Theme: Quality manual. Basic purpose and general provisions. Maintenance of a quality manual. Quality manual elements. Quality manual Structure
Lecture plan:
1 Basic purpose and purposes of the Quality manual
2 Structure of the Quality manual
On QMS terminology the Quality manual is the document defining quality management system of the organizationand belongs to 1 level of documents QMS of the organization. In it all main and auxiliary processes of QMS of the organization are painted and specified, beginning from delivery of raw materials before sale of finished goods, including official functions of the experts participating in these processes i.e. in a quality manual all control system of quality of the made production of the concrete organization is shown.
The quality manual is the generalizing document of quality management system of the enterprise and has to contain the description of policy in the field of quality, basic provisions of QMS, and also data on the enterprise and its activity in the field of quality.
The quality manual is developed to provide:
- effective introduction of quality management system;
- a statement of policy of the enterprise in the field of quality;
- effective management of processes in quality management system;
- standard basis for audit of quality management system;
- stability of functioning of quality management system in the changing conditions;
- preparation of the personnel of the enterprise in the field of ensuring quality;
- demonstration of compliance to QMS of ST RK ISO 9001 by the enterprise in contract conditions.
The quality manual as a rule contains:
- prolog;
- a statement of Policy of the enterprise in the field of quality;
- purposes in area of quality and tasks of the organization;
- characteristic of structure of the enterprise;
- distribution of responsibility and powers, the sections describing the organization of works in quality management system;
- sequence and interaction of processes of quality management system, offer on revision and correction of a quality manual.
Separate requirements of QMS can be excluded if they cannot be applied from - for features of production, requirements of consumers, legislative requirements.
Exceptions are limited to requirements to processes of life cycle of production (the section of 7 ST RK ISO 9001).
Exceptions have to be defined in a quality manual.
Legislative requirements can be applied in all cases even if the area is limited. Requirements of QMS can be strengthened for the purpose of satisfaction of legislative requirements.
| Section of a quality manual | Summary of the section | ST RK ISO 9001-2009 points |
| Contents | The list of all sections of the management with the indication of the pages occupied by appropriate section is provided | |
| Policy in the field of quality | The Policy in the field of quality of the organization is placed | 5.1-5.3 |
| Area of distribution and application of a quality manual | Data on area of distribution and application of a quality manual are provided in the organization and for external users | 4.2.2 |
| Introduction | Contains general information about the organization, production, a quality manual | 4.2.2 |
| Standard references | Contains a list and designations of documents on which references in a quality manual are given | |
| Terms and definitions, reductions and symbols | Terms with the definitions used by reductions and conditional definitions are provided | |
| Organigramma | The organigramma of quality management system is given | |
| Quality management system | The description of a scope and volume of QMS, including justifications of need of exceptions, structure and volume of a documentary basis of system, sequence and interaction of processes is provided | Section 4 |
| Responsibility and powers of the top management | Responsibility for formation of policy is given, the purposes in area of quality and their expansion before processes Is given responsibility and powers of the management in the field of quality responsibility of the representative of the management Is given for: - development and maintenance of processes of quality management; - submission of reports to the top management; - bringing requirements of the consumer to the personnel of the organization; - communication with the external organizations (if necessary) | 5.1; 5,3; 5.4.1. 5.1; 5,2; 5.4.1. 5.5.1; 5.5.3; 5.1-5.4; 5.5.2; |
| Processes | Planning of the purposes in quality area, planning of creation and development of QMS in the organization. The analysis from the management the Short description of processes and the reference to the documents describing them | 5.4.2 5.6 Sections 6-8 |
| Procedures | The short description and references to 6 compulsory procedures (it is possible at the description of processes), and also other documentary procedures | Sections 4-8 |
| Appendices | The organizational structure of the enterprise, organizational structure of management of QMS, the block diagram of service of quality at the enterprise, a matrix of distribution of responsibility for processes and for the activity established in documentary procedures, and also the list of documentation of QMS if at the enterprise there is such list in the form of the separate document are applied) |
Structure of a quality manual, as a rule, similar to structure of the ST RK ISO 9001-2009 standard that provides possibilities of work of external auditors at certification of the quality system. It is specified in a quality manual how at the enterprise compliance to each requirement of ST RK ISO 9001-2001 is reached. In avoidance of excessive volume of the management in it references to the approved and already used documents (standards, procedures, the description of processes, techniques, instructions, programs of quality, etc.) are given
The form of completing of a quality manual gets out such that it was possible to make changes to it easily.
