There are too many and messy ISO systems for guidance, so I can’t figure out which one to do? No problem! Today, let’s explain one by one, which companies should do what kind of system certification is most suitable. Don’t spend money unjustly, and don’t miss out on the necessary certificates!
Part 1 ISO9001 Quality Management System
The ISO9001 standard is universally applicable, which does not mean that the 9000 standard is omnipotent, but because the 9001 is a basic standard and the essence of western quality management science.
Suitable for production oriented enterprises, as well as service industries, intermediary companies, sales companies, etc. Because the emphasis on quality is common.
Generally speaking, the ISO9001 standard is more suitable for production-oriented enterprises because the content in the standard is relatively easy to correspond to, and the process correspondence is relatively clear, so there is a feeling of being in line with the requirements.
Sales companies can be divided into two types: pure sales and production sales companies.
If it is a pure sales company, its products are outsourced or purchased, and their products are sales services, rather than product production. Therefore, the planning process should consider the particularity of the product (sales process), which will make the planning system better.
If it is a production oriented sales enterprise that includes production, both the production and sales processes should be planned in. Therefore, when applying for an ISO9001 certificate, sales companies should consider their own products and distinguish them from production oriented enterprises.
Overall, regardless of the size of the enterprise or industry, all enterprises are currently suitable for ISO9001 certification, which has a wide range of applications and is suitable for any industry. It is also the foundation and foundation for the development and growth of all enterprises.
For different industries, ISO9001 has derived different refined standards, such as quality system standards for the automotive and medical industries.
Part 2 ISO14001 Environmental Management System
ISO14001 Environmental Management System Certification is applicable to any organization, including enterprises, institutions, and relevant government units;
After certification, it can be proven that the organization has reached international standards in environmental management, ensuring that the control of various pollutants in various processes, products, and activities of the enterprise meets relevant requirements, and establishing a good social image for the enterprise.
Environmental protection issues are increasingly receiving attention from people. Since the International Organization for Standardization released the ISO14001 Environmental Management System Standard and several other related standards, they have received widespread response and attention from countries around the world.
More and more enterprises that focus on environmental energy conservation have voluntarily implemented the ISO14001 environmental management system.
Generally, there are several situations in which enterprises implement the ISO14001 environmental management system:
1. Pay attention to environmental protection, hope to fundamentally realize pollution prevention and continuous improvement through the implementation of the environmental management system, and promote the process of enterprises to develop clean products, adopt clean processes, use efficient equipment, and reasonably dispose of waste.
2. Requirements from relevant parties. For requirements such as suppliers, customers, bidding, etc., enterprises need to provide ISO14001 environmental management system certification.
3. Improve the level of enterprise management and promote the transformation of enterprise management models. By controlling the consumption of various resources, we comprehensively optimize our own cost management.
In summary, the ISO14001 environmental management system is a voluntary certification that can be implemented by any enterprise in need of improvement to enhance its visibility and fundamentally improve its management level.
Part 3 ISO45001 Occupational Health and Safety Management System
ISO45001 is an international safety and health management system validation standard, a new version of the original occupational health and safety management system (OHSAS18001), applicable to any organization’s occupational health and safety management system standard,
The purpose is to reduce and prevent the loss of life, property, time, and environmental damage caused by accidents through management.
We usually refer to the three major systems ISO9001, ISO14001, and ISO45001 together as the three systems (also known as the three standards).
These three major system standards are applicable to various industries, and some local governments will provide financial subsidies to certified enterprises.
Part 4 GT50430 Engineering Construction Quality Management System
Any enterprise engaged in construction engineering, road and bridge engineering, equipment installation and other related projects must have corresponding qualification certificates, including the GB/T50430 construction system.
In bidding activities, if you are an enterprise in the engineering construction industry, I believe you are not unfamiliar with the GB/T50430 certification, especially having three certificates can improve the winning score and the winning rate.
