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The only AI-powered Middle Office Platform that unifies PLM, QMS, EHS, and SRM into a single, intelligent solution
Product Lifecycle Management
Enable cross-functional collaboration and accelerate your product lifecycle with a cloud-based platform for innovation
Design Process and Quality System Development Tools in Product Lifecycle
Design Quality
Get full visibility over your product design processes and make collaboration easy to get your products to market faster, compliantly
Design Quality: Connecting Design to Documentation
Complaints Management
Transform customer complaints to valuable sources of insights for continuous improvement through smart automations and integrated regulatory reporting
Challenges with Triage and Investigation in Complaints Management Process
Document and Learning Management
Say goodbye to paper! Modernize your processes with connected document, training, and change management
Manufacturing Challenges and Industry Trends Towards Digital Transformation
Quality Management
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Frost Radar for Quality Management Systems Names ComplianceQuest Leader
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The Ultimate Guide to Next-Generation Supplier Management [e-Book]
Safety Management
Identify and minimize safety events. Prevent accidents, safeguard workers, and ensure their well-being and health
Safety Essentials: Key ‘Must-have’ Components for Safety Management at Any Enterprise
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Environmental & Sustainability Management
Electronic and Automated Approach to Audit Management
Managing the Tools of the Trade
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Leveraging CAPA for Continuous Improvement
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Organization, Collaboration and Governance for Efficient Changes
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Enhance Safety and Compliance with Smarter Chemical Management
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ComplianceQuest covers the whole spectrum of customers, industries and regions across the world. Whether it is a small, medium or enterprise sized manufacturer, companies choose ComplianceQuest for its end-to-end Product Lifecycle, Quality, Safety and Supplier Management Solutions.
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About
About ComplianceQuest
Transform to a fully connected business with a next-generation AI-powered Product Lifecycle, Quality, Safety, and Supplier management platform, built on Salesforce.
Our connected suite of solutions helps businesses of all sizes increase product, quality, safety, and supplier as they bring their products from concept to customer success.
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What is ISO 9001? How compliance drives operational excellence?
Explore what are ISO 9001 Standards and why companies need ISO 9001.
ISO 9001 is a standard that facilitates the incorporation of best practices into an enterprise’s Quality Management System (QMS). Compliance to ISO 9001 needs automation and digital technology like ComplianceQuest’s holistic QHSE system. Our system is mapped to the ISO 9001 requirements for enabling businesses to become compliant and thereby make their quality management system efficient and effective. With ComplianceQuest you can implement proven workflows as per quality management best practices and, when required, it is easily configurable to custom design workflows in case of a special use case. It even catalyzes new thinking and innovation.
With ComplianceQuest QHSE you can drive a culture of quality in your organization and at the same time embrace a safe and healthy workplace for the employees as well as the environment. Sign up for an online demo now.
ISO 9001:2015 is a quality management standard that helps you setup processes and workflows for quality control in your organization.…
Enterprise-wide quality goals cannot be met in silos. It is a continuous process where every stage in your product or…
ComplianceQuest is a 100% cloud based Quality, Health, Safety and Environmental (QHSE) Solution Suite to help you drive quality excellence which leads to business growth while at the same time you can embrace a culture of health and safety to reduce costs of accidents or non-conformance. It is built natively on the Salesforce.com platform, one of the leading business cloud platforms, ensuring high security, future readiness and scalability to the system. Aligning your organization with our ISO 9001 compliance software helps you notch up your business efficiency and customer satisfaction.
Improved Processes
ISO 9001 promotes process-based QMS (Quality Management System), integrating interrelated processes at the enterprise level. This holistic approach ensures greater effectiveness and better integrated processes that can minimize waste and thereby reduce costs.
Improved Decision-Making
Businesses need to be able to take timely decisions that can improve the chances of their success. For this, they need data that can help them make informed decisions. A well-implemented ISO 9001 aims to achieve just that.
Improved Productivity
ISO 9001 compliance effects greater productivity and employee performance over time. Better documentation and predictive analytics enable timely response to challenges and improved employee engagement.
Improved Supply Chain Quality
Provide detailed requirements to the suppliers to ensure quality of products and services supplied. Ensure these processes are functioning optimally every time you conduct your internal ISO 9001 audit check.
Embrace quality efficient business operations by ensuring ISO 9001 compliance. ComplianceQuest QHSE suite can drive the ISO 9001 compliance for you. Contact us for a demo!
