QMS Deliverables

QMS ISO 9001 Sub

ISO 9001 CL.No and
Clause QMS Clauses CL.No and Department Document Purpose
Description
# Description

0 Introduction The adoption of a quality management system

0.1 General Organization ISO Standards is a strategic decision for an organization.
The QM Principles are:—
customer focus
leadership
engagement of people
process approach
improvement
evidence-based decision making relationship
0.2 QM Principles Organization ISO Standards management.
Understanding and managing interrelated
processes as a system contributes to the
0.3 Process Approach 0.3.1 General Organization Gap Analysis Report organization’s effectiveness and efficiency
0.3.2 PDCA Plan, Do Check, Act - Definitions,
Cycle Organization PDCA Lifecycle Methodologies
Achieving an effective quality management
system.
Preventive action to eliminate potential
nonconformities, analysing any
nonconformities that do occur, and taking
Risk Procedure action to prevent recurrence that is
0.3.3 Risk- Risk Plan appropriate for the effects of the
based thinking Organization Risk Guidelines nonconformity.
0.4 Relationship with
other Management
System Standards Organization QMS Matrix
All requirements of
1 Scope international standard ISO
9001:2015 Organization Quality Policy Organization’s Commitment to Quality
 QMS Deliverables
QMS ISO 9001 Sub
ISO 9001 CL.No and
Clause QMS Clauses CL.No and Department Document Purpose
Description
# Description
Fundamentals and
Normative vocabulary for normative
2 ISO 9000:2015, Quality
Reference reference as per ISO
9000:2015 Organization management systems Fundamentals and vocabulary
Terms and Terms and definitions as Terms and definitions given in ISO 9000:2015
3
Definitions per ISO 9000:2015 Organization ISO Standards apply
organization shall determine external and
internal issues that are its strategic direction
Context of
and that affect its ability to achieve the
4 the
4.1 Understanding the Quality Manual intended result(s) of QMS. Issues can include
Organization
Organization and its Issue Log positive and negative factors or conditions for
context Organization Gap Analysis Report consideration.
4.2 Understanding the
needs and expectations of
interested parties Organization Quality Manual What you do to meet the standard
4.3 Determining the scope
of the QMS Organization Quality Manual Organization Scope

Procedures
Checklists
4.4 QMS and its Forms
processes Organization Work Instructions QMS Definitions

Quality Policy
5 Leadership Quality Manual
5.1 Leadership and Organization chart
Commitment 5.1.1 General Organization Plans Commitment, Customer focus, Policy, Planning

Quality Policy
5.1.2 Quality Manual
Customer Org. Structure Commitment, Customer focus, Policy,
focus Organization Plans Planning,
 QMS Deliverables
QMS ISO 9001 Sub
ISO 9001 CL.No and
Clause QMS Clauses CL.No and Department Document Purpose
Description
# Description
5.2.1
Establishing
the quality
5.2 Policy policy Organization Quality Policy Management’s Commitment to Quality
5.2.2
Communicatin
g the quality
policy Organization Quality Policy Posters Management’s Commitment to Quality

5.3 Organizational roles, Quality Manual

responsibilities and Review Procedure Responsibility, Authority & Communication,
authorities Organization Review Plan Review

6 Planning 6.1 Actions to address Risk Procedure

risks and opportunities Organization Risk Plan Risk Identifications, Analysis and Prevention
Vision / Mission Statement Establish quality objectives at relevant
6.2 Quality Objectives and Audit Procedure functions, levels and processes needed for the
planning to achieve them Organization Audit Plan quality management system
Change Procedure / Organization determines the need for changes
6.3 Planning of Changes Organization Guidelines to the quality management system
Resource Management
Procedure
7 Support Training Procedure
Document of Control
7.1 Resources 7.1.1 General HR Procedure

Attendance
Staff Master data
Recruitment Details Determine and provide the persons necessary
7.1.2 People HR Employee History card for the effective implementation
 QMS Deliverables
QMS ISO 9001 Sub
ISO 9001 CL.No and
Clause QMS Clauses CL.No and Department Document Purpose
Description
# Description

