ISO 9001 certification is the international standard for demonstrating your company’s commitment to maintaining an effective quality management system. With the changes of 9001:2008 to its 2015 version, many companies operating under a 2008 compliant system struggle in transitioning their systems. Whether your company is a new applicant or in need of transitioning your existing 2008 system, the 2015 standard helps to provide a solid infrastructure in critical areas of your quality management system in order for you to operate your business more effectively. The ISO 9001:2015 version emphasizes these key areas of change:
Emphasis on Leadership Engagement
Effectively Addresses Supply Chain Management
Addresses Organizational Risks and Opportunities
Your Competitive Advantage
There are clear, empirical competitive advantages for manufacturing companies that implement the ISO 9001 standard for their quality management. Studies show that:
The vast majority of purchasers (82%) rely heavily on ISO 9001 and use it frequently.
Most purchasers use ISO 9001 as a component of their supplier evaluation process.
The lack of certification is a competitive disadvantage for manufacturing companies.
Whether you’re looking to begin the certification process or simply transition your current system, QSI provides a wide range of certification solutions to help you achieve certification and keep your quality management system running efficiently.
QSI offers a proven path to certification, backed by numerous years of industry experience. Whether your quality management system is in need of major or minor changes, our approach helps to foster quality commitment within your organization from the top down.
With QSI, your path to certification and compliance comes with various levels of technical assistance and support. Our consulting services include:
Cost efficient implementation and a dedicated consultant to track your certification timeline.
Customized development of manuals, procedures, work instructions, job descriptions, etc.
Access to your online, web-based QMS portal that houses all your documentation and integrates all your management system standards in a secure location. We provide:
♦ Software setup and deployment
♦ Employee training in software modules and procedures
♦ Data imports of all existing documentation
♦ Ongoing system support and software upgrades
Internal audit and management review
Observations during your certification audit to provide additional guidance.
Implementation and Integration
Because many manufacturing companies choose to integrate their ISO 9001 certification with other management system standards, QSI provides services that help make this implementation and integration seamless. In junction with ISO 9001, other standards that adopt 9001’s requirements include:
ISO 14001:2004; Environmental Management System
ISO 13485:2003; Medical Devises Manufacturing
ISO/TS 16949:2009; Automotive Manufacturing
ISO/IEC/TR 18001:1999; Occupational Health & Safety
ISO/IEC 17025:2005; Testing & Calibration Labs
AS 9100C:2009; Aircraft, Space & Defense
API Spec. Q1/Q2; Manufacturing and Service Organizations in the Petroleum and Natural Gas Industry
For those companies wanting to fully maximize and transition their ISO 9001:2015 systems with as little risk as possible, QSI offers a “Total ISO Certificate Package” – a proven approach meant to provide you with everything necessary to ensure the most successful transition to ISO 9001:2015. In this package you get one-on-one consulting with one of our IRCA/Exemplar Global certified professionals dedicated to transitioning your system – from beginning to end.
Benefits of ISO 9001 Certification
♦ Reduce cost
♦ Improve operational efficiency, productivity, and product reliability
♦ Customer satisfaction - meet customer requirements
♦ Access to new markets
♦ Increase market share and sales
♦ Meet statutory and regulatory requirements
♦ Increased environmental benefit
The Need for Change
Why did ISO change from its 2008 to 2015 version?
♦ The need to harmonize and integrate quality management into a business management system
♦ Easier to adopt muliple ISO series general business management systems together
♦ To simplify the 2008 standard and make it easier to apply uniformly
♦ To make it applicable to service organizations and office environments
♦ To provide a stable core set of requirements for the next 10 years or more
“We are a delighted customer from the services provided by QSI during our QMS software implementation. They provided continuous support, a proactive approach, guidance throughout the process, and highly resolved issues amicably.”
API Spec. Q1
API Spec. Q2
API Lead Auditor
Learn the latest. Stay competitive with training.
Key QMS Software Features
As a tool to assist you in the ISO 9001:2015 certification process, QSI’s approach is to provide our clients with full system access to our web-based QMS portal, uniquely designed to streamline your processes from the top down. Working together, the applications in the software make your QMS more efficient.
Improve Your QMS Efficiency
QSI's web-based quality management software comes loaded with over 20 applications that help you leverage and streamline your business processes. The software applications easily integrate with each other so your QMS stays compliant and runs efficiently. Easily integrate processes, such as:
Corrective and Preventive Action, and much more
Know exactly what's going on in all aspects of your management system. Real-time dashboards give you great visibility and insight. With dashboard reports, you can identify your company's opportunity for improvement and steadily decrease systemic issues, including corrective actions, customer returns or complaints, and audit deficiencies.
Dashboard reports allow you to analyze data and identify trends. For example, view your company's gradual decrease in nonconformities, and watch your company improve its efficiency over time.
Instantly access all your documentation at the click of a mouse with our self-hosted, web-based QMS portal. All information is stored on our secure servers, eliminating the need for expensive IT costs and implementation. Get visibility to all areas of your QMS, across all your departments and locations world wide - no matter your company size.
Hassle no more during an audit. With quick search and record retrieval, our software allows you to quickly access your QMS documentation without flipping though mounds of paperwork. The system also comes pre-configured with various sort and filter options, which can also be customized to meet your needs.
Get Notifications. Track Due Dates.
Track due dates with interactive calendar management. Get email notifications of key due dates, such as:
Calibration / maintenance due dates
CAPA / NCR approval and assignment
All the software applications you need to manage your compliance.
Bud Weightman, President of QSI, is an international management systems expert involved with management and technical systems for over 40 years. As President of QSI, Bud is involved with the industry committees responsible for emerging requirements, including: revision of API specifications, leading various API Task Groups, and lead auditor for the accreditation of SEMS Audit Providers through the Center for Offshore Safety. Bud’s experience includes working with ISO 9001, ISO 14000, and OHSAS 18000 management systems, as well as industry-specific certification schemes such as API Q1 and Q2, AS9100, ASME systems, and numerous other standards.
Other Key Consulting Services
Pre-assessments for determining your conformance/compliance readiness
Technical conformity assessments
Gap analyses for comprehensive conformity/compliance checks
Manual and procedure reviews, detailing the missing pieces in your own manual and/or procedures
Regulatory compliance assessments