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QUALITY MANAGEMENT SYSTEM

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EXECUTIVE SUMMARY
A set of inter-related or interacting elements, that
organizations use to formulate quality policies &
objectives and to the establish the processes that are
needed to ensure that these policies are followed and
these objectives are achieved
First published in 1987
Updated in 1994, and again in 2000 & 2008
Current version published in September, 2015

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QMS PRINCIPLES
The Quality management principles are:

Customer Focus
Leadership
Engagement of people
Process Approach
Improvement
Evidence based decision making
Relationship Management

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CUSTOMER FOCUS
In order to enhance corporate performance & sustained
success:
Focus on both customers & interested parties
Understand the current and future requirements &
expectations of customers
Understand the current and future requirements &
expectations of interested parties
Trying to meet these requirements & exceed these
expectations

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LEADERSHIP
In order to enhance corporate performance & sustained
success:
Suitable leadership at all levels
Leaders at all levels establish a unity of purpose
Create environment that encourage people to pursue
and achieve a set of quality objectives
All strategies, policies, processes and resources
aligned and being used to pursue a common direction

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ENGAGE & INVOLVE PEOPLE
In order to enhance corporate performance & sustained
success, organization must be able to create and deliver
value, by:
Have competent people
Enhance their knowledge & skills
Effectively empowering them
Encouraging their involvement and engagements at all
levels
Recognizing their achievements

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PROCESS APPROACH
SCHEMATIC REPRESENTATION OF ELEMENTS OF A
SINGLE PROCESS

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PROCESS APPROACH Contd.
PLAN DO CHECK ACT CYCLE

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ENCOURAGE IMPROVEMENT
In order to enhance corporate performance & sustained
success, organization must encourage & support
improvement, by:

Maintain current level of performance


Respond to changing conditions
Identify, create and exploit new opportunities
Establish and sustain an ongoing focus on
improvement

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USE EVIDENCE TO MAKE DECISIONS
In order to enhance corporate performance & sustained
success, organization must establish an evidence-based
decision making process:
Decision making is evidence based as multiple types of
inputs are gathered from multiple sources
Facts are analyzed objectively
Cause & effect relationships examined
Potential unintended consequences considered
All of above used to make corporate decisions

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MANAGE CORPORATE RELATIONS

In order to enhance corporate performance & sustained


success, organization must:

Manage relationships with suppliers


Manage relationships with customers
Manage relationships with interested parties
Maintain relationships carefully because suppliers,
customers partners & other interested parties can
influence corporate performance and undermine
corporate success.

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ISO 9001:2015 CLAUSES
The requirements of ISO 9001:2015 QMS are found in
following main clauses:
4. Context
5. Leadership
6. Planning
7. Support
8. Operations
9. Evaluation
10. Improvement

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ISO 9001:2015 CLAUSES

1. Scope
This section describes the scope of management system
2. Normative reference
References other relevant standards, mainly ISO 9000, Quality
Management System Fundamental & Vocabulory
3. Terms & Definitions
All terms & definitions relevant to ISO 9001:2015 are defined
under this clause

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ISO 9001:2015 CLAUSES
4. Context of the Organization
4.1 Understanding the Organization and its context
Ascertain, monitor and review both external & internal issues
that are relevant to its purpose & strategic direction
Might suggest greater union between QMS & wider business
planning activities
4.2 Understanding the needs & expectations of Interested
parties

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ISO 9001:2015 CLAUSES

Understanding Interested Parties


When determining the scope of the organization, we shall consider
the expectations of relevant interested parties
All of the following can be "interested parties"
Person or group having an interest in the performance or success of
an organization includes:
Customers, Owners,
Employees, Contractors,
Suppliers, Investors,
Unions, Partners or Society,
Regulatory & statutory bodies

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ISO 9001:2015 CLAUSES

4.3 Determining the scope of QMS


Scope statement must state the products & services covered
4.4 The QMS and its processes
Reinforces a process planning approach

5. Leadership
Increased emphasis on people owning the QMS rather than an individual
5.1 Leadership & Commitment
Greater emphasis on Top Management
Requires Top Management to demonstrate leadership & commitment and
expects a more hands-on approach

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ISO 9001:2015 CLAUSES
5.2 Policy
Quality Policy should be appropriate to the context of the organization and it
should be applied throughout the organization
5.3 Organizational roles, responsibilities & authorities
Requirement of Management representative no longer specified
Responsibilities may be split across several roles
6. Planning
The new standard includes risks and opportunities
Setting of goals & objectives to achieve plans & resources
6.1 Action to address risks & opportunities
Risk based approach

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ISO 9001:2015 CLAUSES

Understanding Risks & Opportunities


Organizations of all types and sizes face internal & external factors and
influences that make it uncertain when they will achieve their objectives
The effect of this uncertainty on an organizations objectives is risk.
An opportunity is something that can be beneficial in the future.
Risks may turn into problems. We can reduce or avoid future problems by
reducing their consequences or their probabilities .
Opportunities may turn into benefits. We can increase future benefits by
increasing their probabilities
Risks - What can go wrong?
Current opportunities - Which opportunities do we have now?
New opportunities - Which new opportunities will the change open up?

