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2
Part 1 : Introduction to the changes
Questionnaire covered :
1-14 employees 12 %
15-49 employees 8%
50-249 employees 24 %
250-499 employees 14 %
(6) Others
Analysis of survey findings revealed
following
user and customer needs :-
Management I
I Responsibility S n
n a t
t R t e
e e I r
r q Resource Measurement, s e
e u management f s
analysis,
s i a t
r
improvement c
t e
e e t d
d m i
e o p
p n n a
a t
Product Output r
Input Product/
r s (and/or service) t
services
t realization y
y
ISO 9000:
1994
{ subcontractor supplier customer
Clause 4.1 Quality Management
System (General
Requirements)
Organization shall establish, document,
implement, maintain and continually improve
quality management system. Steps required are:
Clause 5.1
Management Commitment
Documented : Yes
ISO 9001:1994 : Clause 4.1.1
Clause 5.4 Planning
Clause 5.4.1 Quality objectives
Top management shall ensure that quality
objectives:
- are established at relevant functions and
levels
- are measurable and consistent with QP
(including commitment to continual
improvement)
- include objectives needed to meet
requirements of product
Documentation : Yes
ISO 9001:1994 : Clause 4.1.2.1 (specifies defined and
documented)
Clause 5.5.2 Management
Representative
- Resource needs
Clause 6.1
Provision of resources
- General (8.1)
- Measurement and monitoring (8.2)
- Control of non-conforming (8.3)
- Analysis of data (8.4)
- Improvement (8.5)
Clause 8.1 General
- Processes (8.2.3)
- Product (8.2.4)
Documented procedure:Yes
ISO 9001:1994 Clause : 4.13 (requirement has been slightly
enhanced)
Clause 8.4 Analysis of data
- Collect and analyze appropriate data
- Data analysis to be used for determining
suitability and effectiveness of QMS and for
identifying areas for improvement
- Data to be analyzed may include those from
measuring and monitoring activities
Improvement covers :
- Corrective Action(8.5.2)
- Preventive Action(8.5.3)
Procedure to cover :
- Identification of non-conformities (including customer
complaints)
- Determination of causes of non-conformities
- Evaluation of need for actions to prevent recurrence
- Determine and implement corrective action needed
- Review of corrective action taken
Procedure to cover :
- Identification of potential non-conformities
- Determine of potential causes
- Determination of preventive action needed
- Implementation of preventive actions
- Review of preventive action taken
- Transitional/Intermediate Users
- New Users
Current Users