9001:2015

Quality Management System

 1 SCOPE

This International Standard specifies requirements for a quality

management system when an organization:
a) needs to demonstrate its ability to consistently provide products
and services that meet customer and applicable statutory and
regulatory requirements, and
b) aims to enhance customer satisfaction through the effective
application of the system, including processes for improvement of
the system and the assurance of conformity to customer and
applicable statutory and regulatory requirements.
All the requirements of this International Standard are generic and are
intended to be applicable to any organization, regardless of its type or
size, or the products and services it provides.
NOTE 1 In this International Standard, the terms “product” or
“service” only apply to products and services intended for, or
required by, a customer.
NOTE 2 Statutory and regulatory requirements can be expressed as
legal requirements. 2
 2 NORMATIVE REFERENCES

The following documents, in whole or in part, are normatively

referenced in this document and are indispensable for its
application. For dated references, only the edition cited
applies.
For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 9000:2015, Quality management systems — Fundamentals
and vocabulary

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 3. TERMS AND DEFINITIONS

For the purposes of this document, the terms and definitions given
in ISO 9000:2015 (Quality management systems — Fundamentals
and vocabulary) apply.

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4 Context of Organization

➢ 4.1 Understanding the organization and its context

➢ 4.2 Understanding the needs and expectations of interested parties
➢ 4.3 Determining the scope of the Quality Management System
➢ 4.4 Quality Management System and its processes
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Basis of Auditing

• Description of the interaction of the

processes
• List of process owners
• Tasks, function/job description of
Examples of process owners
Documentation/ • process indicators for measuring
Evidences effectiveness of processes
• Assignment of the process indicators to
the processes
• Measurement, monitor and evaluation
of the processes

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Basis of Auditing

•Linking the processes with further documents

Examples of •Available resources
•Analysis of processes with regard to risks and
Documentation/ opportunities
•And associated planning, implementation and
Evidences assessment of actions
•List of the documents needed for implementation
of the processes, document control and storage

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5 Leadership

➢ 5.1 Leadership and commitment

➢ 5.2 Policy
➢ 5.3 Organizational roles, responsibilities and authorities
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 •Written quality policy and objectives
•Evidence of training on quality policy / informative events
•Statements of top management
•Evidence of attainment of targets (BSC)
•Improvement projects
•Results from top management meetings
•Management review
•Performance charts
•Reaction plans if results/targets not achieved

Examples of •Training plans/ evidences regarding process approach,

processes, methods

Documentation/ •Communication with employees regarding the effectiveness of

the QMS

Evidences •Personnel development plans

•Employment of personnel
•Protocols regarding targets
•Project plans
•Investment plans
•Training budget
•Factory agreements with employees
•Continual improvement projects
•Corporate policies
•Mission statement
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 • Analysis of customer satisfaction
• SWOT analysis
• Action plans
• List of customer requirements
Examples of • List of statutory and regulatory
requirements
Documentation/
• Assessment of fulfillment of
Evidences
customer requirements
• Analysis of customer surveys
• Market analysis
• Analysis of complaints
documentation
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 • Written statement of Q policy
• Review of Q policy for
appropriateness
Examples of
Documentation/ • Written version of Q policy
Evidences • Documentation from informative
events, Intranet entries etc. for
employees, printed versions for
stakeholders of the organization,
possibly publish on the internet

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6 Planning

➢ 6.1 Actions to address risks and opportunities

➢ 6.2 Quality objectives and planning to achieve them
➢ 6.3 Planning of changes
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 • Project plan for change projects with inputs
• List of external
• List of internal
• List of risks
• List of opportunities
• Investment plans
• Strategy plans
Examples of • QM plans
• Production plans
documentation • Resource plans/evidences

and evidences • List of risks

• List of opportunities
• FMEAs
• Risk analysis
• Action plans
• Resource plans/evidences
• Process descriptions

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• Work and test plans
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Basis of Auditing

• Q objectives and their determination

and communication
• Internal/external target
agreements(business plans, project
plans, qualify agreements)
Examples of • Organization-related, product-related,
documentation customer-related objectives
• Employee information
and evidences
• Rules regarding updating
• Rules regarding control
• Harmonization with Q policy
• Level of achievement and trends

