Quality Manual - ISO
Date: 01-July-2025 Last Updated: 07-MAY-2026
Document No.: QM-IQ-001
1.0 Purpose
The purpose of this Quality Manual is to define the structure, scope, and key elements of the Quality Management System (QMS) implemented by MICROSOLV Technology Corporation (MICROSOLV). This manual provides a high‑level description of how MICROSOLV meets the requirements of ISO 9001 and ensures consistent product quality, scientific integrity, and customer satisfaction.
2.0 Scope
The Quality Management System applies to:
3.0 Normative References
4.1 Understanding the Organization and Its Context
MICROSOLV Technology Corporation is a U.S.-based manufacturer and distributor of high‑performance chromatography products and laboratory consumables serving pharmaceutical, clinical, environmental, chemical, forensic, and research laboratories worldwide. Key product categories include HPLC columns, autosampler vials, filtration products, tubing, and performance qualification solutions.
MICROSOLV operates in a non‑regulated but quality‑driven market where customers depend on consistent product performance, traceability, and technical accuracy to support analytical results and downstream regulatory compliance. Quality, scientific accuracy, and customer experience are core elements of the company’s mission and long‑standing business philosophy.
MICROSOLV maintains a list of Internal and External issues that may affect the QMS and routinely discusses these issues in accordance with ISO 9001.
4.2 Interested Parties
MICROSOLV has identified the following interested parties relevant to the QMS and their key needs and expectations:
4.3 Scope of the Quality Management System
The scope of the Quality Management System is defined as:
“The design, manufacture, sourcing, quality control, distribution, and customer support of chromatography products.
MICROSOLV’s Quality Policy is defined as”
“At MICROSOLV, we are committed to providing high-quality laboratory supplies that achieve customer satisfaction. Our goal is to ensure the reliability, accuracy, and safety of our products through continuous improvement”
This scope applies to all relevant operations conducted at MICROSOLV facilities and through controlled external providers and distribution channels supporting customers worldwide.
Any ISO 9001 requirements that are determined to be not applicable are documented and justified. No exclusions reduce MICROSOLV’s ability to consistently provide conforming products or meet customer requirements.
4.4 Quality Management System and Its Processes
MICROSOLV has established, implemented, and maintains a Quality Management System in accordance with ISO 9001. The QMS is based on a process approach and risk‑based thinking and includes:
Top management demonstrates leadership and commitment to the QMS by:
MICROSOLV plans the QMS with consideration of organizational risks and opportunities. Actions are taken to:
MICROSOLV provides the resources necessary for the effective operation of the QMS, including:
8.0 Operation
Operations are planned and controlled through documented procedures, work instructions, and quality controls to ensure consistent product realization. Customer communication, order processing, supplier control, and manufacturing activities are managed to meet specified requirements.
9.0 Performance Evaluation
MICROSOLV monitors, measures, analyzes, and evaluates QMS performance through:
10.0 Improvement
MICROSOLV is committed to continual improvement of the QMS. Nonconformances are documented, investigated, and corrected to prevent recurrence. Improvement activities are driven by data analysis, audit results, customer feedback, and management review decisions.
To view, print or save a PDF version control document of this manual please click the following link: Download QM-IQ-001_-_Quality_Manual.pdf
Document No.: QM-IQ-001
1.0 Purpose
The purpose of this Quality Manual is to define the structure, scope, and key elements of the Quality Management System (QMS) implemented by MICROSOLV Technology Corporation (MICROSOLV). This manual provides a high‑level description of how MICROSOLV meets the requirements of ISO 9001 and ensures consistent product quality, scientific integrity, and customer satisfaction.
2.0 Scope
The Quality Management System applies to:
- Product design and selection
- Manufacture (inhouse and outsourced) and sourcing
- Quality control and performance verification
- Distribution and order fulfillment
- Customer communication, technical support, and service
3.0 Normative References
- ISO 9001:2015 – Quality Management Systems – Requirements
4.1 Understanding the Organization and Its Context
MICROSOLV Technology Corporation is a U.S.-based manufacturer and distributor of high‑performance chromatography products and laboratory consumables serving pharmaceutical, clinical, environmental, chemical, forensic, and research laboratories worldwide. Key product categories include HPLC columns, autosampler vials, filtration products, tubing, and performance qualification solutions.
