ISO 15189 2022 Package
2024-11-26 14:28ISO 15189 2022 Package
Get your accreditation at the lowest possible cost
ISO 15189 2022 complete package
2022 version
Price : 389 $
The complete ISO 15189 2022 package is a comprehensive document package that contains everything from all the templates of procedures, processes, forms, checklists, tools, detailed guides, and instructions needed to:
- Start your ISO 15189 2022 process.
- Create your ISO 15189 2022 documentation.
- Quickly access ISO 15189 2022 accreditation.
- Benefit from an ISO 15189 2022 management system that is simple and adapted to the needs of your organization.
Why start with a blank page. Start your Project TODAY, and save up to 80% on your time and money.
This package comes with 1 hour Live 1-to-1 Online Session with ISO consultant, document reviews, continual email support for 12 months and regular update service.
Cost-Effective Implementation: Much cheaper than an on-site consultant, and requires much less time than doing it from scratch
ISO 15189 2022 Version Complete Package
• Added Value: All ISO 15189 2022 requirements have been developed into an efficient process that adds operational value to your Laboratory and consequently increases productivity.
• Effective: Minimal effort is required to follow procedures necessary to meet all requirements of ISO 15189 2022 version.
• Simplified: Bureaucracy and excessive paperwork have been eliminated from each process to make it easy – while remaining fully compliant with ISO 15189 2022.
Start your Project TODAY, and save up to 80% on your time and money.
The all-in-one document package for ISO 15189 2022 version
Save time, save money and simplify the accreditation process.
Documents included:
Procedures
- Impartiality Procedure
- Confidentiality Procedure
- Patient Feedback and Complaint Handling Procedure
- Examination Request Management Procedure
- Sample Collection and Handling Procedure
- Sample Transportation Procedure
- Nonconforming Work Procedure
- Document Control Procedure
- Record Control Procedure
- Risk and Opportunity Management Procedure
- Corrective Action Procedure
- Internal Audit Procedure
- Management Review Procedure
- Method Validation and Verification Procedure
- Equipment Management Procedure
- Equipment Calibration and Maintenance Procedure
- Reagent and Consumable Management Procedure
- Data and Information Management Procedure
- Emergency Preparedness Procedure
- Staff Competence and Training Procedure
Plans
- Risk and Opportunity Management Plan
- Training and Development Plan
- Equipment Maintenance and Calibration Plan
- Emergency Preparedness Plan
Manual and Policies
- ISO 15189 Quality Manual
- Quality Policy
- Confidentiality Policy
- Impartiality Policy
- Non-Discrimination Policy
- Continuous Improvement Policy
Records
- Examination Request Form
- Sample Collection Checklist
- Sample Transport Log
- Nonconformance Report Form
- Corrective Action Request Form
- Risk Assessment Form
- Internal Audit Report Form
- Management Review Input and Output Form
- Equipment Maintenance Log
- Calibration Record Form
- Training Attendance and Competency Assessment Form
- Reagent and Consumable Receipt and Testing Form
Comprehensive Breakdown of ISO 15189 2022: Chapter-by-Chapter Guide for Medical Laboratory Quality and Competence
Chapter 1: Scope
The scope of ISO 15189:2022 outlines the requirements for medical laboratories to ensure quality and competence. It applies to laboratories aiming to establish a robust management system, demonstrate operational competence, and achieve recognition from users, regulatory authorities, and accreditation bodies. The standard also includes specific considerations for point-of-care testing (POCT), ensuring alignment with relevant international, national, or regional regulations.
Key Requirements:
- Specifies quality and competence requirements for medical laboratories.
- Applicable to laboratories developing management systems or confirming competence.
- Includes provisions for point-of-care testing (POCT).
- Acknowledges additional regulations or requirements that may apply to laboratories.
Chapter 2: Normative References
Chapter 2 specifies the normative documents that are essential for the application of ISO 15189:2022. These references are integral to understanding and implementing the standard’s requirements. The referenced documents, such as ISO/IEC 17025:2017 and ISO/IEC Guide 99, provide foundational principles and definitions that support the accurate interpretation and application of the ISO 15189:2022 standard.
Key Requirements:
- ISO/IEC Guide 99:2007: Covers the international vocabulary of metrology and its basic and general concepts.
- ISO/IEC 17000:2020: Defines terms and general principles of conformity assessment.
- ISO/IEC 17025:2017: Establishes general requirements for the competence of testing and calibration laboratories.
- Ensures that the latest editions of these references are used unless otherwise stated.
