Which iso900 1 quality management system should be documented?

The quality management system documents shall include:

A) Documented quality policy and quality objectives;

B) quality manual;

C) Documents and procedures required by this standard;

D) Documents required by the organization to ensure the effective planning, operation and control of its process;

E) Records required by this standard (see 4.2.4).

(1) main quality management system documents

(1) Document the quality policy and quality objectives.

② Quality manual.

(3) ISO 900 1 standard clearly stipulates the program files to be compiled, and * * * has six places:

file control

Record control

inside audit

D.8.3 nonconforming product control

corrective measure

preventive measure

(4) written documents, such as program documents and work instructions, appropriately added to ensure the effective management of the process.

⑤ Records explicitly required by ISO 9001standard.

(3) General written procedure

(1) file control program

② Record the control program.

③ Management review control procedures

④ Training control procedure (human resource management procedure)

⑤ Quality planning control procedures

⑥ Customer-related process control procedures

⑦ Design and develop control programs.

⑧ Procurement control procedures

Pet-name ruby customer property control procedures

Attending production and service action control procedures

Facilities and equipment management control program

Work environment management control program

Process confirmation control program

Product protection and delivery control procedures

Control program of monitoring and measuring device

Quality target management and statistical technology application control program

Data analysis and application control program

Identification and traceability control procedures

Process monitoring and measurement control program

Product monitoring and measurement control program

○2 1 nonconforming product control procedure

22 Corrective and preventive measures control procedures

23 internal quality audit procedures

○24 information exchange control program

○25 Continuous improvement of control procedures

26 customer satisfaction evaluation procedures

(4) the existence form of the document

Files can exist in any medium, which can be in the form of paper, photos, samples, disks, etc.

(3) Classification of documents

① Internal documents

A system documents: quality manual, procedure documents, quality plan, general management instruction, etc.

B. Management documents of functional departments: such as regulations on various management activities such as marketing, procurement, service and training, management work instructions, etc.

C technical documents: such as design drawings, technical specifications, procurement documents, inspection and test documents, process documents and equipment documents;

A form for collecting and reporting data or information.

② Foreign literature

A. international/national/industrial/local standards, laws and regulations;

B. requirements of customers for providing drawings;

C forms designated by customers and relevant institutions, such as customs declaration forms.

4.2.4 Record control

Records shall be established and maintained to provide evidence of compliance with requirements and effective operation of the quality management system. Records should be kept clear and easy to identify and retrieve. A documented procedure shall be prepared to specify the identification, storage, protection, retrieval, retention period and control required for the disposal of records.

Key points of understanding and implementation

The concept of (1) record

Documents that clarify the results achieved or provide evidence of completed activities are called records.

The evidence documents that prove the conformity of products and the effective operation of the quality management system are called quality records.

Forms are not records, but descriptive documents. When the form is filled in, it becomes an evidence document, which is called a record.

(2) Settings of records

The requirements for establishing records come from:

① ISO 900 1 standard requirements;

(2) program documents, quality plans and other documents;

③ Requirements for specific verification, improved verification and traceability;

④ Requirements of interested parties.

When writing records, the purpose should be clear, the items should be comprehensive, the filling should be simple, the format should be standardized and the arrangement should be convenient.

(3) the role of records

(1) meets the requirements and provides objective evidence for the effective implementation of the quality management system;

(2) provide confirmation for retrospective occasions;

③ Provide objective basis for taking corrective and preventive measures.

(4) the scope of the record

Records include records from within the organization, suppliers, customers and other interested parties (such as customs).

It must be recorded in the notes of "See 4.2.4" in the standard, and the standard * * * has 19. The record required in the standard is 2 1.

In addition to controlling the records specified in the ISO 900 1 standard, some records added as needed should also be controlled.

Important records include (note: those marked with * are specified in ISO 900 1 standard):

① Management review record * (see ISO 90065438 5. 6. 1+0)

② Personnel education, training, skills, experience and appraisal records * (see ISO900 16.2.2e).

(3) Records of confirmation process and product conformity * (see 7. 1d of ISO900 1).

