1. Overview of ISO, ISO Certification, and ISO Standards
1.1. What is ISO?
ISO stands for International Organization for Standardization. It is an independent, non-governmental organization that develops and publishes international standards. These standards are often adopted as laws through agreements or national standards. Therefore, the standards issued by ISO have global applicability.
ISO was founded on February 23, 1947, and is headquartered in Geneva, Switzerland. As of 2018, ISO has 161 national member bodies. Vietnam joined ISO in 1977, becoming the 77th member of the organization.
ISO's main mission is to build and promulgate standards. These standards typically become law through agreements or national standards. Therefore, the standards issued by ISO have global applicability.
ISO has issued over 20,000 standards. These standards cover everything from manufactured products and technology to food safety, agriculture, and healthcare.
1.2. What is an ISO Standard?
As mentioned, ISO's mission is to develop and promulgate standards. The standards issued by this organization are commonly referred to as ISO Standards.
With the participation of most countries in the world, ISO Standards issued by ISO have global validity.
ISO Standards are internationalized rules. They are recognized and have global value. ISO Standards help organizations operate sustainably. They help businesses produce products that meet customer requirements with consistent quality.
IN OTHER WORDS: ISO Standards are a common yardstick for businesses worldwide to strive for.
ISO issues international ISO Standards to ensure that everything is done to the correct standard. This includes international requirements to ensure that products, services, and systems are of high quality. ISO Standards are a tool to facilitate international trade. They help organizations that apply them gain trust from partners and consumers or the conditions to enter the global supply chain.
To date, the International Organization for Standardization ISO has issued over 22,000 International Standards and related documents. ISO Standards cover all industries. Such as technology, food safety, agriculture, and healthcare.
1.3. What is ISO Certification?
ISO Certification is the process by which an organization is assessed by a certification body and granted an ISO Certificate. The certification body confirms that the organization's management system meets the requirements of the corresponding ISO standard.
The outcome of ISO Certification is the ISO 9001 Certificate, often referred to as the ISO 9001 Certificate.
1.4. ISO Certification Bodies
An ISO certification body is a legal entity with a clear legal status. Importantly, the certification body must be licensed (designated) by the Ministry of Science and Technology in the field of certification.
Currently, there are many certification bodies in Vietnam that businesses can choose from. However, it is important to note that not all certification bodies currently operating have been accredited by the Ministry of Science and Technology for the field of certification.
1.5. What is an ISO Certificate?
An ISO Certificate is the result of an assessment and serves as evidence that an organization has a system that meets the requirements of an ISO standard. After the certification body has conducted the assessment and confirmed that the organization's system is compliant,
The organization will be issued a certificate by the certification body with the following contents:
- Name of the Certification Body
- Information about the certified organization.
- Certification standard.
- Scope of certification (business area).
- Certificate number; Date of issue; Expiry date.
- Certification mark.
- Other necessary information
2. Why is ISO Certification Necessary?
Benefits for Businesses:
- Improves and enhances the reliability and image of the company's products.
- Enhances processes and production lines.
- Enhances decision-making based on data.
- Creates a culture of improvement for the organization.
Benefits for Customers and Consumers:
- Increases customer satisfaction.
- Provides peace of mind when using products from ISO-certified businesses.
Benefits for Government Agencies: Facilitates quality and standard management for products.
3. Popular ISO Standards in Vietnam
Currently, Vietnamese businesses are implementing and applying the following basic ISO standards:
ISO 9001:2015
ISO 9001:2015, Quality Management System – Requirements, is the fifth version of the ISO 9001 series of standards. First published in 1987, it has become a global benchmark for ensuring quality requirements and improving customer experience in the supplier-consumer relationship.
The 2015 version of ISO 9001 has been improved compared to previous versions through a risk-based approach. It helps organizations identify factors that can cause their quality management system or process to deviate from the originally planned course.
At the same time, ISO 9001:2015 certification ensures that the organization can develop preventive control measures to minimize negative impacts and maximize opportunities when they arise.
