ISO9001 Standard

ISO 9001:2015
Quality Management Systems (QMS) – Requirements

(A detailed description of elements in plain English with examples)
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ISO 9001:2015
Overview of Standard

1. Scope
• Specifies requirements of a QMS
a) To demonstrate ability to meet
• Customer requirements
• Legal requirements
Customer Legal Requirements

Requirements
Customer Satisfaction
b) To enhance customer satisfaction, through

• An effective system
• Improvement processes, and
• Assurance of conformity
• NOTE 1: Terms ‘product‘ or ‘service’ means only those required by
customers
• NOTE 2: Statutory & regulatory requirements can be expressed as
Legal requirements

2. Normative References
• ISO 9000:2015
• QMS – Fundamentals & Vocabulary

3. Terms & Definitions
As given in ISO 9000:2015

Clause 4
CONTEXT OF THE ORGANIZATION

4.1 Understanding the organization and its context
• Determine ‘Internal’ and ‘External’ Issues
• Relevant to ‘purpose’ and ‘strategic direction’
• That affect ability to achieve QMS results
• Monitor & review

4. Context of the organization
4.2 Understanding the needs and expectations of
interested parties
a) Determine the interested parties (IPs) (relevant to QMS)
b) Their requirements (relevant to QMS)
• Monitor & review

4.3 Determining the scope of the QMS
• Establish QMS Scope by
• Determining ‘boundaries’ & ‘applicability’ of QMS
• Consider
a) External & internal issues (4.1)
b) Requirements of relevant IPs (4.2)
c) Products & services

4.3 Determining the scope of the QMS (Contd.)
• Apply all requirements of this standard, , if applicable
• Scope to be available and documented
• Scope to cover
• Products & services
• Justification for non-applicability of requirements
• Non-applicable requirements not to affect ability

4.4 QMS & its processes
• 4.4.1 Establish, implement, maintain and continually improve
• A QMS
• Processes needed
• Their interaction
• As per the standard

• Determine processes and their application, and
a) Determine process inputs & outputs
b) Sequence & interaction of processes
c) Criteria & methods for effective operation & control
(monitoring, measurement & performance indicators)
d) Resources & their availability
e) Responsibilities & authorities
f) Address risks & opportunities (6.1)
g) Evaluate processes and implement changes
h) Improve processes and QMS

• 4.4.2
a) Maintain documented information for processes
b) Retain documented information to have confidence
Maintain Retain

Clause 5
LEADERSHIP
5.1 Leadership & commitment
• 5.1.1 General
• Demonstrate leadership &
commitment w.r.t. QMS by
a) Taking accountability for
effectiveness
b) Ensuring quality policy &
objectives
• Compatible to context and
strategic direction
c) Integration of QMS into
business processes
d) Promoting process approach
& risk based thinking

5.1 Leadership & commitment (Contd.)
e) Ensuring availability of resources
f) Communicating importance of effective QMS
g) Ensuring intended results
h) Engaging, directing & supporting persons
i) Promoting improvement
j) Supporting leadership roles

5.1 Leadership & commitment
• 5.1.2 Customer Focus
• Demonstrate leadership & commitment w.r.t. customer focus
by ensuring
a) Customer & legal requirements are determined, understood &
consistently met
b) Risks & opportunities affecting conformity & satisfaction are
determined & addressed
c) Focus on enhancing customer satisfaction is maintained

5.2 Policy
• 5.2.1 Establishing the quality policy
• Establish, implement & maintain a policy
a) Appropriate to purpose, context and strategy
b) Provides framework for objectives
c) Includes commitment to satisfy applicable requirements
d) Includes commitment to continual improvement of QMS

5.2 Policy
• 5.2.2 Communicating the quality policy
• The quality policy shall be
a) Available & maintained as documented information
b) Communicated, understood & applied
c) Available to relevant IPs

5.3 Organizational roles, responsibilities & authorities
• Ensure responsibilities and authorities for relevant roles
• Are assigned
• Communicated & understood

