ISO 15189 2022 Package
2024-10-31 15:12ISO 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
- Quality Manual
- Document Control Procedure
- Record Control Procedure
- Internal Audit Procedure
- Corrective Action Procedure
- Preventive Action Procedure
- Control of Nonconforming Output Procedure
- Management Review Procedure
- Competence, Training, and Awareness Procedure
- Equipment Calibration and Maintenance Procedure
- Purchasing and Supplier Evaluation Procedure
- Sample Reception and Handling Procedure
- Pre-analytical Procedure
- Analytical Procedure
- Post-analytical Procedure
- Reporting of Results Procedure
- Quality Indicators and Monitoring Procedure
- Customer Complaints Procedure
- Confidentiality and Information Security Procedure
- Laboratory Safety Procedure
- Waste Management Procedure
Records and Forms:
- Quality Manual Approval Form
- Document Change Request Form
- Training Record Form
- Internal Audit Report Form
- Corrective Action Request Form
- Preventive Action Request Form
- Nonconformance Report Form
- Management Review Meeting Minutes
- Equipment Calibration and Maintenance Records
- Supplier Evaluation and Approval Form
- Sample Reception and Handling Log
- Test Result Record
- Quality Indicator Monitoring Log
- Customer Complaint Log
Manual and quality policy
• ISO 15189 Quality Manual
Others:
- Laboratory Quality Policy
- Laboratory Scope of Accreditation
- Organizational Chart
- Job Descriptions
SOPs
- SOP for Document Control
- SOP for Record Control
- SOP for Internal Audits
- SOP for Corrective Actions
- SOP for Preventive Actions
- SOP for Control of Nonconforming Outputs
- SOP for Management Review
- SOP for Competence, Training, and Awareness
- SOP for Equipment Calibration and Maintenance
- SOP for Purchasing and Supplier Evaluation
- SOP for Sample Reception and Handling
- SOP for Pre-analytical Processes
- SOP for Analytical Processes
- SOP for Post-analytical Processes
- SOP for Reporting of Results
- SOP for Quality Indicators and Monitoring
- SOP for Customer Complaints
- SOP for Confidentiality and Information Security
- SOP for Laboratory Safety
- SOP for Waste Management
Comprehensive Breakdown of ISO 15189 2022: Chapter-by-Chapter Guide for Medical Laboratory Quality and Competence
Chapter 1: Scope
This chapter defines the scope and applicability of ISO 15189 2022, focusing on the quality and competence requirements for medical laboratories.
Key Requirements:
- Applicability: ISO 15189 applies to medical laboratories that perform clinical testing, providing guidelines for managing laboratory quality systems and ensuring the accuracy and reliability of patient results.
- Competence and Quality: The standard outlines requirements for quality management systems (QMS) and for the technical competence of medical laboratories in both management and technical aspects.
- Regulatory Compliance: Laboratories must ensure they meet applicable regulatory and legal requirements alongside ISO 15189 standards.
Chapter 2: Normative References
This chapter outlines the other documents and standards that are referenced in ISO 15189 2022 and are necessary for understanding and implementing the requirements.
Key Requirements:
- Referenced Standards: ISO 15189 makes use of relevant ISO standards such as ISO 9001 for quality management and ISO/IEC 17025 for testing and calibration laboratories, ensuring consistency across quality frameworks.
Chapter 3: Terms and Definitions
This chapter provides definitions of key terms used throughout the standard to ensure a common understanding of core concepts.
Key Requirements:
- Key Terminology: This section clarifies terms such as “laboratory director,” “examination,” “quality indicator,” and “nonconformity.” These terms are fundamental to ensuring that all users of the standard interpret it consistently and correctly.
Chapter 4: Management Requirements
This chapter focuses on the quality management system (QMS) requirements that medical laboratories must implement to ensure high-quality service and reliable patient results.
Key Requirements:
- Quality Management System: Laboratories must establish, implement, and maintain a QMS covering all aspects of their operations. This system should be documented, ensuring all processes and procedures are in place to guarantee quality.
- Leadership Commitment: Laboratory leadership is responsible for the effectiveness of the QMS, including establishing a quality policy, setting measurable quality objectives, and ensuring the availability of resources.
- Risk Management: Laboratories must have a risk management framework that addresses potential risks to quality and patient safety, including identifying, assessing, and controlling those risks.
- Document and Record Control: Document control procedures must ensure that all relevant information, including policies, procedures, and records, is properly managed, accessible, and regularly reviewed to ensure accuracy and compliance.
Chapter 5: Resource Management
This chapter addresses the resources that medical laboratories need to implement and maintain the quality management system and to perform laboratory tasks competently.
Key Requirements:
- Personnel Competence and Training: Laboratory staff must be competent, with education, training, and experience relevant to their roles. Continuous training programs must be in place to ensure staff skills remain current.
- Facilities and Environmental Conditions: Laboratories must provide and maintain adequate facilities and environmental conditions to prevent contamination or deterioration of samples and to ensure accurate results.
