What is ISO9000?

The International Organization for Standardization (ISO) is a worldwide federation of national standards
bodies from 100 countries, one from each country. This council decided upon a set of industrial standards in
1947 and has been updating them ever since. Recently, ISO9000 has become commonplace in the industrial
world. Usually, one of the first questions that customers will ask of a potential supplier is, "Are you ISO9000
certified?" That certainly explains the importance of ISO9000.

What is a good example of a 'standard' at work?

Imagine for a moment that each credit card company decided to make their cards different thicknesses. Each
department store would have to have several different scanning machines in order to read all the different
cards. Instead, a standard was set and agreed upon by everyone who made credit cards. The standard stated
that all credit cards (and indeed, any card requiring scanning) is to be 0.76mm thick. That is a standard at its
best! What did it achieve? It made life simpler, increased reliability, and it increased effectiveness of the
cards and in effect a large portion of the economic world.

So, I've answered the first two questions that should have told you what ISO9000 is and why it is needed.
Now, how does this relate to the chemical industry?

Let's say that you are the owner of a large chemical company that uses methanol to produce many various
chemicals for your customers. If the methanol that you are purchasing is not 99.5% pure, you can't use it due
to process problems that it would create not to mention the poor product quality that may result. You have
the utmost confidence in your Quality Control department to catch these shipments that do not meet your
purity requirements. So, you require your supplier to perform any organized testing methods for the methanol
that they send to you. Although the chances are slim, a shipment that is only 99% pure slips through the
suppliers testing due to an oversight in procedures and the same oversight in procedure at your company
allows the methanol to enter the reactors at your plant. What happens? Off specification products that have
to be downgraded cost your company thousands of dollars. Then the remaining methanol has to be pumped
out of the tank and sent back to the supplier. Now, you are very upset with your supplier and begin to seek
another. But how can you find a supplier that won't make the same mistake? What about the mistake that
happened in your lab which allowed the methanol to pass inspection and get into the production line? What
could have happened? Maybe the NMR used to analyze the sample wasn't cleaned properly. Why not? It's
not stated in the procedure manual and a new lab technician was on duty. This is where ISO9000 comes into
play. A large part of ISO9000 is to help close these quality "holes" where problems like this can come into
play. If your company and your methanol supplier were ISO9000 certified, you could have been assured that
proper procedures were in place to prevent such an incident. That is not to say that is still could not have
happened, but now both companies have grounds for disciplining the employees at fault to ensure that it
doesn't happen again, because after all, "it was in the procedure manual!"

This 'offbeat' example should have made you think about the advantages of ISO9000 and why so many
customers are interested in it. It is a very complex system that is designed to help assure quality products,
improve safety, reduce waste, reduce costs, and increase efficiency. If you remember anything about

1 of 2 9/28/2009 1:27 PM
 ISO9000, remember that last statement. If I had to summarize ISO9000 in a statement, I would chose the
same one that many people do:

In order to become ISO9000 certified, a company has to implement a standard way to documentation and
operation. The procedure manuals for companies that are ISO9000 certified should be formatted according to
a specific outline. The link below will show this outline and detail its makeup.

ISO9000 STANDARDIZATION OUTLINE

ISO9000 is a very complex quality control system. I have presented the basics for you here. If you like
further information, just jump onto your favorite search engine and search for 'ISO9000' and you should find
enough information to keep you busy for hours. One side note, many educational institutes are already
beginning to teach ISO9000 and a required course. If you think that you can slip through the chemical
industry without ever having to deal this ISO9000, you couldn't be more wrong!

2 of 2 9/28/2009 1:27 PM
 ISO 9002 INTERNATIONAL STANDARD
A BRIEF EXPLANATION OF THE TWENTY CLAUSES

Clause 4.1

CLAUSE 4.1.1 "QUALITY POLICY"

To comply with this requirement there must be a written Quality Policy for the organization. This Quality
Policy document must be signed by the current management for the location or site in question. It must also be
ensured that the Quality Policy, the objectives and the statement of intent are established and identified in the
Quality Manual.
The following criteria must be fulfilled:

The company has a brief but comprehensive Quality Policy.

