Upgrading ISO 9001:2008 to ISO 9001:2015 Instructions

Introduction

Good businesses understand quality; great businesses implement it. An ineffective QMS can cost you time, money, and customers. That’s why it’s important to get it right from the start. Implementing a framework based on ISO 9001:2015 helps your business consistently deliver and drive continual improvement in your products and services. Gain the required skills to conduct a base-line review of your organization’s current position and implement the key principles of ISO 9001:2015. Using a step-by-step approach, you’ll learn how to develop an implementation plan, create necessary documentation, monitor your QMS, and achieve continual quality improvement. Background on revision ISO 9001 QMS standard was revised recently, and organizations are granted a three-year transition period until Sept 2018, to migrate their quality management system to the new edition of the standard. After the transition period, organizations need to maintain the system as per the 2015 version of the QMS. The old edition, ISO 9001:2008 will then be out of date.

Objectives

The purpose of this training course is to help organizations understand how the revised standard will impact their existing QMS, and to plan for transition to the new standard, in view of the changes in the revised ISO 9001:2015 compared to 2008 version.In addition, it will also help qualified internal auditors to upgrade their qualification and competency to the latest version of the standard.

What will you learn?

You will learn about:

• A typical framework for implementing ISO 9001:2015 following the PDCA cycle
• Considering key concepts and requirements of ISO 9001:2015 from an
• implementation perspective
• Implementing key concepts and requirements of ISO 9001:2015
• Specific documented information requirements of ISO 9001:2015
• Using gap analysis to conduct a baseline review of your current system

How will you benefit?

This course will help you:

• Identify key benefits to your organization from implementing an effective QMS
• Develop a plan and determine the resources required for the implementation
• Apply good practice to the implementation using proven tools and techniques
• Implement a system that enables a better response to customer requirements and market changes
• Provide products and services that consistently meet customer needs and enhance customer satisfaction.

Training Methodology

This is an interactive course. There will be open question and answer sessions, regular group exercises and activities, videos, case studies, and presentations on best practice. Participants will have the opportunity to share with the facilitator and other participants on what works well and not so well for them, as well as work on issues from their own organizations. The online course is conducted online using MS-Teams/ClickMeeting.

Who Should Attend?

The course is designed for quality control professionals, quality assurance, or regulatory affairs personnel who have responsibility for quality systems.

Course Outline

Day 1 :

• Course Introduction
• Reasons for Revision
• ISO 9001:2015 Timeline
• Annex SL
• Key Changes
• Clause Structure
• Requirement Grouping
• Quality Management Principles

Introduction to ISO 9001:2015

• The ISO Standards for Quality Management
• Process Approach
• Plan-Do-Check-Act Cycle
• Risk-based Thinking
• Compatibility with Other Management System Standards
• Scope
• Normative References
• Terms and Definitions

Day 2:

• Context of the Organization
• Understanding the Organization and its Context
• Requirements and Changes
• Understanding the Needs and Expectations of Interested Parties
• Requirements and Changes
• Determining the Scope of the Quality Management System
• Requirements and Changes
• Quality Management System and its Processes
• Requirements and Changes
• Class Workout – Clause 5
• Leadership
• Leadership and Commitment for the Quality Management System
• Requirements and Changes
• Customer Focus
• Requirements and Changes
• Quality Policy
• Requirements and Changes
• Organizational Roles, Responsibilities, and Authorities
• Requirements and Changes
• Class Workout – Clause 6

Day 3:

• Planning for the Quality Management System
• Actions to Address Risks and Opportunities
• Requirements and Changes
• Quality Objectives and Planning to Achieve Them
• Requirements and Changes
• Planning of Changes
• Requirements and Changes
• Class Workout – Clause 7
• Support
• Resources
• General
• Requirements and Changes
• People
• Requirements and Changes
• Infrastructure
• Requirements and Changes
• Environment for the Operation of Processes
• Requirements and Changes
• Monitoring and Measuring Resources
• Requirements and Changes
• Organizational Knowledge
• Requirements and Changes
• Competence
• Requirements and Changes
• Awareness
• Requirements and Changes
• Communication
• Requirements and Changes
• Documented Information
• General
• Requirements and Changes
• Creating and Updating
• Requirements and Changes
• Control of Documented Information
• Requirements and Changes
• Class Workout – Clause 8

Day 4:

• Operation
• Operational Planning and Control
• Requirements and Changes
• Determination of Requirements for Products and Services
• Customer Communication
• Requirements and Changes
• Determination of Requirements related to Products and Services
• Requirements and Changes
• Review of Requirements related to Products and Services
• Requirements and Changes
• Design and Development of Products and Services
• General
• Requirements and Changes
• Design and Development Planning
• Requirements and Changes
• Design and Development Inputs
• Requirements and Changes
• Design and Development Controls
• Requirements and Changes
• Design and Development Outputs
• Requirements and Changes
• Design and Development Changes
• Requirements and Changes
• Control of Externally Provided Products and Services
• General
• Requirements and Changes
• Type and Extent of Control
• Requirements and Changes
• Information on External Providers
• Requirements and Changes
• Production and Service Provision
• Control of Production and Service
• Requirements and Changes
• Identification and Traceability
• Requirements and Changes
• Property Belonging to Customers or External Providers
• Requirements and Changes
• Preservation
• Requirements and Changes
• Post-Delivery Activities
• Requirements and Changes
• Control of Changes
• Requirements and Changes
• Release of Products and Services
• Requirements and Changes
• Control of Nonconforming Process Outputs, Products, and Services
• Requirements and Changes
• Class Workout – Clause 9

Day 5:

• Performance Evaluation
• General
• Requirements and Changes
• Customer Satisfaction
• Requirements and Changes
• Analysis and Evaluation
• Requirements and Changes
• Internal Audit
• Requirements and Changes
• Management Review
• Requirements and Changes
• Class Workout – Clause 10
• Improvement
• General
• Requirements and Changes
• Nonconformity and Corrective Action
• Requirements and Changes
• Continual Improvement
• Requirements and Changes
• Closing