· pdf fileadded new references: ntc -iso -iec 17065 , ntc - iso -iec 17067, iso 19011 and...

PRODUCT CERTIFICATON REGULATION

RG-01i V10


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Responsible Version of the document Effective from

Certification Manager 10 September of 2015

Control of modifications in this document.

Reasons for the modification Modification made

NC and aspects to improve detected during ONAC’s accreditation audit conducted from September 13th to September 16th of 2011)

Included new reference documents (Numeral 3) New definitions for the following concepts: Interested Parts Committee, Related Organs, Complaint and Appeal. (Numeral 4)

Participation of the Interested Parts Committee in Complaints and Claims process. (Numeral 6)

Specified the conditions of the acceptance of the certification agency that issues the ISO 9001 certificate. (Numeral 5.1)

Established definitions related with certification systems 1a, 1b and 5. (Numeral 4.).

Defined the conditions that can give, maintain, extend, reduce, suspend or withdraw the certification for systems 1a, 1b and 5.

Incorporated the complaints and appeals process that is going to be accomplished by the Interested Parts Committee. (Numeral 6).

Rights and obligations of the Certification Agency (CA): “The Certification Agency is responsible that each member of the Interested Parts Committee becomes an active part, and that he or she is previously informed when requirements in the certification process are modified.” (Numeral 11).

Addition of criteria for the acceptance or rejection to change the auditor when he or she requests or requires it.

Time definition to send the action plan when on an evaluation there are detected nonconformities. (Numeral 5.7).

Definition of sending the document RG-04, Regulation for QCERT Brand use.

Definition of procedure to follow when QCERT implements changes in the certification process. (Numeral 12.2)


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Reasons for the modification Modification Made (November of 2012)

Clients suggestion Clarification of sanctions referenced in the Certification service contract.

Reasons for the modification Modification Made (January of 2013)

Follow-up Audit ONAC 2012 Criteria for the acceptance of test reports for

document audits 5.6.1

Reasons for the modification Modification Made (April of 2014)

Re accreditation of the agency under regulation NTC-ISO-IEC 17065

Changes in the regulatios governing the Certification Agency, guided by NTC/ISO/IEC 17065.

The scope for service presentation gets modified. Added new references: NTC-ISO-IEC 17065, NTC-

ISO-IEC 17067, ISO 19011 and others. Modifications in the description of the

certification process based on regulations NTC-ISO-IEC 17065, NTC-ISO-IEC 17067.

Clarification of the QCERT brand use and surveillance applying for scheme 5.

Definition of how the agency is going to watch over the certifications.

Modifications of the chart that gives the conditions for granting, maintenance, extension, reduction, suspension, or withdrawal of a certification.

Adjustment of the annex 1, indicating it appliance for scheme 5.

Reasons for the modification Modification Made (July of 2014)

Re accreditation audit from ONAC conducted on June of 2014.

Included the disposition that defines that Certification Agency must report in advance to the client about the information that is going to have a public display. (11. Rights and Obligations)

Reasons for the modification Modification Made (January 0f 2015)

Quality Management System coherence review.

Include a disposition that determines for Surveillance Audits that, for companies certified with Quality Management System (QMS) ISO 9001 that were evaluated during the conferment, do not require visit to the fabric. If the companies are not certified with ISO 9001, it is required an attestation in site.


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Clarification of numeral 9.1 informing that certifications can be suspended if the certified company does not use the Brand Qcert.

Reasons for the modification Modification Made (February of 2015)

Clarification of the Ministerio de Minas y Energía, regulation RETIE 2013, numeral 33.2.4

Page 15 Numeral 5.5. Clarification of dispositions

about procedure to follow in the granting process

and in the follow-up for scheme 5 that always

requires attestation in site for the production

process in the Quality Management System. If the

client is not certified, it is required an evaluation

to the production process through a visit to the

factory.

Only in some special cases determined by critical

aspects of geographical position, pertinence and

necessities of the parts, the evaluation of a QMS

can be performed by documents review. In those

cases the following aspects are to be evaluated:

Reasons for the modification Modification Made (April of 2015)

Quality Management System coherence review.

Included a code form to evaluate the viability of

the certification. (FPR-02-03), it includes the

accredited laboratories in Colombia.

In the Annex 1 of the commercial proposal, the

client accepting it must fill the consent letter.

FPR-02-04

Included the certification service contract code.

FPR-02-06.

Included accredited laboratories in Colombia that

can perform with accredited tests the object of

evaluation.

In the evaluation assignation was included the PR-

09 assigned with (FPR-02-20) and the auditor with

(FPR-02-17).

Included the numeral 5.5. The nonconformities

are reported in FPR-02-13. “No conformidades de

la ejecución de la evaluación” (Nonconformities of


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implementation of the evaluation)

Included numeral 5.7 in record FPR-02-14

“Selección de muestras”. (Sample Selection)

Included numeral 5.8 FPR-09-05 “Evaluación de

laboratorios de ensayos y de calibración”,

(Evaluation of testing laboratories and calibration)

referenced at Annex 1 RG 05 Non accredited

laboratories evaluation form.

Inluded itme 5.11 the following forms: “Informe

de evaluación de otorgamiento” FPR-02-08

(Conferment evaluation report), or “Informe de

evaluación de seguimiento” FPR-02-07 (Follow-up

evaluation report)

In Numeral 5.13 included a requirement about

the use of Qcert brand in the product,

advertisement, or in web page. The omission of

this results on a report of a nonconformity and

the suspension of the certificate until evidence of

the use.

Reasons for the modification Modification Made (May of 2015)

Qcert Quality Management System coherence review, in the meeting with the technical committee conducted May 27th of 2015.

Added a clause referring to the inclusions of

products in certificates already granted.

Reasons for the modification Modification made (September of 2015)

QCERT’S Quality Management System coherence review.

In numeral 5.2 "products and references", the

laboratory part is added within the review of the

viability of certification. It clarifies that the

acceptance of the certification process can be

done in writing mode or by the payment of the

process.

In numeral 5.8 indicates that not accredited

testing labs will be accepted, within the

evaluation process, according to current


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regulations.

Numeral 5.8 and numeral 5.9 are unified into a

single paragraph.

In numeral 5.11 changes are made to the

conditions, for not granting the certificates.

In numeral 5.13 and in numeral 9.1, the

conditions by which it is suspended and

withdrawn the certifications are modified.

In numeral 12.4 clarifies that the evaluation

process should be formalized by an agreement,

express or implied.

