What Is a Quality Management System?

Quality Management System (QMS) refers to the management system that directs and controls the organization in terms of quality. The quality management system is a systematic quality management model established within the organization and necessary to achieve quality goals, and is a strategic decision of the organization.

Quality management system

Quality Management System (QMS) refers to the management system that directs and controls the organization in terms of quality. The quality management system is established within the organization to achieve

In response to the requirements of the quality management system, the International Organization for Standardization's Quality Management and Quality Assurance Technical Committee

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The planning and design phase of the quality system is mainly to do a variety of preparations, including education and training, unified understanding, organization and implementation, drawing up plans; determining the quality policy, formulating quality goals; current situation investigation and analysis; adjusting the organizational structure, and allocating resources, etc. .

After the quality system documentation is completed, the quality system will enter the trial operation stage. The purpose is to test the validity and coordination of the quality system documents through trial operation, and to take improvement measures and corrective measures for the problems that are exposed to achieve the purpose of further improving the quality system documents. During the trial operation of the quality system, we must focus on the following tasks:

1. Targeted promotion and implementation of quality system documents. Make all staff realize that the newly established or perfect quality system is a change to the past quality system, in order to be in line with international standards. To adapt to this change, we must carefully study and implement the quality system documents;

2.

Quality system audits are often more important in the initial stages of system establishment. At this stage, the focus of the quality system audit is mainly to verify and confirm the applicability and effectiveness of the system documents.

1. The main contents of audit and review include:

(1) Whether the prescribed quality policy and quality objectives are feasible;

(2) Whether the system documents cover all major quality activities and whether the interfaces between the documents are clear;

(3) Whether the organizational structure can meet the needs of the quality system operation, and whether the quality responsibilities of each department and position are clear;

(4) Whether the selection of quality system elements is reasonable;

(5) Required

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First-party audits, also known as internal audits, are used for internal purposes and are performed by or on behalf of the organization and can serve as the basis for the organization's self-declaration of conformity. Internal audit is a quality system certification audit of the quality management system.

The role of internal audit is as follows:

(1) In accordance with the requirements of the quality management system, check the activities and processes, and evaluate the requirements of the procedures and management system and corresponding regulations.

(2) Verify whether the organization's own quality management system requires continuous and effective implementation and maintenance.

(3) Evaluate the effectiveness and efficiency of managers' decisions, quality policies and goals, the organization's own regulations, and contract requirements.

(4) As an important management method, timely find problems, take corrective or preventive measures, and provide information for continuous improvement.

(5) Promote the improvement of product quality, continuous customer satisfaction, and the continuous improvement of meeting regulatory requirements and quality management systems.

For internal audit, the organization shall prepare the corresponding procedural documents, which shall include the planning of the audit plan, the requirements of the auditor, the implementation of the audit, ensuring the independence of the audit, the record of the results and the reporting of activities to the manager, the tracking of corrective actions, Validation, recording and reporting requirements are clearly defined.

Second-party audits are performed by customers of the organization or by others on behalf of customers.

The role of the second party audit:

(1) When there is an intention to establish a contractual relationship, make a preliminary evaluation of the supplier.

(2) In the case of contractual relationship, verify whether the supplier's quality management system continues to meet the specified requirements and is running.

(3) As one of the basis for formulating and adjusting the list of qualified suppliers.

(4) Communicate the consensus between the supplier and the buyer on quality requirements.

Third-party audits are performed by an external independent audit service organization. Such organizations are generally accredited and provide certification or registration that meets (eg, ISO9001) requirements.

The role of third-party audits:

(1) Determine whether the requirements of the quality management system meet the requirements.

(2) Determine whether the current quality management system is effective in achieving the specified quality objectives.

(3) Determine whether the quality management system of the auditee can be certified / registered.

The establishment and improvement of a quality system generally requires planning and design of the quality system.

Chapter I General Provisions

Article 1 These Measures are formulated in a timely, accurate and fair manner to handle complaints and complaints of certification and accreditation, and to protect the lawful rights and interests of the parties. According to the relevant laws and regulations of the State and the functions assigned to the State Certification and Accreditation Supervision and Administration Commission (hereinafter referred to as the CNCA), .

Article 2 Any organization or individual who believes that the acts of certification and accreditation agencies, personnel, or certified organizations is illegal and violates regulations shall have the right to lodge an appeal or complaint with the CNCA in accordance with these Measures.

Article 3 The following principles shall be followed in handling appeals and complaints:

(1) taking the facts as the basis and the laws and regulations as the criterion;

(2) the principle of protecting the lawful rights and interests of the parties;

(3) the principles of legality and rationality;

(4) Principles of openness, fairness and impartiality;

(5) Efficient and economic principles.