Part 5 ISO27001 Information Security Management System
Industry with information as its lifeline:
1. Financial industry: banking, insurance, securities, funds, futures, etc
2. Communication industry: telecommunications, China Netcom, China Mobile, China Unicom, etc
3. Leather bag companies: foreign trade, import and export, HR, headhunting, accounting firms, etc
Industries with high reliance on information technology:
1. Steel, Semiconductor, Logistics
2. Electricity, Energy
3. Outsourcing (ITO or BPO): IT, software, telecommunications IDC, call center, data entry, data processing, etc
High requirements for process technology and desired by competitors:
1. Medicine, Fine Chemicals
2. Research institutions
Introducing an information security management system can coordinate various aspects of information management, making management more effective. Ensuring information security is not just about having a firewall or finding a company that provides information security services 24/7. It requires comprehensive and comprehensive management.
Part 6 ISO20000 Information Technology Service Management System
ISO20000 is the first international standard regarding the requirements of IT service management systems. It adheres to the concept of “customer oriented, process centered” and emphasizes the continuous improvement of IT services provided by organizations in accordance with the PDCA (Deming Quality) methodology.
Its purpose is to provide a model for establishing, implementing, operating, monitoring, reviewing, maintaining, and improving the IT Service Management System (ITSM).
ISO 20000 certification is suitable for IT service providers, whether they are internal IT departments or external service providers, including (but not limited to) the following categories:
1. IT service outsourcing provider
2. IT system integrators and software developers
3. Internal IT service providers or IT operations support departments within the enterprise
Part 7ISO22000 Food Safety Management System
The ISO22000 Food Safety Management System Certificate is one of the essential certificates in the catering industry.
The ISO22000 system is applicable to all organizations in the entire food supply chain, including feed processing, primary product processing, food manufacturing, transportation, and storage, as well as retailers and the catering industry.
It can also be used as a standard basis for organizations to conduct third-party audits of their suppliers, and can also be used for third-party commercial certification.
Part 8 HACCP Hazard Analysis and Critical Control Point System
The HACCP system is a preventive food safety control system that evaluates potential hazards that may occur in the food processing process and then takes control.
This system is mainly aimed at food production enterprises, targeting the hygiene and safety of all processes in the production chain (responsible for the life safety of consumers).
Although both ISO22000 and HACCP systems belong to the food safety management category, there are differences in their scope of application: the ISO22000 system is applicable to various industries, while the HACCP system can only be applied to food and related industries.
Part 9 IATF16949 Automotive Industry Quality Management System
The enterprises suitable for IATF16949 system certification include: manufacturers of cars, truck, buses, motorcycles and parts and accessories.
Enterprises that are not suitable for IATF16949 system certification include: industrial (forklift), agricultural (small truck), construction (engineering vehicle), mining, forestry and other vehicle manufacturers.
Mixed production enterprises, only a small portion of their products are provided to automobile manufacturers, and can also obtain IATF16949 certification. All management of the company should be carried out in accordance with IATF16949, including automotive product technology.
If the production site can be distinguished, only the automotive product manufacturing site can be managed according to IATF16949, otherwise the entire factory must be executed according to IATF16949.
Although the mold product manufacturer is a supplier of automotive supply chain manufacturers, the products provided are not intended for use in automobiles, so they cannot apply for IATF16949 certification. Similar examples include transportation suppliers.
Part 10 Product after-sales service certification
Any enterprise legally operating within the People’s Republic of China can apply for after-sales service certification, including enterprises that manufacture tangible goods, sell tangible goods, and provide intangible goods (services).
Goods are products that enter the consumer field. In addition to tangible products, goods also include intangible services. Both industrial and civilian consumer goods belong to the category of commodities.
Tangible goods have external form, internal quality, and promotional elements, such as quality, packaging, brand, shape, style, color tone, culture, etc.
Intangible goods include labor and technical services, such as financial services, accounting services, marketing planning, creative design, management consulting, legal consulting, program design, etc.
Intangible goods generally occur with tangible goods and also with tangible infrastructure, such as aviation services, hotel services, beauty services, etc.
Therefore, any production, trade, or service enterprise with independent legal personality can apply for after-sales service certification for goods.
Part 11 Automotive Functional Safety Certification ISO26262
ISO26262 is derived from the basic standard for functional safety of electronic, electrical, and programmable devices, IEC61508.
Mainly positioned in specific electrical components, electronic devices, programmable electronic devices, and other components specifically used in the automotive industry, aiming to improve international standards for the functional safety of automotive electronics and electrical products.
ISO26262 has been officially formulated since November 2005 and has been around for 6 years. It was officially promulgated in November 2011 and has become an international standard. China is also actively developing corresponding national standards.
