Guidelines for the preparation of quality manuals in Venezuela

The purpose of this standard is to provide guidelines for the preparation, preparation and control of quality manuals adjusted to the specific needs of the user. These manuals will reflect the documented quality system procedures required by the COVENIN ISO 9000 family of standards.

Normative references

As all standards are subject to revision, it is advisable to analyze the coexistence of using the most recent editions of the standard listed below:

Covenin-iso 8402: 1995. Quality management and quality assurance. vocabulary

Definitions

For the purposes of this standard, the definitions given in the Venezuelan standard covenin-iso 8402: 1995 apply.

Quality system documentation

This standard describes a typical hierarchy of quality system documentation in its annex A. The order of development of this hierarchy in an individual organization depends on the circumstances of that organization, but usually begins with the development of the policy and objectives of the quality of the organization.

Documented quality system procedures:

The documented procedures of the quality system must form the basic documentation used for the general planning and management of the activities that have an impact on quality, they must also cover all the applicable elements of the quality system standard. Said procedures must describe the responsibilities, authorities and interrelationships of the personnel who manage, carry out and verify the work that affects quality, how the different activities must be carried out, the documentation that must be used and the controls that must be applied.

Each documented procedure must cover a part of the quality system, such as a complete element of the quality system or a part of it, or a sequence of interrelated activities linked to more than one element of the quality system.

The user is the one who will determine the number of documented procedures, the volume of each one and the nature of its format, depending on the complexity of the facilities, the organization and the nature of the company.

If the procedures are organized in the same structure and format, users will be able to become familiar with the consistent approach applied to each requirement and thus there will be more possibility of achieving systematic compliance with the standard.

Quality Manuals:

The quality manual must refer to documented procedures of the quality system intended to plan and manage the set of activities that affect quality within an organization. This manual should also cover all applicable elements of the quality system standard required for an organization. Documented procedures related to the quality system that are not covered in the standard selected for the quality system but that are necessary for the adequate control of activities must also be added or referenced to the quality manual.

Quality manuals are developed and used by an organization to:

• Communicate the quality policy, procedures and requirements of the organization Describe and implement an effective quality system Provide adequate control of practices and facilitate assurance activities Provide documentary bases for audits Train personnel in the requirements of the quality system.

Present the quality system for external purposes: for example, to demonstrate conformity with COVENIN-ISO 9001, 9002 or 9003 standards.

Demonstrate that the quality system meets the quality requirements demanded in contractual situations.

Although there is no structure or format required for quality manuals, there are methods to ensure that the subject is properly oriented and located; One of these would be to base the sections of the quality manual with the elements of the standard that governs the system. Another acceptable approach would be to structure the manual to reflect the nature of the organization.

A quality manual can:

• Be a compilation of documented procedures Be a series of documented procedures for specific applications Be more than one document or level Have a common core with appropriate appendices Have hours numerous possible referrals based on organizational needs

The most common application of a quality manual is used for both quality management and quality assurance purposes. However, when the organization considers that a distinction in its content or use is necessary, it is essential that the manuals that describe the same quality system are not contradictory.

3. Process of preparing a quality manual

Responsible for the Elaboration:

The process regarding the elaboration with the assignment of the coordination task to a competent delegated body. Actual writing and transcription activities should be performed and controlled by that agency or by various individual functional units, as appropriate. The use of existing references and documents can significantly limit the time to prepare the quality manual, as well as help to identify those areas in which there are deficiencies in the quality system that must be considered and corrected.

Use of References:

Whenever appropriate, reference to standards or documents that exist and are available to the user of the quality manual should be incorporated.

Accuracy and Adequacy:

The delegated competent body must ensure that the outline of the quality manual is accurate and complete, and that its continuity and content are adequate.

Quality manual approval, issuance and control process

Review and Final Approval:

Before the manual is issued, the document must be reviewed by responsible individuals to ensure clarity, accuracy, adequacy, and proper structure. The issuance of this manual must be approved by the management responsible for its implementation and each copy of it must carry evidence of its authorization.

Distribution of the Manual:

The method of distribution of the manual should provide assurance that all users have appropriate access to the document. Distribution can be facilitated by encoding copies.