The ComplianceQuest QHSE solution suite provide you with the four critical areas for ISO 9001 compliance of EDMS, QMS, Supplier Quality Management and Complaints/Field Service Quality. Along with this there are other safety & quality modules to manage Audit, Risk, Training, Conformance, Inspection, Incident, Health and Safety, Sustainability and more that also integrate seamlessly together.
Some features that ensure ISO 9001 compliance and which will drive operational excellence are:
Powerful dashboards built into the solution provide reports and insights based on the role of the user, the function, the region or at the corporate level.
System provides user-level customizations and access, ensuring privacy and security.
With the help of data, analytics and AI, the ComplianceQuest solution can help with root cause analysis in case of any incidents or accidents, identify and recommend the next best action.
Integrates well with the existing ERP, CRM, PLM, LIMS, HRMS and other critical systems.
As you become ISO 9001 compliant, many quality and safety management systems get implemented across your organization boosting process efficiency, employee productivity and reducing customer complaints. Some of these systems include:
Document Management
The ISO 9001:2015 standard emphasizes documentation, capturing procedures, forms, and work instructions. Streamlining documentation becomes more convenient through improved version control, collaboration, and accessibility during auditing processes.
Collaboration
Drive collaboration of teams across geographies and departments and enable version control of documents.
Automation
Automation enhances internal audit, document management, corrective and preventive action (CAPA), and other quality processes. Organizations can optimize these processes by implementing automated systems, reducing manual effort, and improving efficiency.
Once the ISO 9001 processes are fully implemented, evaluating internal conformance to the standard is essential. This evaluation can be conducted by trained employees or outsourced to a subcontractor. It is important to note that the audit should not be a one-time event but carried out periodically to ensure ongoing compliance and continuous improvement.
Provide detailed requirements to the suppliers to ensure quality of products and services supplied. And ensure that these standards are met by all suppliers.
Customer Complaints
An enterprise-wide quality culture looks at the entire lifecycle of an organization across suppliers, internal processes, and all customer-related workflows thus improving customer experience many folds.
Contact us today to understand the next steps to ISO 9001 compliance for your organization.
ISO 9001 implementation is essential to an organization’s growth strategy across industries. An organization that is ISO 9001: 2015 compliant is shown to have clarity and compatibility with other management system standards. ISO 9001 implementation is driven by the need to meet international quality regulations, deliver customer delight, and effect continuous improvement in quality management in an organization. Before starting with the implementation process, it is crucial to perform a gap analysis or needs assessment to understand the compliance requirements of the business. Once there is an understanding of the requirements, follow these five steps as part of the implementation process:
Customer Success
ISO 9001 implementation has become an essential part of many organization’s growth strategy. It is impelled by the need to deliver customer delight, meet international quality requirements and effect continuous improvement (in terms of quality management) in one’s own organization.
At ComplianceQuest, we’ve helped customers at 1000+ locations around the world implement an automated workflow for Quality Control. We believe that the following five factors will determine how well ISO 9001 will be implemented in your enterprise.
However, compliance will in fact create confidence in the customers about the business’ commitment to quality and efficiency. It will be the driving force behind the company’s quality policy as well as implementation. A well-implemented ISO 9001 process will, in fact, make life much easier for your entire workforce. When the ISO 9001 workflow is automated, it’ll also help your people develop an inherent quality culture.
ComplianceQuest, a 100% modern cloud-based Enterprise Quality & Safety Management System (QHSE) goes above and beyond the requirements for ISO 9001:2015 while automating your entire quality management system requirements. Our product and automation features significantly reduce the efforts involved in maintaining your ISO 9001:2015 Quality System. The product is designed to deliver flexibility, scalability, customizations and data visibility.
In addition, it provides a complete view of your organization’s data – a key aspect to drive continuous improvement of your quality management process.
We are still getting started and have only just implemented Document Management. We are very excited about the potential for managing our QMS and can’t wait to move onto the other ComplianceQuest modules with the help of Amit.
Karen Bligh,Australian Dental Manufacturing
Congratulations! If you have reached this page, then it shows you are seriously contemplating pursuing your ISO certification and are wondering how to go about it. Getting an ISO certification is no walk in the park but it is well worth the effort.
In this post, we keep it simple and deliver a 6-step guide to becoming ISO 9001 certified.
