Iso 34 PDF

: Technical assistance
3** for Commerce in Colombia

MINISTRY OF COMMERCE, INDUSTRY AND TOURISM
• ISO/IEC GUIDE 34:2009
ISO/IEC GUIDE 34:2009
GENERAL REQUIREMENTS FOR THE TECHNICAL COMPETENCE OF

REFERENCE MATERIALS PRODUCERS

DEFINITION
Reference Material (RM): material sufficiently homogeneous and stable
with respect to one or more specific properties, which has been established
to be suitable for its intended use in a measurement process.
Certified reference material (CRM): reference material that is

characterized with a metrologically valid procedure for one or more specified
properties, accompanied by a certificate that provides the value of those
specified properties, their associated uncertainty, and a statement of
metrological traceability .

REFERENCE MATERIALS
Why do we use Reference Material:
-Internal quality control
-Proficiency testing programs
-Transfer values to the properties of another material.
-Validation of measurement procedures
-Provide metrological traceability of measurements
-Provides an alternative to ensure the uncertainty of a measurement
-Calibration of measuring equipment

REFERENCE MATERIALS
Qualification IRAM ISO Guide
Standard
Vocabulary. Terms and definitions used in 451:1994 30:1992: modified
connection with these materials. in 2008
Content of certificates and labels. 452: 2004 31:2000
General and statistical principles for 453:2001 35:2006

certification.
Uses of reference materials 454:2006 33:2000
General requirements for the competence of 455:2002 34:2000

producers of reference materials.

REFERENCE MATERIALS
The reference material producer must comply with technical requirements
to ensure that it can manufacture reference materials with the characteristics
it certifies.
The producer must have a production plan in which he identifies all the
factors and processes that directly affect the quality of his product and has
instructions and resources to carry out all the necessary activities.
You must ensure the quality of the final product . To do this, all stages of
manufacturing must be evaluated, including those carried out by
subcontractors, from the selection of materials to final packaging.
REFERENCE MATERIALS

In order to ensure the value of the property defined by the MR

it is essential to take into account metrological traceability
and the estimation of uncertainty.
Technical assistance
to Commerce in Colombia
REFERENCE MATERIALS
In order to ensure the competence of a producer of

reference materials (RM), this must meet the requirements
established in ISO Guide 34: 2009 “General requirements
on the technical competence of producers of
reference materials" .

DEFINITION
• Reference Material Producer: Body (organization or company, public or
private) responsible for planning the production project and its management,
and for deciding on the assignment of values to the properties that are
certified and the issuance of the certificates. or other statements
accompanying the reference material.
• Reference Material Production: All necessary tasks and activities that lead to
supplying reference materials to customers. It includes: planning and control of
production, handling and storage of material, processing of material, ensuring
homogeneity and stability, characterization, assignment of values to its
properties with their corresponding uncertainties, issuance of certificates, after-
sales service and distribution.
DEFINITION
• Subcontractor: Entity (organization or company, public or private) that is

responsible for aspects of the processing, handling, ensuring stability and
homogeneity, characterization, storage or distribution of the reference
material, on behalf of the producer of reference materials, on a contractual
basis, whether paid or free.

• ISO 34 MANAGEMENT REQUIREMENTS

4. Requirements for the Quality System
^ The MR producer must establish, implement and maintain a Quality System (QMS)
appropriate to the field of its activities, including the type, range and magnitude of MR
production.
^The properties of an MR must be characterized to a level of accuracy required for the

purpose for which it is intended.
^The MR producer must describe the procedure for establishing the quality of its MR, as a
component of its QMS.
^MR producers should define the scope of MR in terms of its application, the methods used to
determine homogeneity, stability and characterization studies, and any limitations due to the
material matrix.

^ .1.2 QUALITY POLICY
The MR producer must:
Define and document your policies, objectives and commitments to ensure and
maintain quality in all aspects of MR production, including:
^ the quality of the MR (homogeneity, stability),
^ its characterization (equipment calibration, method validation),
^ the assignment of values to its properties (t. statistics),
^ procedures for the handling, storage and transportation of MR.


4.1.3 QUALITY SYSTEM
The MR Producer must have a QMS that includes the following aspects:
a) Agree on the characteristics to ensure an adequate choice of the candidate reference

material.
b) Procedures for preparation,
c) Ensure the required degree of homogeneity for the MR
d) Ensure the stability of the MR. Determine and evaluate the certified or declared
validity period.
e) Procedures to carry out its characterization.
f) Ensure commutability.
4.3 CONTROL OF DOCUMENTS AND INFORMATION
4.4 ORDER, OFFER AND CONTRACT REVIEW



4.5 COLLABORATORS OR SUBCONTRACTORS
The MR producer must evaluate the competence of the subcontractor in one of

the following ways:
- Audits under the guidelines of the ISO/IEC 17025 standard.
- Evaluation of historical performance through participation in interlaboratory

exercises.
- Evaluation through quality control materials.


4.6 OBTAINING SERVICES AND SUPPLIES

The producer must have procedures to ensure that the materials purchased
and the services contracted meet the specified requirements, and must
maintain records of the actions taken.
The equipment purchased and the materials to be consumed must not be used
until they have been inspected, calibrated or subjected to another action that
verifies compliance with the standard specifications or requirements defined in
specifications for the production, characterization, and certification of their MR.


4.7 USER SERVICE
4.8 COMPLAINTS
The Producer must have a policy and procedures for the resolution of
complaints received from the user or from other parties.
Records of all complaints and investigations and corrective actions taken by the
producer must be maintained.