5.3 Organizational roles, responsibilities & authorities
• Assign responsibility & authority for
a) Ensuring QMS as per the standard
b) Ensuring intended process outputs
c) Reporting on QMS performance & opportunities
d) Promotion of customer focus
e) Ensuring QMS integrity in case of changes

Clause 6
PLANNING
6.1 Actions to address risks & opportunities
• 6.1.1 When planning for QMS
• Consider issues (4.1) & IP requirements (4.2)
• Determine risks & opportunities to
a) Assure QMS results
b) Enhance desirable effects
c) Prevent or reduce undesirable effects
d) Achieve improvement

• 6.1.2 Plan
a) Actions to address risks & opportunities
b) How to
1) Integrate & Implement actions into QMS processes
2) Evaluate effectiveness of these actions
• Actions to be proportionate to potential impact on conformity

6.2 Quality objectives and planning to achieve them
• 6.2.1 Establish quality objectives at relevant functions, levels &
processes
• The objectives to be
a) Consistent with policy
b) Measurable
c) As per applicable requirements
d) Relevant to conformity & enhancing satisfaction

e) Monitored
f) Communicated
g) Updated as appropriate
• Maintain documented information

• 6.2.2 Planning to achieve objectives to include
a) What will be done
b) What resources required
c) Who will be responsible
d) When it will be completed
e) How it will be evaluated

• 6.3 Planning of changes
• Changes to QMS to be planned
• Consider
a) Purpose of changes & consequences (risks)
b) Integrity of QMS
c) Availability of resources
d) Allocation or reallocation of responsibilities & authorities

Clause 7
SUPPORT
7.1 Resources
• 7.1.1 General
• Determine & provide resources for QMS
• Consider
a) Capabilities & constraints on internal resources
b) Needs to obtain external resources

7.1.2 People
• Determine & provide persons
• For effective implementation of QMS
• For operation & control of processes

7.1.3 Infrastructure
• Determine, provide & maintain infrastructure for
• Operation of processes
• Achievement of conformity
(Note: Building & utilities, equipment, transport, ICT)

7.1.4 Environment for operation of processes
• Determine, provide & maintain environment for
• Operation of processes
• Achievement of conformity
(Note: can include social, psychological, physical environment,
depending on product or service)

7.1.5 Monitoring & measuring resources
• 7.1.5.1 General
• Determine & provide M&M resources
• Ensure that resources are
• Suitable
• Maintained for fitness
• Maintain documented information of fitness

• 7.1.5.2 Measurement traceability
• When required or essential, equipment to be
a) Calibrated or verified or both
• At specified intervals or prior to use
• Traceable to international or national standards (or basis)
b) Identified for status
c) Safeguard from adjustments, damage, deterioration
• When found unfit, determine validity of previous results and
take action

• 7.1.6 Organizational knowledge
• Determine ‘knowledge’ for operation & conformity
• Maintain and make available this knowledge
• Determine how to acquire additional knowledge and updates
Notes:
1. Org. specific, by experience, Used &
shared for objectives
2. Based on internal & external sources

7.2 Competence
a) Determine competence of persons
b) Ensure competence based on education, training or
experience
c) Where applicable, act to acquire competence and evaluate
effectiveness
d) Retain documented information
• Note: actions can include training, mentoring, reassignment, or
hiring, contracting

7.3 Awareness
• Ensure persons are
aware of
a) Quality policy
b) Relevant quality
objectives
c) Contribution to QMS
effectiveness & benefits
d) Implications of not
conforming

7.4 Communication
• Determine internal & external communications relevant to
QMS, including
a) What
b) When
c) With whom
d) How
e) Who

7.5 Documented information
• 7.5.1 General
• QMS to include Documented information
a) required by standard
b) Determined by organization for effectiveness
• Note: extent can differ from one organization to another