Produced By Reviewed by Approved by

Beatriz Zapata Daniel Baena Alejandro Alzate Blair


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CONTENIDO

1. OBJETIVE .................................................................................................................................................. 8

2. SCOPE ...................................................................................................................................................... 8

3. REFERENCES ............................................................................................................................................. 8

4. VOCABULARY ........................................................................................................................................... 9

5. PROCESS DESCRIPTION .......................................................................................................................... 13

5.1. SCHEME TYPES IN A PRODUCT CERTIFICATION .................................................................................. 13

5.2. PRODCUT CERTFICATION APPLICATION ............................................................................................. 14

5.3. EVALUATION ASSIGNMENT ............................................................................................................... 17

5.4. REVIEW AND ANALYSIS OF COMPLAINTS AND CLAIMS ...................................................................... 17

5.5. EVALUATION OF THE QUALITY MANAGEMENT SYSTEM IN THE PRODUCTION PROCESS ................... 18

5.6. QUALITY OF THE RAW MATERIALS .................................................................................................... 19

5.7. SAMPLE SELECTION ........................................................................................................................... 19

5.8. LAB TESTS .......................................................................................................................................... 19

5.9. COMPLEMENTARY EVALUATION ....................................................................................................... 20

5.10. EVALUATION REPORT AND CERTIFICATE DECISION............................................................................ 20

5.11. NOT GRANTING THE CERTIFICATION .................................................................................................. 21

5.12. USE OF THE BRAND QCERT ................................................................................................................ 21

5.13. VALIDITY AND TRACING OF THE CERTIFICATES .................................................................................. 21

6. COMPLAINTS AND/OR APPEALS ............................................................................................................ 23

7. CHANGES THAT AFFECT THE CERTIFICATION .......................................................................................... 24

8. CERTIFICATION RENEWAL ...................................................................................................................... 25

9. CONDITIONS TO GRANT, MANTAIN, EXPAND, REDUCT, SUSPEND OR WITHDRAW THE CERTIFICATION

FOR SCHEMES 1A, 1B Y 5. ............................................................................................................................... 25

9.1 CONDITIONS TO SUSPEND OR WITHDRAW A CERTIFICATE UNDER SCHEME 5. ......................................... 27

10. RIGHTS AND OBLIGATIONS OF THE CLIENTS. ..................................................................................... 28

11. RIGHTS AND OBLIGATIONS OF THE CERTIFICATION AGENCY QCERT .................................................. 31

12. OTHER DISPOSITIONS ........................................................................................................................ 32


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12.1. EVALUATION CONTRACT ................................................................................................................... 32

12.2. CHANGES IN THE CERTIFICATION PROCESS ........................................................................................ 32

ANNEX 1 ......................................................................................................................................................... 33

1. OBJETIVE

Establish guidelines for QCERT to grant, maintain, renovate or suspend a product certification, and

the commitments acquired by the certification agency and the client during the certification process.

This regulation is based in the requirements established in NTC-ISO-IEC 17065 y NTC-ISO-IEC 17067

and is part of the contractual requisite that subscribes both, the holder of the certification and

QCERT.

2. SCOPE

This regulation establishes de conditions that rule the product certification service, defines the

duties, rights and obligations for both, the client and the certification agency QCERT for the

certification schemes named:

Scheme 1a.

Scheme 1b.

Scheme 5.

3. REFERENCES

MSGC-01, Manual del Sistema de Gestión de Calidad. (Quality Management System Manual)

MPRC-02, Manual de perfiles, responsabilidades y cargos. (Positions, responsibilities and profiles

manual)

FPR-02-08, Informe evaluación. (Evaluation report)

FPR-02-13, No conformidades de la ejecución de la evaluación. (Nonconformities of implementation

of the evaluation)

RG-01, Reglamento de certificación de productos. (Product certification regulation)

RG-04, Reglamento de uso de la marca QCERT. (QCERT Brand use regulation)

RG-05, Reglamento de uso de laboratorios. (Laboratories use regulation)

PR-08, Procedimiento para auditoría interna. (Internal audit procedure)


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FPR-03-03, Contrato de trabajo de prestación de servicios profesionales de evaluación. (Contract to

provide professional evaluation services.)

NTC-ISO-IEC 17065: 2013 Evaluación de la conformidad. Requisitos para organismos de certificación

de productos, procesos y servicios. (Nonconformity evaluation. Required for certification agencies.)

NTC-ISO-IEC 17000:2005 Evaluación de la conformidad. Vocabulario y principios generales.

(Conformity evaluation. Vocabulary and basic principles.)

NTC-ISO-IEC 17007, Evaluación de la conformidad. Orientación para la redacción de documentos

normativos apropiados para la evaluación de la conformidad. (Conformity evaluation. Orientation for

de redaction of proper regulation documents to evaluate conformities.)

NTC-ISO-IEC 17067: 2013 evaluación de la conformidad. Fundamentos de la certificación de

productos y directrices para los esquemas de certificación de productos. (Conformity evaluation.

Product certification foundations and directions for product certification schemes.)

NTC/ISO/IEC 17020, Evaluación de la conformidad Requisitos para el funcionamiento de diferentes

tipos de organismos que realizan la inspección. (Conformity evaluation. Requirements for the

function of different types or certification agencies that perform the inspection)

NTC/ISO/IEC 17021, Evaluación de la conformidad. Requisitos para los organismos que realizan la

auditoria y la certificación de sistemas de gestión. (Conformity evaluation. Requirements for the

certification agencies that perform audits and certifications of Management Systems.)

ISO/IEC 17025, Evaluación de la conformidad. Requisitos generales para la competencia de los

laboratorios de ensayo y de calibración. (Conformity evaluation. General requirements for the test

laboratories and calibration competence.)

ISO 19011:2011 Directrices para la auditoría de los sistemas de gestión de la calidad y/o ambiental. (Directions for audit Quality Management or environmental systems.) GTC-ISO/IEC28: 2006 Evaluación de la conformidad. Orientaciones para un Sistema de certificación

de productos de tercera parte. (Conformity evaluation. Orientations for a third party product

certification system.)

R-AC-01: Reglas del Servicio de Acreditación Organismo Nacional de Acreditación, ONAC (Accrediting

service rules of the National Accreditation Organism, ONAC)

4. VOCABULARY

To facilitate de understanding of the concepts referenced in the different QCERT documents, here

we present some basic definitions:

Attestation scope: Extension or characteristics of the conformity evaluation objects covered by the

attestation.


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Corrective actions: Actions that have for objective eliminated the cause of a nonconformity

detected, as to avoid its repetition.

First party conformity evaluation activity: Conformity evaluation activity performed by the person

or organization that provides the object.