Article 4 The Department of Policy and Legal Affairs of the Certification and Accreditation Administration (hereinafter referred to as the "Ministry of Law") is responsible for uniformly accepting accreditation and accreditation complaints and complaints, and organizing investigation and punishment of major acts of certification accreditation.

Article 5 Appeals and complaints for general violations of certification and accreditation shall be transferred by the Ministry of Law to relevant business supervision departments; Appeals and complaints for major violations or illegal acts of certification accreditation shall be handled by the Ministry of Law in setting up cases for relevant business supervision departments Review by the working group.

Chapter II Procedures for Handling Appeals

Article 6 If the parties have any objection to the decision of the certification and accreditation agency, they shall file an appeal with the decision-making agency. If there are still objections to the results of the processing, they may file an appeal with the CNCA.

If the parties believe that the acts of the certification and accreditation agency have seriously infringed their own legitimate rights and interests, they may also directly file an appeal with the CNCA.

Article 7 A party's appeal to the CNCA shall meet the following conditions:

(1) there is a clear respondent;

(2) having specific appeal requests, facts and reasons;

(3) It belongs to the scope of certification and accreditation.

Article 8 The appeal of the parties shall be in written form, in duplicate, and the following matters shall be stated:

(1) the name, address, contact telephone number, and postal code of the party (if the party is a natural person, the name, address, contact telephone number, and postal code);

(2) the name, address, telephone number, and postal code of the respondent;

(3) The requirements, reasons and relevant factual basis of the appeal.

Article 9 Where a party entrusts an agent to make an appeal, it shall submit a power of attorney to the CNCA.

Article 10 The accreditation commission shall, within 7 working days from the date of receipt of the appeal, make the following treatments:

(1) The appeal shall be accepted if it meets the requirements of these Measures;

(2) If the appeal does not meet the requirements, the complainant shall be notified in writing, and the reasons for rejection shall be informed.

Article 11 The following complaints shall not be accepted or terminated:

(1) the court, arbitration institution or other administrative organ has accepted or handled it;

(2) The parties are unable to prove that their rights and interests have been infringed;

(3) Those that do not belong to the scope of certification and accreditation work.

Article 12 After the accreditation commission accepts the parties' appeal, the undertaker shall fill in the registration form for filing the appeal case and attach relevant materials.

Article 13 After accepting the appeal case, the CNCA shall send a copy of the appeal to the respondent within 5 working days. After receiving the copy of the appeal, the respondent shall submit a statement of defense and relevant evidence within 5 days.

Article 14 The parties shall provide evidence for their own appeal to collect or convene the parties concerned for investigation by themselves, and the parties concerned shall cooperate.

Article 15 The Certification and Accreditation Administration may entrust relevant certification and accreditation institutions to assist in investigation and evidence collection, and entrusted certification and accreditation institutions shall assist. Article 16 If the Certification and Accreditation Administration believes that special issues need to be identified or tested, it may be referred to a legal appraisal or testing agency agreed by the parties, or it may be a legal appraisal or testing agency designated by the Accreditation Commission and agreed Identification and testing. The appraisal or testing expenses shall be paid in advance by the appellant or the respondent. At the end of the processing, the expenses shall be borne by the responsible party.

Article 17 If the appeal case filed by the parties belongs to a negotiated settlement or mediation, a mediation letter shall be prepared.

Article 18 The mediation statement shall clearly state the results of the appeal request and the parties' agreement. The mediation letter shall be signed by the contractor and served with the seal of the accreditation commission.

Article 19 The accreditation commission shall make a decision within three months from the date of accepting the parties' appeal.

If it is necessary to extend the processing period due to special circumstances, it shall be reported to the supervisor of the supervisory committee for approval. Article 20 The accreditation commission may make decisions on notification, criticism, suspension of relevant qualifications, etc. for the respondent's violations.

Article 21 The accused's illegal acts shall be transferred by the State Certification and Accreditation Administration to the local quality inspection administrative department for processing. The local quality inspection administrative department shall report the investigation and punishment to the supervisory commission in time.

Chapter III Procedures for Handling Complaints

Article 22 A complaint to the CNCA shall include the following matters:

(1) there is a clear party to be complained;

(2) Having specific complaint facts;

(3) Contact information with the complainant.

Article 23 After receiving the complaint, the Legal Department of the CNCA shall conduct preliminary verification. The following complaints will not be accepted or terminated:

(1) the court, arbitration institution or other administrative organ has accepted or handled it;

(2) The facts of the complaint are not conclusive, sufficient or inconsistent with the facts;

(3) Those that do not belong to the scope of certification and accreditation work.

Article 24 Where a complaint meets the requirements for filing a case, a registration form for filing a complaint case shall be completed and the case shall be accepted in accordance with the provisions of Article 5 of these Measures.