• 7.5.2 Creating & updating
• When creating documented information, ensure
a) Identification & description (e.g. title, date, author, or ref. no.)
b) Format (e.g. language, software version, graphics)
Media (e.g. paper, electronic)
c) Review and approval

• 7.5.3 Control of documented information
• 7.5.3.1 Control documented information to ensure
a) It is available & suitable, where & when
b) It is adequately protected (confidentiality, misuse, integrity)

• 7.5.3.2 Address the following
a) Distribution, access, retrieval, use
b) Storage, preservation, incl. preservation of legibility
c) Control of changes (e.g. version)
d) Retention & disposition
• Identify & control external documented information
• Protect evidences of conformity from alterations

Clause 8
OPERATION
8.1 Operational planning & control
• Plan, implement & control processes (4.4)
• To meet product & service requirements
• To implement actions on risks (6), by
a) determining product/service requirements
b) criteria for
• Processes
• Acceptance of products
& services
c) resources needed

d) Implementing control of processes
e) Determining, maintaining & retaining doc. Info.
1) To have confidence on process compliance
2) To demonstrate conformity
• Output of planning to be as suitable
• Control planned changes
• Review unintended changes
• Take action to mitigate effects
• Control outsourced processes (8.4)

8.2 Requirements for products & services
• 8.2.1 Customer communication
• Communication to include
• Information on products & services
• Enquiries, contracts, orders & changes
• Customer feedback & complaints
• Customer property control
• Contingency actions, when relevant

• 8.2.2 Determining the requirements for products & services
• Ensure before offering that
a) Requirements are defined, including
• Statutory & regulatory requirements
• Those considered necessary
b) Organization can meet the claims of offers

• 8.2.3 Review of requirements for products & services
• Conduct review before committing to supply
• Include requirements:
a) Specified by customer
b) Not stated, but necessary for use
c) Specified by organization
d) Statutory & regulatory requirements
e) Differences from previous offers – Resolve

• Confirm requirements when not documented by customer
• Retain doc info on
• Review results
• New requirements

• 8.2.4 Changes to requirements for products & services
• When requirements change
• Amend relevant documented information
• Make relevant persons aware

8.3 Design & development of products & services
• 8.3.1 General
• Establish, implement & maintain a process appropriate to
ensure subsequent provision
(ability to manufacture / provide)

• 8.3.2 Design & development planning
• For determining stages & controls, consider
a) Complexity of design
b) Required stages, including reviews
c) Required verification & validation
d) Responsibilities & authorities

e) Resource needs (internal & external)
f) Control of interfaces in design
g) Involvement of customers & users
h) Requirements of subsequent provision
i) Control of design expected by customers & IPs
j) Doc. info. needed to demonstrate meeting requirements

• 8.3.3 Design & development inputs
• Determine product requirements.
Consider:
a) Functional & performance requirements
b) Info from previous designs
c) Statutory & regulatory requirements
d) Standards & codes committed by
organization
e) Potential consequences of failures
• Inputs to be adequate, complete &
unambiguous
• Resolve conflicting inputs
• Retain documented information on
inputs

• 8.3.4 Design & development controls
• Apply controls to design process to ensure
a) Results to be achieved are defined
b) Reviews are conducted to evaluate ability of results
c) Verification to ensure output meet input requirements

d) Validation to ensure products meet intended use
e) Actions from reviews, verification & validation are taken
f) Retain documented information

• 8.3.5 Design & development outputs
• Ensure that outputs:
a) Meet input requirements
b) Adequate for subsequent provision
c) Include M&M and acceptance criteria
d) Specify characteristics for intended purpose & provision
• Retain documented information on outputs

• 8.3.6 Design & development changes
• Identify, review & control changes
• During or subsequent to design
• Ensure no adverse effect on conformity
• Retain documented information on
a) Changes
b) Results of review
c) Authorization of changes
d) Actions to prevent adverse effects

