Quality Management System ISO 9001:2008

Introduction Definition of ISO & Background Quality Management System vs. Quality Control Why do we need this standard? How will it benefit us? What does it have to do with me?

Definition of ISO International Organization for Standardization (ISO) International Group Representatives from approximately 160 countries Working together to create worldwide standards ISO 9001:2008 Quality Management Systems Standard Provides guidance and tools for organizations who want to ensure that: Products and services consistently meet customer’s requirements Quality is consistently improved

ISO Quality Management System A quality management system (QMS) is a set of policies, processes and procedures to help the organization meet customer requirements. Being ‘ISO 9001 Certified’ or ‘Registered’ lets our customers and others know that we have: Formalized business processes A secure management structure Customer Focus – We are focused on meeting or exceeding customer expectations

American Certification Structure Performance Review Institute (PRI) RABQSA Certified Auditor Robert Fletcher Aka “Bobby Fletch” Waco Products

Benefits of ISO Customer Satisfaction & Retention Marketing Tool Companies who are focused on delivering quality products and services increase customer satisfaction and retention. Happy customers are repeat customers. Marketing Tool ISO 9001 certification can be used as a marketing tool to promote quality to end users. Customers are more likely to do business with an ISO certified company than one who is not. Greater Profits One of the most compelling benefits of adopting ISO strategies is that reducing waste and increasing productivity leads to greater profits for certified companies. A recent study, written by David I. Levine of the University of California, Berkeley, and Michael Toffel of the Harvard Business School, reinforces the idea that companies and their employees benefit from adopting ISO 9001. The report and its findings can be found at the following link: http://www.anab.org/news/2010/2010/03/companies-benefit-from-iso-9001.aspx

How does it benefit me? Clearly Defined Processes and Expectations Creating documentation so that work is done properly each and every time creates a more efficient, effective operation. Each employee, no matter how large or small the company, can benefit from documented processes. Preventive vs. Reactive Management Continuous improvement of products, processes, facilities, and management support. Positive Culture and Teamwork Attitude Everyone works together toward achieving common goals Becoming certified to the ISO 9001 standard raises quality awareness among employees and motivates them to attain quality objectives. Corrective action and preventive action help to keep quality objectives in the minds of employees.

8 Principles of the ISO 9001 based Quality Management System Principle 1 – Customer focus Principle 2 – Leadership Principle 3 – Involvement of people Principle 4 – Process approach

Principle 4: Process Approach PDCA P – Plan Establish objectives and processes to deliver results D – Do Implement the Processes C – Check Monitor and measure processes and products against documented processes, objectives, and product requirements and report results A – Act Take action to improve performance Repeat

8 Principles of the ISO 9001 based Quality Management System Principle 5 – System approach to management Principle 6 – Continual improvement Principle 7 – Factual approach to decision making Principle 8 – Mutually beneficial supplier relationships

Waco Products, Inc. Quality Management System Established, documented, implemented, maintained, and continually improving.

Basics Quality Policy & Objectives Quality Manual Provides definition of the structure and serves as the foundation of our Quality Management System

The Waco Products, Inc. Quality Management System (QMS) 6 required processes

Taken from 7. 1. 1 of the Waco Products, Inc Taken from 7.1.1 of the Waco Products, Inc. Quality Manual Rev 1/15/14.

Customer Requirements Process Section 7.2 of Quality Manual This is your core process See handout

What to expect In the coming weeks…

ISO Certification Process Stage 1 & Preassessment March 12, 2014 & March 13, 2014 Address Corrective Actions from Stage 1 Stage 2 Certification Audit April 22, 2014 Address Corrective Actions from Stage 2 Receive Certification CELEBRATE!

‘Low Hanging Fruit’ Every auditor knows exactly what to look for first. First impression and presentation is important. Everyday we should be ready for an audit. Here are some things to keep in mind: Good Housekeeping. We want to be presentable and make a good first impression. Dispose of or store Drawings and Job Documentation you’re NOT currently working on. Document Control – Form numbers on forms, job numbers on job related paperwork Records easy to retreive

Important Things to Remember Where can you find our posted Quality Policy & Objectives? How does your day to day work contribute to these objectives? Where do you find the Quality Manual? Where is the ‘controlled’ or ‘official copy’ stored? How do you know if you have the latest version of a Quality Management System Document?

Important Things to Remember The auditor is checking that we are doing what we say we are doing in our documented core process, while keeping compliance with support processes Core Process? Control of Documents, Records, Control of Nonconforming Product, Corrective Preventive Action, Internal Audits, etc.?

During the Audit Make sure your area is clean and free of clutter. Be ready and willing to answer questions. Try not to volunteer too much additional information. Answer the question asked. No less, no more. Relax, be yourself, and remember it is an assessment of the PROCESS, not you as an individual.