ISO 9001:2000 STANDARD: INSPECTION REQUIREMENTS

Navin Shamji Dedhia

Hitachi Global Storage Technologies, Inc.
5080 Bougainvillea Drive
San Jose, CA 95111
U.S.A.

SUMMARY

As of December 15, 2003, the only valid accredited certificate will be those
that state conformity to the requirements of the ISO 9001:2000. Therefore it is
necessary that individuals responsible for inspection activities in an organization
certified to this standard have a clear understanding of those requirements.

Inspection is one of the key requirements stated directly or indirectly in the

quality management systems standard. The inspection requirements in the
standard are implied explicitly or implicitly in the planning process, documentation,
measurements, records keeping and continual improvement activities.

INTRODUCTION

Inspection includes activities such as measuring, examining, testing, gauging

one or more characteristics of a product or service, and comparing with specified
requirements to determine conformity. Inspection is defined as conformity,
fulfillment of a requirement, evaluation by observation and judgment as
appropriate by visual observation, measurement, testing or gauging. Inspection
means to examine carefully or to evaluate the quality of specific product
characteristics in relation to a reference value. Inspection is performed according to
the established criteria and specification.

Inspection and testing is required for product and services at various stages
during receipt of the incoming product or service, during the process of producing a
product or service and on the final product or service. Inspection is used to measure
process and product performance in order to understand better the nature of the
characteristics, interactions and resulting actions for improvements.

It is important to properly inspect and test parts and supplies received,

inspect and test product in process, and inspect and test product before delivery to
verify they meet specifications and other requirements. This is to avoid the risk of
using out-of-specification parts and supplies and delivering out-of-specification
product.

Effective inspection and testing will result in reduced costs due to eliminating
wasted effort and material. It will also ultimately result in increased business due to
high customer satisfaction and customers getting expected goods and delighted
services.

Customers require products with characteristics that satisfy their needs and
expectations. These needs and expectations are satisfied through the inspection, test
and other activities. Inspection provides a basis to determine the effectiveness
and efficiency of processes. Effectiveness and efficiency are defined as:

EFFECTIVENESS means:

- Results of the process confirm the achievement of the desired outcomes

- Extent to which planned activities or planned results have been realized
or accomplished
- Comparing the results with the stated objectives
- Achievement showing a level of process compliance, product conformity
and customer satisfaction
- Outputs are meeting requirements
- Doing the right things
- Achievement of the desired results

EFFICIENCY means:

- Relationship between the results achieved and the resources used

- Resources used per unit in terms of time and money
- Doing things right
- Achieving desired results with the planned use of resources

QUALITY MANAGEMENT SYSTEMS (QMS) - ISO 9000:2000 –

Standard means something accepted as a basis for comparison. ISO

9000:2000 Standard is based on the process approach to improve the effectiveness
and efficiency of the QMS system and thereby enhancing customer satisfaction. For
an organization to function effectively and efficiently, it has to identify and manage
numerous linked activities. The adoption of a quality management system is a
strategic decision of an organization. The quality management system is process
based and the model uses ”Plan-Do-Check-Act” (PDCA) methodology . The
“Check” activity in the PDCA cycle includes monitoring and measuring of processes
and products against policies, objectives and requirements for the product.

All work is a process. A process is a sequence of related tasks that act on

inputs adding value to create outputs. It uses resources and is subject to controls
and influences. A procedure is a recorded description of how an activity or a task is
carried out.

An advantage of the process approach is the ongoing control over the linkage
between the various processes and interaction. Inspection and test provide a basis
for the control by taking appropriate corrective and preventive actions. Inspection
is associated with monitoring and measuring. The requirements related to
inspection are understood from the standards as:

a) Monitor, measure and analyze the processes

b) Monitoring inputs and outputs to verify that individual processes are
linked and operate effectively and efficiently
c) The input to management review shall include information on process
performance and product conformity
d) Documentation related to processes should support measurement and
audit of processes
e) Results from verification and validation of processes and outputs should
be considered as inputs to a process to achieve continual improvement of
performance and the promotion of excellence throughout the organization
f) An operating plan should be defined to manage the processes, including
verification and validation of processes and products
g) During the design and development planning the organization shall
determine the review, verification and validation that are appropriate to
each design and development stage
h) Examples of verification activities for output of the design and
development process include evaluation against similar products, and
evaluation against lessons learned from past process experience, such as
nonconformities and deficiencies
j) Examples of measurement of performance of the organization’s processes
include measurement and evaluation of its products
k) When selecting measurement methods for ensuring that products conform
to requirements and when considering customer needs and expectations,
the organization should consider inspections or testing required to be
witnessed or performed by statutory and regulatory authorities
l) The organization should consider the type of testing, in-process inspections
or testing and product verification as required by the customer or
statutory and regulatory authorities
m)The organization should consider final inspection to confirm that
verification and validation activities have been completed and accepted
n) Typical examples of product measurement records that could be
 considered for performance improvement include inspection and test
reports and others.