8.4 Control of externally provided processes, products &
services
• 8.4.1 General
• Ensure that they conform to requirements
• Determine controls to be applied when:
a) Intended for incorporation
b) Provided directly by external providers
c) A process or its part provided by external provider

• Determine & apply criteria for
• Evaluation
• Selection
• Performance monitoring, and
• Re-evaluation
• Retain documented information

• 8.4.2 Type & extent of control
• Ensure that external products do not adversely affect ability to
conform
a) Ensure that external processes are within control of QMS
b) Have controls both for provider as well as for output
c) consider:
1) Impact on meeting customer & legal requirements
2) Effectiveness of controls
d) Determine verification /other activities to ensure conformity

• 8.4.3 Information for external providers
• Ensure adequacy of requirements prior to communication
• Communicate requirements for
• processes, products, services
• Approval of
• Products & services
• Methods, processes, equipment
• Release of products & services
• Competence including any qualifications of persons
• External providers interactions with organization
• Control & monitoring to be applied by organization
• Verification or validation intended at provider’s premises

8.5 Production & service provision
• 8.5.1 Control of production & service provision
• Implement under controlled conditions
• Include, as applicable
a) Availability of documented information
1) Product characteristics to be produced/services to be
provided/activities to be performed
2) Results to be achieved
b) Availability & use of suitable M&M resources
c) Implementation of M&M activities to verify compliance

d) Use of suitable infrastructure & environment
e) Appointment of competent persons (including any
qualification)
f) Validation & periodic re-validation (special processes)

g) Prevention of human error actions
h) Release, delivery & post delivery activities

• 8.5.2 Identification & traceability
• Identify outputs (when required for conformity)
• Identify status of output (w.r.t M&M activities – throughout)
• Control unique identification of outputs (when traceability is
required)
• Retain documented information for traceability
OK
HOLD
NOT
OK
Status Traceability
Identity

• 8.5.3 Property belonging to customers or external providers
• Exercise care with property
• Identify, verify, protect, and safeguard
• When lost, damaged or found unsuitable –report & retain
documented information
• Note: can include materials, components, tools, equipment,
premises, intellectual property and personal data

• 8.5.4 Preservation
• Preserve the output
• During production or service delivery
• To ensure conformity
• Note:
• Identification
• Handling
• Contamination control
• Packaging
• Storage
• Transmission or transportation
• Protection

• 8.5.5 Post-delivery activities
• Meet post-delivery requirements of products & services
• Consider
a) Statutory & regulatory requirements
b) Undesirable consequences
c) Nature, use & intended lifetime of products & services
d) Customer requirements
e) customer feedback
• Note: can include actions
under warranty, contracts
(e.g. maintenance,
recycling or final disposal)

• 8.5.6 Control of changes
• Review & control changes for production & service provision
• Results of review
• Person(s) authorizing
• Any actions from review

• 8.5.7 Release of products & services
• Implement planned arrangements
• At appropriate stages
• To verify product or service requirements
• Release only after completion of planned arrangements
• Unless otherwise approved by an authority and customer
• Retain documented information on release of products &
services. Include:
a) Evidence with acceptance criteria
b) Person(s) authorizing release

8.7 Control of nonconforming outputs
• Identify & control (to prevent use or delivery)
• Action based on nature of NC & its effects
• NC during production/service or after delivery
• Deal with NC thro’ one or more of following ways:
a) Correction
b) Segregation, containment, return or suspension of provision
c) Informing the customer
d) Obtaining authorization
(under concession)
• Verify conformity when
outputs are corrected

• 8.7.2 Retain
documented
information that
a) Describes the NC
b) Describes the
actions taken
c) Describes
concessions
d) Identifies authority
deciding action

Clause 9
PERFORMANCE EVALUATION
9.1 Monitoring, measurement, analysis and evaluation
• 9.1.1 General
• Determine
a) What to monitor & measure
b) Methods for monitoring, measurement, analysis & evaluation
c) When to monitor & measure
d) When to analyze & evaluate
• Evaluate the performance & effectiveness of QMS