Infrastructure List
Maintenance AMC Determine, provide and maintain the
7.1.3 Service Cards infrastructure necessary for the operation of
Infrastructure HR Emergency Procedures its processes
7.1.4
Environment Work Environment Standard
for the Procedure
operation of List of Equipment’s and Provide and maintain the environment
processes Admin / HR utilities necessary for the operation of its processes
Equipment User Manuals
7.1.5 Warranty calibrated or verified, or both, at specified
Monitoring and Guarantee cards intervals, or prior to use, against measurement
measuring Equipment Maintenance standards traceable to international or
resources Admin / HR record national measurement standards

Training Requisition Form

Training Calendar
7.1.6 HR Training Attendance Form
Organizational HR Training Feedback and knowledge shall be maintained and be made
knowledge HR / Training Evaluation Form available to the extent necessary
7.2 Competence HR Competency & skill Matrix Knowledge Database of all employees
Organization shall ensure that persons doing
work are aware of
a) Quality policy
b) relevant quality objectives
Quality Policy Posters c) their contribution to the effectiveness of
Audits the quality management system, including the
7.3 Awareness Admin / HR Safety rules and guidance benefits of improved performance
Organization / HR / Determine the internal and external
7.4 Communication Admn Mail / Posters / Meetings communication
 QMS Deliverables
QMS ISO 9001 Sub
ISO 9001 CL.No and
Clause QMS Clauses CL.No and Department Document Purpose
Description
# Description
7.5 Documented Documented information required by this
Information 7.5.1 General All Employees QMS Awareness International Standards

Identification and description (e.g. a title, date,

author, or reference number)Format (e.g.
language, version, graphics)Media (e.g. paper,
7.5.2 Creating ProceduresChecklistsFormsW electronic)Review and approval for suitability
and updating All Employees ork Instructions and adequacy

Procedures Available and suitable for use, where and

Checklists when it is need
7.5.3 Control Forms Adequately protected (e.g. from loss of
of documented Work Instructions confidentiality, improper use, or loss of
Information All Employees Configuration Procedure integrity
Plans
8 Operation 8.1 Operational planning Sales Procedure Demonstrate the conformity of products and
and control All Employees Procurement Procedure services to their requirement
8.2.1
Customer
8.2 Requirements for communicatio List of customers Handling enquiries, contracts or orders,
products and services n Sales / Purchase Enquiry Register including changes
8.2.2
Determining
the
requirements Challans/Invoice Determining the requirements for the
for products Purchase Orders products and services to be offered to
and services Sales / Purchase Purchase Item customers
8.2.3 Review
the
requirements Contract review check list Requirements not stated by the customer, but
for products Verification/records necessary for the specified or intended use,
and services Sales / Purchase inspection when known
 QMS Deliverables
QMS ISO 9001 Sub
ISO 9001 CL.No and
Clause QMS Clauses CL.No and Department Document Purpose
Description
# Description
8.2.4 Changes
to
requirements
for product Ensure that relevant documented
and services Sales / Purchase Customer Order register information is amended

Equipment List
8.3 Design and Maintenance Information
development of products Sales / Purchase / User Manuals
and services 8.3.1 General Technical Review Procedure
8.3.2 Design
and
development Sales / Purchase / Responsibility and authority Stages and controls for design and
planning Technical Matrix development
8.3.3 Design
and
development Sales / Purchase / Job orders/Work orders
inputs Technical record Statutory and regulatory requirements
8.3.4 Design Internal Communication
and records
development Review Plan Reviews are conducted to evaluate the ability
controls Technical Staffs Review Logs of the result
8.3.5 Design
and Minutes of the Management
development review Monitoring and measuring requirements, as
outputs Technical Staffs Acceptance Criteria Document appropriate, and acceptance criteria
8.3.6 Design System flow chart
and Change Management
development Procedure
changes Technical Staffs Approval Mechanism Authorization of the change
 QMS Deliverables
QMS ISO 9001 Sub
ISO 9001 CL.No and
Clause QMS Clauses CL.No and Department Document Purpose
Description
# Description

