ios-9001 good presentation to take it and omproving

Clause 7: Support
Module V: QMS Requirements

Support 7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented
Information
7
Clause 7: Support

CONSIDER:
A. Capabilities and
constraints of internal
resources
B. Needs to be obtained
from external providers
7.1 Resources
Clause 7: Support
REQUIREMENT
7.1.1 General
The organization SHALL
determine and provided the
resources needed for the:
QMS
Establishment
Implementation
Maintenance
Continual
Improvement

7.1 Resources
Clause 7: Support
REQUIREMENT
P I E
M O

7.1 Resources
Clause 7: Support
REQUIREMENT
7.1.2 People
determine and provide the
persons necessary for the
effective implementation and
control of the QMS and for
the operation and control of
its processes
Note:
The agency should ensure that existing CSC laws, rules and
regulations regarding recruitment, training and developing employee
competence are considered in managing people

7.1 Resources
Clause 7: Support
REQUIREMENT
7.1.3 Infrastructure
determine, provide and
maintain the infrastructure
needed to achieve the
conformity to service and
necessary for the operation of
processes.
Can include:
• Buildings and associated utilities
• Equipment, including hardware and software
• Transportation resources
• Information and communication technology

7.1 Resources
Clause 7: Support
REQUIREMENT
7.1.4 Environment for the Operation of Processes
maintain the environment
necessary for the operation
of processes and achieve
conformity to service
requirements
Can be a combination of human and physical factors:
• Social - e.g. calm
• Psychological – e.g. burnout prevention
• Physical – e.g heat, airflow, hygiene

7.1 Resources
Clause 7: Support
REQUIREMENT
7.1.5 Monitoring and Measuring Resources
maintain the M&M
resources to ensure valid
and reliable results when
used to verify the conformity
of products and services to
requirements

7.1 Resources
Clause 7: Support
REQUIREMENT
The organization
SHALL ensure that
the resources
provided:
 Suitable for the activities
to be undertaken
 Maintained to ensure
continuing fitness for use
The organization SHALL retain documented
information as evidence of fitness for purpose.

Measuring equipment shall be:
 Calibrated or verified, or both, at specified intervals
or prior to use
 Identified in order to determine their status
 Safeguarded from adjustments, damage or
deterioration
7.1 Resources
Clause 7: Support
REQUIREMENT
NOTE:
Appropriate action shall be undertaken when previous
measurement results has been adversely affected
when equipment is found unfit for intended purpose.

The organization SHALL:
 Determine, maintain and
ensure availability
 Consider current
knowledge in addressing
changing needs and trends
 Determine how to acquire
or access any necessary
knowledge and required
updates
7.1 Resources
Clause 7: Support
REQUIREMENT
7.1.6 Organizational Knowledge

7.1 Resources
Clause 7: Support
REQUIREMENT
 Specific to the
organization
generally gained
by experience.
 Information that is
used and shared
to achieve
organization’s
objectives

7.1 Resources
Clause 7: Support
REQUIREMENT
Internal Sources:
 Intellectual Property
 Experience
 Lessons learned
 Results of improvement
 Standards
 Knowledge from
customers and external
providers
External Sources:
 Academe
 Conferences

7.2 Competence
Clause 7: Support
REQUIREMENT
The organization SHALL:
 Determine the necessary competence for
personnel performing work affecting conformity
to product and service requirements
 Provide training or other actions to achieve
the necessary competence
 Evaluate the effectiveness of the actions taken
 Maintain records of education, experience,
training and qualifications
Applicable Actions:
 Training
 Mentoring
 Re-assignment
 Hiring or contracting of
competent persons/providers

7.3 Awareness
Clause 7: Support
REQUIREMENT
Ensure that persons doing work under
the organization’s control are aware of:
 Quality Policy
 Quality Objectives
 Employees are aware of the
relevance and importance of their
activities, how they contribute to
achieve the quality objectives
 Implications of Nonconformities