Safety is one of the key elements in future automotive research and development, and new features are not only used for assisting driving, but also for dynamic control of vehicles and active safety systems related to safety engineering.
In the future, the development and integration of these functions will inevitably strengthen the requirements of the security system development process, while also providing evidence to meet all expected security objectives.
With the increase in system complexity and the application of software and electromechanical equipment, the risk of system failure and random hardware failure is also increasing.
The purpose of developing ISO 26262 standard is to provide people with a better understanding of safety related functions and to explain them as clearly as possible, while providing feasible requirements and processes to avoid these risks.
ISO 26262 provides a lifecycle concept for automotive safety (management, development, production, operation, service, scrapping) and provides necessary support during these lifecycle stages.
This standard covers the overall development process of functional security aspects, including requirements planning, design, implementation, integration, verification, validation, and configuration.
The ISO 26262 standard divides the system or a certain component of the system into safety requirement levels (ASIL) from A to D based on the degree of safety risk, with D being the highest level and requiring the most stringent safety requirements.
With the increase of ASIL level, the requirements for system hardware and software development processes have also increased. For system suppliers, in addition to meeting existing high-quality requirements, they must also meet these higher requirements due to increased safety levels.
Part 12 ISO13485 Medical Device Quality Management System
ISO 13485, also known as “Quality Management System for Medical Devices – Requirements for Regulatory Purposes” in Chinese, is not sufficient to standardize medical devices solely according to the general requirements of the ISO9000 standard, as they are special products for saving lives, aiding injuries, and preventing and treating diseases.
For this reason, the ISO organization has issued the ISO 13485-1996 standards (YY/T0287 and YY/T0288), which put forward special requirements for the quality management system of medical device manufacturing enterprises, and played a good role in promoting the quality of medical devices to achieve safety and effectiveness.
The executive version up to November 2017 is ISO13485:2016 “Quality Management Systems for Medical Devices – Requirements for Regulatory Purposes”. The name and content have changed compared to the previous version.
Certification and registration conditions
1. Production license or other qualification certificates have been obtained (when required by national or departmental regulations).
2. The products covered by the quality management system applying for certification should comply with relevant national standards, industry standards, or registered product standards (enterprise standards), and the products should be finalized and produced in batches.
3. The applying organization should establish a management system that meets the certification standards to be applied for, and for medical device production and operation enterprises, they should also comply with the requirements of YY/T 0287 standard. Enterprises producing three types of medical devices;
The operation time of the quality management system shall not be less than 6 months, and for enterprises producing and operating other products, the operation time of the quality management system shall not be less than 3 months. And have conducted at least one comprehensive internal audit and one management review.
4. Within one year before submitting the certification application, there were no major customer complaints or quality accidents in the products of the applying organization.
Part 13 ISO5001 Energy Management System
On August 21, 2018, the International Organization for Standardization (ISO) announced the release of a new standard for energy management systems, ISO 50001:2018.
The new standard has been revised based on the 2011 edition to meet the requirements of ISO for management system standards, including a high-level architecture called Appendix SL, the same core text, and common terms and definitions to ensure high compatibility with other management system standards.
The certified organization will have three years to convert to new standards. The introduction of Appendix SL architecture is consistent with all newly revised ISO standards, including ISO 9001, ISO 14001, and the latest ISO 45001, ensuring that ISO 50001 can be easily integrated with these standards.
As leaders and employees become more involved in ISO 50001:2018, the continuous improvement of energy performance will become a focus of attention.
A universal high-level structure will make it easier to integrate with other management system standards, thereby improving efficiency and reducing energy costs. It can make organizations more competitive and potentially reduce their impact on the environment.
Enterprises that have passed the energy management system certification can apply for green factory, green product certification, and other certifications. We have government subsidy projects in various regions of our country. If you have any needs, you can contact our partners to obtain the latest policy support information!
Part 14 Implementation of Intellectual Property Standards
Category 1:
Intellectual property advantages and demonstration enterprises – requiring compliance with standards;
Category 2:
1. Enterprises preparing to apply for famous and well-known trademarks at the city or province level – the implementation of standards can serve as effective proof of intellectual property management norms;
2. Enterprises preparing to apply for high-tech enterprises, technological innovation projects, industry university research cooperation projects, and technical standard projects – implementing standards can serve as effective proof of intellectual property management norms;
3. Enterprises preparing to go public – implementing standards can avoid intellectual property risks before going public and become effective proof of the company’s intellectual property regulations.