• 9.1.2 Customer Satisfaction
• Monitor customer’s perceptions
• Degree of fulfillment of their needs
• Determine method for
• Obtaining
• Monitoring
• Reviewing this information
• Note:
• Customer surveys
• Feedback on products & services
• Meetings with customer
• Market share analysis
• Compliments, warranty claims, & dealer reports

• 9.1.3 Analysis & evaluation
• Appropriate data and information from M&M
• Use results to evaluate
a) Products & services conformity
b) Customer satisfaction
c) Performance & effectiveness of QMS
d) Effective implementation of planning
e) Effectiveness of actions to address risks & opportunities
f) Performance of external providers
100 East
g) Need for improvements to QMS 80
60
40 West
• Note: 20
0 North
• Can include statistical techniques 1st 2nd 3rd 4th
Qtr Qtr Qtr Qtr

• 9.2 Internal audit
• 9.2.1
• Conduct internal audits
• At planned intervals
• To provide information on
a) conformity of
1) Organization’s own QMS
2) This International standard
b) Effective implementation &
maintenance of QMS

• 9.2.2
a) Have audit programme(s)
• Include frequency, methods, responsibilities,
planning & reporting
• Consider
• Importance of processes
• Changes affecting organization
• Results of previous audits

b) Define audit criteria & scope
c) Ensure objectivity & impartiality
d) Results reported to relevant management
e) Correction & corrective action without delay
f) Retain documented information
Note: ISO 19011 for guidance

9.3 Management review
• 9.3.1 General
• Review QMS
• at planned intervals
• To ensure
• continuing suitability
• Adequacy
• Effectiveness
• Alignment

• 9.3.2 Management review inputs
a) Actions from previous reviews
b) Changes in external & internal issues
c) Performance & effectiveness of QMS, including trends in
1) Customer satisfaction & IP feedback
2) Quality objectives
3) Process performance & product & service conformity
4) Nonconformities & corrective actions
5) Monitoring & measurement results
6) Audit results
7) Performance of external providers
d) Adequacy of resources
e) Effectiveness of actions on risks & opportunities
f) Opportunities for improvement
• Management review outputs
• Include decisions & actions on
a) Opportunities for improvement
b) Need for changes to QMS
c) Resource needs

Clause 10
IMPROVEMENT
10.1 General
• Determine & select opportunities for improvement
• Implement actions to meet customer requirements and
enhance satisfaction
• Include
a) Improving products & services
b) Correcting, preventing, reducing undesirable effects
(rejections, rework, wastes, etc.)
c) Improving performance & effectiveness of QMS
• Note:
• Improvement examples include correction, corrective action,
continual improvement, breakthrough change, innovation & re-
organization

10.2 Nonconformity & corrective action
• In case of a nonconformity (NC), including complaint
a) React to NC, as applicable
1) To control & correct it
2) Deal with consequences
b) Evaluate action to eliminate causes to avoid recurrence:
1) Review & analyze NC
2) Determine causes
3) Determine similar NCs or potential NCs
c) Implement actions needed
d) Review effectiveness
e) Update risks & opportunities
f) Change QMS, if necessary
• Corrective action to be appropriate
to effects of NCs
• 10.2.2
• Retain documented information as evidence of
a) Nature of NCs and actions taken
b) Results of any corrective action

10.3 Continual Improvement
• Continually improve
• Suitability
• Adequacy
• Effectiveness of QMS
• Consider
• Results of analysis & evaluation
• Management review outputs

Thank you!
For more courses on management systems, please contact:
avinit.singh@gmail.com
www.qpglearning.com
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ISO 9001:2015

Quality Management Systems (QMS) – Requirements

© All rights reserved, Quality Professionals Group

© All rights reserved | www.qpglearning.com

Customer Legal Requirements

b) To enhance customer satisfaction, through

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CONTEXT OF THE ORGANIZATION

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