Challans/Invoice
8.4 Control of externally Approved vendor list
provided processes, Purchase Orders Determine and apply criteria for the
products and services 8.4.1 General Purchase / Finance Purchase Item evaluation, selection
8.4.2 Type and
extent of Approved vendor list Determine and apply criteria for the
control Purchase / Finance Validation Procedure evaluation, selection
8.4.3
Information for
external Purchase / Finance Approved vendor list Competence, including any required
providers / HR List of customers qualification of person
8.5.1 Control
of production
8.5 Production and and service Finance / Purchase Testing ProcedureQuality Validation, and periodic revalidation, of the
service provision provision / Technical Report ability to achieve planned results
8.5.2
Identification
and Finance / Purchase Control the unique identification of the
traceability / Technical Traceability Matrix outputs when traceability is a requirement
8.5.3 Property
belonging to
customers or Equipment List Materials, components, tools and equipment,
external Finance / Purchase Maintenance Information premises, intellectual property and personal
providers / Technical Test Reports data
Storage Procedure Handling, contamination control, packaging,
8.5.4 Packing Procedure storage, transmission or transportation, and
Preservation Packing / Dispatch Despatch Guidelines protection
8.5.5 Post-
delivery Customer Satisfaction report
activities Dept. Head / Sales Customer Complaints Customer feedback
8.5.6 Control
of changes Dept. Head / Sales Customer Order register
 QMS Deliverables
QMS ISO 9001 Sub
ISO 9001 CL.No and
Clause QMS Clauses CL.No and Department Document Purpose
Description
# Description
Delivery Challans
8.6 Release of products Purchase orders
and services Packing / Dispatch Vouchers if any Approved by a relevant authority for deliver
Audit Procedure Describes the nonconformity and actions
8.7 Control of Audit Plan taken
nonconforming outputs IT Audit Report Describes any concessions obtained
9.1 Monitoring,
Performance
9 measurement, analysis Performance and the effectiveness of the
Evaluation
and evaluation 9.1.1 General IT / All Employees Audit Participation quality management system

Customer Satisfaction report

9.1.2 Customer Surveys Monitor customers’ perceptions of the
Customer Market Analysis degree to which their needs and
satisfaction Sales / GM Dealer Reports expectations have been fulfilled

Customer Satisfaction report

Customer Surveys Analyse and evaluate appropriate data and
9.1.3 Analysis Market Analysis information arising from monitoring and
and evaluation Sales / GM Dealer Reports measurement
Audit Procedure Audit programme(s) including the frequency,
Audit Plan methods, responsibilities, planning
9.2 Internal Audit All Employees Audit Report requirements and reporting
Employee Performance Report Review the organizations performance, at
Audit Report planned intervals, to ensure its continuing
Sales report suitability, adequacy, effectiveness and
Customer feedback alignment with the strategic direction of the
9.3 Management Review 9.3.1 General All Employees /suggestion organization
 QMS Deliverables
QMS ISO 9001 Sub
ISO 9001 CL.No and
Clause QMS Clauses CL.No and Department Document Purpose
Description
# Description
Minutes of the Management
review Audit results
Review Procedure Customer satisfaction and feedback
9.3.2 Action Plan Performance of external providers
Management Risk Review Effectiveness of actions taken to address risks
review inputs All Employees Customer Feedback Form and opportunities

Suppliers/Vendors/Outsource
d Activities Performance
Competency and skill
matrixInternal Communication
9.3.3 recordsApplicable Statutory Opportunities for improvementResource
Management and legal requirementsNon needsAny changes to the process
review outputs All Employees Compliance ReportRisk Report improvements
IT / All Employees / Correcting, preventing or reducing undesired
10 Improvement
10.1 General Organization Non Compliance Report effects
Non Compliance Report
10.2 Nonconformity and IT / All Employees / Corrective and Prevention
corrective action Organization Action Plan Determining the causes of the nonconformity
Continually improve the suitability, adequacy
10.3 Continual IT / All Employees / and effectiveness of the quality management
improvement Organization QMS Implementation system