A Complete Automation of Your Organization’s ISO 9001 Process

We live in exciting times. Ideas can be converted to action and the results shared with the world in a significantly short time thanks to the evolution of technology. Businesses can source their raw materials from anywhere in the world and distribute the finished products in any other part of the world. They can even outsource their entire manufacturing process while only retaining the brand identity. This can cut down costs significantly and pass on the benefits to the customers, thus creating a win-win situation for all.

However, this has added a layer of complexity to the entire process. The brand has no control over the quality of inputs, manufacturing, or even distribution. There is a limit to how much a company can enforce processes and procedures on third-party vendors. More importantly, it cannot even have visibility into the processes followed by the vendors except through a few inspections which may or may not be representative of what really goes on.

On the other hand, customers are becoming vigilant and more demanding. They expect the brands to vouch for the quality of products and services and stand by the promises a brand makes. They are aided in this by the increasingly stringent regulatory bodies that require businesses to conform to the standards and regulations stipulated by them specific to their industry.

In the process, businesses are required to provide documentary evidence, subject themselves to periodic audits, report non-conformances, ensure customer satisfaction, handle complaints, initiate CAPA, and so on. In other words, Quality Management is a critical function for most enterprises around the world. This includes companies in healthcare and life sciences, manufacturing, consumer goods, oil and gas, automotive, aerospace, industrial and hi-tech.

Overall, digital transformation and automation is the key to quality management and ISO 9001 compliance. Without automation and digital technologies like AI, data analytics and cloud, it’ll be impossible to build an enterprise-wide culture for quality management.

For one, just keeping track of every problem or potential issue, documenting it, tracing the causes and the consequences, addressing it in a timely manner, and informing all the departments concerned for appropriate action is not humanly possible in a manual system. By automating the quality management system, all the pieces are connected to provide a holistic view, predict potential problems, manage documents, initiate corrective action, and manage change processes to prevent future occurrences.

ISO 9001 Quality Management Software

ISO 9001:2015 equips businesses to manage the quality creation, implementation, and maintenance process through a Quality Management System (QMS). With ISO 9001, businesses can experience an improved internal system that facilitates quality management, while also pushing for continuous improvement (CI) of quality processes.

ISO 9001 requires businesses to document and record:

• Equipment calibration
• Training, skills, experience and qualifications
• Product/service requirements review
• Design and development inputs, outputs and controls
• Design and development changes
• Characteristics of product to be produced and service to be provided
• Customer property
• Change management
• Non-conformances
• Audit management
• Corrective actions

All these require periodic monitoring and measuring that an automated solution makes easier to manage. A quality checklist is maintained by the quality leader at all times.

Moreover, it facilitates collaboration of teams across geographies and departments and enables version control of documents. Management of remote teams and suppliers is also made possible, thereby improving visibility and control of quality.

A solution, such as the one from ComplianceQuest, is mapped to the ISO requirements for enabling businesses to become compliant and thereby make their Quality Management System efficient and effective.

Its features include:

• Audit Management
• CAPA for Continuing Improvement
• Change Management for organization, collaboration and governance for efficient changes
• Complaints Management to create loyalty by address customer complaints smartly
• Document Management for relevant information to be within reach always
• Equipment Management for keeping the tools of the trade in top condition
• Inspection Management
• Nonconformance Management across departments and locations
• Risk Management
• Supplier Management
• Training

With a QMS like the one from ComplianceQuest built on the scalable and robust Salesforce.com, businesses can experience the benefits of automating their quality process across the enterprise right from design to continuous improvement.

Oh, and one more thing: A next-generation quality management is crucial to make the automation process simpler, easier and better.

ComplianceQuest’s Next-Gen QHSE has been built on our five guiding design principles aimed to deliver this Quality Excellence for your enterprise:

Principle #1: Core Quality Promise

Enabling critical business decision making

Principle #2: User Experience

Simple, seamless and consistent

Principle #3: Data at its Core

Single source of truth

Principle #4: Standardization and Flexibility

Modular, cloud-based, best practices driven and capable of being tailored

Principle #5: Continued Improvement

Across quality, business process, systems, design, and people

To find out more, read this whitepaper:
https://www.compliancequest.com/whitepaper/five-guiding-principles-for-a-next-generation-eqms/