Incorporation of Changes:

A method must be designed to provide the proposal, preparation, revision, control and incorporation of changes in the manual. When processing changes, the same review and approval process used when developing the core manual should be applied.

Control of Issuance and Changes:

Controlling the issue and changes of the document is essential to ensure that the content of the manual is properly authorized. Different methods can be considered to facilitate the physical process of making the changes. Regarding the updating of each manual, a method must be used to ensure that each owner of the manual receives the changes and includes them in their copy.

Uncontrolled Copies:

All those manuals distributed for proposal purposes, off-site use by the customer, and other distribution of the manual where control of changes is not foreseen must be clearly identified as uncontrolled copies.

4. Outline of the content of a quality manual

to. The title, scope and field of application.

b. Table of Contents.

c. The introductory pages about the organization and the manual

d. The quality policy and objectives.

and. Description of the organization's structure, responsibilities and authorities.

F. Description of the elements of the quality system.

g. Definitions, if appropriate

h. Guide to the quality manual, if appropriate.

i. Appendix, if appropriate.

It is important to mention that the order of the content of the quality manual can be changed according to the user's needs.

What to include in a quality manual

Title, Scope and Field of Application:

The title and scope of the quality manual should define the organization to which the manual applies. This section should also define the application of the elements of the quality system. It is also convenient to use denials, for example, what aspects a quality manual does not comply with and in which situations it should not be applied. This information can be located on the title page.

Table of Contents:

This should present the titles of the sections included and how they can be found. The numbering of sections, subsections, pages, figures, illustrations, diagrams, tables, etc., must be clear and logical.

Introductory Pages:

The introductory pages of a quality manual should provide general information about the organization and the quality manual.

Information about the organization should be its name, site, location and the media; You can also add information about your business line and a brief description of its background, its history, its size.

Regarding the information about the quality manual, it should include the current edition, the date of publication, a good description of how the quality manual is reviewed and kept up to date, a brief description of the documented procedures used to identify the status and to control the distribution of the manual and must also include evidence of approval by those responsible for authorizing the content of the quality manual.

Quality Policy and Objectives:

This section of the quality manual should formulate the organization's quality policy and objectives. Here is the organization's commitment to quality.

¡Said section should also include how it is achieved that all employees know and understand the quality policy and how it is implemented and maintained at all levels.

Description of the Organization, Responsibilities and Authorities:

This section provides a description of the high-level organization structure. It can also include an organizational chart that indicates responsibility, authority, and interrelationship structure.

Likewise, sub-sections within this section should provide details of the responsibilities, authorities and hierarchy of all functions that direct, perform and verify work that affects quality.

Elements of the Quality System:

The remainder of the manual should describe all applicable elements of the quality system. This can be done by including documented quality system procedures.

As quality systems and quality manuals are unique for each organization, it is not possible to define a unique format, scheme, content, or presentation method for the description of the elements of the quality system.

The standards of the COVENIN-ISO 9000 family or the standard used by the organization, provide the requirements for the elements of the quality systems.

After selecting the standard to use, the organization must determine the elements of the quality system that are applicable, and based on the requirements of said standard, the organization will define how it intends to apply, achieve and control each of the selected elements.

In determining the organization's approach, the following should be considered:

• The nature of the business, manpower and resources The importance attached to quality system documentation and quality assurance The distinctions between policies, procedures and work instructions The medium selected for the manual

The resulting manual should reflect the organization's own methods and means to satisfy the requirements formulated in the selected quality standard and its elements of the quality system.

Definitions:

This section should be located immediately after the scope and field of application. This section should contain the definitions of the terms and concepts that are used only within the quality manual. The definitions should provide a complete, consistent and unambiguous understanding of the content of the quality manual. The use of references such as the COVENIN-ISO 8402 standard is recommended.

Guide to the Quality Manual:

A guide can provide a description of the organization of the quality manual and a brief summary of each of its sections.

With the help of this section readers who are interested only in certain parts of the manual should be able to identify which part of the manual may contain the information they are looking for.

Appendix for Supporting Information:

Lastly, an appendix can be included that contains information to support the quality manual.

5. Conclusion