Third category:
1. Large and medium-sized enterprises with complex organizational structures such as collectivization and shareholding can streamline their management thinking by implementing standards;
2. Enterprises with high intellectual property risks – By implementing standards, intellectual property risk management can be standardized and infringement risks can be reduced;
3. Intellectual property work has a certain foundation and hopes to be more standardized in enterprises – implementing standards can standardize management processes.
Fourth category:
Enterprises that frequently need to participate in bidding can become priority targets for procurement by state-owned and central enterprises after completing the bidding process
Part 15 ISO/IEC17025 Laboratory Management System
What is laboratory accreditation
·Authoritative institutions establish a formal recognition process for the ability of testing/calibration laboratories and their personnel to perform specified types of testing/calibration.
·A third-party certificate officially stating that the testing/calibration laboratory has the ability to carry out specific types of testing/calibration work.
The authoritative institutions here refer to CNAS in China, A2LA, NVLAP, etc. in the United States, and DATech, DACH, etc. in Germany
Comparison is the only way to distinguish.
The editor has specially created the following comparison table to deepen everyone’s understanding of the concept of “laboratory accreditation”:
·The testing/calibration report is the reflection of the final results of the laboratory. Whether it can provide high-quality (accurate, reliable, and timely) reports to society, and receive reliance and recognition from all sectors of society, has become the core issue of whether the laboratory can adapt to the needs of the market economy. Laboratory recognition precisely provides people with confidence in the trust of testing/calibration data!
Part 16 SA8000 Social Responsibility Standard Management System Certification
SA8000 involves the following main contents:
1) Child labor: Enterprises must control the minimum age, juvenile labor, school learning, working hours, and safe work scope in accordance with the law.
2) Compulsory employment: Enterprises are not allowed to engage in or support the use of forced labor or the use of bait or collateral in employment. Enterprises must allow employees to leave after shifts and allow employees to resign.
3) Health and safety: Enterprises must provide a safe and healthy working environment, protect against potential accidents and injuries, provide health and safety education, and provide hygiene and cleaning equipment and regular drinking water.
4) Freedom of association and collective bargaining rights: Enterprises respect the right of all personnel to form and participate in selected trade unions and engage in collective bargaining.
5) Differential treatment: Enterprises shall not discriminate based on race, social status, nationality, disability, gender, reproductive orientation, membership, or political affiliation.
6) Punishment measures: Material punishment, mental and physical suppression, and verbal abuse are not allowed.
7) Working hours: Enterprises must comply with relevant regulations, overtime must be voluntary, and employees must have at least one day of vacation per week.
8) Remuneration: The salary must reach the minimum limit set by law and industry regulations, and there must be any income in addition to meeting basic requirements. Employers shall not use false training plans to evade labor regulations.
9) Management system: Enterprises must establish a policy of public disclosure and commit to complying with relevant laws and other regulations;
Ensure a summary and review of management, select enterprise representatives to supervise the implementation of plans and control, and select suppliers who also meet SA8000 requirements;
Identify ways to express opinions and take corrective measures, publicly communicate with reviewers, provide applicable inspection methods, and provide supporting supporting documentation and records.
Part 17 ISO/TS22163:2017 Railway Certification
The English name of railway certification is “IRIS”. (Railway certification) is formulated by the European Railway Industry Association (UNIFE) and has been vigorously promoted and supported by four major system manufacturers (Bombardier, Siemens, Alstom and AnsaldoBreda).
IRIS is based on the international quality standard ISO9001, which is an extension of ISO9001. It is specifically designed for the railway industry to evaluate its management system. IRIS aims to improve the quality and reliability of its products by improving the entire supply chain.
The new international railway industry standard ISO/TS22163:2017 officially took effect on June 1, 2017 and replaced the original IRIS standard, marking a significant milestone in the IRIS certification of the railway industry quality management system.
ISO22163 covers all the requirements of ISO9001:2015 and incorporates railway industry specific requirements on this basis.
Post time: Apr-14-2023