Organizational Roles, Responsibilities, Collaborator Skills & Training, Knowledge Management

The leadership section of ISO 9001:2015 describes that roles and responsibilities must be assigned, communicated and understood. The organization chart makes it easy for end users to understand the organization functions with their responsibilities. By drilling down the organization chart, end users can view the related sub processes a process owner is responsible for and […]

Six Sigma Project Management

Six sigma has its roots in statistical process control. When a process operates at the six sigma level, the resulting products and services are 99.9997% defect free. As an example for drug prescriptions, improving the process capability from 3.8 sigma (99% good) to six sigma (99.9997% good) would reduce wrong drug prescriptions from 200,000/year to […]

Context of the Organization

This section of ISO 9001:2015 is for your organization to have a clear scope of the environment it engages in and direct + indirect customers that it serves. BPA provides a SWOT analysis tool to assess the influencers that come from both external sources (Opportunities and Threats) and internal sources (Strengths and Weaknesses). The competitive […]

Change Management

Planning of changes refers to those changes that are part of everyday business, new programs, changing financial structures, end-of-life of a product and obsolescence of an equipment. All of these changes can affect the QMS. With BPA, each change request is considered as a project with timing, cost and impacts on the QMS. Impacted QMS […]

Process Approach

ISO 9001:2015 utilizes a process approach in the implementation and auditing of a QMS. A process has five distinct characteristics: Inputs Outputs Use Transformation Measurability Ownership In this last revision, the process approach was enhanced with the consideration of the PDCA cycle and risk-based thinking. Therefore, having a process approach helps with multiple standards, like […]

Deploying Your ISO 9001:2015 Quality Management Software

BPA Solutions has developed a flexible and cost effective quality management software to help you to deploy ISO 9001:2015 in your organization. Process Approach Achieve continuous improvement with a collaborative PDCA tool Navigate your QMS easily from a graphical core process map Select your key processes among 50+ described processes Be compliant with any QHSE […]

US States *

Employees *