The quality management system is that part of the organization’s

management system that focuses on the achievement of results, in relation to the
quality objectives, to satisfy the needs, expectations and requirements of customers,
as appropriate.

The ISO 9000 standard encompasses a) system management, b) system

methodology and c) system maintenance. Inspection process is a part of the system
maintenance. ISO 9000:2000 is based on the eight quality management principles.
Process approach, continual improvement and factual approach to decision making
principles are directly related to the inspection process. Inspection is a process,
and the results are based on the actual data obtained by observing, measuring
or testing. The actual data are used to improve the processes to achieve continual
improvement. ISO and inspection requirements can be summarized as:

a) Say what you do…….

Document the process using the document control system. Procedures

must reflect actual practices.

Inspection is a process and inspection requirements are documented in the

procedures. Processes are used to achieve a result, whereas procedures
are used to perform a task. Processes are difficult to measure, whereas
procedures are easily measurable. Inspection requirements include
inspection points, instruments used, calibration requirements if any,
sampling plans, sampling criteria, accept/reject criteria, disposition of the
product, result recording methods and inspector training qualification
criteria.

b) Do what you say……

Implement the documented procedure. Practices must reflect procedures.

Perform the inspection and document the results.

c) Show me, show evidence, prove it with a record……

Process results must be kept in the record form.

Keep inspection results as a record in a readily available format when

demanded.
QUALITY MANAGEMENT SYSTEMS – INSPECTION REQUIREMENTS

Directly or indirectly specified inspection requirements in the QMS

9001:2000 standard are:

1) Clause 4.1 General Requirements: “e) The organization shall monitor,

measure and analyze these processes…….”

Processes can be controlled and managed efficiently by monitoring,

measuring the outputs against the goals and objectives and analyzing the
data to initiate appropriate actions.

2) Clause 4.2.1 General: “…….d) The quality management system

documentation shall include documents needed by the organization to
ensure the effective planning, operation and control of its processes……”

Inspection plan including inspection points, sampling plan, instruments

used, instrument calibration instructions, accept/reject criteria and
disposition of the product must be documented.

3) Clause 5.6.2 Review Input: “c) The input to management review shall
include information on process performance and product conformity……”

Management must review product and process performance information

derived from the inspection data and results to initiate required actions
for improvements.

4) Clause 7.1 Planning of Product Realization: “c) In planning product

realization, the organization shall determine the required verification,
validation, monitoring, inspection and test activities specific to the product
and the criteria for product acceptance…….”

Planned inspection activities must add value to the organization, provide

needed process/product performance information and meet customer
requirements.

5) Clause 7.3.1 Design and Development Planning: “b) During the design and
development planning, the organization shall determine the review,
verification and validation that are appropriate to each design and
development stage……”

Inspection data obtained during the design and development stages should
have a capability to reveal product flaws, product faults, basic
 performance and functions. Verification is a confirmation through the
provision of objective evidence, that specified requirements have been
fulfilled. Validation is a confirmation through the provision of objective
evidence, that the requirements for a specified intended objectives or
application have been fulfilled.

6) Clause 7.3.5 Design and Development Verification: “Verification shall be

performed in accordance with planned arrangements to ensure that the
design and development outputs have met the design and development
input requirements. Records of the results of the verification and any
necessary actions shall be maintained….”

Verification activities will include various inspection, tests, simulation and

trails at various stages. The resulting data has to be provided to the
Design team for the evaluation and changes.

7) Clause 7.4.3 Verification of Purchased Product: “The organization shall

establish………..and implement the inspection or other activities necessary
for ensuring that purchased product meets specified purchase
requirements…….Where the organization or its customer intends to
perform verification at the supplier’s premises, the organization shall state
the intended verification arrangements and method of product release in
the purchasing information……..”

