Activity 4.- Quality Manuals

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ESPINOSA VALVERDE KARLA SAMANTHA. 9.A T/M

MAIN QUALITY SYSTEMS IMPLEMENTED BY ORGANIZATIONS.

ISO 10013

The objective of the standard is to provide guidelines for the development and maintenance of the documented information necessary to support the effective operation of a quality management system, adapted to the specific needs of the organization. This standard can also be used to support other management systems, for example occupational health and safety management systems. This document is not intended for contractual, regulatory or certification / registration purposes or to be used as requirements for any purpose.

3 Terms and definitions For the purpose of this Technical Report, the terms and definitions given in ISO 9000 and the following apply. An organization's quality management system may use different terminology for the defined types of documentation. 3.1 work instructions detailed description of how to perform and record tasks Note 1 to entry: Work instructions may or may not be documented. Note 2 to entry: Work instructions can be, for example, detailed written descriptions, flow charts, templates, models, technical notes embedded within drawings, specifications, equipment instruction manuals, photos, videos, checklists , or a combination of the above. Work instructions should describe any materials, equipment, and documentation to be used. Where relevant, work instructions include acceptance criteria. 3.2 form document used to record the data required by the quality management system Note 1 to entry: A form becomes a record when data is entered into it.

NORM 9001 2015

ISO 9001 Standard that describes the requirements of the quality management system

Terms and definitions that apply to all quality management standards

Fundamentals and vocabulary

Composed of ISO 9000 ISO 9001 ISO 9004 standards

ISO standards review process

Proposals for new work topics

Committee draft

Working draft

Draft international standard

Final draft of international standard

International norm

The process is divided into six stages

All Iso standards are reviewed by its technical committee every 5 years, with the aim of analyzing whether they need modifications.

advantages of implementing ISO 9001

Quality management approach

This standard provides guidelines to organizations to help them achieve success.

The ISO 9001 standard is applicable to any type of company regardless of its size or sector.

ESPINOSA_VALVERDE-ACTIVITY 4

Basic concepts.

Products and services: They are products and services that organizations orient to the customer

Risk-based approach: It's risk-based thinking

Documented information: Procedures, instructions, protocol forms

External provider: Supplier, partner, subcontractor.

NORM ISO 9000 2015

Quality management systems fundamentals and their vocabulary

Fundamental principles

Decision making

Improvement

Process approach

Commitment of people

Competent staff committed to the organization

Leadership

Continuous improvement in the coordination and direction of the organization towards the proposed objective

Customer approaches

Possible actions

Present to the organization these needs or expectations of the client to make adjustments in the care.

Listen to your needs and expectations

Recognize direct and indirect customers

Key Benefits

Raise reputation, increase profits by staying in the market.

Increase in value, satisfaction, loyalty and customer expansion

Rational basis

Statement

Fundamental concepts

concerned parties

Support for

Awareness and communication

Competition

Company staff

Senior management

contact of an organization

Quality management system

Quality