Quality Management Systems: A Comprehensive Guide to ISO 9000 and ISO 14000
Quality
Quality: The set of characteristics of an entity that bear on its ability to meet the explicit and implicit needs.
ISO 9000
ISO 9000: A set of rules that constitute a model for quality assurance in design, development, production, installation, and servicing. This rule allows for the development and implementation of quality management within a company.
Pyramid Documentary
The Pyramid Documentary is the hardware that sits on the management system of quality. It comprises:
- Quality Manual: Defines the quality policy of a company and includes a brief summary of quality procedures.
- Procedures: Define how things are done in the company.
- Technical Instructions: Technical information based on some of the company’s procedures, including instructions for machines and external regulations to be met by the business.
- Standard: In general, the standard of ISO 9000 quality assurance.
- Quality Management System: A set of rules and forms of work to be followed by a company to meet the philosophy and strategies for products that customers demand.
- Supplier: The company intends to implement a system of quality management.
- Audit: A revision of the quality of a company.
- Certification: The process by which a company gets the call quality certification under the ISO 9000 standard.
- Consultant: Person responsible for the company to implement and develop the quality system.
- Senior Director of Quality: Person in charge of everything related to quality.
- Documents: Quality Manual, procedures, technical manuals, manufacturers’ instructions, any standard.
- Data: List of customers, suppliers, or employees, list of rules, surveys, planning.
- Quality Record: Cash, certified checks.
- Format: The physical medium that, once compliant, is a record.
- Non-compliance: Quality does not exist in things done badly.
- Quality Plan: Planning with dates, responsibilities, tasks performed, and goals to achieve in any aspect of quality.
ISO 14000 Standards
Companies that implement these standards assure their customers that the quality of the product they purchase will be maintained over time.
ISO 14000
ISO 14000: Part of a family of standards concerning environmental management applied to firms, which aims to standardize ways to produce and provide services that protect the environment.
ISO (International Organization for Standardization)
- Rationale: Economic globalization makes production processes standardized worldwide. The concern for health and social responsibility.
Historical Overview
The ISO Central Secretariat in Geneva, Switzerland, coordinates the system. It is a non-governmental organization and does not depend on any other international body. It has no authority to impose its standards on any country.
Members of ISO are national standards institutes or similar organizations, the most representative of standardization in their country.
Standards developed by the ISO launch the development of new standards for which there is clearly a demand in the market.
Technical Committees
Experts from the industrial, technical, and business fields who have created the rules and used them later.
Development Process
National delegations of experts from a technical committee meet to talk and discuss before reaching a general agreement on a project.
Timeliness
For some users of standards, including technology workers, the standards are changing rapidly.
History of the ISO 14000 Standard
In the 1990s, many countries began to implement their own environmental standards, which varied widely from country to country.
ISO was invented at the Earth Summit. At this event, ISO committed to creating international environmental standards named ISO 14000.
It is worth noting two variants of ISO 14000:
- Certification of environmental management systems.
- The environmental seal (green label).
The ISO 14000 international standard was approved in September 1996, and the adaptation of the standard range of “national standards” in Europe occurred in March 1997.
The standard comprises five elements:
- Environmental management system.
- Environmental audit.
- Environmental performance evaluation.
- Environmental labels.
- Terms and definitions.
System Conformity Assessment
Directors
Policy documents to be transposed into the relevant legislation at the European level to be applied directly by the countries.
CEN
Organization in charge of all the laws that try to specify the requirements of the applicable rules in accordance with evaluators.
EN ISO/IEC 17025
Laboratory testing and calibration.
Assess how these evaluators meeting standards will be assessed by an independent third party.
Accreditation
Formal recognition by an accredited third party.
Situation in Spain
To accredit testing laboratories and ensure that results can cross borders on an equal footing with the rest of the European community.
RELAY (Spanish Network of Testing Laboratories)
ENAC (National Accreditation Body) evaluates public and private laboratories intending to carry out the official supply of food for healing and health.
Latest Developments
UNE-EN ISO/IEC 17025
Quality Chemical Laboratories
Tests or analyses must be comparable to similar results regardless of the laboratory that performs them.
American Society for Quality
Quality Control: The entire functions and features of a product or service targeted to its ability to meet the needs of a user.
ISO
The common point to all definitions is that they emphasize the needs of the user who expects, implicitly or explicitly, a feature of their product.
System Needs
- Customer Confidence
- Cost reduction within the laboratory
- Laboratory confidence in their results
Quality System
The entire organizational structure of responsibilities, procedures, processes, and resources that are established to carry out quality management.
Organization Recognized Standards
- ISO 9000: Certification company product or service/process model
- ISO/IEC 17025: Testing or calibration laboratory accreditation
- ISO 15189: Medical laboratories—Requirements for quality and competence
- BPL’s: Certification testing laboratory accreditation research
- EFQM: Managing performance evaluation
Estates of Quality System
4 Basic Cups
- Raw material/input
- Process/activities
- Product/output
- Control activities
Needs of Different Models
- Request
- Sample handling
- Quality system
Depending on the Type of Work Performed
- Repetitive work in a short period produces a test report.
- Non-repetitive work that requires decision-making and usually continues for a significant period.
Reasonable Responsibilities
- Fixing performance criteria
- Monitoring of compliance with criteria
- Assessment shows the progress of the process.
- Appropriate training.
B)
- Determination of criteria and decision-making
- Adequate staffing
- Assessment of compliance with the steps of each point
Working Procedures
- Personal
- Premises and equipment
- Test report
- Records
- Control system
Mediation and Trial
The rule provides for the treatment of equipment and quality assurance measures, a number of requirements on the organization of the laboratory system.
All These Requirements
- Control system
- Calibration and verification system
- Maintenance system
Purpose and Scope
The ISO takes into account that sampling and test methods can be non-standard or be developed by the laboratory.
Management Requirements
- Organization
- Quality Management System
- Document Control
- Review of requests, tenders, and contracts
- Outsourcing of tests and calibration
- Purchasing services and supplies
- Customer Service
- Claims
- Job control test
- Corrective actions
- Preventive actions
- Control of records
- Internal audits
- Reviews by the review
Technical Requirements
- General
- People
- Installation and environmental conditions
- Method of testing and calibration
- Teams
- Traceability of measures
- Sampling
- Handling of test and calibration
- Quality assurance and test results
- Reporting results