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ISO 9001:2015 CLAUSES

6.2 Quality Objectives and planning achieve them


SMART Objectives to be set for all relevant processes
Should include description, who is responsible, target value and date
Progress must be monitored
6.3 Planning of changes
The organization shall consider:
Purpose of changes and their potential consequences
The integrity of QMS
The availability of resources
The allocation or reallocation of responsibilities and authorities

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ISO 9001:2015 CLAUSES
7. Support
7.1 Resources
7.1.1 General
The organization shall consider:
The capabilities of, and constraints on, existing internal resources
What needs to be obtained from external providers
7.1.2 People
Organization shall determine & provide persons necessary for effective
implementation of its QMS and for operation and control of its processes
7.1.3 Infrastructure
Building & associated utilities
Equipment including hardware & software
Transport resources
Information & communication technology

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ISO 9001:2015 CLAUSES
7.1.4 Environment for operation of processes
Social, psychological & Physical
7.1.5. Monitoring & Measurement Resources
7.1.5.1 General
7.1.5.2 Measurement Traceability
7.1.6 Organizational knowledge
Internal resources
External resources
7.2 Competence
Determine the necessary competence
Ensure persons competent on the basis of education, training or experience
Take action to acquire competence and evaluate effectiveness
Retain appropriate documented information

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ISO 9001:2015 CLAUSES
7.3 Awareness
Quality Policy, Relevant quality objectives, Their contribution towards
effectiveness of QMS including benefits of improved performance; and
implications of non conformance
7.4 Communication
Organization shall determine the internal and external communication
process relevant to the QMS
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information

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ISO 9001:2015 CLAUSES
8. Operation
8.1 Operational planning & control
Determine requirements of products & services
Establish criteria for
a) The processes
b) The acceptance of products & processes
) Determine the resources need to achieve conformity
) Implementing control of the processes
) Determining, maintaining and retaining documented information;
a) to have confidence that the processes have been carried out as planned
b) to demonstrate the conformity of products and services to their
requirements

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ISO 9001:2015 CLAUSES
8.2 Requirements of products and services
8.2.1 Customer Communication
8.2.2 Determining the requirements of products & services
8.2.3 Review of requirements of products & services
8.2.4 Changes to requirements of products & services
8.3 Design & development of products & services
8.3.1 General
8.3.2 Design & development planning
8.3.3 Design & development inputs
8.3.4 Design & development controls
8.3.5 Design & development outputs
8.3.6 Design & development changes

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ISO 9001:2015 CLAUSES
8.4 Control of externally provided processes, products &
services
8.4.1 General
8.4.2 Type and extent of control
Ensure that externally provided processes, products & services remain
within control of its QMS
Define controls to be applied to the external provider and to the resulting
outputs
Consider potential impact of externally provided processes, products &
services on ability to meet customers and statutory & regulatory
requirements
Consider effectiveness of controls
Determine the verification activities

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ISO 9001:2015 CLAUSES
8.4.3 Information for external providers
8.5 Production & service provision
8.5.1 Control of production & service provision
a) Availability of characteristics of the products & services to be provided and
the results to be achieved
b) Availability of suitable measuring & monitoring resources
c) Implementation of monitoring & measuring activities at appropriate stages
d) Use of suitable infrastructure and environment
e) Competent persons
f) Validation of processes where resulting output can not be measured or
monitored
g) Implementation of actions to eliminate human errors
h) Implementation of release, delivery & post delivery activities

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ISO 9001:2015 CLAUSES
8.5.2 Identification & Traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post delivery activities
8.5.6 Control of changes
8.6 Release of products & services
8.7 Control of nonconforming outputs
8.7.1 Ways to deal with nonconforming outputs:
Correction
Segregation, containment, return or suspension of outputs
Informing the customer
Obtaining authorization for acceptance under concession

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ISO 9001:2015 CLAUSES

8.7.2 Documented information


Description of nonconformity
Action taken
Any concessions obtained
Identifies the authority deciding the authority in respect of nonconformity
9. Performance evaluation
9.1 Monitoring, measurement, analysis & evaluation
9.1.1 general
What needs to be measured and monitored
Methods for monitoring, measurement, analysis & evaluation
When to perform measuring & monitoring
When to analyze and evaluate the results

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ISO 9001:2015 CLAUSES
9.1.2 Customer satisfaction
9.3 Analysis and evaluation
Conformity of products and services
Degree of customer satisfaction
Performance & effectiveness of QMS
Effective implementation of planning
Effectiveness of actions taken to address risks & opportunities
Performance of External providers
Need for Improvements
9.2 Internal audit
9.3 Management Review
9.3.1 General
9.3.2 Management review inputs
9.3.3 Management review Outputs

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ISO 9001:2015 CLAUSES
10. Improvement
10.1 General
10.2 Nonconformity & preventive action
10.2.1 Actions
a) React as applicable - Control and correct; Deal with consequences
b) Evaluate need for elimination - Review and analyze; Root cause analysis;
Determine similar nonconformities or could occur
c) Implement action
d) Review effectiveness
e) Update risks and opportunities
f) Make changes to QMS
10.2.2 Documented information
10.3 Continual Improvement

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ISO 9001:2015 BENEFITS

The ability to consistently provide products & services that meet


the customer and applicable statutory and regulatory
requirements
Facilitating opportunities to enhance customer satisfaction
Addressing risks and opportunities associated with its context
and objectives
The ability to demonstrate conformity to specified quality
system requirements

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