7.4 Communication
Clause 7: Support
REQUIREMENT
The organization SHALL determine the internal and
external communications relevant to the QMS.
• What will be communicated
• When to communicate
• With whom to communicate
• How to communicate
• Who communicates

7.5 Documented Information
Clause 7: Support
REQUIREMENT
The organization’s QMS SHALL include
documented information:
a. Required by the standard
b. Required by QMS
c. External origin

Clause 7: Support
REQUIREMENT
7.5.2 Creating and
updating
Appropriate
Identification and
description (e.g. title, date,
author, or ref. no)
Appropriate format (e.g.
e.g. language, software version,
graphics) and media (e.g.
paper, electronic)
Review and approval for
suitability and adequacy
7.5.3 Control of
Documented Information
Ensure availability and
suitability for use where and
when it is needed
Adequately protected (e.g. from loss
of confidentiality, improper use or loss of
integrity)

7.5.3.1 Address the following for the control of
documented information:
Clause 7: Support
REQUIREMENT
Storage and preservation, including legibility
Distribution, access, retrieval and use
Control of changes
Retention and dispositon

Clause 7: Support
REQUIREMENT
/Identification and
controls for
documented
information of external
origin which are
necessary for the
planning and
operation of QMS
/Protection form
unintended
alterations of
retained
documented
information as
evidence of
conformity

1. Information to support the operation of its
processes, e.g. procedures, work instructions,
workflow etc. (4.4.2)
2. Scope of QMS and justification for any ISO
9001:2015 requirement that is not applicable to the
scope (4.3)
3. Quality Policy (5.2.2a)
4. Quality Objectives (6.2.1)
5. Characteristics of the product, services and/or
activities to be performed (8.5.1a-1)
6. Results to be achieved during production and
service provision (8.5.1a-2)
Required Documented Information

7. Information to have confidence that processes are
carried out as planned and to demonstrate the
conformity of products and services to their
requirements (8.1e)
8. Information as evidence of fitness for purpose of the
monitoring and measurement resources (7.1.5.1)
9. Information used as basis for calibration or
verification of measuring equipment when no int’l or
national standards exist (7.1.5.2a)
10.Organizational knowledge necessary for the
operation of its processes and to achieve conformity
of products and services (7.1.6)
11.Evidence of competence (7.2d)

12.Results of the review of requirements for products and
services (8.2.3.2a)
13.New requirements for the products and services
(8.2.3.2b)
14.Information needed to demonstrate that design and
development requirements have been met (8.3.2j)
15.Design and development inputs (8.3.3)
16.Design and development outputs (8.3.5)
17.Design and development changes (8.3.6a), results of
review (8.3.6b), authorization of changes (8.3.6c), and
actions taken to prevent adverse impacts (8.3.6d)
18.Controls applied to the design and development process

19. Evaluation, selection, monitoring of performance, re-
evaluation and actions arising from the evaluations of
external providers (8.4.1)
20. Information on what occurred when customer or external
provider’s property is lost, damaged and/or found to be
unsuitable for use (8.5.3)
21. Information describing the results of the review of changes
during production and service provision, the person/s
authorizing the change, and any necessary actions rising
from the review (8.5.6)
22. Evidence of conformity with the acceptance criteria during
release of products and services (8.6a)
23. Traceability to the person/s authorizing the release of
product/service (8.6b)

24.Description of Nonconformity (8.7.2a), actions taken
(8.7.2b), concessions obtained (8.7.2c), and authority
deciding the action/s in respect of the nonconformity
(8.7.2d)
25.Results of evaluation on QMS performance and
effectiveness (9.1.1)
26.Implementation of the audit programme and audit
results (9.2.2f)
27.Results of management reviews (9.3.3)
28.Nature of NCs and any subsequent actions taken
(10.2.2a)
29.Results of corrective action to nonconformities
(10.2.2b)

Clause 7: Support
Module II: QMS Requirements
- END -

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