(Manufacturer of Refrigeration Equipment and Supplies) - QMS Certification
GEA Refrigeration
Jack Sekhon and Associates assisted GEA Refrigeration Inc in achieving certification to ISO 9001 QMS Standard.=
Case Study
Highlights of certification project:
PLANNING STAGE:
- Appointment of project sponsor for overseeing the project.
- Formation of senior management team for on-going commitment, engagement and support.
- Formation of process teams for engaging in functional hands-on approach.
- Training on process approach and risk-based thinking.
- Training on ISO 9001 Standard requirements.
- Determination of QMS scope-including project management, engineering, research and development, procurement, shipping/receiving, production, maintenance, warranty, sales and marketing, assembly and commissioning.
FRAMEWORK DEVELOPMENT
- Development of Process Lists through identification of functional processes based on process approach.
- Development of Risk Registers through application of appropriate risk assessment methodology.
- Development of Legal Register related to products/services.
QMS DEVELOPMENT
- Quality Policy, Quality Objectives and Quality Manual.
- System procedures based on risk assessment and ISO Standard.
- Operating procedures for various functions based on risk assessment.
- Product, Process and System KPIs.
- Tools (Templates, Forms, Databases, Checklists).
QMS IMPLEMENTATION
- Training on their QMS.
- QMS Management Questionnaire.
- QMS Employee Questionnaire.
- Assistance during implementation.
QMS INTERNAL EVALUATION
- Process and risk based Internal audit including product and process audits.
- Value adding management review based on analyzed data and ISO 9001 Standard requirements.
- Follow-ups on internal audit and management review gaps.
QMS EXTERNAL EVALUATION
- Stage 1 external audit.
- Follow up on stage 1 gaps.
- Stage 2 external audit.
CERTIFICATION RESULTS
- Non-conformance free certification.
- Enhanced customer satisfaction.
- Increased market share.
- Efficiency and effectiveness improvements.
Bio-Edge
Bio-Edge, a manufacturing company based in San Diego, California specializes in the production of polymer based medical device components. With a commitment to achieving certification of their QMS to ISO 9001:2015 Standard. Read Full Case Study.
Wastech Services Ltd
The project commenced with the formation of executive and process teams. A project execution plan was prepared. Read Full Case Study.