Second party conformity evaluation activity: Conformity evaluation activity performed by a person

or organization that has interest as user in the object.

Third party conformity evaluation activity: Conformity evaluation activity performed by a person or

organization that works independently from the person or organization that is promoting the object

and also the interests of the user of it.

Appeal: Request form the provider of the conformity object evaluation to the conformity evaluation

organism or the accreditation organism to reconsider the decision made towards the object.

Attestation: To declare, based on a review that the specified requirements are accomplished.

Audit: Systemic process, independent and documented to obtain records, declarations, pertinent

facts and information for an objective evaluation to determine it the specified requirements are

accomplished.

Certification: Third party attestation regarding products, processes, systems or persons.

Competence: Personal qualities and aptitudes demonstrated for the application of knowledge or

skills.

Evaluation Criteria: Set of policies, procedures or requirements. The evaluation criterion is used as

reference to compare the evaluation evidence.

Conformity evaluation scheme: Relative to the specific objectives of the conformity evaluation, to

which it applies the same specified requirements, rules and procedures.

Scheme 1a: In this type one or more product samples are submitted to determination activities. Can

be issued a conformity certificate or other conformity declaration for this type of product, its

characteristics are detailed in the certificate or in a document referenced in the certificate. The

elements of posterior production are not covered by the conformity attestation of the certification

agency.


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Scheme 1b: This type involves a whole lot of products immediately after the selection and

determination according the scheme. The proportion tested can include all of the lot units (100%

tested) based for example in lot uniformity and sample application when it applies. If the result,

review and definition is positive, then all of the lot products can be described as certified and can use

the conformity brand.

Scheme 5: This is a surveillance scheme that allows choosing between, taking a product sample

periodically. The origin of the product can be either production, a local store or both. The products

are submitted to the required tests in order to determine whether the products produced after

comply the first attestation. The surveillance includes a periodic evaluation of the production

process, management system audit, or both. The extension under which the four activities are

accomplished may change for a determined situation defined by the scheme. If surveillance includes

management system audit its obligatory an initial audit on the system.

Regulation Authorities: The regulation authorities for product certification services are National

Accreditation Organism – ONAC and Superintendence of Industry and Commerce - SIC.

Evaluation Team: Two or more experts that perform an evaluation. One of the evaluating experts is designated as a leader. The evaluation team may include evaluation experts in training.

Evaluation: Systemic process, independent and documented to obtain evidence and evaluate it

objectively to determine the extension to which the evaluation criteria is accomplished.

Conformity Evaluation: Demonstration that the specific requirements related to the product,

process, system, person or entity are accomplished.

Evaluating expert: A person with the professional and academic skills to perform an evaluation. Evaluating expert in training: Person with the professional and academic skills to perform an evaluation, but still requires the support and supervision of a leader evaluating expert to the development of the activities.

Leader evaluating expert: Besides the technical, academic and professional skills, the leader must have additional qualities to facilitate the evaluation process and promote a more efficient and effective review.

Evaluation evidence: Declarations, records or other information relevant to verify the evaluation criteria. This can be quantitative or qualitative.


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Form: Document used as record of the data for the QMS.

Inspection: Design test for a product, process or installation to determine its conformity with the

specific requirements or base don professional judgment with general requirements.

Findings: Results of the evaluation based on evidence regarding the evaluation criteria. This findings can turn into a conformity, a nonconformity or an improvement opportunity. Nonconformity: Detected observation of non-compliance to the requisites obligated by de QMS.

Technical Standard: Document established by consent and approved by a recognized organism. It

provides for common use the rules, directions and characteristics for the activities. These are

directed to establish order in a given context. The Technical standards must be based in the result of

science, technology and experience. The objectives must be the common good of a community.

Sampling: To obtain based on procedure a representative sample of the evaluation subject.

Conformity evaluation agency: Agency that provides conformity evaluation services.

Accreditation Organism: Agency with the authority to grant an accreditation.

Procedure: A specific method to perform a process or activity.

Product: The result of a procedure.

Evaluation program: One or more evaluations planed for a period of time and directed for an specific purpose.

QCERT: Quality Certification.

Complaint: Different from appeal is an expression of dissatisfaction presented by a person or

organization to a conformity evaluation organism or accreditation organism related to one or more

activities of the mentioned organism. It is expected an answer to the complaint.

Responsible for the process: The head or leader of the area related to the process.

Review: Verification of the suitability, adequacy and effectiveness of selection and determination

activities, and its results regarding the compliance with the specified requirements, object of

conformity assessment.

QMS: Quality Management System.


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Conformity evaluation system: Rules, procedures and directions to performe a conformity

evaluation.

Suspension: Partial or total temporary invalidation of a conformity declaration. This can be for all or

just part of the specified attestation scope.

Specified Requisite: Established need or expectation.

Withdraw: To remove or annul a conformity declaration.

Surveillance: Systemic repetition of the evaluation activities, to validate the initial declaration fo

conformity.

5. PROCESS DESCRIPTION

5.1. SCHEME TYPES IN A PRODUCT CERTIFICATION

QCERT as a certification agency attends the product certification requests based on the established

regulations. The product certification schemes are developed by defining specific activities for each

one of the applicable functions described in the following chart:

CHART 1 PRODUCT CERTIFICATION SCHEME OFFERED BY QCERT SAS

Conformity evaluation functions and activities under the product certification

schemes.

Scheme

Type

1a 1b 5

I Selection, includes planning, preparation, requirement specific activities

determined by standard documents, and samples selection if it is applicable.

X X X

II Determine characteristics, if they apply, through:

a) Tests

b) Inspection

c) Design Assessment

d) Product or services evaluation

e) Other determination activities such as verification.

X X X

III Review:

Test the conformity evidence obtained during the determination stage, to

establish if the specific requirements are accomplished.

X X X

IV Decision about the certification:

Grant, maintenance, extension, reduction, suspension or withdrawal of the

certification.

X X X


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V Attestation, license

a) Issue of a conformity certificate or other conformity declaration

(attestation)

X X X

b) Right granted to use the certificate and the conformity declarations. X X X

c) Conformity certificate emitted for a product lot. X

d) Right granted to use the conformity brands (license) based on

surveillance (VI) or lot certification.

X X

VI Surveillance, if applicable.

a) Test or inspection of samples form open market. X

b) Test or inspection of samples from Factory. X

c) Production evaluation, operation process or production render service. X

d) Management System audits combined with random tests or

inspections.

X

The agency accomplishes all of the requirements established for each certification scheme under its

scope. Here are noted and described.

