities) and measurements, analysis and improvements.
The quality manual expresses management engagement for quality, define the activities (scope) of the QMS, identifies and controls the update of the various documents (procedure and work instruction, form, recording and traceability processes).
Procedures are established according to a risk based approach

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