The changes in quality management principles in ISO 9001:2015 compared to previous versions are reflected in the following:
- Customer focus
- Leadership
- Engagement of people
- Process approach
- Improvement
- Evidence-based decision making
- Relationship management
ISO 9001:2015 was officially released on September 24, 2015 and is still in use today. The validity of an ISO 9001:2015 certificate is 3 years after it is granted. The organization will have to undergo two surveillance audits. When the certificate expires, the organization can request a re-evaluation and re-certification.
ISO 14001:2015
ISO 14001:2015 is part of the ISO 14001 series of standards issued by the International Organization for Standardization (ISO). Its primary goal is to assist organizations in minimizing their negative environmental impact and adhering to relevant regulations, laws, and policies. The ultimate aim is to ensure the sustainable development of the planet.
ISO 14001 is one of six standards in the ISO 14000 family. It specifies requirements for an environmental management system (EMS) that organizations can use to enhance their environmental performance.
The ISO 14001:2015 standard was released on September 15, 2015. This 2015 version is the most recent, covering the following: Structure, terms, and key requirements, system implementation and operation and how to meet the requirements of multiple clauses
The basis of the environmental management system according to ISO 14001: 2015 is based on the PDCA cycle - Plan Do Check Act. This model creates a process where tasks are repeated with the aim of continuously improving and monitoring the operation of the environmental system. The PDCA cycle is briefly described with 4 steps:
ISO 22000:2018
ISO 22000:2018 is the latest standard for food safety management. It was published by the International Organization for Standardization (ISO) on June 19, 2018. It is titled Food safety management systems - Requirements for any organization in the food chain.
The previous version was published on September 1, 2005. ISO 22000 is based on the Codex Alimentarius' HACCP (Hazard Analysis and Critical Control Points) and GMP (Good Manufacturing Practices) principles. It applies to all organizations in the food and feed industry, regardless of their size or sector.
The structure of ISO 22000:2018 follows the High-Level Structure (HLS) of Annex SL, which includes the following sections:
- Scope
- Normative references
- Terms and definitions
- Organization context
- Leadership
- Planning
- Support
- Operation
- Performance evaluation
- Improvement
ISO 22000:2018 requires organizations to implement a comprehensive food safety management system that includes: Communication, Management system, Prerequisite programs and HACCP.
HACCP Certificate
HACCP stands for Hazard Analysis and Critical Control Points. It is a systematic preventive approach to food safety that focuses on identifying, evaluating, and controlling hazards throughout the food production process.
HACCP is currently required by many countries around the world for food production and processing facilities.
HACCP focuses primarily on food safety issues rather than product quality. However, HACCP certification is still a mandatory requirement to ensure food safety by identifying, assessing, controlling, and eliminating hazards.
HACCP is applied throughout the entire food chain, from raw material input to final consumption. Therefore, HACCP is applied in the implementation of quality management systems such as ISO 9001 or ISO 22000.
The HACCP system operates based on seven basic principles:
Principle 1: Conduct a hazard analysis, including biological, physical, and chemical hazards.
Principle 2: Identify critical control points (CCPs).
Principle 3: Establish critical limits for each CCP.
Principle 4: Establish monitoring procedures for each CCP.
Principle 5: Establish corrective action procedures for each CCP.
Principle 6: Establish verification procedures.
Principle 7: Establish documentation and record-keeping procedures.
These seven principles are also the final seven steps in the total of 12 steps for building a HACCP system for a business.
Applying HACCP standards helps to affirm product quality and increase the competitiveness of businesses in the international market.
ISO 13485:2016
ISO 13485 is a standard that specifies requirements for a quality management system for organizations involved in the production, distribution, installation, and servicing of medical devices.
The first version of ISO 13485 was published in 2003, equivalent to the national standard TCVN ISO 13485:2004.
The currently applicable version was issued on March 1, 2016. ISO 13485:2016 specifies requirements for the application of a quality management system to organizations, manufacturers, and suppliers of medical devices.
ISO 13485 certification is built on the foundation of ISO 9001 and includes requirements, regulations, and customer-related regulations, risk management, and maintaining an effective process.
Decree 36/2016/ND-CP of the Prime Minister on the management of medical equipment, which took effect on July 1, 2016, clearly specifies regulations regarding ISO 13485.
Specifically, "medical device manufacturing facilities must complete the application of ISO 9001 quality management system before January 1, 2018 and ISO 13485 quality management system before January 1, 2020." Therefore, January 1, 2020 was the deadline for businesses to establish ISO 13485:2016 certification.