Chapter 3: Terms and Definitions
Chapter 3 provides a comprehensive glossary of terms and definitions used throughout ISO 15189:2022. These definitions ensure a consistent understanding of key concepts, processes, and requirements related to medical laboratories. The chapter draws on terminology from related standards, such as ISO/IEC Guide 99 and ISO/IEC 17000, and tailors them to the specific context of medical laboratory operations.
Key Requirements:
- Bias: Systematic measurement error estimate, relevant for quantitative measurements.
- Biological Reference Interval: A range of values derived from a biological population, often used for clinical decision-making.
- Competence: The demonstrated ability to apply knowledge and skills to achieve intended results.
- Examination Procedure: A set of specified operations used to determine a property or characteristic of a sample.
- Impartiality: Objectivity in laboratory activities, free from conflicts of interest.
- Measurement Uncertainty: A parameter that quantifies the dispersion of measurement values.
- Quality Indicator: A metric used to evaluate the degree to which laboratory processes meet established requirements.
- Medical Laboratory: An entity that examines materials from the human body to provide diagnostic or therapeutic information.
The chapter ensures clarity and precision in the application of terms across all clauses of the standard.
Chapter 4: General Requirements
Chapter 4 of ISO 15189:2022 outlines the foundational principles necessary to ensure the impartiality, confidentiality, and patient-centric focus of medical laboratory activities. These requirements establish the ethical and operational framework for laboratory practices, emphasizing the protection of patients’ rights and the integrity of laboratory processes.
Key Requirements:
Impartiality:
- Laboratory activities must be conducted impartially and structured to prevent conflicts of interest.
- Management must commit to safeguarding impartiality and address any identified risks.
Confidentiality:
- Laboratories must protect patient information through enforceable agreements and ensure its privacy.
- Confidential information can only be shared with patient consent or as required by law.
- Personnel must maintain confidentiality, including contractors and external parties.
Requirements Regarding Patients:
- Processes must prioritize patient well-being, safety, and rights.
- Laboratories must:
- Provide transparent information about examination procedures and costs.
- Periodically review and ensure the clinical appropriateness of examinations.
- Obtain informed consent where applicable.
- Handle patient samples and remains with respect and care.
- Maintain the integrity and availability of patient samples and records during significant changes, such as laboratory closures.
Chapter 5: Structural and Governance Requirements
Chapter 5 focuses on the structural and governance framework essential for medical laboratory operations. It mandates clear organizational structures, leadership responsibilities, and quality management practices to ensure compliance, efficiency, and accountability. This chapter emphasizes the role of the laboratory director and the need for well-defined policies, objectives, and risk management strategies.
Key Requirements:
Legal Entity:
- The laboratory must be a legally recognized entity accountable for its activities.
Laboratory Director:
- Must possess the qualifications, competence, and authority to fulfill the requirements of ISO 15189.
- Responsibilities include implementing the management system and overseeing risk management.
- Duties can be delegated to qualified personnel, but ultimate responsibility remains with the director.
Laboratory Activities:
- Clearly document the scope of activities, including those performed outside the main location (e.g., point-of-care testing).
- Ensure all activities comply with relevant requirements and user needs.
Structure and Authority:
- Define the laboratory’s organizational structure, including responsibilities and communication lines.
- Establish quality management processes, ensuring resources are available to implement, maintain, and improve the management system.
Objectives and Policies:
- Develop measurable objectives and policies aligned with patient needs, good professional practices, and the requirements of ISO 15189.
- Ensure these objectives are implemented at all organizational levels.
Risk Management:
- Identify and address risks to patient safety and opportunities for improvement.
- Evaluate and modify risk management processes for effectiveness.
Chapter 6: Resource Requirements
Chapter 6 outlines the resources necessary for the effective functioning of a medical laboratory. It specifies requirements for personnel, facilities, equipment, and external services to ensure accurate and reliable laboratory results. This chapter emphasizes maintaining a competent workforce, suitable environmental conditions, and properly managed materials and equipment.
Key Requirements:
General:
- The laboratory must ensure adequate personnel, facilities, equipment, reagents, and consumables to support its activities.
Personnel:
- Define competence requirements for all roles affecting laboratory results.
- Provide initial and ongoing training, including professional development.
- Maintain records for competence, training, and authorization to perform specific tasks.
Facilities and Environmental Conditions:
- Maintain facilities that support valid results and ensure the safety of patients, personnel, and visitors.
- Implement controls to prevent contamination and ensure confidentiality and quality.
- Provide adequate storage for samples, equipment, and hazardous materials.
Equipment:
- Ensure equipment is appropriately selected, installed, calibrated, maintained, and decommissioned.
- Maintain records for equipment, including maintenance, calibration, and performance.