5.2. PRODCUT CERTFICATION APPLICATION

To start with the certification process QCERT will send the FPR-02-01 form, for the client to fill and

send back to QCERT by email. This form contains the following information:

The products to certify and its references.

Regulations and/or regulation documents for which the client wants to the certification.

Desired certification scheme (1a, 1b or 5).

Customer information, including name and address of the physical location, the activities of

the company and any other relevant legal obligation.

Manufacturer company name and address.

Information related to the QMS ISO 9001:2008 or production process.

If it is a training company, it must show evidence or authorization of the Manufacturer

Company (With letterhead, signature and seal) and attach it to the documents.

Indicate if the product already has a testing protocol.


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Once the filled form is received, the certification agency will proceed to analyze the viability of the

request. For this, the form FPR-02-03 will be used. This form evaluates the following aspects:

That the information given about the client and the product is enough to proceed with the

certification process.

That the scope of the certification sought is defined.

That it has the means to perform all evaluation activities in accordance with current

regulations regarding accredited and non-accredited laboratories.

That has the competence and ability to perform the certification activity, (assessors,

certification committee and internal staff with the competence and power to certify the

products).

Given the case that the requested information is not complete or drawbacks of understanding of it

occurring, QCERT will communicate this to the client in order to clarify the respective questions or

issues.

On the other hand, if the certification agency is not in the capacity, competence or scope, QCERT can

decline the specific product certification request; whatever the decision, it will be reported to the

customer and the respective record will be done in each application.

If the client appeals the decision, QCERT will revise again the request and inform the client the

reasons why the evaluation cannot be developed; if the appeal is in favor of the client, the

certification agency initiates the certification process sending a formal quote to proceed with the

product evaluation.

When QCERT has certified a product coming from a determined fabricator, there can be an omission

of activities already developed before, provided that it ceases record within the assessment process

before what were the certifications issued. Since the case where the client requests the justification

for omitting certain activities, QCERT by a formal report to the communication issued by the agency.

Now, if the results of the viability analysis are satisfactory, QCERT sends to the client a commercial

and technical proposal under the code FPR-02-04, according to the filled information in the

application form, in which the cost is attached as evaluation concept. In the Annex 1 of the same,

client makes the acceptance of the business proposal. It is understood that the customer has also

accepted the proposal through a written record or by the payment verification process.

The annex 2 defines the plan and activities of the evaluation, in the following way:


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Purpose of the evaluation.

Scope of the certification.

Regulation or norm that will certify the products.

Used certification scheme.

Tests to develop.

Support documents to perform the evaluation.

Used method for testing, as well as selection and label of the samples.

Subcontracted activities.

The sampling plan according to regulation NTC 2859-1 and to instructive IN-06.

The evaluation stages are described as: Opening meeting, gathering data, evaluation of the quality

management system of the production process if the company has ISO 9001:2008 certificate or the

evaluation of the production process, if the company does not have a QMS certificate (if the

certification scheme is 5), selection and label of the samples (applicable to schemes 1a, 1b or 5),

evaluate laboratories without accreditation (if it applies), test development, results analysis, closure

meeting, report elaboration, concept of the certification committee, results notification, issue the

certificate.

During the evaluation, there may be evidence or nonconformity, to which should be given the

relevant treatment as enshrined in this Regulation and in the form FPR-02-13 "NON-COMPLIANCE

PERFORMANCE EVALUATION"

Before sending the commercial proposal, QCERT will verify if the request contains the last version

and year of the regulation, in case that there is an updated version, the client will be informed of the

novelty.

If the proposal sent is accepted by the client, it must fill the consent letter attached to the

commercial proposal FPR-02-04 or make a written notification approving the issue of the bill. Once

received this information, the commitment of QCERT as a certification agency and the client is

complete, and it will be documented in a certification services contract FPR-02-06 (which can accept

either expressly or tacitly), that on it establishes the following conditions:

Declarations, object, use of the certificate, contract validity, confidentiality, causes for the

suspension or withdraw of a certificate, obligations of the company with the certified product,


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obligations of the certification agency, use of the confidential information, use of the Brand

QCERT and advertisement, responsibilities and compensations, client default policies, changes in

the regulations, validity, follow-up and termination of the contract, certificated product follow-up

under scheme 5, claims, complaint and nonconformities policy, conditions to renew a certificate

and advertisement about the certificates issued by QCERT.

5.3. EVALUATION ASSIGNMENT

QCERT uses procedure PR-09 that explains the method for selection and qualification of the

evaluators for different products identified under the scope and accreditation, as well as the

recruitment process for evaluators. After the client issues the payment, QCERT informs through a

written communication to the client the evaluator assigned to the process FPR-02-20 and sends the

evaluator a communication indicating the client data and the date to initiate the evaluation FPR-02-

17.

Once the evaluator is assigned, the client has the right to accept or reject the evaluator during the

next 5 labor days. In case that QCERT has no client communication in this term, the evaluator

assigned will be considered as approved by the client.

If on the other hand the client considers that the evaluator assigned to the process has some sort of

impediment to perform the job, it can request a change of evaluator.

QCERT will evaluate the request if it is supported with a verbal or written justification. The justification will be evaluated under the following criteria:

Incapacity to execute the evaluation that was not previously manifested by the evaluator. Difficulties in past evaluations. Incompatibility in the execution of the evaluation.

If approved the request, QCERT will assign other evaluator. In case the new evaluator is also rejected

QCERT will return to the client 80% of the payment and will terminate the process.

5.4. REVIEW AND ANALYSIS OF COMPLAINTS AND CLAIMS

During the process the evaluator will review the complaints and claims record of the evaluated

products, to verify that there is a proper procedure and documented actions consequence of the

received claims and complaints.


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5.5. EVALUATION OF THE QUALITY MANAGEMENT SYSTEM IN THE PRODUCTION PROCESS

When the certification is based on scheme 5, QCERT evaluator or the subcontracted entity must

always attest in site the Quality Management System in the production process, for that it will be

verified that the ISO 9001:2008 certificate is issued by an agency accredited by members of

evaluation must be included in the certificate scope.

In cases that the client has no Quality Management System certificate the production process must

be evaluated by an in site visit to the factory.

Just in exceptional cases determined by critical aspects of geographical position, pertinence and

needs of the involved parts, the evaluation of the Quality Management System can be made by a

document review. In this cases the following aspects will be evaluated:

The client must have the Quality Management System certification under the linings of

NTC/ISO9001:2008

The Quality Management System certificate must be issued in English and Spanish.

The certificate must have been issued by an accredited agency that belongs to the

international forum and signer of the multilateral recognition agreements of IAF or

accredited by ONAC.

