Introduction to ISO9001 Quality Management System Certification

The International Organization for Standardization (ISO) established the Technical Committee on Quality Management and Quality Assurance (TC176) in 1979, responsible for developing quality management and quality assurance standards. Since its release in 1987, the ISO9000 series of standards has undergone revisions in 1994, 2000, and 2008, forming the current ISO9001:2008 series of standards.

The 2008 version of the ISO9000 family of standards includes the following closely related core standards for quality management systems:
ISO 9000 Quality Management System Fundamentals and Terminology
ISO9001 Quality Management System Requirements
ISO9004 "Guidelines for Performance Improvement of Quality Management Systems"
ISO 19011 Guidelines for Quality and/or Environmental Management System Audit

The ISO9000 family of standards is widely used in many economically developed countries around the worldA scientific summary of practical experience in quality management, applicable to various types, scales, and organizations providing different products. The implementation of ISO9000 family standards can promote the improvement and perfection of organizational quality management system, and play a good role in enhancing the management level of the organization.

Requirements for Enterprises to Apply for ISO9001 Certification

Registration requirements for applying for quality management system certification by enterprises:
1. The applying organization should hold a legal entity business license or a document confirming its legal status.
2. Has obtained a production license or other qualification certification (when required by national or partial regulations);
3. 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 standardized and produced in batches.
4. The applying organization shall establish a governance system that meets the certification standards to be applied for, with a quality management system operating for no less than 3 months and a special industry (such as construction, nuclear industry, etc.) system operating for no less than 6 months.
5. The applicant organization has conducted at least one internal audit and one governance review.
Within one year prior to submitting the ISO9001 certification application, there have been no significant customer complaints or quality accidents related to the products of the applying organization.

