No evidence of measurements of customer satisfaction.
No procedure and lack of evidence of compliant internal audits being conducted.
Processes and product are not being monitored effectively to ensure quality.
Nonconforming products are not identified or are reworked without being reinspected afterwards.
Data is not being collected and analyzed on customer complaints and product conformity in order to demonstrate the suitability of the processes, and drive continual improvement.
No systematic evidence of continual improvement i.e. Continual Improvement Plan.
No corrective action being conducted.
Confusion between corrective and preventive action.
Common findings during certification audits to ISO 9001:1994:
Element 4.1 Management Responsibility
Objective evidence that top management is not committed or involved in the ISO implementation/ adoption
No Management Review meeting was held.
No Management Representative was designated.
Lack of knowledge or involvement of Top Management in the corrective action system.
Lack of understanding or knowledge of the quality system.
Lack of resources committed and identified to meet the ISO 9000 requirements (no verification, audit, or QA personnel. Refusal of expenditures towards meeting calibration requirements
Designated ISO/Management Representative has limited knowledge of ISO 9000 requirement or intent. (see
Element 4.2 Quality System
Lack of Level 1, 2 and 3 documentation.
Canned Manuals and procedures that have nothing to do with company's operation.
Element 4.3 Contract Review
No actual review of quotes, bids, POs or Sales Orders
No amendments to contracts conducted when an order is going to ship late, incomplete or in deviation of customer
No feedback loop from production/planning to adequately conduct a determination of capability before taking and
No feedback loop from production/planning to adequately conduct amendments to contracts when production is going to deviate from the order requirements (due date, specs, qty etc..)
Sales personnel taking orders that they know they cannot really fulfill (due date, specs, qty
Element 4.4 Design Control
Design Project records not maintained.
No evidence of planning and planning updates during design cycle. Planning does not include Design Review, Output, Verification or validation
Verbal design inputs are not documented. No evidence of review of the design input. No evidence of design parameters verification or validation.
Confusion between design reviews and design verification, or design verification and validation. No complete design cycle
No Configuration Control for software design.
Element 4.5 Document and Data Control
Working drawings and specs with unauthorized changes such as whiteout, or changes in
Customer supplied drawings or specs with unauthorized changes. Pattern of lack of control of documents such as forms (logs, checklists), internal
Xerox copies of documents that are under distribution control such as procedures and work instructions. Obsolete documents at the work place.
Uncontrolled postings, markings, and instructions at the workplace.
Uncontrolled documents of external origin (ISO, IPC standards)
Element 4.6 Purchasing
Purchases done verbally with no records of the purchasing data (POs, contracts, specs
Purchases conducted with unapproved vendors (subcontractors) for items critical to quality (calibration services, maintenance services, carriers etc) ASL kept but not really
Product or service nonconformities linked to vendors are not fed-back to Purchasing in order to continuously evaluate vendors.
Element 4.7 Control of customer supplied product
Customer supplied products not recognized as such, and treated like regular
Equipment supplied by customers not considered as CSP (computers, inspection
Element 4.8 Identification and traceability
Products or material not identified at various stages of the process neither by labels, markings, process documents, nor by location. The employees just know what it is
Multiple errors in serialization where traceability is a required.
Element 4.9 Process Control
No Preventive, or Predictive maintenance procedures or records.
Lack of effective procedure(s) for scheduling/planning.
Lack of quality plans for service companies.
Insufficient level 3 documentation to address the process.
A lot of recording activities not covered in the work instructions or procedure, and the recording media is not referenced (forms, logs
Process parameters specified without allowance for normal variation (range).
Element 4.10 Inspection and Testing
Inspections conducted without clear inspection criteria in the procedures or in the inspection documents.
Inspection documents lacking clear Pass/Fail information.
No incoming inspections (PO vs. Packing slip, shipping damages, Qty, C of Cs).
No inspections at all when inspections can/should be conducted.
Inspection records not kept or maintained as Quality Records.
Element 4.11 Calibration
Lack of understanding of what needs to be under calibration control. Measuring instruments are usually left out.
Recall process managed by calibration vendors not by the supplier.
Majority of devices is "For Reference Only"
No investigation of prior use when a device is found to be out-of-calibration.
Test software not under calibration control.
Element 4.12 Inspection and Test Status
Products at certain stages of the process without any way to tell whether they have been inspected, have passed, or have failed inspection. "The operators just know".
Element 4.13 Control of nonconforming product
"This is not nonconforming product, this is good product! It is only missing serialization labels!"
Products that do not meet a certain requirement (qty, inspection, minor features) not identified as
Nonconformities and dispositions not documented.
No bug-tracking system/database for software nonconformances.
Element 4.14 Corrective and Preventive Action
Customer Complaints not logged.
No feeding of customer complaints (major or trends) into the Corrective Action system.
Product nonconformities (MRB, NCMRs) not linked with the corrective action
Nobody or few people aware of the Corrective Action System.
Top Management not in the loop.
Very shallow or nonexistent root-cause analysis.
No verification of effectiveness conducted. CAR timelines are not managed and majority is open.
"This corrective action is also a preventive action because it prevents the problem from happening
Confusion between Corrective and Preventive action. (COMMON)
Element 4.15 Handling, Storage, Packaging, Preservation and Delivery
Products with shelf life, or preservation issues not identified and controlled/protected against
Chaotic storage system.
No procedures for Handling, Storage, Packaging, Preservation, or Delivery.
No periodic maintenance and check of ESD systems.
4.16 Control of Quality Records
"This is not a Quality record! It has nothing to do with
Records stacked, hidden, and/or difficult if not impossible to retrieve.
Only completed forms becoming quality records.
Quality Records kept in shoeboxes and exposed to damage.
4.17 Internal Quality Audits
No CARs issued per internal audit. "Everything was
No complete audit conducted (all applicable ISO elements, all Departments/activities)
Element 4.18 Training
No training records kept. No training records relating to the quality system: Procedures, Work Instructions, quality
Training needs determination is not related to the quality system.
No identification of qualification requirements.
Employees not trained on ISO 9000, quality policy or procedures... (see Online training).
Element 4.19 Servicing
Confusion between maintenance and
Servicing element applicable but not recognized (supplier offering extended warranties, repair services not under
No contract review/amendments on servicing orders.
Element 4.20 Statistical Techniques
Statistical techniques used but not
No statistical techniques used on customer complaints, and product or service
ASL kept but not really used.
Process without inspections, SPC or product validation.
For more detailed information on the ISO 9000 standard and its interpretation consult
For Training on ISO 9000 and internal auditing see Online training
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