The product to certify must be covered under the scope of the Quality Management System

certificate.

The certificate must be valid to the verification date.

The address of the production factory must be included in the Quality Management System

certificate.

QCERT must verify that any change in the Quality Management System certificate has been notified

by the certificate owner to the certification agency QCERT.

In all of the cases that the production process evaluation is performed, the evaluator or the

subcontracted entity will follow the linings established in Annex 1 RG-01 Evaluation of the Quality

management system in the production process for the product certification regulation.

If in the evaluation are reported nonconformities that affect the quality of the production process,

the evaluation will be suspended until the detected nonconformities are corrected. Otherwise the

process continues. Detected nonconformities are reported in FPR-02-13 Nonconformities of

implementation of the evaluation.


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Note: The initial attestation ot the Quality Management System in the production process, or the

evaluation of the production process does not apply for the lot certification and simple type.

5.6. Quality of the raw materials

If the raw materials used in production does not have a conformity certificate, the evaluator must

verify if the client has an inspection and reception program for this materials, and if this program is

enough to secure the quality of the products. This must be reported on the document that the

evaluator presents to QCERT.

5.7. Sample selection

QCERT or a subcontracted entity will select the indicated samples in the technical proposal, or the

sample it consideres relevant, taking samples during the prodction process, sales or storage of the

fabricator/trader. The record will be noted in document FPR.02-14 “Sample Selection”.

The certification agency has a document that explains sample selection techniques, and describes the

procedure to select the adequate amount of samples according to the tests and the type of product

in evaluation. The document related is IN-06 “Instructions for sample selection”.

The samples must be labeled to easy identification, and relate the results obtained for each one in

the evaluation record.

5.8. Lab tests

To use the services of a laboratory, QCERT will verify its competence and suitability, where will

perform an evaluation to determine the accomplishment of NTC-ISO-IEC 17025 regulation, according

to the form FPR-09-05 “Evaluation of testing laboratories and calibration”, and also Qcert will revise

the validity of the accreditation certificates issued by ONAC.

For the test results given by accredited international laboratories and/or recognized by multilateral

agreements (MLA); QCERT will receive the reports and verify the possibility for homologation in the


In case the laboratories are not accredited or recognized by international agreements, its

competence will be evaluated filling the “Non-accredited laboratories evaluation form” part of the

Regulation document RG-05; the aspects evaluated with this form are considered accordant when


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there is objective evidence to sustain the accomplishment. The validity of the acceptance of testing

issued by a laboratory not accredited, are subject to the current regulations.

The evaluator that assesses the laboratory evaluation, must be competent in NTC-ISO-IEC 17025

regulation, and must have knowledge in the tests that can be performed there. This laboratory will

be evaluated to verity the competence to perform the required tests for the evaluation.

The reports emitted by National Institutes of Metrology are accepted and if so, it is unnecessary to

perform an evaluation in the laboratories that has these reports.

5.9. Complementary evaluation

If during the certification are presented nonconformities, the evaluator will notify the client, and it

must send and action plan to correct this, expressing the interest to continue with the certification

process in 10 working days. The count starts on the date the form FPR-02-13 is signed. Once the plan

is accepted, the evaluator gives the client 3 months to correct the identified nonconformities.

After this evaluation, the evaluator will document in the form FPR-02-07 or FPR-02-08 all the

activities developed in the evaluation process including the ones associated with the identified

nonconformities.

If in the complementary evaluation are detected the same nonconformities already announced, the

process will be finished and the client will be notified that the agency cannot grant the certification,

explaining the reasons for it. If the client still wants to certify the product, he must start all over the


5.10. Evaluation report and certificate decision.

When the evaluation process is terminated and having closed the nonconformities if applicable, the

evaluator delivers a granting evaluation report FPR-02-08 or a follow-up evaluation report FPR-02-07

and sends it to QCERT. The report is analyzed and sent to the product certification committee for its

revision and concept development, deciding to grand, confirm, renew, suspend or withdraw the

certification.

If the process is successful and the certification is granted, QCERT finishes the process by emitting a

product conformity certificate and becomes responsible towards the client to perform follow-ups of

the results in time.


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After sending the certificates, the client receives a survey to find out if the certification service was

satisfactory. This survey must be filled and set to the certification agency as feedback and continued

improvement in the offered service.

5.11. Not granting the certification

The Certification Body QCERT will abstain of granting a certificate in the following cases:

If during the evaluation is detected that the products object of the evaluation are already

certified by the agency and a valid certification exists.

If there were a malicious or tendentious use of the documents associated to the process.

When the obligations of the contract have not been paid in accordance to the contract

agreed between the parties.

When nonconformity doesn’t be approved by the client.

5.12. Use of the Brand QCERT

According to what is established in the contract and under the schemes 1a, 1b or 5, the owner of the

certificate must use the QCERT Brand in the publicity associated to the product such as web page,

catalogs, documents that refer to the product, among others.

During the granting evaluation, the evaluator must inform the client that in case the certificate is

granted they must use the Brand QCERT.

If the evaluation is designed as follow-up or renewal there must be evidence in the product of the

use of the Brand QCERT. It can be in the product, in the web page, in advertisement, contrary to this

the evaluator will report a nonconformity and the certificate will be suspended until there is

evidence of the use. The evaluator must remind the client they need to keep using the brand.

For both cases, the client must be reminded that the use of the Brand QCERT must be done under

the linings established on Regulation for QCERT Brand use, RG-04. The non-compliance of this

requisite generates the suspension of the certificate.

5.13. Validity and tracing of the certificates

If the certification is under scheme 5, this will have 3 years of validity, in which there must be done

an annual tracing. The certification will be conditioned to the results of this tracing. If the owner of


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the certificate does not want to continue with the certification, it must inform to the certification

body, justifying the decision through a written communication.

During the validity time, the certification body QCERT, will perform tracing evaluations minimum

once a year. This to verify that the product still fulfills the quality and performance requisites under

which the certification was granted.

During the tracing evaluation, QCERT will verify the following aspects:

If the company has a QMS certificate that was evaluated in the process, QCERT will ask for

the copy of the valid QMS certificate in order to verify if the ISO 9001:2008 certificate is

granted by an accredited certification body by members of multilateral agreements of

international recognition such as IAF, ILAC etc., or accredited by ONAC. There will be

photographic record of this verification.

The certificate must be in English and Spanish.

The product object of the certification must be covered in the scope of the QMS.

The fabric or Manufacturer Company where the product comes from, must be included in

the certificate.

