GENERAL INFORMATION
1. What is Quality Management System (SGC for its abbreviation in Spanish)?
It is the system that integrates the required activities and resources for providing services so they meet customers' expectations.
Moreover, it establishes the activities that assure technically valid results for determined analysis techniques.
2. Where are SGC aims established?
In quality policies. The quality policy establishes organization purpose and its compromise:
“To provide laboratory services and environmental studies in the time committed to, according to customers requirements; directed to achieving their satisfaction in accordance to the applicable norm by a process of on-going improvement.”
3. How can I interpret this committment clearer?
-
Providing services on time: Delivering results to the client at the time established.
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Providing reliable services: Performing the services committed to according to methodologies established (technical procedures) that allow obtaining reliable results.
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According to the applicable norm: Services for which methodologies are based on documents issued by authorities (norms), internal procedures, and requirements established by the client.
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Directed to achieve customer satisfaction: It involves complying with the committment aquired with the customer, treating the customer professionally, and being accessible in showing the work that is being performed.
4. Does SGC cover all the activities in the Center?
No, SGC, has a defined approach; it is only applicable to the following services:
- Process of Specialized Technical Studies (Environmental Studies).
- Process of Laboratory Services (Laboratory analyses – mainly seven laboratories). See point 15 in this section.
- For support processes in which support activities allow haveing viable "infrastructure" to lend such services. This processes are: Maintenance, Provision of Good, Services, and Human Resources, Directive and Control processes, and SGC Follow-up.
- It also applies to specific testing methods where technically valid results are credited (accreditation).
5. What areas are involved in these processes?
FUNDAMENTAL Processes:
a) Specialized technical studies:
- Assistant Coordinator's Office of Environmental Studies and Specialized Services.
b) Laboratory services:
- Chemical Water Analysis**,
- Soils **,
- Spectrophotometry of Atomic Absorption **,
- Proximal Chemical Analysis *,
- Physiological Biochemistry *,
- Microbiological Diagnosis **,
- Molecular Biology *
- Chromatography***
- Biotherium***
* Certifies Quality Management System, according to ISO 9001:2008,
** Quality Management System certified according to ISO 9001:2008 and laboratories with creditation testing methods,
*** Laboratories with creditation testing methods and in process of being authorized by CCAYAC.
Areas participating in support processes:
- Specialized Support Services: Electronic Engineering Services, Electromechanic Workshop.
- Specialized Laboratory Services: Residual Management.
- Assistant Director's Office of Information Systems: Area of Information Infrastructure and Services.
- Administrative Director's Office: Maintenance Department, Patrimonial Control Department, Services Department, Assistant Director's Office of Human Resources.
- Board of Directors.
- Internal Auditing Team.
6. Why does the approach include the fundamental processes previously mentioned?
Because it is based on application standards that establish requirements which direct organizations toward:
- Customer satisfaction. ISO 9001:2008. CERTIFICATION.
- Obtaining technically valid results. NMX-EC-17025-IMNC-2006. ACREDITATION.
7. If I do not participate in providing the customer services defined in the approach (fundamental processes) why am I involved in SGC?
SGC is for certain processes or testing methods (analysis techniques) that are directly related to external customers; however, the fact they are provided by a determined area, it does not mean they do not require “infraestructure” and support that allows lending such services.
8. In what document is that related with SGC described?
The complete information that describes SGC is found in the quality handbook. This handbook makes reference to the whole SGC document (quality, policy, objective, and procedure plan).
The quality plan describes in detail that related to the processes and the procedures describe specifica activities for each area involved.
9. Where can I find all the information related to SGC?
In QDoc, which is the software for document control. It has all the information in force (Policy, handbook, quality plan, procedures, formats, and regulation).
QDoc Web software is installed in the internal network of the Center and the staff involved in SGC has access with username and login.