This Quality Policy should be included in the Quality Manual as well as being on public display.
Quality Objectives have been established by management and there is a statement outlining the intent to
deliver against these objectives.
The company must ensure that:

The Quality Policy is communicated throughout the organization.

All employees, at all levels, receive the same message from management. All statements relating to quality
that are in documents, training manuals, advertising literature, etc. must be consistent with the Quality
Statement.
Any changes must be issued in a controlled manner and must be properly communicated to all employees.
It is now necessary for companies to clearly establish goals and appraise the needs and expectations of
customers. As the goals will change and evolve these could be documented and expressed in a quality
improvement plan which must be thoroughly examined at management reviews. (discussed below).
CLAUSE 4.1.2.1 "ORGANIZATION: RESPONSIBILITY AND AUTHORITY"
To satisfy this requirement the company must ensure that:

The Quality Manual contains an Organizational Chart.

The Organizational Chart is current, authorized and issued as a controlled document.
The management function responsible for quality is clearly identified.
The responsibilities and authority of the Quality function are clearly defined.
Responsibility and authority under this clause have been extended to cover product processes and quality
system non-conformances. This now places greater emphasis on internal quality system activities such as

1 of 10 9/28/2009 1:28 PM
 internal quality audits, corrective/preventative actions and management review.
CLAUSE 4.1.2.2 "ORGANIZATION: RESOURCES"
The company must ensure that:

Adequate resources are provided to allow the effective and efficient operation of the Quality Management
system.
All personnel involved in the verification of the quality of work have sufficient training and resources to allow
them to carry out their duties.
All operations involved in the verification of work are identified.
Training records are maintained to provide evidence demonstrating that suitable training has been provided.
Training records are treated as Quality Records and managed as such.
Establish a clear division between the responsibility for the work and the responsibility for performing
assessments. Until recently it was normal to have these different tasks carried by different groups reporting to
different managers but there is no reason why self checking cannot be employed with the same person
performing both roles but work must also be subjected to independent verification.
Adequate training is provided to do both roles and keep the roles separate.
Resources required must be adequately identified in the quality system: for example Human Resources will
be identified under clause 4.18 (Training) and Calibration under clause (4.11)
CLAUSE 4.1.2.3 "MANAGEMENT REPRESENTATIVE"
The company needs to ensure that:

A member of the management team is clearly identified as the person with responsibility for implementing and
maintaining the requirements of ISO 9000.
This authority is formally defined by some method such as job description, organizational chart or Quality
Manual.
The management representative must be a member of the management team. A formal mechanism must exist
to facilitate the management representative to report to management on system, process or product failures
with a view to continually improving the quality system. The standard suggests that the Management
Representative be the liaison person with external parties.
CLAUSE 4.1.3 "MANAGEMENT REVIEW"
According to ISO 9002 management are required to assess the suitability and effectiveness of the quality
system, at regular intervals, so that they may identify areas where improvements can be made.
It is suggested that:

All affected groups are represented at management review meetings.

The review process is described in the Quality Manual.
Minutes of meetings are kept, to show what decisions were made and who was responsible for their
implementation.
Reviews are held at regular intervals (at least once per year).
Evidence needs to be provided for external auditors to demonstrate that reviews are planned, effective and
that corrective action decisions are made and implemented. It should be noted that the last section of this
particular ISO 9002 requirement specifies that records of management reviews are required.
Management review records should be treated as quality records and managed at such.
The review must now, in addition to assessing the continuing suitability and effectiveness of the system,
determine whether the stated quality objectives have been achieved. This can only be done by agreeing
objective targets for quality system improvements and assessing if these have been achieved.

2 of 10 9/28/2009 1:28 PM
 Clause 4.2

Clause 4.2 covers the quality system of the organization and it's documentation. Initially the system
organization is dealt with and recognized to be part of TQM (Total Quality Management). Output from each
function or part must meet agreed customers' requirements, be they internal or external.
The quality system is understood to be interrelated aspects of:

Suppliers' needs and interests.

