Kategorier: Alle - evaluation - benefits - audit - compliance

af Jonathan Castillo Vallejo 4 år siden

196

Castillo_Vallejo_Activity 4

A Quality Management System (QMS) certification involves several critical stages. Initially, organizations submit a request detailing their size, scope, and the time frame for certification.

Castillo_Vallejo_Activity 4

Quality Management System (QMS)

Información

Where can I store the information
Electronic media

Advantages:

Reduces pollutants.

Deleting a document is easier.

We can access to a document wherever we want.

We can print any document whatever we want.

Changes and accesses are faster and controlled.

Available at all times.

Paper

References

Pola Maseda, Ángel (1988). Gestión de la calidad. Barcelona, España. Editorial: Marcombo Boixareu Editores.
Peach, Robert W. (1999). Manual de ISO 9000. Distrito Federal, México. Editorial: McGraw-Hill Interamericana editores.
Vivek Nanda (2005). Quality management system handbook for product development companies. A CRC press book.
ISO 10013
ISO 9000:2005

Purpose and benefits

To establish a way to audit the QMS.
Suppliers requirements.
To provide customer confidence.
To work in a continuous improvement process.
Operation coherence.
To maintain order and balance.
Database of employees information.
To generate records of achieving goals.
To declare activities.
To keep a base of expectations work.
To ease the understanding between employees and direction.
To help employees to know what de need to do inside of an organization
To show the compromise of the high direction with quality.
Groups information and their functions.
To show the QMS´s structure.

Definition

It is a kind of management system to lead and control an organization regarding quality.

Documentation

What kind of documentation can I find in the QMS?
External documents

Those documents that contain information related to products and services contracted externally. It also includes new laws and norms established by the nation.

Specification

Can be relate to:

Products

Like: product specification and performance.

Activities

Like: procedure, process and test specification.

It´s the document stipulating requirements.

Quality plans

Specification of the procedures and associated resources to apply. It relates to strategic planning.

Forms and records

Used to write down the results.

Work instructions

A work instruction can be:

Check lists.

Videos.

Drawings.

Templates and Notes.

Flowcharts.

Written detailed description.

Those are detailed description of how to perform and document a task. It describes the material, equipment and documentation used

Document procedures

It´s the document tha show you the way of carrying out a set of systematized activities with start and end dates.

Quality manual

It´s a document that specifies the QMS. The manual adjusts to the complexity of the organization.

Note: no all the companies have the same content.

The content of the quality manual is:

QMS audits.

Quality cost.

Non-conforming materials.

Service and assistance.

Handling, storage and dispatch.

Special process

Final control.

Process control.

Relationship with providers.

Project and design control

Quality function planning.

Organization for quality.

Quality policies.

Its principles are:

Relation management.

Decision making

Continuous improvement.

Process focus.

Commitment to people.

Leadership.

Customer focus.

It tells the global intation of an organization made by high direction. it relates to an organization or company´s mission and vision.

Documentation dependents of:
Personal competence.
Complexity of the processes.
Type of organization and its activities.
The way to integrate the documentation of an QMS can be:
A mix of them.
Structure of the standard norm used.
Own organization procedures itself.

Basic stages for QMS certification

In includes:
Supervision

Certifications have a validity time. when this time is about to run out, auditors must go back to the compañy to verify if it still agrees with the requirements.

Certification

There are three results:

Disapproval

When it disagrees with the requirements, the quality system documentation is not present in the compañy.

Provisional approval

It agrees with almost all the requirements, they give you time to make need changes.

Approval

It agrees with all the requirements.

Evaluation

It is determined when quality system documentation agrees to norm requirements. Two or three auditors stay in installation for two or five days, but the audit time depends of comañy size.

Previous evaluation

It´s a first visit to the company installations with the objective to know how much well-prepared the company is. No all companies need a previous evaluation.

Documentation review

The main document that a the organization review is the quality manual in order to know a general point of view of the company or organization.

Request

It´s a kind of contract where specifies size company, the company scope and the specific time to certificate.

Quality management

It has four elements
Quality improvement

Enhancement in the effectiveness and efficiency of process and enhacement in the extent to which a product satisfies applicable requirements. It includes The Deming cycle (Plan, Do, Check and Act).

Quality assurance

Is comprises all the planned and systematic activities implemented within the quality system that can be demostrated to provide confidence that a product or service will fulfill requirements quality.

Quality control

Activities to fulfill requirements for quality. It focuses on the product.

Quality planning

Are the activities that are performed to establish quality objetivesn identify quality requirements, plan for a QMS and plan for process execution.

Define as:
It comprises all activities that are required to plan for quality in an organization and the activities to satisty quality objectives.