If the company still does not have a QMS certificate, QCERT will perform again the

attestation in place to evaluate the quality and validity of the production process. The

evaluator will use the Annex 1 RG-01 Quality evaluation of the production process in the

Product certification regulation. The following aspects will be evaluated: Management of

claims and complains, nonconforming product control, raw material, production equipment,

measuring tools control, defined activities to control the production process, and that

manufacturing complies with the design specification.

Take random samples of the production area, commerce or storage, to perform the

established tests in the technical proposal attached in the surveillance notification; or

through the inspection of the products installed where the evaluator can verify the correct

operation. (When it applies).

The results obtained will be evaluated to establish if the product still complies the conditions

under the given certificate.

Use of the Brand QCERT.

Information will be sent to the certification committee, who will revise and decide about the

certification.

The client will be notified about the committee decision and the certificates will be updated

if recommended or required.


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To continue using the certification, the client is conditioned by the results of the surveillance

evaluation. The certification agency QCERT will send information regarding the date, cost of the

follow-up, and test to be performed depending on the nature of the product.

If during the tracing evaluation there are presented nonconformities, the client must send to QCERT

a corrective action plan that needs to have evidence of how the problem is going to be corrected,

and what is going to be done to prevent it. The certification agency will evaluate the information sent

and will establish if necessary a complementary evaluation that must be executed in a 3 moths term

counted form the date the nonconformity was found. The evaluator of the process will be the one

who, evaluating the severity of the nonconformity, determines the whether or not to suspend the

certificate, stating the measures to the specific case should be applied.

Notes:

The certification type 1a, will be granted to audited products that comply all the

requirements established on the applicable regulation. The scope does not include other lots

of the same product that have not been audited. In the certificate is established the amount

of certified products.

The certification type 1b, will be granted to audited samples that complied with the

certification requirements and will not cover other samples of the same product that have

not been audited.

6. COMPLAINTS AND/OR APPEALS

QCERT will attend complaints, appeals and risks of impartiality through procedure PR-04, where it is

explained methods and directions to follow the treatment of complaints and appeals at the

certification agency.

Any user of a product certification service has the right to present a written and sustained complaint related to the given service. The client has the right to present appeals to QCERT direction, related to decisions made. It has to be written and sustained in the next ten (10) labor days after the notification is delivered. The certification agency has determined as a fundamental part to solve complaints, appeals and impartiality risks a higher level in the organization with the Interested Parties and Impartiality Committee. Its objectives are to ensure that policies concerning the content and function of the certification system are complying, intervene to solve complaints and appeals imposed to the organization, and solve the interest conflicts that may present with related organisms so that it can guarantee a balance, and liberation of commercial and financial pressures.


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The members of the Interested Parties and Impartiality Committee, represent independently the certification agency and the interests of those different guilds, searching for a balanced and righteous participation in the decision making process regarding the organization policies, assuring Independence, integrity, impartiality principles promoted by the certification agency.

7. CHANGES THAT AFFECT THE CERTIFICATION

If there are significant changes in the certification process QCERT will communicate the client, giving

information related with the modification and asking the client to give comments about this changes.

In applying cases there will be meetings and polls, to establish a period of time for the client to make

changes or adjustments.

When the client requests a change in the scope of the certification, QCERT receives it for evaluation

and review. Then decides how to proceed with it:

Updating certificates issued before regarding the enlargement or reduction of the scope; the

old certificate will lose validity, and will be evidenced in the certification agency web page.

Requiring additional tests to modify the scope of the certificate(s)

Requesting to start a certification process from the beginning.

If the client requests to include one or more products in a valid certificate; an evaluation of

the process to follow is to be made:

Class 1: The reference included only varies in aesthetic characteristics and do not require

additional laboratory tests. IN this case the certification professional will execute the

inclusion.

Class 2: The reference object of the inclusion is different to the certified references, it is

required to perform additional laboratory tests. In this case the certification professional will

perform a complementary evaluation, generate a report, and present it to the certification

committee for a decision regarding the inclusion.

The inclusions associated with enlarging the scope of a certificate already issued has an

administrative cost.

Any decision of how to proceed must be documented and justified. Explaining why evaluation,

revision or decision activities can be excluded. QCERT will authorize or unauthorized the use of the

brand for this products.

The new certificate emitted will have the same number, including the letter i to identify that

it has an inclusion.


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8. CERTIFICATION RENEWAL

According to established linings by the certification agency QCERT, the renovation of the certificate

will be made in the third year after de issue date. The client interested in maintaining the

certification will request for renovation 2 months before the expiration. The renewal only applies for

certification scheme 5.

9. CONDITIONS TO GRANT, MANTAIN, EXPAND, REDUCT, SUSPEND OR WITHDRAW THE

CERTIFICATION FOR SCHEMES 1a, 1b Y 5.

This chart is a summary of the conditions for each activity depending on the certification scheme.

Certification Scheme

Grant Maintenance / Surveillance

Expansion /Reduction

Suspension Withdrawal

1a

The product must comply with requirements present in pertinent regulations or technical rules. Samples must be identified with QCERT logo.

N/A, because the certification issued is only valid for the evaluated lot. This must be properly identified.

N/A, because the certification issued is only valid for the evaluated lot. This must be properly identified.

N/A, because in case the owner of the issued certificate missuses the document, QCERT will suspend it.

If the certification owner uses improperly the certificate, including products that are not identified in the evaluated lot.

1b

The product must comply with all the requisites established in the pertinent regulation or technical rules The lot must be identified with QCERT brand.

N/A, because the issued certificates is only valid for the evaluated samples and it is identified completely in the certificate.

N/A, because the issued certificate is only for evaluated samples, and it is identified completely in the certificate.

N/A, because in case the owner of the certificate missuses the Brand, QCERT will withdraw the certificate.

If the owner of the certificate does an improper use of the certificate, including products that are not identified in the evaluated lot.

5

The products evaluated must comply all the requirements established on the applicable regulation or technical rules. The evaluation process can be done through evaluating the production process in a visit to the Factory. - The process of

There will be done annual evaluation follow-ups, to verify that the product still complies with the requirements under which the certificate was issued. There will be a documental audit of the QMS if the company has one, to

The owner of the certificate must send a written request to expand or reduce the scope of the issued certification, identifying the products and references. The certification agency will analyze pertinence, and in

The causes for suspension or withdrawal are specified in numeral 9.1.