MICROSOLV operates in a non‑regulated but quality‑driven market where customers depend on consistent product performance, traceability, and technical accuracy to support analytical results and downstream regulatory compliance. Quality, scientific accuracy, and customer experience are core elements of the company’s mission and long‑standing business philosophy.
MICROSOLV maintains a list of Internal and External issues that may affect the QMS and routinely discusses these issues in accordance with ISO 9001.
4.2 Interested Parties
MICROSOLV has identified the following interested parties relevant to the QMS and their key needs and expectations:
- Customers & Distributors: Consistent product quality, accurate specifications, reliable performance, responsive technical support, on‑time delivery.
- Employees & Upper Management: Clear roles and responsibilities, appropriate training, safe working conditions, effective and efficient processes and continual improvement.
- Suppliers and Contract Manufacturers: Clear specifications, effective communication, and fair evaluation.
- Ownership: Business sustainability, customer satisfaction, risk control, and continual improvement
4.3 Scope of the Quality Management System
The scope of the Quality Management System is defined as:
“The design, manufacture, sourcing, quality control, distribution, and customer support of chromatography products.
MICROSOLV’s Quality Policy is defined as”
“At MICROSOLV, we are committed to providing high-quality laboratory supplies that achieve customer satisfaction. Our goal is to ensure the reliability, accuracy, and safety of our products through continuous improvement”
This scope applies to all relevant operations conducted at MICROSOLV facilities and through controlled external providers and distribution channels supporting customers worldwide.
Any ISO 9001 requirements that are determined to be not applicable are documented and justified. No exclusions reduce MICROSOLV’s ability to consistently provide conforming products or meet customer requirements.
4.4 Quality Management System and Its Processes
MICROSOLV has established, implemented, and maintains a Quality Management System in accordance with ISO 9001. The QMS is based on a process approach and risk‑based thinking and includes:
- Defined and documented core and supporting processes
- Identification of process sequence and interaction
- Quality objectives aligned with the company’s strategic direction
- Risk‑based methods to prevent nonconformities and improve outcomes
- Monitoring, measurement, analysis, and evaluation of performance
- Continual improvement through corrective action, internal audits, management review, and employee training
- Product design and selection
- Supplier evaluation and purchasing
- Manufacturing and quality control
- Order processing and fulfillment
- Customer communication and technical support
- Nonconformance management and corrective action
- Document and record control
Top management demonstrates leadership and commitment to the QMS by:
- Establishing and supporting the Quality Policy and quality objectives
- Promoting customer focus throughout the organization
- Ensuring the availability of required resources
- Assigning and communicating quality‑related roles and responsibilities
- Supporting continual improvement of the QMS
MICROSOLV plans the QMS with consideration of organizational risks and opportunities. Actions are taken to:
- Address risks that could affect product conformity or customer satisfaction
- Enhancing opportunities for improvement
- Establish and monitor measurable quality objectives
MICROSOLV provides the resources necessary for the effective operation of the QMS, including:
- Competent and trained personnel
- Appropriate infrastructure and work environment
- Controlled documented information
8.0 Operation
Operations are planned and controlled through documented procedures, work instructions, and quality controls to ensure consistent product realization. Customer communication, order processing, supplier control, and manufacturing activities are managed to meet specified requirements.
9.0 Performance Evaluation
MICROSOLV monitors, measures, analyzes, and evaluates QMS performance through:
- Customer feedback
- Key performance indicators
- Internal audits
- Management review
10.0 Improvement
MICROSOLV is committed to continual improvement of the QMS. Nonconformances are documented, investigated, and corrected to prevent recurrence. Improvement activities are driven by data analysis, audit results, customer feedback, and management review decisions.
To view, print or save a PDF version control document of this manual please click the following link: Download QM-IQ-001_-_Quality_Manual.pdf