ISO 19001 - Quality Management System (QMS)

Describe the ISO 9001 Quality Management System (QMS)-Requirements standard and development process

• Describe the intent and requirements of ISO 9001:2015
• Determine the evidence needed to demonstrate conformity to ISO 9001:2015
• Evaluate documented information required by ISO 9001:2015 and the interrelationships between the quality processes, quality planning, policy, and objectives 
• Apply the principles, processes, and methods of auditing
• Demonstrate the activities involved in preparing for an audit
• Determine an effective audit in the context of the auditee’s organizational situation
• Apply effective audit skills and practice personal behaviors necessary for an effective and efficient conduct of a management system audit 
• Establish and plan the activities of an audit team
• Manage the audit process
• Prepare the audit report and perform an audit follow-up

Content:

Definition and Fundamentals

• Introduction to ISO 9001
• Basic terminology and definitions of Quality Management Systems
• Fundamental principles of Quality Management Systems
• Introduction to ISO 9001 family of standards and versions
• Fundamentals of ISO 9001:2015

Structure

• Changes in ISO 9001:2015
• Requirements of ISO 9001:2015 and its clauses
• Layout standards that follow the PDCA (Plan, Do, Check, Act) cycle
• Approaches and implementations
• Scope and limitations

Quality Improvements

• Compliance procedures
• Planning for improvement
• Rectifying errors efficiently
• Quality Management principles
• Implementation of Quality Management

Internal Audit Structure

• Auditing types, procedures, and planning
• Auditing techniques, decision-making processes and corrective actions
• Phases of an audit
• Assessment of audit reports and documents

Internal Auditor

• Roles, responsibilities and leadership skills of an internal auditor and their team members
• Choosing the right audit plan for a business

Quality Control

• Evaluation of reports and write-ups
• Records and follow-ups
• Using correct procedures in reference to the 9001:2015 standard

Procedures

• Definition of scope, objectives, and policies of a QMS
• Analysing implementation methodologies
• Methods to operate a QMS efficiently
• Planning, selecting, and reviewing the implementation process
• Different ways to detect problems
• Roles and responsibilities of a Lead Implementer and quality team

Implementing an ISO 9001 QMS

• Report reconciliation and documentation
• How to maintain QMS structure through compliance policies
• Sequential operation process
• Measurement, monitoring and controlling of errors   

Lead Auditor Training

• Roles and responsibilities of a lead auditor
• Lead Auditor requirements, scope, and procedures
• Report preparation, findings, reconciliation, and conclusions

On-Site Lead Audit Techniques

• Team selection and planning
• Interactive meetings
• Opening meeting
• Daily discussion meetings
• Closing meeting
• Objective of an Audit Report
• Presentation of reports
• Techniques and processes of an audit

Closure of Audit

• Prevention of errors
• Rectifying errors efficiently
• Reviewing audit strategies and plans
• Follow ups
• Checklist closure
• Surveillance audit

Methods of Collecting Information

• Visual observation
• Examination of records
• Employee interviews

Training Methodology

The training methodology combines lectures, discussions, group exercises and illustrations. Participants will gain both theoretical and practical knowledge of the topics. The emphasis is on the practical application of the topics and as a result participant will go back to the workplace with both the ability and the confidence to apply the techniques learned to their duties.