Conditions for obtaining ISO 13485 certification:
- The enterprise has established and applied procedures following the ISO 13485 standard.
- The enterprise conducts a certification assessment by a reputable and licensed certification organization.
ISO 45001:2018
The ISO 45001:2018 certification standard establishes requirements, structure, and related issues for Occupational Health and Safety Management Systems (OHSMS). It was issued to replace the OHSAS 18001:2007 standard. Additionally, ISO 45001:2018 is based on guidelines and standards on labor from the International Labour Organization.
This standard was officially released on March 12, 2018, with the aim of regulating and helping businesses better manage occupational health and safety issues. ISO 45001:2018 is built on the foundation of OHSAS 18001.
Therefore, the ISO organization currently allows businesses to transition from OHSAS 18001 to ISO 45001:2018 through 12 steps, including:
- Determining the organizational context.
- Listing interested parties.
- Reviewing the scope of OH&SMS.
- Demonstrating leadership.
- Aligning OH&S objectives with the organization's strategy.
- Assessing risks and opportunities.
- Identifying hazards and evaluating them.
- Determining compliance obligations.
- Controlling all documentation.
- Controlling operations.
- Evaluating performance.
- Measuring and reporting.
Businesses and organizations that want to be certified to ISO 45001 must meet the three mandatory requirements: internal audit, management review, and corrective action.
ISO 27001:2013
ISO 27001:2013 specifies the requirements for an ISMS. It was published on October 1, 2013, to replace the previous version, ISO 27001:2005. The main objective of ISO 27001:2013 is to ensure the confidentiality, integrity, and availability of information within an organization.
The entire operation of the ISMS is based on identifying potential problems, also known as risk assessment, and then determining what can be done to prevent them. The risk management approach in ISO 27001:2013 is implemented through six steps: Define risk treatment scope, identify risks, analyze risks, evaluate risks, treat risks, monitor and review risks.
The ISO 27001:2013 certification process consists of three main steps:
Stage 1 Assessment: Document review by experts.
Stage 2 Assessment: On-site assessment by experts at the organization to verify compliance with the standard and ISMS documentation.
Stage 3 Assessment: Surveillance assessment conducted after the organization has been certified. During the three-year validity period of the certificate, experts will conduct an assessment to verify whether the organization maintains the ISMS.
In addition to organizations, ISO 27001 certification can also be granted to individuals. Individuals must attend certain courses to obtain the certification. The most common courses are:
- ISO 27001:2013 Lead Auditor training course.
- ISO 27001:2013 Implementation training course.
- ISO 27001:2013 Internal Auditor training course.
- There are many other ISO standards.
4. Conditions for Obtaining ISO 9001:2015 Certification
Condition 1: Building and Applying the ISO 9001 Standard:
- Enterprises must build and apply the ISO 9001:2015 standard - a quality management system suitable for their specific needs.
- The process of building and applying the standard varies for each enterprise due to differences in scale, scope, number of employees, departments, offices, products, etc. Therefore, from the outset, enterprises must have a plan and program for building and applying the ISO 9001 standard for their own enterprise.
- This condition includes several important tasks such as: determining the scope of the enterprise's activities, holding a leadership meeting to commit to building and applying the ISO 9001 standard, establishing an ISO committee with members representing various departments to implement the project; planning risks and opportunities, quality objectives; human resources involved; implementation; evaluation of implementation results; improvement and remediation.
Condition 2: Register for ISO 9001 Certification:
- Register for ISO 9001 certification with ISOCERT, a certification organization. After registration, the certification organization will conduct an assessment of the quality management system according to the ISO 9001 standard.
- If the enterprise's quality management system meets the content requirements of the ISO 9001 standard, the certification organization will issue the enterprise an ISO 9001 certificate (ISO 9001 certificate).
Condition 3: Maintaining the System and Validity of ISO 9001 Certification:
- Continue to maintain the quality management system according to the requirements of the ISO 9001 standard and the validity of the ISO 9001 certificate.
- After achieving ISO 9001:2015 certification, enterprises need to continuously improve and maintain the application of the system.