Equipment Calibration and Metrological Traceability:
- Establish calibration processes for measurement equipment to ensure accuracy and traceability to recognized standards.
Reagents and Consumables:
- Verify the quality of reagents and consumables before use.
- Maintain an inventory system and appropriate storage to ensure integrity.
Service Agreements:
- Establish agreements with users and ensure external service providers meet laboratory requirements.
Externally Provided Products and Services:
- Verify the suitability of externally provided products and services.
- Maintain a list of approved external providers, including referral laboratories and consultants.
Chapter 7: Process Requirements
Chapter 7 focuses on the processes that medical laboratories must implement to ensure accurate, reliable, and timely results. It covers the complete workflow from pre-examination, examination, and post-examination processes, emphasizing risk assessment, patient safety, and quality assurance. The requirements ensure that laboratory activities align with user needs and regulatory standards.
Key Requirements:
General:
- Identify risks to patient care across pre-examination, examination, and post-examination processes.
- Develop processes to mitigate risks and monitor effectiveness.
Pre-Examination Processes:
- Provide detailed information to users and patients about laboratory services.
- Ensure clear procedures for examination requests, sample collection, and transportation.
- Establish acceptance criteria for samples and document deviations.
Examination Processes:
- Use validated methods appropriate for the intended purpose.
- Periodically review methods to ensure clinical relevance.
- Document examination procedures and ensure consistency in application.
Validation and Verification:
- Verify that new examination methods meet performance specifications before use.
- Validate methods developed in-house or used outside their intended scope.
Ensuring Validity of Examination Results:
- Implement internal quality control (IQC) to monitor examination accuracy.
- Participate in external quality assessments (EQA) to benchmark performance.
- Evaluate measurement uncertainty for quantitative methods.
Biological Reference Intervals and Clinical Decision Limits:
- Define reference intervals and decision limits to aid result interpretation.
- Periodically review and communicate any updates to users.
Post-Examination Processes:
- Ensure timely, accurate, and clear reporting of results.
- Develop procedures for result review, release, and communication of critical findings.
- Retain and store samples post-examination based on defined criteria.
Nonconforming Work:
- Establish procedures for managing work that does not meet quality requirements.
- Halt examinations if there is a risk to patient safety and take corrective action.
Data and Information Management:
- Implement robust systems for managing laboratory information.
- Ensure data security, backup, and accessibility during downtime or emergencies.
Complaints:
- Develop a process for receiving, investigating, and resolving complaints.
- Ensure impartiality and fairness in complaint resolution.
Continuity and Emergency Preparedness:
- Plan for emergencies or disruptions to ensure continuity of laboratory operations.
Chapter 8: Management System Requirements
Chapter 8 establishes the framework for a medical laboratory’s management system, ensuring consistent fulfillment of the requirements in ISO 15189:2022. It emphasizes documentation, continual improvement, risk management, and regular evaluations to align laboratory operations with quality and competence standards.
Key Requirements:
General Requirements:
- Establish, document, implement, and maintain a management system to support the laboratory’s objectives and demonstrate conformity with ISO 15189:2022.
- Ensure all personnel understand their role in contributing to the effectiveness of the management system.
Management System Documentation:
- Develop objectives and policies addressing competence, quality, and consistent operation.
- Maintain documentation related to the management system, including processes, procedures, and records.
Control of Documents:
- Ensure documents are uniquely identified, approved, and periodically reviewed.
- Prevent unauthorized changes, secure accessibility, and retain obsolete documents as necessary.
Control of Records:
- Create and retain records to demonstrate conformity with ISO 15189:2022 requirements.
- Implement procedures for the secure storage, protection, and retrieval of records.
Actions to Address Risks and Opportunities for Improvement:
- Identify risks and opportunities associated with laboratory activities to prevent undesired outcomes.
- Take actions proportional to the impact on laboratory results and patient safety.
- Record decisions and evaluate the effectiveness of actions taken.
Improvement:
- Continually improve the management system, focusing on pre-examination, examination, and post-examination processes.
- Use feedback from personnel, patients, and users to identify areas for enhancement.
Nonconformities and Corrective Actions:
- Establish procedures to respond to nonconformities, identify their root causes, and prevent recurrence.
- Maintain records of nonconformities and actions taken, evaluating their effectiveness.
Evaluations:
- Conduct regular evaluations to ensure laboratory activities meet user needs and comply with ISO 15189:2022.
- Use quality indicators and internal audits to monitor performance and identify improvement areas.
Management Reviews:
- Perform management reviews at planned intervals to assess the system’s suitability, adequacy, and effectiveness.
- Inputs to reviews include feedback, audit results, quality indicators, and risk management outcomes.
