The ISO 9001 Group is a full service consulting, auditing and training firm based in Houston, Texas. Our mission is to help your organization increase profits, improve operations and reduce or eliminate risks and waste. We are the designers of Conformance Manager, which is a secure SaaS web-based management system software solution, which provides confidence that your management system is always in conformance with the latest management system standards.
www.iso9001group.com

Contact Info
5629 FM 1960 Rd W
Houston, TX 77069
info@iso9001group.com
+ 1 (832) 326-9796
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Dashboard

Upon log-in users are presented with graphs and charts, that provides a clear graphical overview of the health of your management system. Dashboard items include: Employee Feedback, Expired Training, Nonconformities, Risks, Incidences, Equipment Maintenance and Calibration Due and Customer Satisfaction

Reminders and Tasks

Never forget to do important activities, such as conducting your internal audit, management reviews and calibration. Set reminders to remind users or assign tasks within modules, to ensure things get done and accountability is assigned. Users receive email reminders to execute assigned tasks 60-30-15 days of the due date, so important tasks are not forgotten

Reporting

Over 15 standard reports are provided and all data can be downloaded in Excel format, for further manipulation, analysis and reporting. Standard reports include: Objectives, Controlled Documents, Record Retention, NCR Register, Internal Audits, Supplier Evaluation, Training, Maintenance and Calibration, Customer Satisfaction, Employee Feedback, Management Reviews, Equipment Inventory, Document Transmittals and Action Confirmation

Objectives and KPIs

Define management system objectives and establish targets. Establish plans, resources and evaluation methods to achieve each objective. Assign objectives to users to drive ownership and accountability. Monitor objectives based upon an established frequency and trend results

Job Descriptions

Define clear job descriptions for each position within your organization, so that employees are clear on their roles and responsibilities. Define job requirements,  responsibilities, education, experience, skill requirements and legal statements. Group employees per job description for easy monitoring

Training and Competency

Define a training matrix of training requirements for each position within your organization and employees that fill those positions. Once training is provided use the training register, to register required training. Design competency test for positions, so that employees can demonstrate their competency of required knowledge and skills

Document Control

Register all of your controlled documents and upload the latest versions, to ensure employees are accessing the latest documents. Manage document revisions, upload latest versions and overwrite superseded versions of documents. When revisions occur, impacted users receive notifications. Establish review frequencies for documents, to ensure they remain relevant

Nonconformity and CAPA

Capture process and product nonconformities. Associate nonconformities to controlled documents. Perform root cause analysis using the Five Why technique. Establish correction and corrective actions. Assign action(s) to users, so that they actually get done. Schedule review and follow up to verify corrective actions were effective

Risk Register

Register internal and external risks, that may have an impact on your organization’s operations and processes. Assign probability of occurrence and magnitude of impact, to prioritize resources. Establish clear risk mitigation and contingency plans, but more importantly assign the action items of the plans to users, so that they actually get done

Supplier Evaluations

Establish supplier profiles for your suppliers.  Register important information such as: company information, contact information, criticality assessment, scope and capabilities. Schedule supplier evaluation frequencies and conduct supplier evaluations. Set up tasks, so that you don’t forget to perform evaluations

Maintenance and Calibration

Set up equipment types, makes, models and conditions. Once set up, establish preventive maintenance, calibration schedules and routines based upon combinations of makes and models of equipment. Inventory and register operating equipment, machinery, monitoring and measuring devices and other assets. Assigned tasks to users to perform maintenance and calibration tasks

Audit Scheduling

Based upon requirements of various management systems, establish internal and external audit schedules and processes to audit. Schedule internal audits based upon specific processes and schedule routine external audit from customers, certification bodies, regulatory bodies and other organizations. Assign audit tasks to users based upon established frequencies. Never forget to perform or be not be ready for audits again

Deviation and Change Requests

Manage and register deviations and changes effectively. Assess the impact and risks associated with deviations or changes, prior to implementation. Define the issue, controlled document requirement, justification for the deviation or change, resources required, associated risks, risk controls and impact on responsibilities and authorities

Failure Mode Effects Analysis (FMEA)

Analyze potential failure(s) that may exist within your product or service design and their consequences. Determine functions, failure modes, failure effects, failure causes, process controls, recommended actions and effectiveness. Upon performing the analysis receive risk priority and criticality scores. Assign actions to user to drive accountability and follow through

Incident Reporting

Register personnel injuries, equipment damage, property damage and environmental incidences. Capture critical information pertaining to the incident, people involved in the incident, impact of the incident, witnesses, investigations and assign corrective actions. Manage changes that may be required as part of corrective action and schedule monitoring of actions

Meetings

Set up meeting types and topics (agendas) for meetings such as, staff meetings,  management reviews, project kick-off, safety, environmental, design reviews, etc. Schedule meetings and establish clear agenda topics. Capture meeting minutes for agenda topics discussed. Assign action items from meetings to users, so that they get done. Track attendees of meetings

Customer Satisfaction

Measure and monitor your customers’ perception of satisfaction. Create customized survey questions and customer groups (sample) to send your surveys to. Establish survey start and end dates. Customer will receive an email with a link to respond. Receive real-time responses and reports for review and actions

Policies

Communicate important company and site specific policies for users to view upon log-in. Communicate quality, health, safety, environmental and other important company policies that may be required by your management system standard or regulatory body

Quality Plans

Create quality plans for products, services or projects (PQP), to ensure quality control and implementation of critical processes. Establish requirements, documentation required, personnel qualifications, inspection and testing criteria, risk management and more. Attach important controlled documents for users to reference

Calibration and Test Methods

Establish calibration and test methods for testing and calibration laboratories or for your in-house calibration program. Define the method, parameters, reference standards and equipment used, actual method or procedure, maintain traceability, pre-checks, recording observations, safety measures, estimation of uncertainties and more

Design and Development

Document product and service design plans and packages. Establish design plans, stages, resources, interfaces, verification and validation, final review, drawings, customer requirements, environmental and operational conditions, methods, historical performance, legal requirements, risk assessment, purchasing requirements, production requirements, servicing requirements, acceptance criteria and more