Customers' needs and expectations.
Therefore a well-planned and managed quality system has to be defined and documented, which are dealt with
by quality plan and quality manual sub-clauses. The quality system and plans should be documented in enough
detail so that suppliers and customers can understand it and audit the quality system themselves.
This clause requires that the different parts of the company recognize that they are both customers of and
suppliers to other parts of the organization as well as to external customers.
Sub-clause 4.2.1 now makes a Quality Manual an essential part of the quality system it also requires that
other documented procedures are referenced from this document. This means that a Quality Manual is now
mandatory and must reference all the operating procedures either directly from the text or through a cross
reference matrix or table.
Sub-clause 4.2.2 requires that procedures are consistent with our Quality Policy and should reflect the
complexity of the work/processes and skills/training required.
The documented procedures must be relevant to the stated quality policy. Where a company can demonstrate
through adequate training or other records the acquisition of skills/training by all relevant personnel,
detailed procedures are not mandatory; for example personnel who have achieved qualifications through
apprenticeship schemes may not require detailed procedures or work instructions.
Sub-clause 4.2.3 requires a company to undertake quality planning as appropriate to the organization and that
this should be defines and documented.

Clause 4.3

This is the clause that the majority of companies have most difficulty with. Some make the mistake of
assuming that this clause applies to the relationship between the company and it's vendors when in fact
it applies to the relationship between the organization's front end and clients/customers.
The 1994 version of ISO 9002 places a much greater emphasis on Contract Review.
Where the sales of product and services are covered by contracts there must be clear evidence of a review of
terms and conditions.
Attention should be paid to the following:

Ensuring requirements are agreed and clearly understood by all involved parties.
Checking that all parties have the necessary resources, organization and facilities.
VERBAL CONTRACTS
Verbal contracts must be agreed before acceptance implying that some positive confirmation of order

3 of 10 9/28/2009 1:28 PM
 requirements must be made. In practice this could be achieved using fax confirmation messages or logging
verbal orders and confirming them back to customers over the phone.
AMENDMENT TO A CONTRACT
This is a new addition to the ISO 9002 requirement for contract review. The company must have a mechanism
for internal communication of all contract amendments ... this could be achieved by reviewing ongoing
contracts at the daily production meetings by putting a system in place whereby Scheduling, Planning and
Production would be alerted to all changes.

Clause 4.4

Clause 4.5

This requirement has been updated in the 1994 version (operational since 1 March, 1995.)
DOCUMENT AND DATA CONTROL

Clause 4.5 deals with how documentation should be treated. All documents in must be checked before issue
or re-issue after revision. Documents must be positioned so that all persons concerned have easy access to
them. A master record file has to be kept.
People responsible for revision and issuing of documentation must be identified.
Sub-clause 4.5.1 clause requires that documents of external origin such as standards and customer drawings
are controlled.
Sub-clause 4.5.2 requires that all obsolete documents be adequately identified and that all such documents
which are held for reference purposes should be suitably identified.
NOTE 10 of ISO 9002 states that documents can be in the form of any type of media such as hard copy or
electronic media. If the system is totally electronic then there has to be sufficient availability of hardware
(terminals, etc.) to facilitate personnel in accessing procedures, work instruction and records.
The procedure for document control must clearly identify who has authority to authorize read and / or write
access to controlled documents.
All electronic document and data systems must have adequate security / backup procedures.

Clause 4.6

Clause 4.6 deals with purchasing. In the procurement of materials or external services, quality need to be
assessed in respect to agreed specifications.
Assessment of subcontractors (i.e. vendors or suppliers), ensures that all have the capability of supplying
materials or services of the required quality. A formal assessment of capability is needed, possibly through an

4 of 10 9/28/2009 1:28 PM
 audit of a subcontractor's quality or by way of other evidence. Documented evidence on formal assessments is
required.
Purchasing data when placing orders should amount to a formal procedure that ensures all necessary
information is given to a vendor. Communication links are a central here and a record of performances is
needed.
Sub-clause 4.6.4.1 "Supplier Verification at Subcontractor's Premises"
This sub-clause requires that all details in relation to product verification and the method of product release by
the supplier at the subcontractor's premises is described on the purchasing documents.