- Outputs include decisions and actions for system improvement and resource allocation.
30 Days Money Back Guarantee
If for whatever reason during the FIRST 30 days of your purchase, you are not satisfied for any reason, simply contact support@qse-academy.com and our support team will issue you an immediate and full refund.
The package includes all the documents you need to comply with ISO 15189 2022- these documents are fully acceptable by the accreditation audit.
All documents are in MS Word or MS Excel, to make them very easy to customize for your business. You can customize them by adding company logos and colors, and edit headers and footers to match your favorite style.
We have already completed about 90% of the information requested on the documents. To complete them you must fill in only the name of the company, the responsible parties, and any other information unique to your company. you will be guided through the process, commenting on the elements that are needed and those that are optional.
We presented the ISO 15189 documentation, so as to assure all its users that they have completed everything accurately and with the utmost efficiency.
All the documents are made so that you can follow the proposed order perfectly, which allows you to make sure that nothing is missing, and that no one gets lost in the process.
The included comments and flowcharts help your staff understand each document and its usefulness, which helps you to make quality management more fluid, and processes easier to follow.
Features of the complete ISO 15189 2022 Kit
Price: 389 $
– Documentation included: 33 documents for the implementation of ISO 15189
– Language: English
– Documents are fully editable – just enter the information specific to your business.
– Acceptable for the ISO 15189 2022 accreditation audit? Yes, all the documents required by ISO 15189 2022 are included, as well as the quality policy and the current but optional procedures.
Instant Delivery – The package is downloadable immediately after purchase
Free Consultation – In addition, you can submit two complete documents for review by professionals.
Created for your business – The models are optimized for small and medium businesses.
Complete ISO 15189 2022 Package
The complete kit to implement ISO 15189
Price : 389 $
ISO 15189 2022 Implementation Project Plan
A Perfect Complement to Our Templates and Forms Package
Achieving ISO 15189:2022 accreditation is now more straightforward than ever with our comprehensive implementation plan, perfectly designed to complement the ISO 15189:2022 Templates and Forms Package. This step-by-step guide aligns seamlessly with our ready-to-use templates, providing the ultimate toolkit to streamline your journey toward compliance.
Phase 1: Project Kick-off and Gap Analysis
1.1 ISO 15189 Kick-off and Awareness
- Task: Organize Kick-off Meeting
- Description: Introduce the ISO 15189:2022 project, emphasizing key updates such as risk-based thinking, impartiality, and patient-centered processes. Highlight objectives, scope, timeline, and resources.
- Deliverables: Project plan, meeting agenda, and minutes.
- Meeting: Initial consultation with management and the implementation team.
1.2 Perform Gap Analysis
- Task: Conduct Gap Analysis Against ISO 15189:2022 Requirements
- Description: Review current laboratory practices, management systems, and technical operations against ISO 15189:2022 requirements to identify gaps. Focus on changes from the 2012 version, including risk management and confidentiality updates.
- Deliverables: Comprehensive gap analysis report with identified gaps and improvement opportunities.
- Meeting: Present findings to senior management and quality teams for alignment on action plans.
Phase 2: General Requirements (Chapter 4)
2.1 Impartiality
- Task: Safeguard Impartiality
- Description: Develop policies and procedures to prevent conflicts of interest, covering all laboratory activities and relationships.
- Deliverables: Impartiality policy, risk identification, and mitigation actions.
2.2 Confidentiality
- Task: Strengthen Confidentiality
- Description: Establish procedures to protect patient data and ensure compliance with legal and contractual obligations.
- Deliverables: Confidentiality agreements, patient information handling procedures.
2.3 Requirements Regarding Patients
- Task: Establish Patient-Centric Processes
- Description: Develop processes ensuring patient well-being, informed consent, and access to examination-related information.
- Deliverables: Patient care policy, consent forms, incident reporting framework.
Phase 3: Structural and Governance Requirements (Chapter 5)
3.1 Legal Entity
- Task: Verify Laboratory’s Legal Status
- Description: Ensure the laboratory is a recognized legal entity responsible for its activities.
- Deliverables: Legal documentation confirming accountability.
3.2 Laboratory Director
- Task: Define Leadership Roles
- Description: Document the laboratory director’s qualifications, responsibilities, and delegation processes.
- Deliverables: Director’s responsibility matrix, delegation records.
3.3 Structure and Authority
- Task: Update Laboratory Organization
- Description: Define roles, responsibilities, and interrelationships within the laboratory structure.
- Deliverables: Updated organizational chart, role descriptions.
3.4 Risk Management
- Task: Implement Risk Management Framework
- Description: Develop a system to identify, evaluate, and address risks in laboratory activities.
