ISO9001 Quality Management System Certification Management Training Consulting Services
Introduction to ISO9001
ISO 9001 is a translation of the world's first quality management system standard BS5750 (written by BSI). ISO, the International Organization for Standardization, has created ISO 9001 as the most mature quality framework in the world, with over 750000 organizations in 161 countries/regions using this framework. ISO9001 not only sets standards for quality management systems, but also for overall management systems. It helps various organizations achieve success through improvements in customer satisfaction, employee motivation, and continuous improvement.
The ISO 9001 quality management system is currently the most widely used and certified international standard system. Since its inception in 1987, it has undergone three editions in 1994, 2000, and 2008. The latest version is currently the 2015 version, and its popularity can be attributed to the fact that this standard provides a universal quality management framework and approach for various organizations, while also establishing the basic confidence for organizations to provide products and services that meet customer and legal requirements. Like all other ISO standards, ISO9001 is reviewed every five years to ensure it is up-to-date and updated in a timely manner
ISO9001 Quality Management System Certification
ISO9001:2015 Quality Management System Certification is a globally recognized core certification for organizational quality management capabilities. The latest national standard currently planned for introduction, ISO9001:2026, is the latest international version. It aims to help organizations improve product/service quality, enhance customer trust, and optimize operational efficiency through standardized processes. The following provides a detailed explanation from six dimensions: certification national standards, certification overview, certification requirements, certification process, certification timeline, and certification standards, providing a comprehensive reference for organizations to understand and advance their certification efforts
Certified national standard
ISO9001 is an international standard issued by the International Organization for Standardization (ISO). When China adopts this standard, it is converted into a national standard (GB/T series) to ensure synchronization with international standards and meet domestic practical needs.
The currently valid corresponding national standard is GB/T 19001-2016 "Quality Management Systems - Requirements", which was officially implemented on July 1, 2017. It is planned to adopt the latest national version GB/T 19001-2026, which is fully equivalent to the international standard ISO 9001:2015 ("equivalent adoption" means there is no difference in technical content and requirements, with only adaptations in format and expression to meet domestic standards and specifications). When applying for ISO9001:2015 certification within China, the audit basis includes both the international standard ISO 9001:2015 and the national standard GB/T 19001-2016, with consistent requirements. The certification results are valid both domestically and internationally.
The significance of certification
Enhancing customer trust: Certification serves as an "international passport" for an organization's quality management capabilities, assisting customers in swiftly identifying reliable partners. This is particularly beneficial for foreign trade enterprises or organizations involved in bidding and tendering processes, where ISO9001 certification is often a prerequisite for participation.
Optimize internal management: By establishing a "Plan-Do-Check-Act (PDCA)" cycle mechanism, clarify the responsibilities of each department, standardize processes (such as procurement, production, service, complaint handling, etc.), reduce waste, and minimize the risk of quality accidents.
Compliance assurance: The standard requires organizations to identify and comply with applicable laws and regulations (such as product safety, environmental protection, consumer rights protection, etc.), to avoid operational risks arising from compliance issues.
Support continuous improvement: By monitoring quality objectives, analyzing customer feedback, and conducting internal audits, we aim to drive the organization to continuously optimize processes and enhance product/service quality.
Introduction to Authentication
ISO9001:2015 (and GB/T 19001-2016) is based on seven quality management principles: "customer orientation, leadership, total involvement of personnel, process approach, improvement, evidence-based decision-making, and relationship management"
Understand the organization and its environment: Identify internal and external factors that affect quality management (such as market competition, laws and regulations, technological changes, employee capabilities), and monitor changes in these factors.
Leadership commitment: The top management must clarify the direction of the quality management system, ensure the allocation of resources (personnel, funds, equipment), and communicate within the organization the importance of "meeting customer requirements".
Quality objectives: Establish measurable and achievable quality objectives (such as "product pass rate ≥ 99.5%" and "100% timely handling of customer complaints") and allocate them to each department.
Human resources: Ensure that personnel involved in quality management possess the necessary competencies (such as skills, knowledge, and experience), enhance their abilities through training, recruitment, and other means, and evaluate the effectiveness of training.
Infrastructure: Provide and maintain appropriate equipment, premises, and software (such as production equipment, testing instruments, and office systems) to ensure they meet process requirements.
Working environment: Create a safe and suitable working environment (such as temperature and humidity control in the workshop, safety protection in the office area) to support efficient work of personnel.
Requirements for products and services: Clarify customer needs (such as contract terms and technical standards), and ensure that the organization has the capability to meet these requirements (such as reviewing the feasibility of the contract).
Design and development (as needed): If product/service design is involved, it is necessary to ensure that the design output meets the requirements through review, verification, and confirmation (such as sample testing and customer trials), while controlling design changes.
Control of externally provided processes, products, and services: Manage suppliers (such as evaluating supplier qualifications, signing quality agreements, and conducting incoming inspections) to avoid the impact of externally purchased products/services on final quality.