10. Does it have general application documents?
Yes, the documents we must all know are:
DOCUMENT
|
ISO 9001:2000 REQUIREMENT |
NMX-EC-17025-IMNC-2006 REQUIREMENT |
Quality policy
|
4.2.1 subsection a |
4.2.2 |
Quality handbook
|
4.2.1 subsection b |
4.2.2 |
Quality plan
|
5.4.2 y 7.1 |
NOT APLICABLE |
| Procedure for document control |
4.2.3 |
4.3.1 |
| Procedure for record control |
4.2.4 |
4.13.1.1 |
| Procedure for internal auditing |
8.2.2 |
4.14.1 |
| Procedure for non compliant work control |
8.3 |
4.9.1 |
| Procedure for corrective actions |
8.5.2 |
4.11.1 |
Procedure for preventive actions
|
8.5.3 |
4.12.2 |
11. How is quality assessed in the processes?
Quality is assessed through indicators with established values that assess in what measure process and SGC objectives are reached.
12. What are the quality objectives?
- Achieve customer satisfaction, ensuring their preference;
- Providing laboratory services, in the time committed and according to customers' requirements;
- Providing environmental studies, in the time committed and according to customers' requirements.
13. What are the process objectives?
- Directive process: Ensure development and implementation of a quality management system, as well as an ongoing improvement process;
- Maintenance process: Provide the required maintenance for the processes that constitute the quality management system;
- Process for providing goods, services, and human resources: Provide the goods, services, and human resources required by the processes that constitute the quality management system;
- Control and follow-up process: Manage approval of SGC requirements (document control, internal auditing, non-compliant product, customer feedback, SGC training, corrective, preventive, and improvement actions). As well as gathering information that generates from these activities to be reviewed by the Director's Office.
14. How is SGC assessed?
Through internal auditing and revision by the Director's Office.
15. How can I know if I am involved or not according to the applicable norm (ISO 9001 o NMX-17025)?
AREA
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ISO 9001 REQUIREMENT:2008 SGC PROCESS
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NMX-EC-17025-IMNC-2006 REQUIREMENT
|
Chemical Water Analysis
|
7. Execution of the product.
Process of laboratory services. |
6 assay methods credited. Total norm NMX-EC-17025-IMNC-2006 applies |
| Soils |
7. Execution of the product.
Process of laboratory services. |
3 assay methods credited. Total norm NMX-EC-17025-IMNC-2006 applies
|
Espectrophotometry of Atomic Absorption
|
7. Execution of the product.
Process of laboratory services. |
1 assay method credited. Total norm NMX-EC-17025-IMNC-2006 applies
|
Proximal Chemical Analysis
|
7. Execution of the product.
Process of laboratory services. |
NOT APPLICABLE
|
| Physiological Biochemstry |
7. Execution of the product.
Process of laboratory services. |
NOT APPLICABLE
|
| Chromatography |
NOT APPLICABLE
|
1 assay method credited. Total norm NMX-EC-17025-IMNC-2006 applies. |
Molecular Biology
|
7. Execution of the product.
Process of laboratory services. |
NOT APPLICABLE
|
Microbiological Diagnosis
|
7. Execution of the product.
Process of laboratory services. |
1 assay method credited. Total norm NMX-EC-17025-IMNC-2006 applies.
|
| Biotherium |
NOT APPLICABLE
|
1 assay method credited. Total norm NMX-EC-17025-IMNC-2006 applies. |
Customer Service
|
7. Execution of the product.
Process of laboratory services. |
4.4. Reviewing applications, supply, and contracts.
Attending external services |
| General Cashier Department |
7. Execution of the product.
Process of laboratory services and Specialized Technical Studies. |
NOT APPLICABLE
|
Waste Management
|
7. Execution of the product.
Process of laboratory services and Waste management. |
5.8 Handling assay or calibration items. Waste management |
| Assistant Director's Office of Environmental Studies and Specialized Technical Studies |
