apply for
1. 1. The applicant shall submit a formal application signed by its authorized representative. The application or its annexes shall include:
1) Brief introduction of the applicant, such as the nature, name, address, legal status and relevant human and technical resources of the organization;
(2) The scope of products or services for which certification is applied;
3) Copy of business license of legal person, and provide copy of qualification certificate and production license when necessary;
4) List of consulting institutions and consultants;
5) National product quality supervision and inspection;
6) General information about the quality system and activities;
7) The applicant agrees to comply with the certification requirements and provide the information required for the evaluation;
8) Description of other standard reference documents applicable to the proposed certification system.
1.2. The certification center shall provide relevant public documents according to the needs of the applicant.
1.3. The certification center shall make a decision of accepting, rejecting or accepting after improvement within 30 days after contract review from the date of receiving the application materials of the applicant, and notify the entrusting party (audited party). Ensure that:
The requirements for certification are clearly defined, recorded and understood;
B. The differences of understanding between the certification center and the applicant are resolved;
C. Certification institutions have the ability to certify the scope of certification, business premises and some special requirements, such as the language used by the applicant;
D when necessary, the certification center requires the auditee to supplement the information and explanations.
1.4. Both parties sign the "Quality System Certification Contract".
When a specific certification plan or certification requirement needs to be explained, the representative of the certification center is responsible for explaining it according to the documents approved by the accreditation body and releasing it to the relevant parties.
1.5. The information received will be used to prepare the on-site audit evaluation. The certification center promises confidentiality and safekeeping.
prepare
2. 1. Before the on-site audit, the documented quality system established by the applicant's ISO9000 standard shall run for 3 months, and the quality manual and required related documents shall be submitted to the certification center at least 2 months in advance.
2.2. The Certification Center will set up an audit team and appoint a full-time auditor or audit team leader to audit the quality manual as part of the formal audit. After the review, fill in the Quality Manual Review Form and notify the auditee, and keep records.
2.3. The Certification Center shall be prepared to negotiate with the auditee to determine the audit date, and consider the necessary management arrangements after the documents are reviewed and approved. Before the initial audit, the auditee shall provide at least one implementation record of internal quality audit and management review.
2.4. The certification center shall designate a qualified audit team, determine the audit team leader, and form an audit team to conduct on-site audit on behalf of the certification center.
A members of the audit team shall be national registered auditors;
B. Hire professional technical experts to assist in the audit when necessary;
C. review the names of team members and experts.
The certification center shall notify the auditee in advance and remind the auditee whether there is any objection to the designated auditors and experts. If there may be a conflict of interest between the above-mentioned personnel and the auditee, the auditee has the right to request the replacement of personnel, but it must obtain the consent of the certification center.
2.5. The Certification Center formally appoints an audit team to prepare the audit plan. The audit plan and date shall be agreed by the auditee. If necessary, an initial visit to the auditee should be arranged before the audit plan is prepared to inspect the site and understand the special requirements.
site audit
According to the certification standard selected by the auditee, the quality system of the auditee shall be audited within the product range specified in the contract. The main procedures are as follows:
3. 1. Convene the first meeting:
A. introduce the members of the audit team and their division of labor;
B. According to the documents and scope, clarify the purpose of the audit;
C. Explain the audit method and confirm the audit plan and the problems that need to be clarified.
3.2. Conduct on-site audit.
Collect evidence and write non-conformance report for nonconformities. The principles for evaluating nonconformity types are:
A. Serious nonconformity mainly means that the quality system does not meet the requirements of the agreed quality system standards or documents; Non-conformities that lead to serious systematic and regional failures or may lead to serious consequences will directly lead to unqualified product quality;
B minor (or general) nonconformity mainly refers to: isolated human error; Occasionally, the document is not complied with, which leads to serious consequences and non-conformity, but it will not have an important impact on the system.
3.3. The audit team prepares the audit report and makes the audit conclusion. There are three kinds of audit conclusions:
1) does not exist or has only a small amount of general nonconformity, so it can be recommended to pass the certification;
2) If many serious nonconformities cannot be corrected in a short time, it is recommended not to pass the certification;
3) If there are some serious nonconformities that may be corrected in a short time, it is suggested to postpone the certification.
3.4. Inform the auditee of the audit situation and conclusions.
3.5. Hold the last meeting, read the audit report, and the auditee will confirm the audit results.
3.6. The Certification Center tracks the effect of corrective measures taken by the auditee for nonconformities.
Certification and approval
4. 1. The certification center shall examine and approve the audit conclusion, and notify the auditee within one month and two months at the latest after the on-site audit, which shall be included in the supervision and management after certification.
4.2. The certification center is responsible for registering and issuing the certification certificate approved by the general manager of the certification center after passing the certification, and publishing the list of quality system certification registration units in the designated publications.
The scope of the announcement includes: the list of certified qualified enterprises and corresponding information (product scope, quality assurance model standard, approval date, certificate number, etc.). ).
4.3. For the enterprise that cannot approve the certification, the certification center shall issue a formal notice explaining the reasons for not approving it. It takes at least 6 months for the enterprise to reapply.
Third-party certification institutions that have obtained the qualification of quality management system certification shall conduct supervision and audit within the year;
Review of quality management system certification for three years.