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Basis of Auditing

Examples of
•Action plans
documentation
and evidences
•Results of
evaluation

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7 Support

➢ 7.1 Resources
➢ 7.2 Competence
➢ 7.3 Awareness
➢ 7.4 Communication
➢ 7.5 Documented Information
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Basis of Auditing

• Requirement profile (employees,

infrastructure) resource planning
Examples of (internal and external)
documentation • Project management
and evidences • Availability (personnel, infrastructure)
• Job or function descriptions
• Service/quality agreement (if using
external resources)

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Basis of Auditing

•Personnel, staff position

planning
•Definition of key
Examples of qualifications
documentation
and evidences
•Status of available qualified
staff and qualifications
•Qualification plan
•Staff deployment planning

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Basis of Auditing

• Investment plans
• Resource planning
• Material flow analyses
Examples of
documentation • Warehouse capacity
and evidences assessment
• Process capability studies
• Measuring instrument
capability studies

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Basis of Auditing

•Handling and storage

conditions (temperature, air
humidity, cleanliness,
Examples of identification, traceability
documentation etc.)
and evidences
•Servicing and maintenance
plans
•Factory tour reports/logs

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Basis of Auditing

• Test planning concept

• Test planning
• Qualification requirements for testers
• Test instructions
• Determination of resource requirements
Examples of • Measuring equipment capability studies
documentation • Validation of test software
and evidences • Register of measuring equipment and
standards
• Evidence of calibration
• Reference to international standards
• Corrective actions in case of defective
measuring instruments

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Basis of Auditing

• Information entry and onwards transfer

points (knowledge hierarchy)
• List of relevant legislation
• Knowledge database
Examples of • Analysis of product management reviews
documentation • Complaint database
and evidences • Employee competence matrix
• Training plans
• Resource plans/project management
• FMEAs

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Basis of Auditing

• Qualification requirement profiles

• Qualification matrix
• Job/function descriptions
• Employee meetings
Examples of
• Initial instruction plans
documentation
• Mentoring programs
and evidences
• Evidences of training
• Assessment of effectiveness of
training or mentoring programs

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Basis of Auditing

• Minutes of meetings regarding

performance and effectiveness
to the system
Examples of • Evidences of initial instruction
documentation and training
and evidences • Participation in complaint
meetings, Q circles
• Evidences regarding knowledge
of Q policy and objectives

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 •Communication plans (internal communication
guidelines)
Examples of •Job/function descriptions
documentation •Meeting hierarchy
•PR plans
and evidences •Marketing concepts
•Meeting reports

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Basis of Auditing

Examples of Examples of Examples of

documentation documentation documentation
and evidences and evidences and evidences
•At least: •8.3.2 evidence of the fulfillment of •8.7 the activities and decision which
•4.3 Scope and exclusion requirements for development were undertaken in relation to the
•4.4 Process model and interactions, •8.3.5 development results nonconforming products/service shall
process responsibilities, performance •8.3.6 development changes be kept as documented information
indicators, risks, opportunities, •8.4.1 results of performance •9.1..1 suitable documented
resources , input, output, necessary monitoring and new assessment information shall be kept as evidence
instructions like test instruction, work of result of monitoring and
•8.5.1 instruction for ensuring
instruction, documented procedures measurement
controlled conditions
•5.2.2 Q policy •9.2.2 documented information as
•8.5.2 storage of documented
•5.2.1 Q objectives evidence of realization of the audit
information for identification with
program shall be kept
•7.1.5 calibration, verification regard to traceability
•9.3.2 the result of the management
•7.2 evidences of competence •8.5.6 changes and result of the
review shall be kept in the for of
•7.5 rules regarding creation, assessment and monitoring for
documented information
updating and control of unplanned changes to
documented information product/service provision
•8.1 evidence of process control • 8.6 evidences regarding conformity
measure with requirements must be kept
•8.2.3 assessment result of offer/ (release), with traceability to the
contract review including new and person responsible for the release
changed requirements

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 • Coding and number key
Examples of • Rules on format
documentation • Establishment of
and evidences responsibilities for review
and approvals

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 •List(s) of valid documents
•Distribution keys/lists
•Revision lists
Examples of
•Change procedures
documentation and
•Release/retrieval procedures
evidences
•Authority and access concept
•Security concept
•Archiving rules