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attestation to evaluate the quality of the production process, must revise all matters related to the production process, and must comply all the requirements of the product certification. There must be a selection sample and tests that evidence the compliment of the product object of the certification. The evaluation can be performed if the following requirements are accomplished: - The company requesting the certificate must have a QMS under regulation ISO 2001:2008. - The Quality Management System certificate must be valid when the revision is done. - The product object of the certification must be under the scope if the QMS. - The certificate is issued by an ONAC or IAF accredited organism. - The certificate must be in Spanish and English. - The fabrication plant where the product is produced must be included in the QMS

verify that the certificate is issued by an accredited organism recognized by IAF or accredited by ONAC in Colombia. The product must be under the scope of the QMS. The Quality Management System must be in English and Spanish. The certificate must be valid for the verification date. The fabrication plant where the product is produced must be included in the QMS certificate. Verify that the conditions of the certificate have not change. If any of this requirements is unaccomplished there must be done a present evaluation of the production process.

case it is affirmative will send the commercial proposal. If the owner of the certificate accepts the proposal, the scope in the certificate will be modified through and addendum and will proceed to start the evaluation process.


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certificate. - The accredited organism must be part of IAF and be signer in the mutual international recognition agreements IAF or accredited by ONAC.

9.1 Conditions to suspend or withdraw a certificate under scheme 5.

The certification body QCERT is responsible for all the granted certificates, and for the maintenances,

suspension and withdraw of them. These are the defined causes:

If the client uses misleading or likely to mislead the user. The company requesting of the service

must engage to responsibility in advertisement, ensuring that will not make dishonest

propaganda, or publicity that does not correspond to reality, also publicity that can lead to a

mistake. If it is presented for a first time, the certificate will be suspended for a period of six

months, in case of repetition the certificate will be withdraw definitely.

Expiration or cancelation of the contract between the certification agency QCERT and the client.

In this case the certificate will be withdrawn until the client requests a new service and the

fulfillment of requirements is verified through a new evaluation.

If the client does not fulfill his economic obligations stipulated in the contract the certificate will

be suspended until the client changes this payment status. In this case the certification is

suspended until the applicant left the service in good standing with the certification body, for a

period not exceeding six months term after which the certificate is withdrawn.

It the product fabricator cannot comply with the requirements established in the applicable

regulation after this regulation was revised or updated and includes new tests. In these cases the

certification body will give a period of six months to the client, to evaluate the possibility of

taking the test, in case the answer is negative the certification will be suspended and the client

must request a change in the scope of the certificate if viable.

Use the certificate for other product that is not included under the scope. If this happens a first

time the certificate will be suspended for six months, in case of repetition the certificate will be

withdrawn definitely.


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When a certified product continuously fails in its function after the installation, and the causes

are manufacture. If it happens for the first time, the certificate will be suspended for six months,

in case of repetition the certificate will be withdraw definitely.

If the follow-up results are unsatisfactory.

When there are not performed programed follow-up evaluations by negligence of the client.

When the owner of the certificate does a written request with just cause to withdraw the

granted certificate.

When the client does not present to the certification body evidence of the use of QCERT brand.

The suspension will be effective until the client complies with this requirement.

In any event of suspension, this will be for a period of six months, counted from the event giving rise

to the suspension. After six months, or the term provided for the cause of the suspension, without

having overcome the inconsistencies that led to it, it will proceed with the withdrawn.

When the certification body suspends or withdraws definitely a product certification, will notify the

owner of the certificate who must suspend immediately advertisement of the certificate. Likewise,

the client must advise his own clients about the novelty; and will authorize the certification body

QCERT to divulge this novelty to the competed authorities and pertinent media.

The suspension or withdraw implies resignation to any legal action against the certification body

QCERT.

The product certification suspended or withdraw will reactivate through a new evaluation, in which

there will be verified if the causes for the suspension or withdraw have been corrected.

10. RIGHTS AND OBLIGATIONS OF THE CLIENTS.

Rights of the client or owner of the certification:

Request a change on the evaluation established dates, it has to be under just cause and mutual

agreement. The evaluation has to be executed no more than two months after the first

assignation.

If the process is terminated before the evaluation starts the client has the right to claim 80% of

the amount paid to the certification agency. The causes for the termination must be justified and

alien to the certification agency.

Use the certificate for commercial ends according to the scope specified in the conformity

certificate.


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Present claims and complaints related to the service of the certification agency QCERT, following

the established procedure.

If the client does not agree with a decision made by the certification agency QCERT, can initiate a

procedure of attention to claims, complaints and appeals following the linings established in this

document.

Obligations of the client or owner of the certification:

Comply with dispositions established in by the certification agency QCERT, these are contained in

this document and other acquired commitments through the contract.

Provide the amount of product needed to perform all the tests established in the regulation or

technical rules and applies to the product in mention.

Assure QCERT free Access to all the places and documents regarding activities related to the

certification, this is: product storage and fabrication and test laboratories. (If applicable)

Pay under the established terms the fees and related expenses, including the surveillance

evaluations.

In case the certificate is under scheme 1a or 1b, labeling the product(s) allowing plain

identification.

Correct use of the obtained certificate so that the certification agency is not discredited and only

for the products identified by the scope granted, under this criteria:

o For certification scheme 1b, the certificate is only valid for the evaluated test and cannot be

extended to other product.

o For certification scheme 1a, the certification is valid for an evaluated lot and cannot extend

to other lot that has not been part of the sampling process.

Assure that no certificate or annex us used in a dishonest way, or generate partial reproductions

of the certificates.

When the client uses the certification in media, such as documents, literature or advertisement,

it must be done complying with the mentions obligations.

Do not use the certificate in cases the product does not comply the conditions under which the

certificate was issued.

Give QCERT the information related to claims and complaints from their own clients, regarding

product conformity and actions taken for this reclamations or product deficiency.

Inform the certification agency QCERT if there are changes that may affect the scope of the

certificate such as:

o Changes in the company name.


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o Change of fabricator.

o Changes in the contract information: Legal representation, address, phone number etc.

o Changes in the characteristics of the certified product.

o Judicial intervention or administrative sanction imposed by competent authorities.

Note:

1. If during the follow-up evaluation, the product cannot be evaluated due to availability un the

Factory or cannot take market samples due to technical capacity of the product fabrication

referenced by the owner of the certificate, it must be performed and evaluation to the system and

inspect the installed product in use.

If the client is unaware of places where the product has been installed, will proceed with the

suspension of the certificate until this evaluation can be made.

In case the product does not accomplish the requirements established in the applicable reference,

the client must:

Act conforming what established in the law and the nonconforming products still in the market.

Accept and execute pickup and destruction of the product when the unities observed are

nonconforming that by its nature imply risks to life and peoples gods.

Eliminate from the product and packaging all reference of the certification.

Assume responsibility over warranties of the product that by law correspond to the company.

Assume legal responsibility over damages to users or thirds that derive to the nonconformity of

the product in this regulation.

