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Document that can be used for ISO 9001:2000 Awareness Training.

Here is my ISO awareness training sheet that I use for an annual ISO awareness training class. All employees should understand these basic requirements and every new employee should receive the training.

  Area Notes
1 Quality 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
2 Management 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
3 Trained or Qualified Personnel

Training and qualifications records are maintained in personnel.

Everyone must be either qualified or trained to do their job.
4 Equipment 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
5 Internal 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.
6 Corrective 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.

7 Design 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.
8 Document 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
9 Control 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.
10 Control 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.
11 Control of Order Entry and Service Processes

Customer requirements must be:

  • Defined
  • Clear
  • Confirmed by qualified personnel
12 Inventory Control

All inventory must be properly marked, packaged stored, separated and protected

ESD sensitive components

Limited Shelf Life components

FIFO

Min tags
13 Process Control and Data Analysis

Our process control is based on:

Independent Quality Audits

Inspection records and NCM

Final test documentation