Clause 4.7

Control of Customer-Supplied Product

Clause 4.7 deals with purchaser supplies. Here, purchaser means our external customers. In manufacturing the
external customer may make "Free Issue", which is where they provide materials for incorporation in products
they ultimately buy back.
The onus is on the issuer to check quality, but this does not absolve us from knowingly incorporating poor
quality components into finished product.
.

Clause 4.8

PRODUCT IDENTIFICATION AND TRACEABILITY

This clause deals with product identification and traceability. A manufactured product must be traced through
the various stages of its production and delivery. This is crucial to help identify the stage and hence the cause
of any product failure. Where different products are similar or identical they must be identified using a method
of labeling or coding.
Note: In the case of a mail-order/telesales business this clause may apply to mail, checks, registration forms,
etc.

Clause 4.9

The company must be able to demonstrate that the overall process (sales right through to delivery to the end
user) is in control.

5 of 10 9/28/2009 1:28 PM
 There are many significantly different processes in both the manufacturing and service sectors. Accordingly
only principles are set out in Clause 4.9, details having to be put in place by each organization.
The main point is that process steps need to be identified and a plan to implement needs to be declared and
documented.
The process must be carried out in a controlled way, so that plans / procedures / instructions are to hand,
equipment and personnel used are adequate and that the general conditions are amenable to achieving the
plans.
To ensure that a process is carried out in a controlled manner the process must be well documented and the
staff well trained.

Many changes have been made in the 1994 version of ISO 9002
This clause addresses inspection and testing for incoming goods, in-process and final inspection.
Inspection of incoming materials must be directed by a sampling plan which details the selection of materials
for inspection / testing from each received batch. Results must be documented, describing material inspected,
number of rejects, reasons for rejection and corrective action.
In-process inspection similarly needs to be dealt with, tying in with clause 4.8 "Product Identification and
Traceability".
Upon completion all products must undergo clearly specified final inspection.
NOTE:
Sub-clause 4.10.2.2 is a new addition and reads as follows... "In determining the amount and nature of
receiving inspection, consideration shall be given to the amount of control exercised at the subcontractor's
premises and the recorded evidence of conformance provided". This deals with the practice of ship-to-stock
based on certificates of conformance or other recorded evidence of conformance of product or service.

Clause 4.11

This clause may not apply if test and measuring is not used, but make sure not to overlook the fact that items
such a weighing scales require calibration and that in the past some auditors have required that steel rules be
calibrated..
CONTROL OF INSPECTION, MEASURING AND TEST EQUIPMENT
This clause covers inspection, measuring and test equipment. It deals with the equipment used in inspection
and testing, ensuring that it is suitable for its purpose. Frequency of calibration of equipment used in
manufacturing should be based on stability, purpose and degree of utilization. Records of maintenance work
must be retained. Recalibration must be in line with official standards or , where this is not the case, with a
clearly documented method.

6 of 10 9/28/2009 1:28 PM
 In order to satisfy this part of the requirement, we must ensure that all equipment used to verify or measure
product is subjected to our management control system. All this equipment must be identified and registered
and we must have a process for putting all newly acquired equipment on the register.
WE MUST ENSURE THAT:

A calibration and maintenance system is in place. A starting point is a calibration register of equipment
coupled with the location capital asset register.
Trained personnel are available to operate the necessary procedures.
No unregistered or overdue equipment is used.
Evidence is provided which confirms that procedures are effective.
All weighing machines are calibrated.
Procedures allow for the use of personal equipment or equipment on loan or trial.
Equipment which does not need to be calibrated is identified.

Clause 4.12

This clause deals with inspection and test status. There needs to be an indicator that states what tests a product
has been through and whether it passed or failed.
In order to satisfy this part of the requirement, the company must:

Have a system or method for identifying the inspection and test status of the product at all relevant stages in
the process.
Ensure that the system used is defined as part of the process specification or is written documented work
instructions.
Ensure that the personnel who operate processes related to this segregation system are trained in the discipline
required to maintain it.
Ensure that only products that have passed the required inspection and tests are shipped, put into use, or
installed.
This clause also refers to sub-clause 4.13.2 "Review and Disposition of Non-conforming Products."

The responsibility for review and authority for the disposition of non-conforming product shall be defined.
Non-conforming material shall be reviewed in accordance with documented procedures and it may be:
Reworked to meet the specified requirements:
Accepted with or without repair or concession:
Regarded for alternative applications:
Rejected or scrapped.