- Deliverables: Risk management plan, risk register, corrective actions framework.
Phase 4: Resource Requirements (Chapter 6)
4.1 Personnel
- Task: Establish Competency Standards
- Description: Define qualifications, training requirements, and ongoing competency assessments for all roles.
- Deliverables: Competence matrix, training program documentation.
4.2 Facilities and Environmental Conditions
- Task: Optimize Laboratory Facilities
- Description: Ensure facilities meet safety, confidentiality, and environmental requirements.
- Deliverables: Environmental control logs, facility maintenance plans.
4.3 Equipment
- Task: Manage Equipment Life Cycle
- Description: Develop procedures for equipment selection, calibration, maintenance, and retirement.
- Deliverables: Equipment records, calibration and maintenance schedules.
4.4 Reagents and Consumables
- Task: Enhance Reagent Management
- Description: Implement systems for acceptance, storage, and inventory of reagents and consumables.
- Deliverables: Inventory system, records of reagent acceptance testing.
Phase 5: Process Requirements (Chapter 7)
5.1 Pre-Examination Processes
- Task: Update Pre-Examination SOPs
- Description: Develop detailed SOPs for sample collection, handling, and transport to ensure integrity and traceability.
- Deliverables: SOPs for pre-examination processes.
5.2 Examination Processes
- Task: Validate and Standardize Examination Methods
- Description: Ensure all examination methods are validated and suitable for their intended use.
- Deliverables: Validation records, examination method SOPs.
5.3 Post-Examination Processes
- Task: Optimize Reporting Procedures
- Description: Standardize result reporting processes, including critical result notification and report amendments.
- Deliverables: Result reporting SOPs, critical result handling logs.
5.4 Non-Conforming Work
- Task: Establish Non-Conformance Handling
- Description: Implement a process for identifying and resolving non-conformities, with corrective actions to prevent recurrence.
- Deliverables: Non-conformance reports, corrective action records.
5.5 Data and Information Management
- Task: Secure Data Management Systems
- Description: Establish robust systems for data security, access control, and continuity during system failures.
- Deliverables: Information management procedures, data backup logs.
Phase 6: Management System Requirements (Chapter 8)
6.1 General Management System
- Task: Establish and Maintain a Management System
- Description: Implement a management system that meets ISO 15189:2022 requirements, integrating risk-based thinking and continual improvement.
- Deliverables: Management system documentation, monitoring framework.
6.2 Documentation and Records Control
- Task: Develop Control Procedures
- Description: Implement processes for managing documents and records, ensuring accessibility, security, and retention.
- Deliverables: Document control registers, retention policy.
6.3 Actions to Address Risks and Opportunities
- Task: Manage Risks and Opportunities
- Description: Identify risks and improvement opportunities and implement proportional actions.
- Deliverables: Risk assessment logs, improvement action plans.
6.4 Improvement
- Task: Drive Continual Improvement
- Description: Establish mechanisms to review performance, including patient feedback, audit findings, and corrective actions.
- Deliverables: Improvement reports, updated objectives.
6.5 Internal Audits
- Task: Develop and Execute Internal Audit Plan
- Description: Conduct audits to evaluate compliance with ISO 15189:2022 and identify improvement areas.
- Deliverables: Internal audit reports, corrective action plans.
6.6 Management Reviews
- Task: Conduct Management Reviews
- Description: Periodically review the management system’s effectiveness and alignment with objectives.
- Deliverables: Management review minutes, action logs.
Phase 7: Certification Audit Preparation
7.1 Pre-Certification Internal Audit
- Task: Conduct Full Internal Audit
- Description: Verify readiness for external certification through a pre-certification audit.
- Deliverables: Audit report, final corrective actions.
7.2 Certification Body Selection and External Audit
- Task: Select and Engage Certification Body
- Description: Research, select, and coordinate with an accredited certification body for ISO 15189:2022.
- Deliverables: Certification body agreement, external audit schedule.
What our customers think:
Our lab had a lot of hardships when preparing to be accredited by the guidelines mentioned in IS0 15189. Thankfully, the easy to follow package of QSE Academy helps simplify that procedure. The documents were very professional, well organized and easy to tailor for our own unique situation — Saving us a ton of time! In addition to that, the 1:1 time helped make sure we were as compliant as possible in every situation.
Rachel Thompson
Laboratory Director
They had a very comprehensive toolkit and step by step process that enabled us to cut through the implementation effort. The templates were extremely practical and the expert consulting sessions answered all our questions. Because of QSE Academy, our lab has become more efficient and we are accreditation ready. Thank goodness we made that investment
Michael Perez
Quality Manager
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