④ Records of product requirements review and follow-up measures * (see 7.2.2 of ISO900 1)

⑤ Design input record * (see 7.3.2 of ISO900 1)

⑥ Records of design review results and their follow-up measures * (see 7.3.4 of ISO900 1).

⑦ Records of design verification results and their tracking measures * (see 7.3.5 of ISO900 1).

⑧ Records of design confirmation results and their tracking measures * (see 7.3.6 of ISO900 1).

Pet-name ruby design change review and its tracking measures record * (see 7.3.7 of ISO900 1)

Attending the record of supplier evaluation and tracking measures * (see 7.3.7 of ISO900 1).

Process confirmation record * (see ISO90065438 7. 4. 1+0)

Product identification records with traceability requirements * (see 7.5.3 of ISO900 1)

Records of property loss, damage and inapplicability provided by customers * (see 7.5.4 of ISO900 1).

Records of calibration or verification results of monitoring and measuring devices * (see 7.6 of ISO900 1)

When there is no national or international calibration standard, the basis for calibrating measuring equipment shall be recorded * (see 7.6a of ISO900 1).

Internal audit records * (see 8.2.2 of ISO900 1)

Product measurement and monitoring records * (see 8.2.4 of ISO900 1)

Records of nonconforming products (including concession records) * (see 8.3 of ISO 900 1)

Records of corrective measures * (see ISO 900 18.5.2e)

Preventive measures record * (see 8.5.3d of ISO900 1)

○2 1 Evaluation record of original test results after measuring and monitoring equipment deviates from calibration state * (see 7.6 of ISO900 1).

22 equipment, tooling acceptance and maintenance records

○23 product emergency release record, customer complaint record, process measurement and monitoring record.

24 internal audit corrective measures tracking and verification records

○25 Document distribution records, etc.

(5) Form of records

Records are mostly in the form of tables and files, including tapes, disks, photos, etc. The latter control form is easy to be ignored and should be paid attention to.

(6) Record requirements

Records should be true, accurate, clear and easy to identify. Records shall not be altered at will, even if clerical errors must be corrected, they can only be corrected at the crossed place, and the name of the person who corrected them shall be signed at the crossed place.

(7) Management of records

A documented procedure for record control shall be established, which shall specify the identification, storage, protection, retrieval, storage period and disposal of records.

① Identification of records

Such as name identification, department identification, number identification, classification identification, importance identification, time identification, etc. The complexity of logo depends on the specific situation.

The purpose of record identification is to facilitate retrieval and has uniqueness and traceability. Any method that can achieve this goal can be regarded as recognition.

② Storage of records

The storage environment should be moisture-proof, fire-proof and moth-proof. And should be easy to access and retrieve.

③ Protection of records

In order to prevent the loss and damage of records, provisions should be made on the collection, transmission, archiving and preservation of records. For example:

A specify the channels and time intervals for record collection, such as daily, monthly, quarterly and annual reports.

B the record issuer should ask the receiver to sign on the back of the original, so as to find out which departments have received the records.

C, arranging and storing records in sequence according to the set serial numbers.

D archiving and storage methods should be easy to obtain and consult, so records should be classified and catalogued.

④ Retrieval of records

The scope (if necessary, the confidentiality level), personnel and procedures that records can be consulted should be specified to prevent irrelevant personnel from consulting, illegally calling and replacing them.

⑤ Retention period of records

The retention period of records shall be specified. The following factors should be considered when specifying the retention period of records:

A. relevant requirements of laws, regulations and product liability.

B. contract requirements.

C product life cycle/responsibility period/warranty period/validity period.

D. time of equipment scrapping.

E. on-the-job time of personnel.

F. Effective retrospective period.

G. certification review cycle, etc.

⑥ Processing of records

For records that have passed the shelf life, the examination and approval procedures and implementation methods for destruction should be stipulated to avoid irreparable losses. File control program.

Recording control program

Environmental factor identification evaluation control program

Hazard identification, evaluation and control process

Control procedures for laws, regulations and other requirements

Information communication control program

Management review control procedure

Human resource control plan

Production equipment management control program

Customer-related process control procedures

Control program of monitoring and measuring device

Environmental operation control program

Safe operation control program