Step 1: Set the Goals for Your Business
There is no one size fits all when it comes to setting the objectives for an ISO 9001 certification. You will have to first identify the results of your past quality efforts, do a gap analysis with regardto ISO requirements and delineate the right approach suited to your company’s culture and requirements. This will determine whether your effort is led by:
Whichever approach you take, training and awareness programs will play a key part in realizing the benefits of the implementation better. Planning your project well for its successful completion is also essential.
Step 2: Document Management
ISO 9001:2015 standard lays stress on documentation capturing procedures, forms and work instructions. Documentation is important to maintain business continuity, affecting operations, efficiency and profitability, and is required during audits. It should describe workflows and processes lucidly – enabling readers to understand it well.
Step 3: Collaborative Mindset for Implementation
Implementation of ISO 9001 quality management system across the business should align with your documentation. It must clearly list out new requirements, if any, that came up during the gap analysis. Communicating the new requirements to the employees to help them understand the new way of working as well as its benefits is essential for its successful implementation.
Step 4: Automation of Internal Audit, Document Management, CAPA, etc.
On completing the implementation of ISO 9001 processes, evaluate the conformance to ISO 9001 internally. Trained employees or a subcontractor can do the audit, which is not a one-time affair but should be conducted periodically. The key to conducting internal audits efficiently is an automated workflow. ComplianceQuest’s QHSE built on the Salesforce.com is flexible, scalable and customizable and will work well for a range of organizations. Automation will enable a range of processes – document management, audit management, CAPA, incident reporting, compliant management, among others. The key point to note here is that getting an ISO certification is only the first step. It needs continuous improvement and monitoring. It needs an enterprise-wide buy-in from stakeholders across the lifecycle of a business.
Step 5: Getting Certified
Once you are sure that ISO 9001:2015 has been implemented as per the documentation you will need an independent, third-party ISO 9001 audit to achieve the certification. The ideal time is two months after the implementation process so that you have records proving your ISO 9001 compliance.
Step 6: Re-certifying
When you obtain the ISO 9001 certification, you have just begun the journey as it is not a one-time event. It is essential to continue to be vigilant since a surveillance site audit will be conducted once or twice a year in order to ensure your continued compliance and improvement.You will have to be recertified every three years to remain certified.
ISO 9001:2015 lays stress on a quality management system as that can smoothen your implementation and continued compliance. A QMS tool such as the one from ComplianceQuest,built on the scalable cloud platform Salesforce.com, is aligned with the ISO requirements and a natural fit. From design, documentation to training and implementation, it can make the ISO implementation process intuitive and easy. If you are embarking on your journey on ISO 9001:2015 implementation or recertification and want to automate your processes, contact us here: contact-us
ISO 9001 Internal Audit Checklist – Part A (General Requirements)
Checklist | May 15th, 2023
ISO 9001 Internal Audit Checklist – Part B (Quality Manual, Document Control)
Is Your Internal Communication Related to QMS (ISO 13485) Adequate?
Checklist | September 27th, 2021
Review and Update Your QMS with 50 Mandatory SOPs as per ISO 13485:2016
Checklist | April 7th, 2021
A generic standard, the 2015 update impacts almost every industry and it’s standards (AS9100D:2016, IATF 16949:2016, etc.). ISO 9001:2015 requires businesses to design their QMS specific to their industry. More than one million organizations in over 170 countries certified in ISO 9001 have upgraded to ISO 9001:2015 to meet this new requirement.
When you obtain the ISO 9001 certification, you have just begun the journey as it is not a one-time event. It is essential to continue to be vigilant since a surveillance site audit will be conducted once or twice a year in order to ensure your continued compliance and improvement. You will have to be recertified every three years to remain ISO 9001 certified.
Compliance to ISO 9001, which can be through voluntary auditing or third party registration, can improve the efficiency of the business, improve customer satisfaction and lead to faster growth.
Typically, the ISO 9001 standard is adopted by a company either because customers mandate it as part of the contract; governments require the certification to allow trading; or when a business wants to improve its products and customer satisfaction.
By complying with ISO 9001, enterprises can:
Provide consistent quality of products and services that meet customer requirements and comply to applicable regulations
Improve customer satisfaction through the effective application of the system
Implement processes that effect continuous improvement of the system
Have a unified quality and EHS system by integrating ISO 9001 with ISO 14001 (Environmental), ISO 45001 (Occupational Health and Safety), etc.
Provide enterprise-wide view of causal relationships and assign responsibilities
Set goals and create a roadmap for growth
Expand into new markets
Assess and analyze risks within the organization
Improve productivity and efficiency effectively
Lower costs of production and quality
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