Beruflich Dokumente
Kultur Dokumente
COURSE Materials
Introduction of the Resource Person
Qualification: B.Sc. Engg. (Chem.), MS (TQM), Lead Assessor ISO 17025, 9000
Professional Trainings:
Measurement standards:
Material measure or physical property that defines or reproduces the unit of
measurement of a base or derived quantity. Such as units of measures; The seven
basic units of the SI system e.g. meter, Kg, Ampere etc.
Product standards:
Cover specifications for dimensions, performance, health, safety, environmental
protection and documentation; Standards for inspection, test methods and analysis.
Management Standards:
Standards that focus on organization, such as for logistics, maintenance,
inventory management, quality management, project management and production
management such as ISO 9000, ISO 14000, ISO 17025, SA 8000, HACCP etc.
Attributes of a standard
ILAC ISO
Legal framework in Pakistan BIPM
IAF
ATION
HACCP ISO14000 ISO 9000 LABORATORIES
Legal
metrology
CALIBR
Microbe Chemical Textile
TESTING SERVICES
Factory Trade
metrology transaction
lab
ENTERPRISES
Renowned Standardization Bodies
ISO International Organization for Standardization
ASTM American Society for Testing and Materials
DIN Deutsches Institut fr Normung
EN European Norms
Act
Do
check
Model of Process based Quality Management System
Continual Improvement of the quality
management system
R S
E A
Q Management
T
C responsibility C
U I
U U
I S
S S
R F
T Measurement, T
E Resource
A
O management
analysis &
O
M improvement C
M M
E T
E E
N I
R Product R
T Product O
realization
S N
ISO 9001:2008
Quality Management System - Requirements
1.0 Scope
2.0 Normative References
3.0 Terms and Definitions
4.0 Quality Management System Requirements
5.0 Management Responsibility
6.0 Resource Management
7.0 Product Realization
8.0 Measurement, Analysis & Improvement
Quality Management System - 1
4.1 General Requirements
a) Identification of the processes for the QMS
b) Determine the sequence of these processes
c) Determine criteria for effective operation &
control of these processes
d) Ensure the availability of resources
e) Monitor, measure (where applicable) and
analyze these processes
f) Implement actions necessary for achieving
planned results and continual improvement
Quality Management System - 2
4.2 Documentation Requirements - 1
4.2.1 General
The QMS Documentation shall include:
a) Quality Policy & Quality Objectives
b) Quality Manual
c) Documented procedures and records required
by this Standard
d) Documents needed for planning, operation and
control of processes
e) Records required by this Standard
Quality Management System - 3
4.2 Documentation Requirements - 2
4.2.2 Quality Manual
a) Scope of QMS / Justification of the Exclusions
b) Documented procedures or reference to them
c) Description of interaction between the processes
of the QMS
Quality Management System - 4
4.2 Documentation Requirements - 3
4.2.3 Control of documents
Establish documented procedure to define method to:
a) Approve documents
b) Review, update and re-approve documents
c) Identify the revision status / changes
d) Ensure availability of relevant versions at point of
use
e) Ensure documents are legible and readily
identifiable
f) Identification and Control the external documents
g) Identification and Control of obsolete documents
Quality Management System - 5
4.2 Documentation Requirements - 4
4.2.4 Control of records
a) Establish / Maintain records to demonstrate
conformity to this International Standard
b) Keep records legible, readily identifiable and
retrievable
c) Establish documented procedure for
identification, storage, protection, retrieval,
specify retention time and their disposition
Documentation Requirements
Clause 4
Documents
Quality manual
Flow chart of major processes and their
interaction
Document control procedure
Record control procedure.
Description of out sourced services and their
control procedure.
Records
Document updating records
Disposal of quality records
Management Responsibility - 1
5.1 Management Commitment
a) Communication to the organization the
importance of meeting customer, statutory
and regularity requirements
b) Establish Quality Policy & Quality Objectives
c) Conducting Management Reviews
d) Ensuring the availability of resources
Specific
Measurable
Achievable
Results orientated
Time bound
Management Responsibility - 5
5.4 Planning - 2
5.4.2 Quality Management System Planning
Top Management shall ensure that
a) Planning is done for meeting the requirements
of this standard (4.1) and Quality Objectives
b) Integrity of the QMS is maintained when
changes to QMS are planned and implemented
Management Responsibility - 6
5.5 Responsibility, Authority and Communication - 1
5.5.1 Responsibility and Authority
Are defined and communicated
5.5.2 Management Representative
The Management Shall appoint a Management
Representative responsible to :
a) Ensure that processes for QMS are established,
implemented and maintained
b) Reporting to top management on performance of QMS
and any need for improvement
c) Ensure the promotion of awareness of customer
requirements throughout the organization
Management Responsibility - 7
5.5 Responsibility, Authority and Communication - 2
5.5.3 Internal Communication
Top management shall ensure that
appropriate communication processes are
established within the organization and that
communication takes place regarding the
effectiveness of quality management system.
Management Responsibility - 8
5.6 Management Review - 1
5.6.1 General
The management shall review the QMS at
planned intervals to ensure its continued
suitability, adequacy and effectiveness
The review shall include :
a) Assessing opportunities for improvement
and need for changes to the QMS
b) Review of the Quality Policy and Quality
Objectives
Records of the reviews must be kept
Management Responsibility - 9
5.6 Management Review - 2
5.6.2 Review Inputs
The Inputs shall include information on:
a) Results of audits
b) Customer feedback
c) Process performance and product conformity
d) Status of preventive and corrective action
e) Follow-up actions from previous
management review
f) Changes which could affect the QMS
g) Recommendations for improvement
Management Responsibility - 10
5.6 Management Review - 3
5.6.3 Review Outputs
The Outputs shall include any decisions and
actions on:
a) Improvement of the effectiveness of quality
management system and processes,
b) Improvement of product related to customer
requirements
c) Resources needs
Documentation Requirements
Clause 5
Documents
Quality objectives at organizational and
functional level.
Organization structure and responsibilities of
management representative and key
functionaries whose job affects product
quality.
Description of internal communication channel. (
This could be specified in quality manual)
Procedure for management review
Records
Evidence of quality planning
Record of management review
Resource Management - 1
6.1 Provision of Resources
The Organization shall determine and provide
resources needed to :
a) Implement and maintain the QMS and
continually improve its effectiveness
b) Enhance customer satisfaction by meeting
customer requirements.
Resource Management - 2
6.2 Human Resources
6.2.1 General
Competent persons should perform work effecting quality
6.2.2 Competence, awareness and training
a) Determine the necessary competence for the
personnel performing work effecting quality
b) Provide training and take action to satisfy these
needs
c) Evaluate the effectiveness of the action taken
d) Ensure that its personnel are aware of relevance and
importance of their activities and how they contribute
to the achievement of the quality objectives
e) Maintain appropriate records of education, training,
skills and experience
Resource Management - 3
6.3 Infrastructure
The organization shall determine, provide and
maintain the infrastructure needed to achieve
product conformity, it includes:
8.5 Improvement - 1
8.5.1 Continual Improvement
The organization shall continually improve the
effectiveness of QMS through the use of :
Quality Policy
Quality Objectives,
Audit Results
Analysis of data,
Corrective and Preventive Actions
Management Review
Measurement, Analysis and Improvement - 10
8.5 Improvement - 2
8.5.2 Corrective Action
QUALITY
Without
U
Thank you !!!