AreaNotes1Quality Manual and Document Levels Level 1: Quality Manual addresses each ISO requirement Includes Quality Statement,

Quality Objectives and Org Chart. Everyone should memorize the quality goal: "Exceed our Customers Expectations...Continuous Improvement?" Level 2: -General procedures Level 3: Detailed Test Data, Production procedures 2Management Commitment and Review Management sets quality statement and objectives Periodic Meetings of executive staff to discuss quality (at least 1 every 12 months) Feedback goes into Corrective and Preventive Actions system (creating an ECO) Meeting records area a quality record and are kept in Doc control 3Trained or Qualified Personnel Training and qualifications records are maintained in personnel. Everyone must be either qualifiedor trained to do their job. 4Equipment Calibration and Maintenance All equipment must have records showing calibration history and status. There is an area in quality for out-of-cal equipment. Records are managed in a database 5Internal Audits Periodic Internal quality Audits to CI system. Full internal quality audit required every 12 months Auditee should help internal auditor find flaws in system so they can be corrected before an external audit. 6Corrective and Preventive Actions Continuous Improvement Systems

Engineering Change Requests =Queue for needed actions Engineering Change Orders=Used to control all changes in documentation Online system for ECRs and ECOs. 7Design Control (9001) All Design projects must have:

Plan Timeline Specifications defined and revision controlled Product must be tested, verified and validated Periodic design reviews must be documented Design notebook is kept as a quality record. 8Document Control Revision Control of all documents using ECO Inventory Control system is the source for current Rev level We use a paperless system (all docs are on-line) Quality Manual and all higher level procedures are on-line 9Control of Non-Conforming Materials Orange Tag system (in-house) and Return Authorization (customer returns) systems There should never be a bad part on the floor without a tag or label. Also used to manage inventory transactions. 10Control of Purchasing Based on central inventory system part master with Mfg part numbers, purchasing info or Doc sets. (Vendor approval process and VLC). Part masters and BOMs have multiple functions (build, cost tracking, selling) ECO required to change. 11Control of Order Entry and Service Processes Customer requirements must be:

Defined Clear Confirmed by qualified personnel 12Inventory Control All inventory must be properly marked, packaged stored, separated and protected ESD sensitive components Limited Shelf Life components FIFO Min tags 13Process Control and Data Analysis Our process control is based on: Independent Quality Audits Inspection records and NCM Final test documentation