Implementation and Documentation of a Quality System to the ISO 9001:2015 Standards
The effect of ISO 9001 on the global marketplace has been far-reaching. The pressure to conform is increasing; making it certain suppliers will have a competitive advantage if they are certified. System Documentation is vital to Quality System maintenance according to ISO 9001. Focus will be upon the simple, concise and clear creation of the Quality Manuals, Procedures, Work Instructions and Control Methods in accordance with ISO 9001:2015. This course incorporates formal presentations, open discussions, teamwork, case studies and a hands-on workshop to create actual documents.
Please note: This is a required course for the AIIM:2015 Certificate or can be attended as a stand-alone course.
This two-day course is designed to provide participants with all of the necessary information, skills and methods for developing quality documentation in compliance with ISO 9001:2015 requirements. Participants will gain the knowledge and competencies required to enable them to assist their company in documenting its quality management system for ISO 9001 certification.
Who Should Attend
- Project leaders responsible for implementing quality system documentation.
- Personnel responsible for creating and maintaining quality system documentation.
- Personnel responsible for training others to prepare and maintain quality system documentation.
- An excellent next step for persons with prior knowledge of ISO 9001 who are looking for practical training in implementing a system.
Upon completion of this course you will have:
- Increased your "hands-on" understanding of the ISO 9001:2015 Standard and its relevance to you.
- Learned how to plan, develop and write procedures most effectively.
- Approached the writing of procedures so that they are consistent, accurately reflect their scope of activity and are auditable.
- Benefited from the expertise and experience of a Quality Systems Lead Auditor.
Day 1 - registration/check-in will start at 8:00 a.m. with sessions to begin at 8:30 a.m. and adjourn at 4:00 p.m. Day 2 will commence at 8:30 a.m. and adjourn at 4:00 p.m. There will be 15 minute mid-morning and afternoon breaks. A light lunch is included from 12 noon to 1:00 pm.
Day 1 - Welcome and introduction
Explaining the documentation structures required for an effective Quality Management System
Explaining the documentation content
A review of ISO 9001:2015; what does each clause require?
Explaining How to Create the Documents
Flow-charting your processes
Translating the flow-chart into a Quality Manual
Sessions Resume Procedures and work instructions
Explaining How to Write the Documents
Exploring Quality Records and Forms Required
Explaining How to Control the Documents
The principles of document control
Some simple control methodologies
Creating the documents - hands-on practice at creating policy, procedures and work instructions
Participants enrolled in the AIIM Certificate Program, of which this course is a required component, will be expected to complete an assignment within two weeks of the last day of the course. Those attending this course as a stand-alone seminar may opt out of the assignment if they wish.
Each participant will receive a complete set of course notes and handouts that will serve as information references.
Kathryn Lynn MacLeod is a certified Lead Quality Auditor and is President of Anchor Professional & Training Services (APTS) Ltd. APTS is a full-service professional training and development practice servicing a diverse international client base. Kathy is an Associate with an internationally recognized Quality Registrar and acts in the capacity of ISO 9001:2015 trainer, lead assessor and market development. Kathy was instrumental in the management and development of Nova Scotia's Quality and Productivity Initiative (QPI). Her expertise lies in the areas of Quality Assurance Systems and Standards (CSA Z299/ISO 9000), Service Quality, Total Quality Management and Organizational Excellence, Productivity Improvement, Food Quality and Safety, Change Management and Organizational Cultures.
Kathy has provided hands-on advice and guidance to over 300 companies. As a certified Lead Assessor, she has assisted her clients in their achievement of registration to international standards of quality assurance and successful implementation of quality processes and philosophies. In addition to her work with ISO 9001, Kathy's management experience covers both the public and private sectors in quality and safety analysis, auditing, assessments, training, facilitation, quality and productivity studies and benchmarking.
A Certified Toastmaster, Kathy has taught public speaking and has given motivational speeches and presentations to groups and organizations on a wide variety of quality and quality related topics. She is also an instructor for Dalhousie University, College of Continuing Education, Continuing Technical Education, and is currently teaching an ISO 9001:2015 certificate program along with several other courses in quality and process improvement. Kathy is a recipient of the ASQ Harry James Quality Commitment Award.