5. How long is an ISO 9001 certificate valid?
The validity of an ISO 9001 certificate is the period from the date of issue to the expiry date. During this time, the certificate is legally binding and the company must comply with its requirements.
Most ISO certifications are valid for 3 years from the date of issue. This is also the case for ISO 9001 certification. During these 3 years, the certification body will conduct surveillance audits of the company's quality management system once a year.
6. In what cases will an ISO 9001 certificate be revoked?
If a company does not implement and operate the ISO 9001 system, the ISO 9001 certificate will be revoked by the certification body. This can happen if the company fails to maintain the system after achieving certification, leading to stagnation, incorrect operation, and non-compliance with the standard during surveillance audits.
7. ISO 9001:2015 certification costs
The cost of ISO 9001 certification varies depending on the company's size, scope, number of products, cost of system implementation and personnel involvement, registration fees, testing costs, etc.
Therefore, companies should carefully plan their budget to ensure it is suitable for their needs.
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8. ISO 9001 Certification Timeline
The process of obtaining ISO 9001 certification for a business can be divided into two main stages:
8.1. Time to build and implement the ISO 9001 standard:
This varies depending on the business and its specific situation. Many businesses can complete this stage within 3 to 6 months, but it may take longer for others.
8.2. Time to receive ISO 9001:2015 certification:
The time it takes to receive ISO 9001 certification is typically shorter than the implementation stage. After applying for certification, the certification body will assign qualified experts to assess the business's management system.
If the assessment finds that the business's quality management system meets the requirements of the ISO 9001 standard, the certification will be issued within a few days.
However, if the assessment finds that the system does not meet the standard's requirements, the business will have 3 to 6 months to take corrective actions. If the issues are not resolved within this timeframe, the assessment will be terminated, and the business will not receive ISO 9001:2015 certification.
The overall timeline for obtaining ISO 9001 certification also depends on the capacity of the certification body. If the body has sufficient resources and qualified experts, the process can be completed more quickly.
9. Applying for ISO Certification at Thiên Di
9.1. Legal Basis
Applicable legal documents:
- Decision 2938/QĐ-BKHCN
- Decision 1250/QĐ-BKHCN
- Decision 2932/QĐ-BKHCN
9.2. Steps to Obtain ISO Certification
Step 1: Register for certification
Step 2: Review and create an assessment plan
Step 3: Document review
Step 4: On-site assessment
Step 5: File review
Step 6: Issuance of certificate
Step 7: Periodic surveillance assessment
Step 8: Recertification assessment
9.3. Application Requirements
Documents to be provided:
- Copy of the business registration certificate or organization establishment decision
- ISO system construction and application document of the organization or enterprise
Information to be provided: Information about products or goods for which ISO certification is requested
9.4. Validity of ISO Certificate
The ISO certificate is valid for 03 years and can be re-applied for after 03 years.
Issuing authority of ISO certificate: ISO certification body that has been granted a business license
9.5. Eligible Applicants for ISO Certification
- Organizations
- Enterprises
9.6. ISO Certification Issuance Time
Within 05 - 07 days, the ISO certification body will issue ISO certificates to organizations and individuals that meet the ISO requirements.
10. Thiên Di's ISO Certification Service
Fast and Convenient Procedures: When using our services, we will always be by your side, providing enthusiastic support for every step of the process, ensuring the smoothest possible experience in completing procedures, registering for assessment, and obtaining ISO certification.
Reasonable Cost: The quality management system certificate meeting the standards recognized by the international certification office is valid worldwide.
Free Support for Customers in Preparing Business Registration and Business License Change Procedures: We offer free support for customers in preparing documents and procedures for business establishment and business license change.
Support Customers in Preparing Documents and Facilities When Functional Agencies Post-Audit or Inspect Businesses: We assist customers in preparing documents and facilities when functional agencies conduct post-audits or inspections of businesses.
Fastest ISO Certification Support Service: We provide the fastest ISO certification support service, ensuring that customers have enough time to prepare bidding documents and capacity documents.
Contact Info:
THIEN DI TRADING SERVICES COMPANY LIMITED
Address: No. 36 Street A4, Ward 12, Tan Binh District, Ho Chi Minh City
Hotline: 0981317075
Phone: 028.6293 9377
Email: info@luatthiendi.com
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