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Basis of Auditing
Examples of documentation
Interpretation/activities
and evidences
• Document control shall • List of necessary external
include the following documents
activities (in so far as • Control and identification
applicable): of external documents,
• Distribution, access, easy e.g.
location and use • - Laws, standards
• Filling /storage and • - Customer specifications,
preservation drawing
• Monitoring of changes • - Requirements/ contract
(e.g. follow up of versions) specification
• Archiving period, disposal • - Datasets
review and approval

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8 Operation

 8.1 Operational planning and control

 8.2 Requirements for products and services
 8.3 Design and development of products and services
 8.4 Control of externally provided processes, products and services
 8.5 Production and service provision
 8.6 Release of products and services
 8.7 Control of nonconforming outputs
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Basis of Auditing

Examples of • Control process planning, controlling documents

documentation • Evidence of product/service acceptances from
customers
and evidences

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 •Product catalogues and
lists, product description
Examples of •Complaint management
documentation •Contingency plans
and evidences •Order documentation,
contract documentation
•Results of customer surveys

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 • Project plans
• Tender and
Examples of
documentation
performance
and evidences satisfactions
• Statutory and
regulatory requirements

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Basis of Auditing

• Key indicators regarding

testing times and costs (e.g.
Examples duration of testing, frequency
of testing , scope of testing)
of Key • Production costs
Indicators • Production time
• Time needed for feasibility
study

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Basis of Auditing

• Project plans
• Development plans/flowcharts
• Milestone plans
Examples of • Measurement and test plans
documentation
• Verification and validation rules
and evidences
• Rules of release/sign-off
• Responsibility matrix
• Risk assessment

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Basis of Auditing

• Documented procedure for design and development

• Process landscape for design and development
• Project plans
Examples of • Development plans/flowcharts

documentation • Milestone plans

• Measurement and test plans
and evidences • Verification and validation rules
• Release specifications
• Responsibility matrix
• Risk assessment

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Basis of Auditing

• Tender specifications/task set

• Performance specifications (as written by
supplier)
• Statutory and/or regulatory implementation
guidelines
Examples of • Reports of result from previous developments
documentation of the same kind
• Evaluation of customer need evaluations
and evidences • Patent searches
• Release documents
• Complaints analysis
• Warranty analysis
• FMEAs

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Basis of Auditing

•Performance
specifications
Examples of •Results of product
documentation
and evidences quality controls
•Verification logs
•Validation records

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Basis of Auditing

• Written change request (e.g. of the

customer, from production)
• New revision status of tender specification,
drawings, process descriptions, test
procedures, test equipment etc.
Examples of • Comment/test reports regarding changes
documentation • Release documents regarding changes
and evidences implemented
• Communications sent to customers and
departments regarding changes
• Withdrawn documents
• Change history

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Basis of Auditing

Assessment criteria
Supplier assessment and evidence
Product specification
QM documentation of the supplier
Examples of Checklist
documentation List/database of approved suppliers
and evidences Supplier Complaints
Statistics of suppliers
Quality agreement
Performance specification

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Basis of Auditing

•Supplier management
•Result of supplier audits
•Own complaints issued to suppliers
Examples of •Result from receiving inspection
•Evidences of communications with external suppliers
documentation •Overviews of requirements
and evidences •Internal evaluations/ reports regarding suitability of the
requirements
•Audit program for supplier audits

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Basis of Auditing

• Written releases from

customers
• Results of internal quality
Examples of controls
documentation
and evidences • Test and measurement
results
• Results from internal
audits

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 • Work instructions
• Accompanying documents, e.g. process
slip/routing card
Examples of • Production plans
documentation • EDP records
• Marking on products
and evidences
• Evidences of testing
• Blocking notes
• Releases

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Basis of Auditing

• Work instruction regarding handling of

customer property
• List of customer property
• Identification marking (labels,
Examples of engraving, storage and warehouse
documentation lists etc.)
and evidences • Correspondence with the customer
• Records of verification and
maintenance that have been
performed
• Receiving inspections

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 •Packaging, storage, preservation and dispatch rules
•Parts lists
•Storage lists
Examples of •Stock location and removal plans
documentation •Rules regarding storage period and any necessary
segregation of items
and evidences •Dispatch labeling
•Shelf life monitoring
•Assembly/operating instructions