Production and service provision: Develop standard operating procedures (SOPs), monitor the production/service process (such as recording key process parameters), and ensure process stability; at the same time, make proper product identifications (such as batch numbers) to facilitate traceability.
Monitoring, measurement, analysis, and evaluation: Equip with suitable testing equipment (such as calipers, spectrometers), and calibrate the equipment regularly; inspect products/services (such as factory inspections), collect customer feedback and process data for analysis and improvement.
Nonconformity control: For nonconforming products/services (such as defective items, customer complaints), corrective measures (such as rework, replacement) need to be taken, and the causes (such as equipment malfunctions, personnel operational errors) need to be analyzed to prevent recurrence.
Continuous improvement: Identify improvement opportunities (such as optimizing process efficiency and reducing costs) through internal audits, management reviews, and data analysis (such as quality target achievement rates), and track the effectiveness of the improvements.
Certification requirements
Business license
When qualification and licensing are required
The management system has been operational for over three months
Certification process
Form a team: Establish a quality management group (it is recommended to be led by the top management, including heads of various departments), and clarify the division of responsibilities (such as the production department responsible for process streamlining, and the human resources department responsible for training).
System planning and document preparation:
Identify the core processes of the organization (such as "order receiving → procurement → production → inspection → shipping → after-sales service");
Develop quality management system documents, with core documents including:
Quality Manual: The "general principle" of the system, which clarifies the organizational structure, quality policy, system scope, and interfaces between various processes;
Program documents: operation specifications for key processes (such as "Procurement Control Procedure" and "Internal Audit Procedure");
Standard Operating Procedure (SOP): operational details for specific positions (such as "Welding Process SOP" and "Customer Complaint Handling SOP");
Record forms: vouchers used to prove the execution of processes (such as purchase orders, inspection records, and training sign-in sheets).
System operation: Publish system documents, organize training for all employees (to ensure they understand their responsibilities and processes), officially implement the system, and maintain its operation for at least 3 months (it is necessary to retain 3 months of operational records, such as inspection records and customer feedback records, as audit evidence).
Internal audit and management review:
Internal audit: Internal auditors (with qualifications) inspect whether the system operation meets standard requirements, identify issues, and implement rectifications;
Management review: Hosted by the top management, it reviews the effectiveness and suitability of the system and determines the direction for improvement (such as resource adjustment and goal updating).
Third-party certification and audit (core process)
Select a certification body: Choose a formal organization approved by CNCA (such as China Quality Certification Center CQC, or CQM), and confirm the qualifications, scope of audit, and cost cycle of the organization.
Submission of application: Submit the "Certification Application Form" to the certification body, and provide materials such as the quality manual, internal audit report, and management review report. After the body reviews and confirms the eligibility of the materials, an audit plan will be determined.
Audit process
Phase I audit (document review + preliminary on-site inspection):
The auditor reviews whether the system documents comply with the ISO9001 standard;
Visit key departments on-site (such as production workshops and quality inspection departments) to confirm whether the system has been actually implemented, identify major risk points, and propose rectification suggestions;
If approved, the application will proceed to the second stage of review; if not, it needs to be rectified and reapplied.
Phase 2 audit (comprehensive on-site audit):
The auditor conducts a comprehensive inspection of the process operations of each department (such as supplier evaluation in the procurement department, process control in the production department, and complaint handling in the customer service department) according to standard terms;
Verify the authenticity of operational records (such as inspection records, training records), and evaluate the achievement of quality objectives;
If no "serious non-conformities" (referring to issues that violate the core requirements of the standard and may lead to quality accidents) are found, and only "general non-conformities" (referring to minor local issues) exist, the organization needs to complete rectification within the specified time (usually 1-3 months). After the auditor verifies that the rectification is qualified, the institution will approve the issuance of the certificate.
Issuance of certificate: After passing the audit, the certification body will issue an ISO9001 certification certificate, which is valid for 3 years.
Annual certificate review
Maintenance after certification (maintaining the validity of certification)
Annual surveillance audit: During the validity period of the certificate, the certification body will conduct a surveillance audit (spot-checking certain clauses and departments) once a year to confirm that the system continues to meet the requirements. If the surveillance audit is not passed, the certificate may be suspended or revoked.
Recertification audit: 3-6 months before the certificate expires, the organization needs to apply for recertification (the process is similar to the second-stage audit). A new certificate will be issued after passing the audit; otherwise, the certificate will become invalid.
Certification time
The total duration of ISO9001 certification is influenced by "organizational readiness, system complexity, and audit agency efficiency", and is typically 3-6 months,
Certification standards
The sole core standard for ISO9001 certification is the international standard ISO 9001:2015 "Quality management systems — Requirements", as well as the equivalent national standard GB/T 19001-2016 "Quality management systems — Requirements" in China.
