? New standard content
? Interpretation of New Edition Change Points and Standards
? Review points of this clause
1 new standard content
Standard original:?
7. 1. 1? general rule
The organization shall determine and provide the resources needed to establish, implement, maintain and continuously improve the quality management system.
The organization should consider:
A) the capacity and constraints of existing internal resources;
B) Resources that need to be obtained from external suppliers.
7. 1.2? personnel department
The organization shall determine and provide the personnel needed to effectively implement the quality management system and run and control its process. ?
7. 1.3? infrastructure
The organization shall determine, provide and maintain the infrastructure required for process operation in order to obtain qualified products and services.
Note: Infrastructure may include:
Buildings and related facilities;
B) Equipment, including hardware and software;
C) transportation resources;
D) information and communication technology.
7. 1.4 process running environment
The organization shall determine, provide and maintain the environment required for process operation in order to obtain qualified products and services.
Note: The suitable process operating environment can be a combination of human factors and physical factors, such as:
A) Social factors (such as non-discrimination, harmony and stability, and non-confrontation);
B) Psychological factors (such as relieving psychological stress, preventing excessive fatigue and protecting personal feelings);
C) Physical factors (such as temperature, heat, humidity, lighting, air circulation, sanitation, noise, etc. ).
These factors may vary greatly due to the different products and services provided. ?
2 Interpretation of the new version of change points and standards?
2. 1 change point:?
7. 1. 1
The supporting process includes resources, abilities, awareness, communication and recorded information.
Expand resources to monitoring and measuring devices instead of infrastructure and process environment and knowledge;
Strengthen and clarify the problems that need to be considered in the resource planning stage. Knowledge is a resource, and so are external partners.
7. 1.2
People are also a kind of resource (regardless of ability, only consider the brain)
7. 1.3
Adjust the infrastructure from the specific content of standard requirements to remarks, and the application is more flexible.
7. 1.4
Title revision
Social process environment, such as harmonious interpersonal relationship, is also an important part of process environment, especially for service industry. ?
2.2 standard interpretation:
7. 1. 1
1) resources are an important part of QMS and its process, including manpower, financial resources, material resources, technology, software, information, infrastructure and working environment.
2) In order to make the system run effectively and satisfy customers, necessary resources must be invested.
3) Resource requirements should be adapted to the actual situation of the organization and allocated reasonably. Lack of resources will affect the realization of policies and objectives. Excess resources will increase costs and affect benefits.
4) Resource allocation should also consider energy saving and consumption reduction, and protect natural resources, which will help to reduce costs, improve efficiency and the sustainable development of the whole society.
5) Evaluate the effectiveness of resources, mainly from whether the resources provided meet the requirements of QMS maintenance and improvement, and whether appropriate process performance is obtained.
Audit points: used to communicate with leaders. Have the additional resources for manpower, equipment, workshop, inspection and office been identified and provided this year?
7. 1.2 ?
1) All personnel engaged in the work affecting product quality and service should be competent, which is the basic guarantee for the effective operation of the system.
2) Employee's ability refers to the proven ability to apply knowledge and skills. To evaluate the ability of personnel, the following four factors should be considered:
-Education level (academic qualifications); Training opportunities (on-the-job training, continuing education and training); Practical skills and work experience.
3) When there is a shortage of personnel, personnel with corresponding qualifications and experience should be hired from relevant institutions and take up their posts after training.
7. 1.3 ?
1) Infrastructure refers to equipment, facilities, houses, software, information, etc. It is the material guarantee for the operation of quality management system. The organization shall confirm, provide and maintain.
2) Determination: According to the requirements of objectives and processes; Supply: including purchasing, equipment and ensuring necessary inputs. Maintenance: maintain the process capability of the facility through a series of maintenance and maintenance management methods and systems.
3) The organization shall establish various management systems by classification to control the use, maintenance, repair, renewal and transformation of infrastructure and equipment to meet the needs of the operation of the quality management system.
4) Equipment life cycle management: requirement statement-feasibility analysis-procurement-installation acceptance-delivery (management number, account, procedures and personnel training)-daily maintenance (level I/II/regular)-maintenance-spare parts management-scrapping.
7. 1.4
1) The requirements of the working environment are to support the realization of products and service processes, and the organization should meet these requirements.
2) Human factors: safety, health, labor protection, ergonomics, social influence, suitable working methods, etc.
3) Material-related factors: temperature, humidity, light, air, noise, vibration, hygiene, cleanliness, rationality of regional layout, etc.
3. What is the focus of this clause review?
Due to different factors such as industry, enterprise scale and management level of ISO900 1 certified enterprises, the specific content and methods of external audit may be different, but the core content is still based on terms. The following summarizes some audit points with general manufacturing enterprises for your reference:
7. 1.2
This clause is considered in conjunction with Section 7.2 Capacity. Provide personnel for the effective operation of the quality management system, including the source of personnel needed in the process, internal training and recruitment, and the process of internal training and recruitment.
7. 1.3 ?
The equipment list shall be combined with the manufacturer's instructions;
Monthly/quarterly/annual maintenance contents;
Check whether the maintenance data, failure rate and maintenance plan/record of 3-5 pieces of equipment conform to the specifications.
Case:
In order to carry out sports, many fitness facilities have been installed in the open space between residential buildings, including swings, slides and swivel chairs. The auditor asked the engineering department to explain how to maintain these facilities. The manager of the engineering department said, "These facilities are welded and strong, so we don't have a routine maintenance plan. If they are broken, we will repair them immediately. " Is this feasible?
7. 1.4
★ Have you determined the environmental requirements of the company's production, warehouse, inspection, experiment and office system?
★ Are the above requirements checked and determined to be qualified?
★ Is a maintenance plan made and implemented according to the above environmental requirements?
★ Is it faulty and has passed the maintenance verification?
Case:
A subway train company promised and stipulated that the temperature of air-conditioned trains should not be lower than 18℃ in winter, but the thermometer of No.5 carriage showed 15.8℃, and passengers complained bitterly. ?
The beer bottles to be canned are stacked on the ground near the gate of the beer canning workshop, and the gate is open. Cars are coming and going outside the gate, and the road is dusty.