10.1 Sanctions

If the owner of the certification fails to comply any of the duties explained before, or missuses the

certification, QCERT will proceed to sanction the client with the suspension and/or withdraw of the

issued certification. The sanction will have a written notification explaining the situation and will be

published in the web page. If the certificate is withdrawn QCERT will assume the end of the contract

for the products related to the fault.


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11. RIGHTS AND OBLIGATIONS OF THE CERTIFICATION AGENCY QCERT

Certification agency QCERT is obligated to:

The certification agency is responsible that every member of the Interested Parts Committee is

active and well informed when there are changes in certifications requirements.

Give information about the certification process to anyone, without discrimination. Including the

scope of the service and commercial proposal.

Manage confidentiality with the documents obtained by the client, related to the certification

activities and use it only for the contracted service. In case third party requests information

related to the process, QCERT will inform the client.

Verify that QMS and product comply with the reference requirements under which the

certification is issued. The use of QCERT Brand does not substitute obligations assigned to control

organizations, determined by its competence.

Once the certification process is finished, send the client the product conformity certificate or

the results notification.

Attend claims and appeals of any client.

Keep an updated record of all the products certificated and the owner of the certification.

The certification agency has the obligation of publishing for anyone the following information

regarding the certification:

- Certificate number

- Status of the certificate

- Owner of the certificate

- Certified products

- Regulation or rule regarding the certification

Certification agency QCERT has the following rights:

The client must pay according to the commercial proposal in the terms and conditions

established in it.

Take necessary actions, including legal, civil or criminal if it applies, against any major fail of the

client. Including rules of consumer protection, any damage to the certification agency according

to what is written in this regulation.


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12. OTHER DISPOSITIONS

12.1. Evaluation contract

Before starting the evaluation process, should be formalized by acceptance, express or implied, the

contract for the provision of the respective service. This regulation is part of the contract concluded

between the parties. No certificate will be awarded if this requirement has been breached.

12.2. Changes in the certification process

If there are changes in the regulations or commandments of the Interested Parties Committee QCERT

will notify the client, making him responsible of taking corrective actions before the next follow-up

evaluation.


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Annex 1

PRODUCTION PROCESS QUALITY SYSTEM EVALUATION

OBJECTIVE

Establish criteria under which the quality system evaluation is evaluated as a requirement for the

product certification process.

SCOPE

This evaluation is preformed when the client request a certification under scheme 5.

EVALUATED ASPECTS

To establish the conformity of quality in the production process, QCERT will evaluate the following

numerals of ISO 9001:2008:

1. Documents Control (Numeral 4.2.3)

2. Record Control (Numeral 4.2.4)

3. Management of resources and infrastructure (Numeral 6.3)

4. Product Fabrication (Numeral 7)

5. Measurement and improvement (Numeral 8)

ACCEPTANCE OR REJECTION CRITERIA FOR THE QUALITY PRODUCTION PROCESS

This describes the evaluation criteria of a quality system, weather any aspect is considered

conformity or nonconformity.

Stage of the audited element Criteria for the conformity

According to the industries characteristics, the element in the

rule does not apply. N.A

If there is not knowledge of the element.

NONCONFORMING The concept is applied informally.

Has a plan to document it.

If there is knowledge of the element. CONFORMING


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Formally applies the concept.

Has documented evidence.

Chart to be filled by the evaluator

Evaluated company:

Address:

Process: Evaluation of the Quality management System.

Evaluator:

Date:

Aspect to evaluate Objective evidence Conforming

YES/NO

How is the infrastructure of the company to produce the good or service? Evaluate: If the company has the appropriate infrastructure to guarantee the production of conforming products. (machines, site organization, adequate tools)

7.1 Planning and fabrication of the product. Objective evidence

Conforming YES/NO

How is the production planned? Evaluate: The existence of quality plans, flowchart, data sheets, general production program.

7.2 Client related processes. Objective evidence

Conforming YES/NO


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What are the requirements for product development? Which of the requirements apply to the product? Legal requirements Applying regulation Technical rules that apply

7.2.2 Review of established product requirements within the product.

Objective evidence Conforming

YES/NO

What are the product requirements? What evidence does the company have for the review of these requirements? How is it determined the capacity of the company to comply the requirements.

7.2.3 Communication with the client. Objective evidence

Conforming YES/NO

What dispositions have been implemented to communicate with the client about: Product information. Consults, contracts, orders. Feedback including claims.

7.3 Design and Development Objective evidence

Conforming YES/NO


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-What is the company doing in terms of design related with the evaluated product? How are they controlled in terms of execution, revision, approval, validation? Attach copies of blueprints or product design object of the evaluation. Verify controls.

7.4 Purchase Objective evidence

Conforming YES/NO

How can the company assure that the purchases comply with the specified requirements? What is the established documents for purchase?

What criteria is established to evaluate the suppliers? What are the actions taken for unapproved suppliers? Are there any services purchased? And what is the control practiced to these services? Evaluate: List of evaluated and approved suppliers. Raw material certificates.

7.5 Production and service rendered. Objective evidence

Conforming YES/NO

How is the control of the production and/or rendered service? Attach flowchart of the process. Evaluate routine tests performed in the product.


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What type of tests have been done and where? Is there any evidence? Attach them in the product object of evaluation.

Hoy is the product identified throughout the production process? If traceability is a requirement, how is it controlled? Attach: Photographic report that identifies the traceability of the product.

How is the product storage and packed to guarantee its preservation? Attach: Photographic report indicating the correct storage of the product.

7.6 Control if equipment and measuring tools. Objective evidence

Conforming YES/NO

How the company does controls the follow-up of equipment and measuring tools in the productive process? What are the requirements for calibration and verification of the measuring tools? Attach copies of the calibration certificates. Calibration plan.

8.2.1 Client satisfaction. Objective evidence

Conforming YES/NO

How the company does evaluates the client perception related to the product and or service?


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What are the actions taken over clients observations? Attach report of client’s satisfaction polls.

8.3 Control of nonconforming product. Objective evidence

Conforming YES/NO

How is the nonconforming product handled? Verify implementation of nonconforming process. What actions have been taken? Attach evidence of the documented procedure. Record control of nonconforming products.

8.5.2 Corrective and preventive actions. Objective evidence

Conforming YES/NO

How are the real or potential nonconformities handled? What corrective or preventive actions have been implemented in order to eliminate nonconformities or to avoid them definitely? Attach record of actions generated to manage complaints or nonconforming products.

Evaluation performed by:

Auditor:_______________________________

Audited:______________________________

Date:______________________________