Clause 4.13

7 of 10 9/28/2009 1:28 PM
 This clause stresses the control of non-conforming product. The aim here is to ensure that non-conforming
product is not used by mistake. Non-conforming material must be isolated and clearly identified.
Every non-conforming lot should be accompanied by paperwork detailing the reasons for failure.
Defects and claims should be sent to vendors without delay.

Clause 4.14

This clause provides for detailed and timely documentation of corrective actions taken. Time must be taken to
learn from mistakes but, strictly speaking, clause 4.14 wants avoidance of mistakes to be achieved following
analysis of quality records, service reports and customer complaints. In all cases corrective action must be
monitored.
To satisfy ISO 9002 requirement 4.14, the Company must:

Establish and document a system for investigating the cause of defective products or processes.
Establish a system for ensuring that appropriate corrective action is decided upon and implemented.
Ensure that responsibility for corrective action is clearly defined.
Establish and document procedures for analyzing the business.
Keep records of all complaints and follow-up actions.
Correct any deficiencies before they can cause defects in products or processes.
Establish and document a process to ensure that corrective actions are implemented in an effective manner.
Keep records of defects, the investigation of their cause and the corrective actions.
Establish and document a process that ensures procedure amendments, resulting from corrective actions, are
recorded and that work methods are changed to reflect the changes in amended procedures.

Clause 4.15

A policy must be set for handling, storage and packaging.

Handling of products, i.e. when loading and unloading, must be done with due care for the product.
Storage areas must be clean and the environment properly controlled (for example, heat, humidity, light.)
Access to storage areas should be controlled. Controls should be implemented to identify slow moving,
obsolete, deteriorated and damaged items (some of these may not apply in all cases but scrap should not be

8 of 10 9/28/2009 1:28 PM
 allowed to accumulate).
The company also needs to ensure the protection of the quality of product after final inspection and test.

Clause 4.16

This clause covers quality records and is of an administrative nature.

Quality records are the routine control and reporting documents that show the progress of the quality
management system.
Quality records should be kept over a reasonable length of time and stored in a safe secure area.
The following are key records to be kept:

Audits of the quality system.

Calibration of test and measuring equipment
Analyses of process control data.
Records of corrective actions.
Customer complaints.
Records of concessions (deviations).
Training records.
NOTE:
Records may be in the form of any type of media, such as hard copy or electronic media.
NOTE:
Procedures must exist for backup / security of all records on electronic media.

Clause 4.17

Planned and documented checks on the implementation and operation of the Quality Management System
help to confirm that it is being operated correctly and effectively.
Internal Quality Audits must be conducted on a regular basis.
Coverage, schedules and standard procedures for each audit must be pre-determined.
Records must be kept, such as the following:

Deficiencies found.
Corrective action required.
Time agreed for corrective action to be carried out.
Personnel responsible for corrective action.
NOTES:
The auditor(s) must be independent of the areas being audited.
The results of such audits must form an integral part of the input to management review activities.

9 of 10 9/28/2009 1:28 PM
 Clause 4.18

Clause 4.18 underlines the need for training. Training of personnel is concerned with the competence of
personnel to do their assigned task.
Where a lack of skills of qualifications is found, staff need to attend internal or external training courses.
If a member of staff is new to the task then efforts must be made to train them.
Staff performance needs to be regularly appraised and recorded.
Know-how must be kept up to date enabling staff to operate adequately the equipment that they are
responsible for.

Clause 4.19

Clause 4.20

Clause 4.20 stresses the value of measurement using statistical techniques.

Statistical techniques should be used to assess the following:

Reliability such as longevity and durability.

Process control / capability studies.
Determining quality levels and thus inspection plans.
Data analysis, performance assessment and defect analysis.
4.20.1 Identification of Need. The term "where appropriate" has been deleted from this clause and the
supplier is required to identify the need for statistical techniques in order to control and verify process
capability and product characteristics.
4.20.2 Procedures. The supplier shall establish and maintain documented procedures to implement and
control the statistical techniques identified.

10 of 10 9/28/2009 1:28 PM