Article 25 The accreditation commission may entrust the complaint cases received to the accreditation institution or the local quality inspection administrative department for processing. The entrusted agency or department shall report the results of the processing to the Legal Department of the Commission in a timely manner.

Article 26 In handling complaint cases, if the CNCA considers it necessary to collect evidence, it may collect evidence on its own or organize personnel to conduct on-site investigations in accordance with the provisions of laws, administrative regulations and rules. .

Article 27 The accreditation commission shall make a decision within three months from the date of filing the case.

Article 28 The accreditation commission may make decisions on notification, criticism, suspension of relevant qualifications, etc. for the complainant's violations.

Article 29 The accused's illegal acts shall be transferred to the local quality inspection administrative department for handling. The local quality inspection administrative department shall report the investigation and punishment to the supervisory commission in time.

Article 30 After handling the complaint case, if there is a clear complainant, the undertaker shall inform the complainant of the result of the processing

Chapter IV Supervision and Management of Appeals and Complaints

Article 31 The Legal Department shall regularly check the handling of appeals and complaint cases and promptly correct any problems found.

Article 32 The accreditation commission shall establish and improve the management system for appeals and complaint files. Within 7 days after the appeal or complaint case is closed, the contractor shall transfer the appeal or complaint file to the Legal Department.

The storage period of the archives can be determined according to the appeal, the importance of the complaint, and the retention value.

Article 33 The accreditation commission shall establish a statistical system for appeals and complaint handling information.

Article 34 Staff members who are responsible for handling appeals and complaint cases should avoid them if they have a direct interest in appeals or complaints.

Article 35 The staff responsible for handling appeals and complaints shall be held responsible for the confidentiality of any non-public situation related to appeals or complaints.

Chapter V Supplementary Provisions

Article 36 The appeal mentioned in these Measures refers to the objection raised by the parties directly affected by the decision made by the relevant certification and accreditation agency.

The complaint mentioned in these Measures refers to any report that any organization or individual believes that there is a problem of violation of laws and regulations with regard to certification and accreditation agencies, personnel, or certified organizations.

The certification and accreditation agencies referred to in these measures refer to accreditation / registration agencies, certification agencies, certification consulting agencies, certification training agencies, and related testing and inspection agencies engaged in certification and accreditation work.

Article 37 The interpretation of these measures rests with the CNCA.

Article 38 These Measures shall be implemented as of the date of promulgation.

The establishment of a quality management system in an enterprise should be based on the correct quality management guiding ideology, guided by scientific quality management principles, and represented by the quality management manual. Through the scientific evaluation of the quality management system, continuous evaluation and amendment are carried out Re-evaluation and re-correction are completed. Generally go through the following steps:

1. Establish the guiding ideology for the enterprise to establish a quality management system. The quality management system is a subsystem of the entire management system of an enterprise, and its established goals must conform to the strategic goals of enterprise development and become a guarantee for the successful development of the enterprise.

2.Clarify the specific functions and establishment of the quality management system of the enterprise

The first method of querying the authenticity of the ISO9001 certification certificate is to query the official website of the certification body, which is the fastest method. The second method is to query the website of the National Certification and Accreditation Administration Committee. There may be delays.
Inquiry path: Open the official website of the State Accreditation and Certification Commission inquiry area certification inquiry public inquiry of management system and voluntary product certification certificate

Personnel engaged in ISO9001 quality management system certification audit activities. It is divided into internal auditors (internal quality auditors) and external auditors (national registered auditors).

Internal auditors refer to a qualification that has been trained and evaluated in accordance with the ISO standards and has obtained an internal quality management system audit. Generally, it is trained and assessed by an organization accredited by the National Accreditation Administration of the People's Republic of China with an ISO-related system consulting qualification. Serve. It is only applicable to the internal audit of an enterprise (unit). It is familiar with the operation process and management responsibilities of the enterprise. It can be competent for the quality management system to self-improve and self-manage a basic means and requirements of the enterprise. It is responsible for internal management review and investigation. Leakage, supervision, and responsibility for proposing rectification plans.

In contrast to internal auditors are nationally registered auditors (also known as external auditors). Those who are engaged in third-party audits in the name of a certification company can go directly to each company to perform the audit. The external auditors implement the national registration system. They need to participate in the training of external auditors and obtain the qualification certificate of external auditors before they can participate in the country every quarter. At the end of the unified exam, you can apply for registration as a national registered auditor of the quality management system after passing the exam. This qualification is subject to a more stringent training exam and internship period, which means that the cumulative review time reaches a certain amount. In addition, it must be linked to a certification body with certification qualifications recognized by the National Accreditation Committee, which can be divided into part-time and full-time.

Generally, companies conduct system certification. First, they organize internal auditors to audit their own companies to determine whether the system is running effectively. Rectify the unqualified and weak links found in the audit, and then the auditing team sent by the certification body to audit the enterprise. To obtain certification.