7. Execution of the product.
Process of Specialized Technical Studies. |
NOT APPLICABLE
|
| Specialized Support Services
(Electronic and electromechanic maintenance) |
6.3 Infrastructure.
Maintenance process. |
5.5 Equipment |
| Assistant Director's Office of Information Systems
(Service and Information Infrastructure Area ) |
6.3 Infrastructure.
Maintenance Process |
NOT APPLICABLE
|
Maintenance Department
|
6.3 Infrastructure.
Maintenance Process. |
NOT APPLICABLE |
| Patrimonial Control Department |
7.4 Purchases.
Process of providing goods and services. |
4.6 Services and supply purchases
Purchases |
| Services Department |
7.4 Purchases.
Process of providing goods and services. |
NOT APPLICABLE |
| Head of Document Control |
4.2.3 Document Control.
Control and follow-up process. |
4.3 Document control
|
| Human Resource Deparment |
6.2.2 Competency, raising awareness, development.
Follow-up and control process. |
NOT APPLICABLE |
Borad of Directors
|
5. Director's Office responsibility.
Directive process. |
4.15 Revision by the Director's Office.
ULSA Principal Technician. |
Internal Auditing Team
|
8.2.2 Internal auditing.
Follow-up and control process. |
4.14 Internal auditing.
All staff involved in accreditation. |
16. Besides the questions described before, what other information or in what other manner can anything be requested by an auditor?
- How do you contribute in complying with quality policy and objectives?
- Do you know the specific objective of the process in which you are involved?
- How do you assure service reliability?
- How do you assure on time delivery?
- Where are the processes, SGC, specific activities documented?
- Do you know what are the markers of the process in which you participate?
- Is there a procedure or document to plan, operate, and control processes?
- How do you carry out record control?
- Do you know how to manage printed documentation?
17. DEFINITIONS
Accreditation. Accreditation is a documented process by which the Mexican Accreditation Entity (EMA for its abbreviation in Spanish) grants formal acknowledgment of competency to perform asses (reliable results) to the laboratories that comply with the requirements established by this organization and the Norm NMX-EC-17025-INMC-2006.
Certification. Verification by a competent, impartial, and independent organism that the management system of the organization is in accordance with the requirements established in a standard, directed to satisfying customer needs (ISO 9001:2008).
Quality Management System (SGC): Management system to direct and control an organization with respect to quality.
Customer: Organization or person that receives a product.
Process: Set of mutually related activities or that interact, which transform incoming elements in results.
Product: Process result. There are four generic product categories:
• Services (for example, laboratory analysis, environmental studies);
• Software (for example, computer programs, dictionary);
• Hardware (for example, mechanical part of a motor);
• Processed materials (for example, lubricant).
Procedure: Specific way to perform and activity or process.
In accordance with: Complying with a requirement.
Non compliance: Failure to comply with a requirement.
Infrastructure:
Installation systems, necessary equipment and services for the good working order of an organization.
Document: Information and its support media.
Record: Document showing the results obtained or provididing evidence of the activities performed.
Objective evidence: Data backing up the existence or truthfulness of something.
Assay method. Analysis technique (denomination used by CIBNOR).
Assay. Determining one or more characteristics according to a procedure.
18. DOCUMENT CONTROL
The entrance to Qdoc document control software is in the following electronic address:
http://200.23.161.204/qdocibnor/principal.asp
The staff involved in SGC, must register in this software by the document controller that will register and provide the access code (password).
The documentation in QDoc is organized according to the following menu:
- Laboratory service processes.
- Specialized technical study processes.
- Provision of goods, services, and human resources processs.
- Maintenance process.
- Control and quality management system follow-up process.
- Directive process.
19. SERVICE PROVISION
LABORATORY SERVICES
To facilitate access to analysis services offered to external customers, the Assistant Coordinator's Office of Service and Support has a CUSTOMER SERVICE window.
This area is in charge of receiving, channeling, following-up, and delivering results to exernal applications. In Customer Service there is a responsible person and a support technician.
ASSISSTANT COORDINATOR'S OFFICE OF SPECIALIZED TECHNICAL STUDIES (SEASE)
The area of the Assistant Coordinator's Office of Environmental Studies and Specialized Services is in charge of receiving, channeling, following-up and delivering specialized technical studies; customer service is performed through: SEASE Responsible technician and responsible for managing applications.
20. ATTENDING COMPLAINTS
POLICY
There is a procedure to attend complaints (CA23) where the process that proceeds is described.
The complaints must be recorded in the INTRANET page, in the COMPLAINT BOX (BUZON DE QUEJAS).
For more information contact: Lilia Ibarra Martínez (Assisstant Coordinator of Quality Management System)
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