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 • Warranty results
Examples of • Obligations regarding
documentation disposal
and evidences • Maintenance
• servicing

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 • Evidences regarding changes in
Examples of the monitoring activities.
documentation • Personnel authorizing the change
and evidences • Documented procedure for
release/change management

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 •Internal evidences
Examples of
documentation
regarding release
and evidences and evidences
from customer

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 •Blocked goods
Examples of
store
documentation •Blocking notes,
and evidences
reminders
•Evidences, see 8.6

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9 Performance evaluation

 9.1 Monitoring, measurement, analysis and

evaluation
 9.2 Internal audit
 9.3 Management review
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Basis of Auditing

• Test planning concept

• Test plans
• Sampling plans
Examples of • Test instructions
documentation • Analysis procedures
and evidences • Analysis (failure/scrap rates,
most frequent failures and
defects, trends)
• Reporting (quality reports, review
reports)

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 •Customer satisfaction surveys (user surveys)
•Reports of visits to customers
Examples of •Analysis of traders statements
•Market surveillance and observation
documentation •Customer satisfaction analysis
•Analysis of market shares
and evidences •Complaint reports
•Spontaneous expressions of satisfaction
•benchmarking

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 • Risk analysis (FMEA)
• Quality records
• Test logs
Examples of • Statistical analysis
• Result of internal and external audits
documentation • Q reports
• Customer satisfaction analysis
and evidences • Supplier assessments
• Action plan for improvement of customer satisfaction or other
improvements
• Management review

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Basis of Auditing

•Documented
procedure for
Examples of internal audits
documentation
and evidences •Set values, target
values with regard
to the requirements

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Basis of Auditing

• Audit program
• Audit plans
• Audit criteria
• Audit records
• Audit evaluations
Examples of • Audit reports
documentation • Nonconformity reports
and evidences • Action plans for introduction of corrective
actions
• Management reviews
• Reports regarding the effectiveness of
corrective and preventive actions
• Proofs of qualification of internal auditors

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Basis of Auditing

• Management review report

• Reports of:
• Internal audits
Examples of • Process audits
• Product audits
documentation • Quality analysis
and evidences • Status of corrective and preventive actions
• Resource requirement and use plans
• Supplier quality status
• Risk analysis (technical/ economic/business)

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 • Management review
Examples of • Status and progress reports
documentation • List of open points (LOP)
and evidences • Records of the follow-up of
corrective and preventive actions

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10 Improvement

➢ 10.1 General
➢ 10.2 Non-conformity and corrective action
➢ 10.3 Continual improvement
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Basis of Auditing

•Improvement projects
•Rules for implementation of improvement projects

Examples of •Continual improvement potential database

•Quality management plans

documentation •Project plans

•Target lists and reports

and evidences •Progress reports

•Management reviews
•Corrective action plans
•Preventive action plans

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Basis of Auditing
Examples of
Examples of Key
documentation
Indicators
and evidences
• Records of fault identification • Complaint rate
• Statistical analysis • Scrap, rework and guarantee costs
• Test/result logs and reports • Goodwill costs
• Instructions for corrective actions • Customer satisfaction index
• Root cause analysis • Self-assessment index
• Training plans • Process performance index
• Training evidences • Process stability index
• Complaint analysis
• Any changed supply contracts
• Q agreements
• Review logs
• Ishikawa diagrams
• Pareto analysis
• Histograms
• 5 Why
• FMEA review
• 8-D report

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10.3 Continual improvement
The organization shall continually improve the suitability, adequacy, and
effectiveness of the quality management system.

The organization shall consider the outputs of analysis and evaluation,

and the outputs from management review, to confirm if there are areas
of underperformance or opportunities that shall be addressed as part of
continual improvement.

Where applicable, the organization shall select and utilize applicable

tools and methodologies for investigation of the causes of
underperformance and for supporting continual improvement.

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Basis of Auditing

Examples of documentation
Examples of Key Indicators
and evidences
• Project plans • Rate of target achievement
• Logs and trends regarding • Number of implemented
set targets improvements
• Progress reports • Benchmarking/ranking
• Management reviews index
• Corrective action plans • Saving from improvement
• Preventive action plans group work
• System of suggestion for • Cost/benefit ratio
improvement • Reaction and
implementation rate

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THANK YOU