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ISO 9001:2000 - Clause 4.2.2

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DEFINITIONS

quality manual document system that specifies the quality management of an organization
NOTE Quality manuals can vary in detail and format to suit the size and complexity of individual organizations. 3.7.4 - ISO 9000:2005

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ANALYSIS REQUIRED - QUALITY MANUAL

OBJECT

establish a quality manual that describes and provides information on the SGC

DATA ENTRY

These should include:

* details of exclusions and of their justification for any requirement of clause 7 of ISO 9001:2000
* information on documented procedures to inculsión through integrated or refer to them

* Details of the QMS processes, how they are interrelated, particularly with regard to their input and output.

ACTIVITIES

An organization must provide a documented overview of the contents of its QMS. This detail must be such as to enable the organization or other external parties to verify that processes are adequately defined and their intancias control (monitoring and / or measurement)

The quality manual should also include details documented procedures for the QMS, and a description of their processes and interaction. Some methods used for the representation of the interaction processes can be, algorithms, flow charts or descriptions

Any exclusion, as well as its justification must be documented in the manual quality, it is necessary to note that these exclusions can only be referred to the requirements specified in clause 7.

OUTPUTS

* A quality manual containing information on the operation of the QMS

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QUALITY MANUAL ISO 9001:2000 - Clause 7.6, CONTROL OF MONITORING AND MEASURING DEVICES

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DEFINITIONS

management system measurements
set of interrelated or interacting necessary to achieve metrological confirmation and continuous control of measurement processes

measurement process all the operations for determining the value of a quantity

metrological confirmation set of operations required to ensure that the measuring equipment meets the requirements
for its intended use
NOTE 1 Metrological confirmation generally includes calibration or verification (3.8.4), any necessary adjustment or repair and subsequent recalibration, comparison with the metrological requirements for the intended use of measuring equipment, as well as any required sealing and labeling.
NOTE 2 Metrological confirmation is not achieved until evidence and document the adequacy of measurement equipment for the intended use.
NOTE 3 The requirements for the intended use may include considerations such as range, resolution, maximum permissible errors, etc.
NOTE 4 Metrological requirements are usually different from the product requirements are not specified in them.


measuring equipment measuring instrument, software, measurement standard, reference material or auxiliary equipment or combination thereof necessary to carry out a measurement process


metrological characteristic hallmark that can influence the measurement results
NOTE 1 The measuring equipment usually has several metrological characteristics.
NOTE 2 Metrological characteristics can be subject to calibration. Metrological function


function administrative and technical responsibility for defining and implementing the management system of measurements
NOTE The word "set" has the meaning of "specified". No terminology used in the sense "to define a concept" (in some languages \u200b\u200bthis distinction is not clear from the context alone).

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REQUIREMENT ANALYSIS -
PROCESS CONTROL DEVICES FOR MONITORING AND MEASURING

OBJECT

Any organization must identify and control factors could possibly affect the "precision" of measurement., this includes items associated with the implementation of these

activities

DATA ENTRY:

may include:

* Reference standards
* Inspection, testing and other documentation of monitoring and measurement, and

The initial review activities should also generate new inputs to be considered in determining the regime of monitoring and measurement required.

ACTIVITIES

An organization needs to determine what factors influence the reliability or uncertainty of measurement result.

* maintenance of equipment under
* operator error,
* an adverse impact on the working environment

The combination of controls needed must be determined and implemented, to give confidence that: * the

cumulative uncertainties in the process of monitoring and measurement are controlled

OUTPUTS

These may include:

* analysis of factors contributing to the uncertainty of measurement

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ISO 9001:2000 Clause 7.3 - DESIGN AND DEVELOPMENT SECTION 4.2.3

GENERAL

A process is "set of interrelated activities or interacting activities which transforms items inputs into outputs "(ISO 9000:2005).

Can be represented graphically as follows:

All processes have an object or purpose, a "something" that seek to achieve and that is given by the area and management of its own. ----------------------------------------------

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7.3.1 Design and development

The organization shall plan and control the design and product development. In planning the design and development organization must determine

a) the stages of design and development

b) the review, verification and validation appropriate to each stage of design and development, and

c) the responsibilities and authorities for design and development.
The organization shall manage the interfaces between the different groups involved in the design and development to ensure effective communication and clear assignment of responsibilities. The results of the planning should be updated, as appropriate, as the design and development progresses.

7.3.2 Input to the design and development

should be identified inputs related to product requirements and keep records. These inputs shall include

a) the functional and performance requirements,

b) the legislative and regulatory requirements,

c) information from previous similar designs, where applicable, and

d) other requirements essential for design and development. These items should be reviewed for suitability. The requirements must be complete, unambiguous and should not be contradictory.

