ISO 9001 An Overview Marc Smith

Introduction The Purpose of this Presentation is to Provide an Overview of ISO 9001 and What It Means to Everyone at Gunderlin Speakers Choice

ISO 9001 The Ultimate Goal of ISO 9001 is to Provide CONSISTENT PROCESSES Documented Systems Provide For Consistency RESPONSIBILITIES Defined Periodic Internal & External Audits Ensure Systems Are Working ISO 9001 is a European Origin STANDARD ISO = Greek isos (equal) International Organisation for Standardisation It is NOT a specification. It is intended to provide for ‘common’ quality systems across borders. It is derived from many quality related documents dating back to the 1950’s from many countries, including documents from the United States. The goal of common quality systems is consistent, controlled processes. It does this by requiring certain documentation telling how things are done and who is responsible for what.

ISO 9001 Origin & Scope Of Application International Organization for Standardization TC 176 - Meets in Geneva, Switzerland TC = Technical Committee Europe Wide Must Be Registered to Sell In Europe Japan is Accepting US Military Switching From MIL-Q-9858A The ISO 9001 document is a joint effort of many countries. Like ‘specificaations’ for things like CD formats and electronics standards, ISO 9001 is an attempt to standardizeQuality Systems across borders. It is authored by TC (technical committee) 176 which meets several times a year. The most recent release is from 1994. It is expected to be updated again in about 2 years - it is scheduled to be revised about every 4 years. To sell product (other than something as benign as toilet paper), a company has to be ISO 9001 registered. The pacific rim countries are incorporating ISO abit slowly. The US military has obsoleted MIL-Q-9858A and is requiring ISO 9001 for new contracts.

ISO 9001 Sections Section 4 - Quality Management System Section 5 - Management Responsibility Section 6 - Resource Management Section 7 - Product Realization Section 8 - Measurement, Analysis and Improvement York Milwaukee Doesn’t Apply ISO 9001 is made up of 20 sub-elements or sections. They are listed here. Each sub-element (or section) addresses a specific aspect of a company’s business systems. Each element addresses a ‘process’ considered to be critical to Quality. The Nonconformance and Corrective Action Systems are aimed at continuous improvement. Note that even Design and Purchasing, which are each really processes, are targeted, not just manufaturing processes.

Responsibility Circle (or Cycle) Of Responsibility Industrialisation 1800's 1930's 1960's Quality In Hands Quality In Hands Of 'Operator' or Of Management Artesian Statistics & ISO 9001 is about responsibility (which is accountability). Historically, quality was in the hands of the individual artesian. As industrialisation occurred, especially when the theory of Interchangeable Parts was acted upon (result = assembly lines), quality came to be perceived to be a function of designers - eventually, by the 1960’s, management had assumed the role as the definer of, and the responsibility for, quality. Quality is now perceived to be what the customer expects - However, the responsibility for quality is again realised to be in the hands of the individual artesian. This coincides with: Empowerment 1990's Data Analysis 1970's Information Age

Documentation Organization Tier 1 Defines Approach Through Policies (We will... or We do…) Applies to the Entire Company Systems Manual Tier (Level) 2 Defines Who, What and When Things Happen (These describe Tier 3 Sub-Systems) Major Systems - Typically Apply to the Entire Company Policies and General Operating Procedures Tier (Level) 3 Answers How Things Happen - The Individual Steps (These describe Tier 4 Documents (Records) Department and/or Location Specific Product and Process Documents Inter-Departmental Procedures Tier (Level) 4 The Results of Tier 3 Systems/Procedures - Evidence of Occurrence such as Inspection and Test Results Procedure Specific Forms and Tags Objective Evidence Records This is a ‘standard’ documentation pyramid. It is annotated on the far left with examples of appropriate Harley-Davidson documents. Tier 1 = Policies (H-D provides systems to address certain items) Tier 2 = Think of these as Overviews of major systems (e.g.: Nonconformance system, Purchasing system, etc. Tier 3 = The actual systems in detail Tier 4 = Objective evidence - Proof that the systems are functioning as well as a source of data for various evaluations (such as inspection & test data). Tier (Level) 5 These Are Typically Investigative Documents and Records Situation Specific Ad Hoc (Temporary) Documents (including any associated records) The 'Standard' Document Pyramid

Documentation Organization Charts Procedures Forms Tags Prints Flow Charts Process Sheets Process Routers Work Instructions Forms Tags Prints Specifications SPC Data Inspection & Test Results These are examples of documentation. Documentation may be: On Paper, A Computer File or Electronic Media, a Book Documentation provides ‘Rules’ on how certain things *must* be done or describes ATTRIBUTES. A word about procedures: Procedures do not have to be long text documents. They can be: VERBAL, a simple FLOW CHART, or a TEXT DOCUMENT. Procedures.

Myths vs. Truths ISO 9001 Is NOT An Effort To CHANGE The Way You Do Things Now! Documentation Is Meant To Be Easily Changed! The Less Documentation, The Better. Think On The Job (OTJ) training. There may be some changes in the way you do the things you do but they should be minor, if any. A common misconception is that once there is documentation, there is no easy way to change the documentation if it is wrong or ineffective or if it should be changed for another reason. This is NOT true. Documentation will be easily and quickly changed when necessary. The idea is NOT to simply put in tons of ‘written procedures’ for people to follow. No procedure will be written detailing how to go to the bathroom or how to go to lunch, for example. It is difficult to quantify ‘adequate’, but the idea is to provide documentation which is ‘adequate’ to ensure quality and consistency of processes.

Basic Rules Your Job & Documentation SAY What You Do DO What You Say You Do Actions If It’s Not WRITTEN Down, It DIDN’T Happen Say what you do - this is the documentation (Tiers 2 & 3) which describes how jobs are performed. Moves - Train: This means for every person doing a job, ensure training so that they can perform the function. Doesn’t - Calibrate: If it takes a measurement or provides a certain measurement (e.g.: torque tools), it MUST be calibrated. If people do not complete forms and tags as necessary, there is no evidence that the event happened.

Real Life What ISO 9001 Means To You You MUST: Know Your Job Duties Know What Training Your Job Requires Be Able To Tell About How You Were Trained Know What Documentation Involves YOU! Know How To Find Out What The ‘Latest’ Version Is Know What The Documentation Says Know How The Documentation Applies To YOU! Know What The INTENT of the Documentation These are items which every employee must know. The auditors will ask these questions of individual employees at all levels of the organization. Two aspects are represented. Job requirements, etc., and the requisite documentation.

Quality Policy You MUST Know What The Quality Policy Is And You WILL Be Asked What The Quality Policy Means To YOU! You do NOT have to memorize it word for word! The auditors will definitely ask these questions. EVERYONE MUST KNOW THE ANSWER TO EACH OF THESE!!!

Things To Be Alert For Container / Job Labeling Documents - Watch for “Headers” Title Date Originating Department or Group Containers and racks should have some type of label, tag or other identification. Documents must have: Some type of title which says what it is. A date (could be effective date, expiration date, etc. A signature or initials of the person authorising the document. The place the document is originated so that it is easy to tell where to go to find out the latest revision level and/or when there are problems found with the document. Special attention must be made to tools used to measure or otherwise record or provide a measurement. This includes assembly tools such as torque guns.