Unit 3

ISO documentation, types of customers and concept of conformity.

ISO 9001 DOCUMENTATTON REQUIREMENTS
ISO 9001: 2008 requires the following documents:
1.Quality Manual:
The quality manual defines how each requirement of the “standard” is applied in the company.
It is are mentioned in section 3.2.2. of ISO 9001: 2008
2. Quality Procedures:
It describe how certain key processes within the company must be performed, and who is
responsible for them.
Quality procedures and their content in given in sections 3.2.3, 3.2.4, 8.2.2, 8.3, 8.5.2, and 8.5.3
of ISO 9001: 2008
3. Quality Policy:
The quality policy will tell the role and intension of company in implementing quality and
fulfilling customer satisfaction. The content of the quality policy must fulfill the requirements
given in Section 5.3.
4. Quality Objectives:
The quality objectives define measurable goals of the company's quality management system.
quality objectives are given in Section 5.4.1.
5. Process Flowchart:
It gives the description regarding relation between various processes of QMS.
It is given in Section 3.2.2.
6. Work Instructions:
Work instructions describe in detail how particular tasks must be performed.
Work instructions are mentioned in section 7.5.1.
7. Records
Records are different from the documents. Generally Documents provide directions on how to
conduct business. Records, on the other hand, are evidence of things done
8. Forms are Optional
And good forms will provide many benefits like time savings to consistency. It will help in
creating the various records. The best forms even act as instructions as they guide the user
through a work process
9. Format and Content
As per ISO 9001: 2008 there is no particular format or layout for every document and form. This
documentation just to provide instructions on how to operate company's ISO 9001 QMS. The
best documentation format must be easy to understand and user-friendly

CONCEPT OF CONFORMITY AND NON-CONFORMITIES

Conformance Non-Conformity
It refers to fulfillment of requirements of ISO It refers to failure to comply with
9001 standards. requirements of ISO 9001 standards

Types of Non-Conformity
 Major Non-Conformance
A deficiency that reduces the
effectiveness of the QMS.
Examples:
1. An element of ISO 9001 not
implemented.
2. Procedures not developed or not
implemented.
3. Failure to take corrective or
preventive action.
4. Several minor non-conformance.
Minor Non-Conformance:
A minor deficiency that does not affect the
effectiveness of the QMS.
Examples:
1. One or a few individuals do not use a
procedure correctly.
2. Procedure needs minor changes to be
effective.
3. One or a few records incomplete.

CONCEPT OF INTERNAL CUSTOMERS AND EXTERNAL CUSTOMER

1. Internal Customers
Internal customers are the people in the same company or perhaps a partner that provides
services in order to deliver company's products or services.
An internal customer is any member of organization who relies on assistance from another to
fulfill its job duties.
For example: sales representative needs assistance from a customer service representative to
place an order.
Significance of Internal Customer
Internal customers is not purchasing the products or services offered by their employer. But the
internal customer relationship with other departments plays a key role in the business success.
For example, the salesperson who does not work well with customer service department, may
have greater difficulty in placing orders or obtaining answers to his external client's questions,
resulting in a poor level of service.
Strained internal relationships can adversely affect company morale and overall business.

2. External Customers
An external customer is one who uses company's products or services but is not part of the
organization.
For example: In retail store, an external customer is an individual who enters the store and buys
merchandise.
Significance of External Customer
External customers are essential to the success of any business, as they provide the revenue
through their purchases that the enterprise needs to survive.
Satisfied external customers often make repeat purchases as well as refer the company to other
people and encourage them to purchase your product.
A customer who suffers through a negative experience with a company, such as being treated
rudely by an employee, can also hinder a business by discouraging others from for purchasing
from your company.

BENEFITS OF IMPLEMENTATION OF ISO 9000 QMS

Most important advantage is that Quality is maintained.
It provides Opportunity to compete with larger companies.
More time and efforts spent in order to achieve customer focus.
It gives confirmation to stake holders that company is committed to quality.
It will facilitate trade and increased market opportunities.
IT helps to increase customer confidence and satisfaction.
QMS includes efficient ways of working which will save time, money and resources.
The improved operational performance will cut errors and increase profits.
QMS will motivate and engage staff with more efficient internal processes.
It will improve financial results.

Negative aspects of ISO 9000

Extra time and money involved in the ISO registration process.
There may be Distraction simultaneously applied from other quality programs
A lot of work is involved in implementation of QMS