Inspection, test and other process control requirements should be

developed jointly with suppliers in order to benefit from supplier’s
knowledge. Supplier will send ahead of time or along with the lot the
required inspection, test and process control data for evaluation. Required
incoming receiving inspection or dock-to-stock strategy will have to be
developed to ensure the effective and efficient operation.

8) Clause 7.5.1 Control of Production and Service Provision: “The

organization shall plan and carry out production and service provision
under controlled conditions. Controlled conditions shall include………”

d) The availability and use of monitoring and measuring devices,

e) The implementation of monitoring and measurement….

Monitoring and measurements are implemented to reduce waste, prevent

potential problems, improve methods and process yields. Measurement
data should be converted to information and knowledge to be of benefit to
the organization.

9) Clause 7.6 Control of Monitoring and Measuring Devices: “The

organization shall determine the monitoring and measurement to be
undertaken and the monitoring and measuring devices needed to provide
 evidence of conformity of product to determined requirements…...Where
necessary to ensure valid results, measuring equipment shall: a) Be
calibrated or verified at specified intervals or prior to use, against
measurement standards traceable to international or national
measurement standards; where no such standards exist, the basis used for
calibration or verification shall be recorded…..”

Measuring and monitoring processes include confirmation that the devices

are fit for use and maintained to suitable accuracy and acceptable
standards by calibrating devices at pre-determined intervals.
Measurement data are important for making fact based decisions.

10) Clause 8.1 General: “a) The organization shall plan and implement
monitoring, measurement, analysis and improvement processes needed to
demonstrate conformity of the product….”

Effective and efficient measurement, collection and validation of data will

ensure the organization’s performance and customer satisfaction.
Inspection and testing done for the product evaluation and process
capabilities will lead to continual improvement of products and processes.

11) Clause 8.2.3 Monitoring and Measurement of Processes: “The

organization shall apply suitable methods for monitoring and, where,
applicable measurement of the quality management system processes……”

Process measurements are used to evaluate process performance.

Measurements of process performance are used to evaluate cycle time,
process capability, yield and waste reduction.

12) Clause 8.2.4 Monitoring and Measurement of Product: “The organization

shall monitor and measure the characteristics of the product to verify
that product requirements have been met….”

Product characteristics to be measured or inspected and product

acceptance criteria are established to improve the processes. Final
inspection on the product is performed to confirm that verification and
validation activities have been completed and accepted. Final inspection
prior to shipment ensures that the product is meeting customer’s
requirements. Product not meeting customer requirements is segregated
the nonconforming product is controlled to prevent inadvertent usage.

13) Clause 8.4 Analysis of Data: “The organization shall determine, collect
and analyze appropriate data to demonstrate suitability and effectiveness
of the quality management system………….data generated as a result of
monitoring and measurement……….”
 Possession of a data is an indication of objectivity and certainty. Data
should be generated based on facts. Data integrity, reliability, accuracy,
timeliness, security and confidentiality must be taken into account all the
time. Data rarely provides a direct and straightforward answer. To
obtain useful information the data must be analyzed wisely. Data,
information and knowledge are key management tools to survive in the
21st century. Data and information are build blocks of knowledge
management. The science of decision making under uncertainty rests
on the collection, analysis, and interpretation of data to provide
information and knowledge.

Suitability is the fitness of the management system for its defined

purpose. Management in a suitable system will be able to direct
and control activities of the organization to achieve its quality
policy and quality objectives.

14) Clause 8.5.1 Continual Improvement: “The organization shall continually

improve…………audit results, analysis of data………”

The aim of continual improvement of a quality management system is to

increase the probability of enhancing the satisfaction of customers and
other interested parties. Actions for improvement include measuring,
verifying, analyzing and evaluating results of the implementation to
determine that the objectives have been met. Corrective actions and
preventive actions are part of the continual improvement activity.
Review and a follow-up are required after the corrective and preventive
actions have been implemented.

QMS system related elements like planning, responsibilities, process, criteria

procedure, resources, training and records are key elements for the inspection
function also. Inspection is a process.

RECEIVING INSPECTION

ISO 9001:2000, Clause 7.4.3, Verification of Purchased Product: “The

organization shall establish and implement the inspection or other activities
necessary for ensuring that purchased product meets specified purchase
requirements.”

In order to avoid using out-of-specification parts and supplies, it is essential

to ensure that incoming product is not used or processed until it has been inspected
or otherwise verified as conforming to specified requirements in accordance with
the quality plan or documented procedure.

