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Iso 9001 - 2015 Clause 7 Support

This document discusses the requirements for Clause 7 of the ISO quality management system standard. It covers 7 sub-clauses: 7.1 resources, 7.2 competence, 7.3 awareness, 7.4 communication, and 7.5 documented information. The key requirements are that organizations must provide adequate resources, ensure personnel are competent, promote quality awareness, plan effective communication methods, and control all documented information relevant to the quality system.
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0% found this document useful (0 votes)
238 views5 pages

Iso 9001 - 2015 Clause 7 Support

This document discusses the requirements for Clause 7 of the ISO quality management system standard. It covers 7 sub-clauses: 7.1 resources, 7.2 competence, 7.3 awareness, 7.4 communication, and 7.5 documented information. The key requirements are that organizations must provide adequate resources, ensure personnel are competent, promote quality awareness, plan effective communication methods, and control all documented information relevant to the quality system.
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CLAUSE 7 SUPPORT - Five Sub-Clauses

7.1 Resources - The organization must provide the resources needed for the establishment,
implementation, maintenance and continual improvement of quality management system.

7.1.2 People - Are the actors for effective implementation of quality management system and for the
operation and control of your processes.They also keep your organization building infrastructure.

7.1.3 Infrastructure -

A. Buildings and Associated utilities

B. Equipment, Including hardware and software;

C. Transportation Resources;

D. Information and Communication Technology

7.1.4 Environment - A combination human and physical factors. It includes the following :

- Heat

- Humidity

- Light

- Airflow

- Hygiene

- Noise

-
7.1.5 Monitoring and Measuring Resources - It ensures valid and reliable results and can be able to verify
the conformity of products and services to requirements that are established.

7.1.6 Organizational Knowledge - Is a knowledge specific to the organization it is generally gained by


experience it is information that is used and shared to achieve the organization’s objectives.
7.2 Competence

To establish, implement & maintain a procedure to ensure that all personnel are trained appropriately to
the requirements of Environmental, Occupational Health & Safety Management System including those
whose work may create a significant impact / Risk on the environment and safety.

Competence – All employees or personnel working for or on behalf & under the control of XXX whose jobs
can affect the Environmental, Health & Safety should be competent. This means that the education,
experience and training requirements for that job must be defined and the employee must meet the
requirement.

Example: At XXX, training are conducted across the organization for various topics as covered in the
training plan. This is to ensure that the employees are made aware of:

● The importance of conformance with the Environment & Safety policy and organizational
objectives derived to meet the policy.

● The control methods derived to reduce the significance of the significant environmental
aspects & OH&S Hazards identified in the area.

● The preparedness for potential emergency situations.

● Environmental Impacts / OH&S consequences actuals or potentials of their work in case of


deviations and appropriate corrective actions for the same.

Employees working or working on behalf & under the control of XXX in the areas where significant
Aspects/Hazards has been identified are trained to build competency for handling the significant Aspects
/ Hazards. MR / HR retains the records of competency. Core Team members of the department within the
scope of EHS shall be responsible for assuring that the appropriate training, awareness, and competence
requirements have been defined and met. The associated records of competency are retained by the HR
/ MR as relevant for fulfilling the requirement of competency.

7.3 Awareness
This clause requires to determine what is needed/necessary. Ensure persons are competent to meet
those needs. Where there are gaps, fill the gaps. And maintain records. Top management is responsible
for ensuring the availability of resources which includes HR.

“Persons doing work under the organization’s control must be aware of the quality policy; relevant quality
objectives; their contribution to the effectiveness of the QMS, including benefits of improved quality
performance; and the implications of not conforming with system requirements.”

Awareness needed by the personnel working under its control are defined. Planning for HR process
controls must include determining competency criteria, skills evaluation, identification of training needs,
types of training, provision of training, how training effectiveness is evaluated, methods to communicate
an awareness of the importance of quality requirements and meeting quality objectives, to all employees.

Quality awareness must be focused on meeting customer and regulatory requirements and Quality
objective. The organization must also promote awareness of its quality policy. The process to promote
quality awareness may include the use of methods such as – cross-functional teams, involvement in
quality planning, quality circles, improvement suggestions, product workshops, zero defect programs,
product review checklist, etc. QMS personnel must be motivated to achieve the organization’s quality
objectives.

7.4 Communication - The organization should determine the internal and external communications
relevant to the Quality Management System (QMS) including on what it will communicate, when to
communicate, with whom to communicate; how to communicate. Communications is a complex and
difficult activity. A bad communication can result to chaos, poor performance, poor morale etc. A good
communication can foster a sense of community, teamwork, and a clear sense of purpose and direction.
In QMS nonconformities, communication problems are the most common cause. Tracking some of the
more serious communication issues could serve as a useful performance indicators to determine and
improve communication process effectiveness

Top management must plan for internal and external communications methods and resources at the high
level using the business planning process and deploy these methods through the IT, logistics, and HR
processes.
The ff. items should be included in the communication plan:

1. What will be communicated?


2. When will you communicate
3. With whom you will communicate?
4. How you will communicate?
5. Who will do the communication?

7.5 Documented Information

ISO 9001:2015 defines documented information as meaningful data that is required to be controlled and
maintained by the organization and the medium on which it is contained. Notes to this definition indicate
that documented information can refer to the Quality Management System (QMS) and its processes,
documentation, and records.

Documented information replaces the requirement for procedures, records and other items of
documentation in ISO 9001:2015. Documented information can be of two types:

● Documented information that needs to be maintained. This will cover procedures, policies, etc.
that would have been referred to as “documented procedures” or just “documents” in ISO
9001:2008
● Documented information that needs to be retained. This will cover what ISO 9001:2008 called
“records”.

A particular support requirement is now documented information. Gone are the terms documents,
documented procedures, and records; everything is now known as documented information whether
that’s records, procedures, processes, etc. and in whatever form e.g. paper, electronic, etc. Documented
information can be used to communicate a message, provide evidence of what was planned has actually
been done, or knowledge sharing. Documentation Information is the information required to be
controlled and maintained by an organization and the medium on which it is contained. It can be in any
format and media and from any source such as paper, magnetic, electronic or optical computer disc,
photograph, master sample, etc. It can refer to:

● Quality management system, including related processes;


● Information created in order for the organization to operate (documentation);
● Evidence of results achieved (records).

The following are some of the main objectives of an organization’s documented information:

● Communication of Information: As a tool for information transmission and communication. The


type and extent of the documented information will depend on the nature of the organization’s
products and processes, the degree of formality of communication systems and the level of
communication skills within the organization, and the organizational culture.
● Evidence of conformity: Provision of evidence that what was planned has actually been done.
● Knowledge sharing
● To disseminate and preserve the organization’s experiences. A typical example would be a
technical specification, which can be used as a base for the design and development of a new
product or service.

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