Annual Training July

2017
Amber Capacitors Limited

Trainer: M. Kaiser Faheem

 Training Contents

Overall view of Quality Management System Requirements

ISO 9001:2015.
1. Quality Policy
2. Quality Objectives
3. Internal Audit
4. Control of Documented Information
5. Corrective Actions
6. Risk Assessment
Overall view of Quality Management System
Requirements ISO 9001:2015.

Section 1: Scope
Section 2: Normative Reference
Section 3: Terms and Definitions
Section 4: Context of the Organization
Section 5: Leadership
Section 6: Planning
Section 7: Support
Section 8: Operation
Section 9: Performance Evaluation
Section 10: Improvement
Section 4: Context of the Organization
Clause 4.1 Understanding the Organization and its context
The organization should determine external and internal issues for the
organization relevant to its purpose, strategic planning and which affect
the organizations ability to achieve its objectives .
The Organization should monitor and review the information about
external and internal issues.
Management Review required the monitoring of external and internal
issues.
The organization must considerissues related to values,culture
knowledge and performance of the organization for understanding of
internal issues.
The organization must considerissues related toarising from
legal,technological, competitive, market, cultural, social, and economic
environments, whether international,national, regional or local for
understanding of external context.
For considering internal context as well as external factors both positive
as well as negative factors must be considered.
Section 4: Context of the Organization
Clause 4.2 Understanding the needs and expectations of interested parties
The organization shall determine relevant interested parties and
relevant requirements of relevant interested parties.
Relevant interested parties to be considered are those that could affect
or potentially affect the organizations ability to constantly provide
products and services that meet customer and applicable statutory and
regulatory requirements.
Monitor and review information related to interested parties and
relevant requirements.
Interested Parties are:
Certification Body, Owner, Customer, Employee/Staff, Supplier, Competitors,
Management, local Community, Regulatory Body, Government
Section 4: Context of the Organization
Clause 4.3 Determining the scope of the quality management system
The organization must establish scope of the quality management system
by determining the boundaries and applicability of the quality management
system.
While determining the scope the organization must consider the internal
and external issues determined in 4.1.,
the requirements of relevant interested parties in 4.2.
and the products and services of the organization.
Requirements from this International standards that can be applied by the
organization shall be applied within the scope of the QMS.Requirements
from this International standards that cannot be applied by the
organization and which does not affect the organizations ability or
responsibility to provide product and services that meet the conformity of
its product and services and enhancement of the customer satisfaction.
The organization must make available the scope and must maintain scope
as documented information stating theProducts and services covered by
the QMS and anyJustification where a requirement of this International
standard cannot be applied.
Clause 4.4Quality management system and its processes

he organization must establish, implement, maintain and continually improve its quality
management system as per the requirement of this standards by determining the process
needed and its application through out the organization .
While determining the processes, the organization must determinethe inputs required and
the outputs expected from these processes,the sequence and interaction of these processes,
The organization must control these processes to ensure its effective operation.
The organization must establish the criteria and methods which include monitoring,
measurements and other related performance indicators to ensure the effective operation
and control of these processes.
The organization must determine and ensure the availability of the resources needed for
effective operation of these processes.The personnel having authorities and responsibilities
for these processes must be identified.
As per clause 6.1, the organization must determinerisk and opportunities, analysis them and
must take appropriate action to address them.There must bemethods for monitoring,
measuring, as appropriate, and evaluation of these processes. The organization must make
changes in its process if it fails to achieve intended result. The organization must look
opportunities for improve for these process and for Quality management system as a whole.
Section 6: Planning
6.1 Actions to Address Risks & Opportunities
6.1 Actions to Address Risks & Opportunities
6.1.1
When planning for the quality management system,the organization shall consider the issues referred
toin Understanding the organization and it context (4.1) and the requirements referred to in
Understanding the needs and expectations of interested parties(4.2) and determine the risks and
opportunities that need to beaddressed togive assurance that the quality managementsystem can
achieve
its intended result(s);
prevent, or reduce, undesired effects;
and toachieve continual improvement.
6.1.2
The organization must plan
actions to address the risks and opportunities determine in clause 6.1.1.
The organization must also plan onhow tointegrate and implement the actions into itsquality
management system processes andevaluate the effectiveness of these actions.Actions taken to address
risks and opportunities must beproportionate to the potential impact on the conformity ofproducts and
services.
Options to address risks can include but not limited to avoiding, risk, taking risk in order to pursue an
opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk,
retaining risk by informed decision or implementing standards like ISO 31000.
Opportunities can lead to the adoption of new practices, launching of new products, opening new
markets, addressing new customers, building partnerships, using new technology and other desirable and
viable possibilities to address the organizations or its customers needs.
Risk Assessment

a systematic process of evaluating the potential risks that may be involved in

a projected ac
tivity or undertaking.
 Risk Assessment
Risk Assessment Team (Name/s): Approved By: Set RPN:


Signature

RA Performed on: Date Conducted:

Risk Identification & Evaluation Risk Control

S
e Function
r Oc De
Sev
Effect of cur Current process tec RP Recommended Action & Action Responsibility Action
. Failure Mode
Failure
eri Cause of Failure
ren Control tio N Taken & Date Results
Remarks
N ty
ce n
Process
o
.

9.
 Quality Policy
It is our policy to continuously improve the quality of our
products and Quality Management System to better satisfy
the needs of our customers, and deliver to them

On time and every time high Quality Products and service

Thereby keep widening the circle of our customers

For progressive prosperity of our company and its

employees.
 Quality Objective
Definition

Thequality objectivesare the main method used by companies to focus the

goal(s) from theQuality Policy into plans for improvement.
TheQualityPolicy is created with the Customer Requirements in mind,
thenquality objectivesare linked back to the Customer Requirements
through theQualityPolicy.
Internal Audit

Internal auditingis an independent, objective assurance and consulting

activity designed to add value and improve an organization's operations.

Purpose of Internal Audit

the purpose of internal audit is to determine whether the quality
management system conforms to the planned arragement to the requirement
of the international standard and to the quality management system
requirements established by the organisation and is effectively implemented
and maintanined
Corrective Action

Corrective actions are improvements to an organization's processes taken to

eliminate causes of non-conformities or other undesirable situations.