4.9 NON-CONFORMING WORK
The producer must have a policy and procedures to implement when any
aspect of production activities is not in accordance with its own specified
production procedures or agreed with user requirements.
When necessary, customers who have purchased a reference material should
be notified if there was a problem with materials already supplied and remove
them from circulation, including certificates.
4.10 CORRECTIVE ACTION
4.10.2 Cause analysis

4.10.3 AC selection and implementation
4.10.4 AC monitoring
4.10.5 Additional audits
4.11 PREVENTIVE ACTIONS
4.12 IMPROVEMENT


4.11 RECORDS
The MR Producer must have procedures to protect electronically stored data at

all times and prevent unauthorized access and modifications of data.
a) QMS records
b) Technical records
The retention time of the records should not be less than the validity period of
the MR.
The results of calibrations or measurements carried out for the produced MR

must be reported in accordance with the ISO/IEC 17025 standard.
4.12 INTERNAL AUDITS
When the results of the Audit indicate doubts about the effectiveness
of the operations or about the accuracy or validity of the MR, the
Producer must take the AC and must notify, in writing , the users
whose activities may be adversely affected.


4.13 MANAGEMENT REVIEW
Should consider:
• Establish whether policies and procedures are adequate

• Analyze reports from senior staff
• The results of recent Internal Audits;
• Corrective Actions and Preventive Actions.
• Evaluations carried out by external organizations;
• Changes in the volume and type of work
• User opinion, including complaints and other relevant factors.
• Recommendations for improvement.
• Other relevant factors such as resources, staff training, technical issues related
to the competence of subcontractors and distributors.
• 5.2 STAFF
• The producer of the reference material should, where possible, have

competence in the production of a particular type of MR (or related
material), as well as have access to experts in the measurements of
the properties to be determined.


5.2 STAFF
Adequate competence of the personnel involved with the activities related
to the production of the MR must be ensured.
Have personnel with the necessary education, training, technical knowledge and
experience to perform the tasks assigned to them.
Ensure, if necessary, that personnel receive additional training to ensure

competent performance in measurements, equipment operation, and any other
activity that affects quality.
Where possible controls will be applied to evaluate the effectiveness of training.
An up-to-date record of personnel authorizations, competencies and professional

qualifications must be maintained .

• 5.3 SUBCONTRACTING
• When a producer of reference material uses subcontractors to perform

part of the production procedure, which includes processing,
evaluation of homogeneity or stability, characterization, handling,
storage or distribution of the reference material ; The producer must
be able to demonstrate that the subcontractor is competent to carry out
the part of the procedure that is his responsibility and that the work
performed and/or the results obtained are of the required quality.

5.2 SUBCONTRACTING
The processes that should not be carried out by a subcontractor are:
• project planning,
• the selection of subcontractors,
• the allocation and decision on property values.
• the authorization or certification of property values
• the making of certificates,
• communications,
• the results report or information sheets (whatever they are called).

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: Technical assistance

3** for Commerce in Colombia

• ISO/IEC GUIDE 34:2009

ISO/IEC GUIDE 34:2009

GENERAL REQUIREMENTS FOR THE TECHNICAL COMPETENCE OF

3** for Commerce in Colombia

Certified reference material (CRM): reference material that is

3** for Commerce in Colombia

3** for Commerce in Colombia

Content of certificates and labels. 452: 2004 31:2000

General and statistical principles for 453:2001 35:2006

General requirements for the competence of 455:2002 34:2000

3** for Commerce in Colombia

3** for Commerce in Colombia

In order to ensure the value of the property defined by the MR

In order to ensure the competence of a producer of

3** for Commerce in Colombia

• Subcontractor: Entity (organization or company, public or private) that is

3** for Commerce in Colombia

• ISO 34 MANAGEMENT REQUIREMENTS

^The properties of an MR must be characterized to a level of accuracy required for the

• ISO 34 MANAGEMENT REQUIREMENTS

The MR producer must:

^ the quality of the MR (homogeneity, stability),

^ its characterization (equipment calibration, method validation),

^ the assignment of values to its properties (t. statistics),

^ procedures for the handling, storage and transportation of MR.

• ISO 34 MANAGEMENT REQUIREMENTS

a) Agree on the characteristics to ensure an adequate choice of the candidate reference

b) Procedures for preparation,

c) Ensure the required degree of homogeneity for the MR

e) Procedures to carry out its characterization.

• ISO 34 MANAGEMENT REQUIREMENTS

4.3 CONTROL OF DOCUMENTS AND INFORMATION

4.4 ORDER, OFFER AND CONTRACT REVIEW

3** for Commerce in Colombia

• ISO 34 MANAGEMENT REQUIREMENTS

The MR producer must evaluate the competence of the subcontractor in one of

- Evaluation of historical performance through participation in interlaboratory

- Evaluation through quality control materials.

3** for Commerce in Colombia

• ISO 34 MANAGEMENT REQUIREMENTS

4.6 OBTAINING SERVICES AND SUPPLIES

MINISTRY OF COMMERCE, INDUSTRY AND TOURISM

3** for Commerce in Colombia

• ISO 34 MANAGEMENT REQUIREMENTS

4.7 USER SERVICE

3** for Commerce in Colombia

• ISO 34 MANAGEMENT REQUIREMENTS

• ISO 34 MANAGEMENT REQUIREMENTS

4.10 CORRECTIVE ACTION

4.10.2 Cause analysis

4.11 PREVENTIVE ACTIONS

3** for Commerce in Colombia

• ISO 34 MANAGEMENT REQUIREMENTS

The MR Producer must have procedures to protect electronically stored data at

The results of calibrations or measurements carried out for the produced MR

• ISO 34 MANAGEMENT REQUIREMENTS

4.12 INTERNAL AUDITS

3** for Commerce in Colombia

• ISO 34 MANAGEMENT REQUIREMENTS

• Establish whether policies and procedures are adequate