7.3.3 Design and development

The results of the design and development should be provided in a form that enables verification against the inputs for the design and development, and should be approved prior to release . The results of the design and development should

a) meet the requirements of the inputs for the design and development,

b) provide appropriate information for purchasing, production and service provision,

c) contain or refer to product acceptance criteria, and

d) specify the product characteristics that are essential for safe and proper use.

7.3.4 Design and development

At suitable stages, systematic reviews should be designing and developing according to plan

a) assess the ability of the results design and development to meet the requirements, and

b) identify any problems and propose necessary actions. Participants in such reviews shall include representatives of related functions (s) stage (s) design and development that is (are) reviewing. Records of the results of the reviews and any necessary action.

7.3.5 Verification of design and development

verification shall be performed according to plan, to ensure that the design and development results meet the requirements of the input items design and development. Records of the results of the verification and any necessary action.

7.3.6 Validation of the design and development

should validate the design and development as planned to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, if known, whenever practicable, validation shall be completed before delivery or implementation of the product. Records of the results of the validation and any necessary action.

7.3.7 Control of design changes and development

design changes and development should be identified and records maintained. Changes must be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of the changes and any necessary action.

7.3 Design and development, ISO 9001:2000

DEFINITIONS

Design and Development
set of processes that transforms requirements into specified characteristics or specification of a product, process or system
NOTE 1 The terms "design" and "development" are sometimes used interchangeably and sometimes utilizanpara define the different stages of whole process of design and development.
NOTE 2 A qualifier can be applied to indicate the nature of what is being designed and developed (eg product design and development, or design and development process.) Verification


confirmation through the provision of objective evidence that they have met the requisitosespecificados
NOTE 1 The term "Verified" is used to designate the corresponding status.
NOTE 2 Confirmation can comprise activities such as:
* the development of alternative calculations, * comparing a new design specification with a specification of a similar design tested
* the completion of tests / trials and demonstrations, and
* Review documents prior to issue. Validation


confirmation through the provision of objective evidence that they have met requisitospara specific use or application intended
NOTE 1 The term "validated" is used to designate the corresponding status.
NOTE 2 The use conditions for validation can be real or simulated.

REQUIREMENT ANALYSIS - PROCESS DESIGN AND DEVELOPMENT

OBJECT

An organization should ensure a systematic and planned approach to control the design and development. This applies to all forms of design and product development, whether tangible (hardware or software) or intangible (eg a service)
If an organization has, or had details of product characteristics necessary for planning processes manufacturing and has to define those features based on customer requirements and / or regulatory bodies, has, by definition, the need for design and product development.

DATA ENTRY

We may include among others:

* functional and performance requirements that may have been supplied directly by the customer or have been determined within the organization, for example as a result of initiative of markenting
* Any legal requirement that relates directly to the product
* Experiences from the design, development and manufacture of similar products before and
* Codes and design standards.

addition to the above, consider other inputs related to the design process, such as:

* Design forms and checklists
* Protocols and documentation processes.

ACTIVITIES

The design and development process is a series of logical steps that include:

* Plan design and development
* Clarify what to achieve the design and development * Perform
the work required to produce results:
- Define the characteristics and criteria product acceptance necessary for its manufacture and
* To systematically review the progress and output data for the design and development and care of any problem is identified formally
* Check that the output data of the design and development meets the requirements
* Confirm the product / service actually does result was asked what to do. * Etc.



One of the key activities to control the design and development planning is to determine not only the general stages of design and development, if not well enough details of each stage, to allow:

* A clear allocation of responsibilities and authorities

The form and extent of the activities of review, verification and validation must be identified and, where appropriate, previously agreed with all stakeholders. ----------------------------------------------

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ISO 9001:2000 - CONTROL OF DOCUMENTS

GENERAL

A process is " set of interrelated activities or interacting activities which transforms inputs into outputs "(ISO 9000:2005).

can be represented graphically as follows:

All processes have an object or purpose, a "something" that seek to achieve and that is given by the area and management of its own. ----------------------------------------------

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Documents required by the QMS must be controlled. Records are a special type of document
be controlled according to the requirements given in 4.2.4.
should be a documented procedure to define the controls needed to
a) approve documents for adequacy prior to issue,
b) review and update documents as necessary and re-approve,
c) ensure that identify changes and current revision status of documents,
d) ensure that relevant versions of applicable documents are available at point of use,
e) ensure that documents remain legible and readily identifiable,
f) ensure that identifies the external documents and their distribution controlled, and
g) prevent the unintended use of obsolete documents and apply suitable identification if they are retained for any reason.

4.2.3 Control of documents, ISO 9001:2000

DEFINITIONS

Document information and its environment EXAMPLE

support registry specification, documented procedure, plan, report, statement.
NOTE 1 The medium can be paper, magnetic disk, optical or electronic, photograph or master sample, or a combination thereof. NOTE 2
often a set of documents, for example specifications and records, called "documentation."
NOTE 3 Some requirements (eg, the requirement to be readable) relate to all types of documents, but may have different requirements for specifications (for example, the requirement to be revision controlled) and records (eg The requirement to be recoverable).

