SERVICES
Consulting Services to achieve ISO 9001, AS9100 and ISO 13485 certification
Consulting services to achieve ISO 9001, AS9100, and ISO 13485 certification involve professional guidance and support to help an organization implement a Quality Management System (QMS) that meets the requirements of the applicable ISO standards.
Key Features of this Service:
Help the organization understand ISO 9001 requirements
Design and implement a QMS tailored to the organization.
Prepare the organization for the certification audit
Ensure ongoing compliance and continual improvement
Internal Audit & QMS System Assessment
Conducting an ISO 9001, AS9100, or ISO 13485 internal audit by experienced consultants provides an objective, expert review of your Quality Management System to ensure compliance with ISO standards. During the internal audit, we can identify gaps, recommend improvements, and help prepare your business for certification or surveillance audits, saving time, enhancing quality, and driving continual improvement.
Key Features of this Service:
Objective Evaluation
External consultants provide an unbiased view, helping identify gaps, inefficiencies, or non-conformities without internal influence.
Gap Analysis
An External ISO consultant can efficiently assess how well current practices align with ISO 9001 requirements and identify areas for improvement.
Audit Planning & Execution
Develop an audit plan, interview staff, review documentation, and observe processes as per ISO 19011 guidelines.
Expert Insights
Consultants can bring best practices from various industries and provide valuable guidance on enhancing your QMS.
Audit Report & Recommendations
A detailed report is provided with findings, risks, and practical recommendations for corrective actions.
Certification Readiness
It prepares your organization for a smooth and successful ISO 9001 certification or surveillance audit.
Internal Audits consulting services are currently provided for the following quality management system standards:
ISO
9001:2015
ISO
AS9100D
ISO
13485:2016
Quality Management System Development
Complete QMS Development
During the Quality System Development process, we help companies to design and implement a structured framework of policies, processes, and procedures to ensure a company consistently delivers products or services that meet customer and regulatory requirements. It forms the foundation for continuous improvement and is often aligned with standards like ISO 9001.
As consultants, we have experience building Quality Management Systems with many different industries such as Electronics Manufacturing, Sheet Metal, Low volume high complex products design and manufacturing, Software companies, Various service providers, Aerospace, Medical Device, and more.
Quality Engineering Services and Support
We provide the following Quality Engineering support for:
Definition of quality inspection methods
Performance Monitoring
CAPA assessments using techniques like 8D, 5Why….
Nonconformances and Corrective / Preventive Action CAPA Management
Use of APQP tools from design to manufacture; monitoring of finished product; using tools such as FMEA, PPS, QRQC, IPCA
Resolve quality issues using effective problem-solving tools
Implement process controls such as Statistical Process Control (SPC)
Improve processes and develop process controls
Quality Engineering in Design and establishment of Design controls.
Data Analysis of previous nonconformances