Professional Documents
Culture Documents
SECT
NO.
1.2
4.1
4.2.1
Documentation includes:
a) statement of quality policy and quality objectives
b) quality manual
c) documented procedures and records
d) those determined necessary to ensure planning, operation and
control of its processes
4.2.2
4.2.3
4.2.4
5.1
5.2
5.3
5.4.1
Date:
Page 1 of 6
QM/
FORM
NO.
Procedur
e/ Page #
Y/N
NO.
5.4.2
5.5.1
5.5.2
Management representative:
a/ b) is identified and has authority to ensure that quality
system is implemented and maintained
c) Promotes awareness of customer requirements
throughout organization
5.5.3
5.6.1
5.6.2
5.6.2
Resource Management
6.2.1
Human Resources: Personnel shall be competent on the basis of education, training, skills and
experience
6.2.2
Human Resources:
a) Determine necessary competence (requirements) for
personnel performing work affecting conformity
b) Provide training
c) Evaluate effectiveness of actions taken
d) Ensure personnel are aware of importance of their work
with respect to QMS
Date:
Page 2 of 6
QM/
FORM
NO.
Procedur
e/ Page #
Y/N
NO.
6.3
6.4
7.1a
7.1b
7.1c
7.1d
7.2.1
7.2.2
7.2.3
7.3.2
Input includes:
a) functional and performance requirements
b) applicable statutory and regulatory requirements
7.3.3
Output shall:
a) meet the input requirements
Date:
Page 3 of 6
QM/
FORM
NO.
Procedur
e/ Page #
Y/N
7.3.5
7.3.5
SECT
NO.
7.3.6
7.3.7
Purchasing
7.4.1
7.4.2
7.4.3
Date:
Page 4 of 6
QM/
FORM
NO.
Procedur
e/ Page #
Y/N
SECT
NO.
7.5.4
Preservation of Product
7.5.5
Determine the monitoring and measurements required and obtain the required equipment
Equipment shall be:
a)
e)
protected from damage and deterioration during handling, maintenance and storage
Assess and record the validity of previous measuring results when the equipment is found not to conform
to requirements
Date:
Page 5 of 6
QM/
FORM
NO.
Procedur
e/ Page #
Y/N
8.2.1
Plan and implement the monitoring, measurement, analysis, and improvement processes needed to:
a)
b)
c)
Customer Satisfaction - monitor info relating to customer perception whether organization met customer
requirements
8.2.2
Procedure includes responsibilities for planning and conducting audits, establishing records and reporting
results
Internal audits (RECORD):
Consider the results of previous audits
SECT
NO.
8.2.4
Date:
Page 6 of 6
QM/
FORM
NO.
Procedur
e/ Page #
Y/N
Analysis of Data
8.4
Determine, collect & analyze data to demonstrate the suitability & effectiveness of
QMS & evaluate continual improvement
Data provided relating to customer satisfaction, product conformity,
process/product trends, supplier information
Improvement
8.5.1
8.5.2
Documented procedure required to take action to eliminate the causes of nonconformities to prevent
recurrence
Corrective action established and include:
a)
b)
c)
evaluating the need for action to ensure that nonconformities do not re-occur
d)
e)
f)
Preventive Action
8.5.3
Documented procedure required to take action to eliminate the cause of potential nonconformities to
prevent occurrence
Preventive action established:
a) to determine potential nonconformities and their causes
b) evaluating the need for action to prevent nonconformities
c) determining and implementing action needed
d)
Date:
Page 7 of 6