Where incoming product is released for urgent production purposes, it is

required to positively identify and record the product in order to permit immediate
recall and replacement in the event of nonconformance to specified requirements.

Receiving inspection is very closely tied with purchasing. The purchasing

process is where controls are put in place to make sure that suppliers provide
quality products and services. When these criteria are established, compatible
inspection and test criteria are also established.

In determining the amount and nature of receiving inspection, consideration

should be given to the control exercised at source and documented evidence of
quality conformance received from the supplier.

IN-PROCESS INSPECTION

ISO 9001:2000, Clause 8.2.3, Monitoring and Measurement of Processes:

“The organization shall apply suitable methods for monitoring and, where
applicable, measurement of the quality management system processes.”

Product conformance to specified requirements is established by the use of

process monitoring and control methods, by holding product until the required
inspection and tests have been completed or necessary reports have been received
and verified. Certain product characteristics cannot be inspected or measured
during the subsequent inspection or tests and are only detected when the product
does not work in the customer’s environment. These characteristics and other
process information is measured when the product is being fabricated.

FINAL INSPECTION

ISO 9001:2000, Clause 8.2.4, Monitoring and Measurement of Product:

“The organization shall monitor and measure the characteristics of the
product to verify that product requirements have been met.”

Final inspection and test are performed to avoid delivery of nonconforming

product and to meet customer’s requirements. Certain parametric testing is
necessary to guarantee that product will work at system level in the higher assembly
level.

INSPECTION, MEASUREMENTS AND RECORDS

ISO 9001:2000, Clause 4.2.4, Control of Records: “Records shall be

established and maintained to provide evidence of conformity to requirements and
of the effective operation of the quality management system.”

Measurements during inspection requires the following steps:

 1) Measure – Regular and effective measurements are performed on
a process or a product as stated in the documented plan.
2) Monitor – Data is checked and studied for validation. Results are
analyzed to create awareness and becomes a part of the decision making
tool.
3) Manage – Actions are taken based on the data analysis.
4) Maximize – To maximize the results, plan is inspection plan is revaluated
for improvements and breakthrough.

To avoid question about the validity of inspection, records must be

maintained to provide evidence that the product has passed the inspection with the
defined acceptance criteria. Records are historic documents at a point in time.

CONCLUSION

Inspection is an activity that compares specified characteristics with specified

requirements in order to establish conformity. More precisely, inspection is
an activity that compares one or more characteristics of process or product with
specified requirements in order to determine if the requirements have been met.

Inspection is performed at the source of operation in order to provide

immediate feedback for improvements. Inspection is a process providing focused
and prioritized improvement opportunities. ISO 9000:2000 stresses inspection in
various clauses with words including monitoring, measuring, analyzing,
documenting, reviewing process performance and product conformity, planning for
the inspection activities, verifying product and controlling processes, monitoring
and measuring processes and products.

There is no requirement that everything has to be inspected. The

requirement is that good parts, raw materials and services go into making of a
product. The standards require that the inspection processes be planned,
developed, documented, implemented, monitored and improved.

Like QMS standard, inspection requires:

- Management commitment, involvement, focus and responsiveness

- Organized, responsible , authorized, empowered, trained and
knowledgeable employees
- Processes that are visible, traceable, consistent, repeatable, measurable
and are documented
- Documents that are appropriate, relevant, simple, understandable and
 consistent

Importance of inspection requirements can be interpreted from the PDCA

model and from the eight quality management principles on which the ISO
9000:2000 is based.

REFERENCES

1. American National Standard: Quality Management Systems – Fundamentals

and Vocabulary, ANSI/ISO/ASQ Q9000-2000, ASQ
2. American National Standard: Quality Management Systems – Requirements
ANSI/ISO/ASQ Q9001-2000, ASQ
3. American National Standard: Quality Management Systems – Guidelines
for Performance Improvements, ANSI/ISO/ASQ Q9004-200, ASQ
4. Dedhia, Navin S., “Does ISO 9000 Recognize Inspection”, ASQC’s 50th Annual
Quality Congress Proceedings, May 13 – 15, 1996, Chicago, Illinois, USA
5. Dedhia, Navin S., “Data, Information and Knowledge for Quality Management”,
An Executive Handbook, World-Class Quality, Section Four: Critical Focus
for World-Class Quality, Chapter 18, pages 339 – 353, Tata McGraw_Hill,
India, Dec 2002