ISO9001 certification consulting process

1、 The process of ISO9001 certification consulting is as follows:
1. Training process:
Internal auditor training ->Basic training
2. Consultation process:
Initial visit ->Contract signing ->Consultant entry ->Plan development ->System construction (quality manual and procedure document development) ->Document approval ->Operation guidance ->Self inspection and correction ->Review guidance ->Consultation summary
3. Certification process:
Submit application ->Sign contract ->Review documents ->On site audit ->Corrective measures ->Approval ->Registration and certification
2、 The specific procedures for ISO 9000 quality management system certification are as follows:
1. Application for Quality System Certification:
1.1. The applicant shall submit a formal application signed by their authorized representative. The application or its attachments should include:
1) Brief introduction of the applicant, including the nature, name, address, legal status, and relevant human and technical resources of the organization.
2) The scope of products or services covered by the certification application.
3) Copy of the business license of the legal entity, and if necessary, provide a copy of the qualification certificate and production license.
4) Recent national product quality supervision and inspection results.
5) General information about quality systems and activities.
6) The applicant agrees to comply with the certification requirements and provide the information required for evaluation.
7) Explanation of other reference documents for the standards applicable to the proposed certification system.
1.2. The certification center shall provide relevant public documents according to the applicant's needs.
1.3. The certification center shall make a decision on acceptance, non acceptance, or improvement acceptance within 7 days after receiving the application materials from the applicant and notify the client (auditee). To ensure:
A. The requirements for certification are clearly defined, documented, and understood;
B. The difference in understanding between the certification center and the applicant has been resolved;
C. The certification body has the ability to implement certification for the scope of certification applied by the applicant, the operating location, and some special requirements, such as the language used by the applicant;
D. When necessary, the certification center requires the auditee to provide additional materials and explanations.
1.4. Both parties sign the "Quality System Certification Contract".
When a specific certification plan or certification requirement requires an explanation, the representative of the certification center is responsible for interpreting it according to the recognized documents of the accreditation body and publishing it to relevant parties.
1.5. The received information will be used for on-site audit and evaluation preparation. The certification center promises confidentiality and proper safekeeping.
2. Preparation before on-site audit
2.1. Prior to on-site audit, the applicant shall establish a documented quality system in accordance with ISO 9000 standards, which shall operate for a period of 3 months. The quality manual and relevant documents shall be submitted to the certification center at least 2 months in advance.
2.2. The certification center is preparing to form an audit team, with dedicated auditors or audit team leaders serving as part of the formal audit to review the quality manual. After the review, they will fill out the "Quality Manual Review Form" to notify the auditee and keep records.
2.3. The certification center shall prepare to negotiate with the auditee to determine the audit date and consider necessary management arrangements after the document review is approved. Prior to the initial audit, the auditee shall provide at least one implementation record of internal quality audit and management review.
2.4. The certification center appoints a qualified audit team, determines the audit team leader, and forms the audit team to represent the certification center in conducting on-site audits.
A. The members of the audit team are national registered auditors.
B. If necessary, hire professional technical experts to assist in the review.
C. Names of audit team members and experts.
The certification center shall notify the auditee in advance and remind them if they have any objections to the assigned auditors and experts. If there may be a conflict of interest between the above-mentioned personnel and the audited party, the audited party has the right to request the replacement of personnel, but must obtain the consent of the certification center.
2.5. The certification center officially appoints an audit team, prepares an audit plan, and the audit plan and date should be approved by the auditee. If necessary, an initial visit to the auditee should be arranged before preparing the audit plan to inspect the site and understand special requirements.
3. On site audit:
Based on the certification standards selected by the auditee, the quality system of the auditee is audited within the product scope determined in the contract. The main procedures are as follows:
3.1. Convene the first meeting:
A. Introduce the members and division of labor of the audit team.
B. Clearly define the purpose of the audit, based on the document and scope.
C. Explain the audit method, confirm the audit plan, and clarify any issues that need to be addressed.
3.2. Conduct on-site audits.
Collect evidence and write a non conformance report for non conformities. The principle for evaluating non compliant item types is:
A. Serious non conformities mainly refer to: the quality system does not comply with the requirements of the agreed quality system standards or documents; Non conformities that cause serious systemic and regional failures or can have serious consequences can directly lead to product quality non-compliance.
B. Minor (or general) non conformities mainly refer to isolated human errors; Occasional non-compliance with files can result in minor consequences that do not have a significant impact on the system.
3.3. The audit team shall prepare an audit report and make an audit conclusion, which can be divided into three situations:
1) If there are no or only a small number of general non compliances, it is recommended to pass certification.
2) If there are multiple serious non compliances that cannot be corrected in the short term, it is recommended not to pass the certification.
3) If there are some serious non conformities that may be corrected in the short term, it is recommended to postpone the certification.
3.4. Report the audit situation and conclusion to the auditee.
3.5. Hold the final meeting, read out the audit report, and the audited party confirms the audit results.
3.6. The certification center tracks the effectiveness of corrective measures taken by the auditee for non conformities.
4. Certification approval
4.1. The certification center shall review and approve the audit conclusion, and notify the auditee no more than two months after the on-site audit, and include it in the supervision and management after certification.
4.2. The certification center is responsible for registering and issuing certification certificates approved by the general manager of the certification center after certification is qualified, and publishing a list of quality system certification registration units in designated publications.
The scope of publication and announcement includes the list of certified qualified enterprises and corresponding information (product scope, quality assurance mode standards, approval date, certificate number, etc.).
4.3. For enterprises that cannot be approved for certification, the certification center shall provide a formal notice, explaining the reasons for the failure. If the enterprise applies again, it shall take at least 6 months before it can be accepted.
5. Expansion and contraction of certification scope and changes in certification standards
5.1 If the certified enterprise needs to expand or reduce the scope of system certification, the certified party shall submit a written application and provide a quality manual corresponding to the expanded or reduced scope of certification. After review and acceptance by the Contract Management Department, the contract for expanding the scope of certification shall be signed. If the scope of certification needs to be reduced, the original contract amendment procedures shall be handled. During on-site audits, we will be responsible for reviewing the relevant elements, departments, and production workshops related to expanding the scope of certification. The specific implementation will follow the 'Quality System Certification (Audit) Implementation and Control Procedure'. After the audit is approved, the certification certificate will be replaced with a new one. The scope of coverage of the certificate will be changed, and the date of replacement will be indicated, but the validity period of the certificate will remain unchanged.
5.2 When a certified enterprise needs to change its system certification standards (mainly referring to changing the certification standards from GB/T19002-1994 idt ISO 9002:1994 to GB/T19001-1994 idt ISO 9001 or GB/T19003-1994 idt ISO 9003:1994 to GB/T19002-1994 idt ISO 9002:1994), the certified party must submit a written application and provide a quality manual that is compatible with the certification standards. The on-site auditor shall review the elements and relevant departments of the certification standard change, and implement it in accordance with the "Quality System Certification (Audit) Implementation and Control Procedure". After the audit is approved, the certification certificate shall be replaced, the certification standard shall be changed, and the date of replacement shall be indicated, but the validity period of the certificate shall remain unchanged.