- Equipment Management: All equipment must be properly maintained, calibrated, and validated to ensure reliability. Laboratories must establish procedures for routine maintenance and corrective actions for equipment malfunctions.
- Supply and Supplier Management: Laboratories must manage supplies such as reagents and consumables, ensuring they meet quality requirements. Approved suppliers should be evaluated and monitored for quality compliance.
Chapter 6: Process Requirements
This chapter covers the laboratory’s technical operations, including pre-examination, examination, and post-examination processes.
Key Requirements:
- Pre-Examination Processes: Laboratories must have defined processes for sample collection, transportation, and handling to ensure the integrity of samples. This includes clear communication with patients, clinicians, and sample collection sites.
- Examination Processes: All laboratory testing must be validated, standardized, and documented, ensuring that procedures meet regulatory requirements and produce accurate, reliable results.
- Post-Examination Processes: Laboratories must ensure that the results are verified and reported in a timely manner, with mechanisms in place for reviewing and amending reports if necessary. Reports must be accurate, secure, and confidential.
- Laboratory Information Systems: Where applicable, laboratories must implement and maintain robust information management systems to securely handle patient data, test results, and reports.
Chapter 7: Continual Improvement
This chapter focuses on the need for laboratories to regularly monitor and improve their processes, quality management system, and performance.
Key Requirements:
- Internal Audits: Laboratories must conduct regular internal audits of their QMS and technical operations to identify areas for improvement. The findings should be documented and followed by corrective actions.
- Quality Indicators: Laboratories must establish key performance indicators to monitor process performance and quality outcomes. These indicators help in assessing customer satisfaction, test accuracy, and timeliness of service.
- Corrective and Preventive Actions: Nonconformities must be addressed through documented corrective actions, while preventive actions must be taken to avoid future nonconformities.
- Management Review: Regular management reviews of the QMS should assess the laboratory’s performance, quality objectives, and opportunities for improvement.
Chapter 8: Risk Management and Patient Safety
This new chapter in ISO 15189 2022 emphasizes risk management and patient safety, recognizing the critical nature of medical laboratory testing in healthcare.
Key Requirements:
- Risk Identification and Control: Laboratories must systematically identify risks related to laboratory activities, processes, and services that could impact patient safety and testing quality.
- Proactive Risk Management: Processes must be put in place to assess risks proactively, ensuring that potential issues are addressed before they impact patient safety or the accuracy of results.
- Incident Reporting: Laboratories should have systems for identifying, reporting, and analyzing incidents or adverse events, with corrective actions to prevent recurrence.
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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: 58 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
Achieving ISO 15189 compliance is a significant milestone for any organization, signifying a commitment to data protection and privacy. Our expert consultants are here to guide you through every step of the implementation process, from initial consultation and gap analysis to final assessment and compliance certification. With our comprehensive project plan, tailored training programs, and dedicated support, we ensure your organization meets all ISO 15189 requirements efficiently and effectively. Partner with us to enhance your organization’s credibility, improve data handling processes, and gain trust on an international scale. Let us help you achieve excellence in data privacy management.
Introduction: Project Kick-off and Gap Analysis
Introductory Tasks
1.1 ISO 15189 Kick-off and Awareness
Task: Organize Kick-off Meeting
- Description: Hold a kick-off meeting to introduce the ISO 15189 project, explaining the objectives, scope, timelines, and resource requirements to key stakeholders.
- Deliverables: Project plan, meeting agenda, and minutes.
- Meeting: Initial consultation with senior management and the implementation team.
1.2 Perform Gap Analysis
Task: Conduct Gap Analysis Against ISO 15189 2012 Requirements
- Description: Assess the current laboratory processes, management system, and technical operations against the requirements of ISO 15189:2012 to identify gaps.
- Deliverables: Gap analysis report with identified non-conformities.
- Meeting: Review findings with management, laboratory heads, and quality teams.
Section 1: QMS Documentation and Quality Policy
2.1 Develop and Document Quality Policy and Objectives
Task: Define Quality Policy and Objectives
- Description: Establish the laboratory’s quality policy and measurable quality objectives, aligning them with ISO 15189:2012 and the organization’s strategic direction.
- Deliverables: Documented quality policy and objectives.
- Meeting: Review and approve with senior management.
2.2 Develop Quality Management System Documentation
Task: Create QMS Documentation (Procedures, Work Instructions)
- Description: Develop the necessary documentation for the quality management system, including a quality manual, process procedures, and work instructions that meet ISO 15189 requirements.
- Deliverables: Quality manual, procedures, work instructions.
- Meeting: Review documentation with the QMS team.
Section 2: Laboratory Operations and Risk Management
3.1 Implement Laboratory Operations Procedures (ISO 15189 Clauses 5.4, 5.5, 5.6)
Task: Establish Procedures for Laboratory Operations
- Description: Document and implement procedures for pre-examination (sample collection), examination (testing), and post-examination (reporting) phases of laboratory work, ensuring compliance with ISO 15189:2012.