REQUIREMENT ANALYSIS - PROCESS CONTROL OF DOCUMENTS

OBJECT

Identifying, controlling and making available all documents relevant to the operation of the QMS, this consideration is extended to the relevant documents of external origin.

DATA ENTRY

include details of the documentation and information systems that an organization uses to support its QMS. This consideration also applies to external documents:

- documents that require control, how are, how often change, who owns
- the type or class of such documents, for example, plans, designs, formats, electronic media, audio, posters, etc
- identifying documentation needs
- identification of various control options, for example, software, ringtones, databases, file systems and library. ACTIVITIES

should establish a (I) procedures (s) documented (s) to define the controls needed to meet the requirements of clause 4.2.3 of ISO 9001:2000. This procedure should clearly define the areas where they apply (use) the different documents, and the various responsibilities associated with the generation, review, monitoring and maintaining them. The documentation must be available and accessible when required.

OUTPUTS

include:

- a (I) document (s) of procedure including the responsibilities and authorities

- registration document or similar index, to enable identification of changes or revisions to state

- distribution of documents or storage systems, for example, in paper or electronic media, intranet, internet, etc.

- records system files

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ISO 9001:2008 - QUALITY

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THE NEXT STEP, THE CONCEPT AND ITS EVOLUTION

often arises that quality is a modern (twentieth century), but since the genesis of mankind, one can see a concern for a job well done, in this context we can say that there has always been intuitive concept of quality.

From the initial meaning of quality and product attributes to the current applied to all activities of the company, and therefore their management (that is being called "Total"), has come a long way.

worth a visit this historic journey to understand better and deeper its true meaning, and also to assess the situation of us relating to this development.

The evolution of the concept of quality in the twentieth century has been very dynamic. It has been adapting to changes in the industry, having developed several theories, concepts and techniques, reaching what is now known as Total Quality.

These theories have been developed primarily in more advanced countries and entrepreneurs as the U.S. and Japan, the latter being where he started in business implementation of total quality, culture and the techniques and tools.

have been different trends and authors in those countries that have been providing solutions, new ideas, etc. that have enriched the quality principles in their application to different fields of business and changing market situations. These authors include: Shewhart, Crosby, Deming, Juran, Ishikawa, Ohno, Taguchi, Imai and Suzaki.

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Some

quality DEFINITIONS

ISO 9000:2005

degree to which a set of inherent characteristics qualify
NOTE 1 The term "quality" can be used with adjectives such as poor, good or excellent.
NOTE 2 "Inherent", as opposed to "assigned" means that there is something, especially as a permanent feature.

Philip Crosby:

Compliance with clearly established requirements (customer, design, etc)

Joseph Juran:

Fitness for use

Kaor Ishikawa:

design, produce and offer a good or service that is useful, ecnómico as possible and always pleasing to the customer

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ISO 9001: 2000 - CLAUSE 4.2.4 CONTROL OF RECORDS

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DEFINITIONS

registration document stating results achieved or providing evidence of activities performed
NOTE 1 records can be used, for example, to document traceability and to provide evidence of verification, preventive and corrective actions.
NOTE 2 Generally records need not be subject to control review state. 3.7.6, ISO 9000:2005

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REQUIREMENT ANALYSIS - PROCESS CONTROL OF RECORDS

OBJECT

An organization must maintain records to show them that its QMS operates effectively. The records must document the SGC to demonstrate compliance with codes and was to be maintained, remain legible and properly identified, must also be indexed to be easily retrievable, stored so as to prevent deterioration, damage or loss, and ultimately must be retained for an appropriate period.

DATA ENTRY

* Training Results

* Reviews customer requirimientos

* Product design and development results

* Results of the evaluation of suppliers

* Results from process validation

* Loss and damage to customer products

* Results of process and product

* Identification of the product (if required)

* Authority to release the product

* Reports of the calibration of equipment

measurement

* Reports nonconforming products

* Results of remedial actions

* Results of preventive actions

ACTIVITIES

The type and extent of records saved depends on the processes and products involved, but must be designed to demonstrate compliance with the requirements. Should include records pertaining to suppliers

lso

An organization requires that its records are complete, legible and properly identified. The records must be stored in a safe place where are easily accessible and protected from damage. The records must be protected properly.

should be established (I) procedure (s) documented (s) to define the controls needed for the records. In addition to the above one organziación should consider:

- the authority to remove records

- confidentiality of records

- regulatory requirements, statutory and contractual retention records, and

- related issues use of electronic records

OUTPUTS

may include:

-Procedures for the control of the records (identification, distribution, maintenance and disposal of records)
- Hosted records properly and easily recoverable

OTHER CONSIDERATIONS

records required by ISO 9001:2000

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----------------------------------------- For questions about services consulting and / or training, please contact:
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