- Deliverables: Standard operating procedures (SOPs) for laboratory operations.
- Meeting: Review and validate procedures with laboratory staff and technical teams.
3.2 Develop Risk Management Procedures
Task: Implement Risk Management in Laboratory Activities
- Description: Develop procedures to identify, assess, and control risks associated with laboratory activities, including patient safety risks and equipment malfunctions.
- Deliverables: Risk management plan and procedure.
- Meeting: Review risk management process with the technical and quality teams.
Section 3: Competence and Training
4.1 Competence of Laboratory Personnel (ISO 15189 Clause 5.1)
Task: Define Competence Requirements for Laboratory Staff
- Description: Establish criteria for the competence of laboratory personnel, including qualifications, skills, and training required for each role within the laboratory.
- Deliverables: Competence matrix and job descriptions.
- Meeting: Review with HR and department heads to finalize staff roles and competence requirements.
4.2 Develop Training and Competency Assessment Program
Task: Create and Implement a Training Program
- Description: Develop a training program to ensure that all laboratory personnel are competent to perform their assigned tasks, and establish procedures for ongoing competency assessments.
- Deliverables: Training program documents and records of completed training.
- Meeting: Training sessions with staff on new processes and assessments.
Section 4: Equipment Management and Traceability
5.1 Equipment Management (ISO 15189 Clause 5.3)
Task: Implement Equipment Calibration and Maintenance Procedures
- Description: Establish procedures for the calibration, maintenance, and qualification of laboratory equipment to ensure accuracy and reliability.
- Deliverables: Equipment management procedure, calibration schedule, maintenance logs.
- Meeting: Review and implement equipment management with the technical team.
5.2 Ensure Traceability of Measurement Results
Task: Develop and Implement Traceability Systems
- Description: Ensure traceability of all measurement results, from sample collection to the final report, to ensure the reliability and reproducibility of test results.
- Deliverables: Traceability procedure and records.
- Meeting: Review traceability systems with the laboratory and quality teams.
Section 5: Document Control and Non-Conforming Work
6.1 Implement Document Control System (ISO 15189 Clause 4.3)
Task: Establish Procedures for Document Control
- Description: Develop a document control system to manage all QMS-related documentation, ensuring that all documents are reviewed, approved, and updated regularly.
- Deliverables: Document control procedure, document registers.
- Meeting: Train staff on the document control system.
6.2 Non-Conforming Work and Corrective Actions (ISO 15189 Clause 4.9)
Task: Establish Procedures for Handling Non-Conforming Work
- Description: Implement a process to identify, document, and resolve non-conforming work (e.g., erroneous test results), ensuring appropriate corrective actions are taken to prevent recurrence.
- Deliverables: Non-conformance reports, corrective action logs.
- Meeting: Post-audit review to discuss non-conforming work and corrective actions.
Section 6: Internal Audits and Continuous Improvement
7.1 Develop Internal Audit Program (ISO 15189 Clause 4.14)
Task: Create an Internal Audit Plan
- Description: Establish an internal audit program to evaluate the effectiveness of the QMS, covering all critical laboratory processes and ISO 15189 requirements.
- Deliverables: Internal audit plan, audit checklist.
- Meeting: Review audit plan with the audit team and quality manager.
7.2 Conduct Internal Audits
Task: Perform Internal Audits
- Description: Conduct internal audits to verify compliance with ISO 15189 and QMS requirements. Identify areas for improvement and implement corrective actions.
- Deliverables: Internal audit reports, non-conformance reports.
- Meeting: Post-audit review meeting with the management team to discuss findings and corrective actions.
Final Assessment: Certification Audit Preparation and External Audit
8.1 Conduct Pre-Certification Internal Audit
Task: Perform a Pre-Certification Internal Audit
- Description: Conduct a full internal audit to assess the laboratory’s readiness for the ISO 15189 accreditation audit, ensuring that all identified gaps have been addressed.
- Deliverables: Pre-certification audit report.
- Meeting: Review audit findings with management and finalize corrective actions.
8.2 Certification Body Selection and External Audit
Task: Select Certification Body and Schedule Certification Audit
- Description: Research and select an accredited certification body for ISO 15189. Schedule the external audit and ensure the laboratory is fully prepared.
- Deliverables: Certification body selection report, external audit schedule.
- Meeting: Final meeting with management and quality team to confirm readiness for the certification audit.
This 8-month project plan for ISO 15189:2012 implementation ensures a structured approach to achieving accreditation for medical laboratories. It covers all key areas, including quality management, laboratory operations, equipment management, non-conformance handling, internal audits, and certification preparation, ensuring compliance with ISO 15189 by the end of the project.
What our customers think:
Taking steps to comply with ISO 15189- The experience of our lab“Our laboratory 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. To a brighter 2018 full steam ahead on the quest for accreditation with more confidence from our team to continue working at the highest calibre.
Rachel Thompson
Laboratory Director
After we listened to how great they were in helping other labs get their ISO 15189 accreditation, we decided to go with QSE Academy. 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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