Control questions:
1 Give definition to the term Quality manual
2 Purposes and problems of the Quality manual
3 Structure of the Quality manual
4 Contents of the section RK - "Area of distribution and application of a quality manual"
5 Contents of the section RK "Quality management system"
6 Contents of the section RK "Responsibility and Powers of the Top Management"
7 Contents of the section RK "Processes"
Literature
1 СТ РК ИСО/ТО 10013-2008. Система менеджмента качества. Руководящие указания по документированию, Астана, 2008 год;
2 Методические рекомендации по разделу 5 «Ответственность руководства» СТ РК ИСО 9001-2009 «Система менеджмента качества. Требования», Астана, 2002;
3 Методические рекомендации по разделу 6 «Менеджмент ресурсов» СТ РК ИСО 9001-2009 «Система менеджмента качества. Требования», Астана, 2002;
4 Руководство по пункту 1.2 «Применение» ИСО 9001:2000, Астана, 2001;
5 Методические рекомендации по применению принципов менеджмента качества, Астана, 2002;
6 Руководство по требованиям ИСО 9001:2008 к документации, Астана, 2002;
Lecture 8
Theme: Maintenance of elements of a quality manual. Responsibility of the management. Management of documentation and records in QMS. Management of resources. Production. Measurement, analysis and improvement.
Lecture plan:
1 Requirements of ST RK ISO 9001 of the item 5 Responsibility of the Management
2 Purposes in quality area
3 Plans in the field of quality
4 Responsibility and powers
1 According to the item of 5 ST RK ISO 9001-2009. Responsibility of the management and item 5.1 of the Obligation of the management. The top management has to provide certificates of the obligation for development and deployment of QMS, and also continuous improvement of its productivity by means of:
- bringing to data of the organization of importance of implementation of requirements of consumers, and also the legislative and regulating requirements;
- development of policy in the field of quality;
- ensuring development is more whole in the field of quality;
- carrying out the analysis from the management;
- providing with necessary resources.
The main requirement of section 5 of the standard is that participation of bosses of the enterprise have to be obvious to all.
For this purpose the top management has to:
- to create at the enterprise Council for quality whose duties includes implementation of requirements of subparagraphs 5 and), - d) the standard. Functions of Council are formulated and approved in the form of the Provision on Council for quality of the enterprise.
- inclusion of questions of development and improvement of QMS in agendas the meetings of the top management existing at the enterprise - meetings at the first director.
- carrying out regular internal and external audits;
- introduction in the organization of procedures of strategic planning and operational planning;
- the publication of the data concerning quality and responses of consumers or the description of the purposes in quality area for all structural divisions;
- existence in the organization of the formalized procedure of providing feedback with consumers.
It is necessary to realize one of the main principles of QMS - orientation to the consumer and for this purpose it is necessary to include such processes as:
- the top management has to provide creation of mechanisms identification of requirements and expectations of consumers on representation of the demanded services and tracking of level of satisfaction of consumers to them. The top management is obliged to provide compliance of production and processes of QMS to requirements of the legislation and to the regulating requirements of bodies of the state control.
- the policy in the field of quality has to be a component of the general statement for mission and appointment of the enterprise and to consider requirements and expectations of consumers. The policy in the field of quality is established by the top management of the enterprise. The policy has to be closely coordinated, to strategic and operating plans of the organization and find reflection in its activity.
2 Purposes in quality area
The top management has to establish in strategic and operating plans of the purpose, facing the enterprises in the field of quality. These purposes have to be formulated not only for the enterprise, but also for its separate divisions. These purposes have to belong to the main activities of the enterprise, to be measurable and to be considered in the schemes of the analysis and audit aimed at providing continuous improvement of QMS of the enterprise
On the basis of the accepted policy in the field of quality the top management of the organization has to develop specific goals and provide the management of activities for achievement of the objectives, conducting to improvement of activity of the organization.
Activities for achievement of goals have to be planned.
When developing the purposes of the organization the top management has to consider:
- modern and future requirements of the organization and inquiries of consumers;
· relevant data on results of management of the organization;
· indicators of quality of production and processes;
· degree of satisfaction of all interested parties;
· results of a self-assessment of activity of the organization;
· results of an assessment of competitors;
· definition of control points for an activity assessment;
· possibilities of improvement of production, processes, systems of management;
· necessary resources for achievement of goals.
The purposes of the organization have to be measurable. It means that they can be characterized by either concrete sizes, or the planned efficiency which can not be expressed by numerical size.
The purposes have to cover all organization and contain the instruction on the persons responsible for their achievement.
The purposes should be brought to all workers accurately.
The purposes have to be analyzed and be reconsidered periodically as required.
Can be the directions of the purposes:
· purposes in the relation of consumers;
· business purposes;
· the purposes connected with production;
· purposes of interested parties.
The purposes in area of quality can be established in the form of the program of quality of the organization, actions for improvement of quality, or other program documents which are developed traditionally by the enterprise, containing sections on improvement of quality, technical re-equipment of the enterprise, introduction of progressive technologies. To professional development of the personnel, improvement of interaction with suppliers, to satisfaction of requirements of consumers.
Actions of program documents of the organization have to be directed on achievement of the objectives in the field of quality, and also contain concrete terms and executives at all levels of management.
The major output data for planning of quality includes:
· strategy of the enterprise;
· the legislative and standard requirements stated in
standards and other normative and legislative documents;
· requirements, requirements and expectations of consumers and other interested parties;
· characteristics of production;
· characteristics of processes of quality management system;
· conclusions by results of the previous activity;
· opportunities for improvements;
· assessment of possible risks and activities for reduction of their consequences.
At establishment of the purposes it is necessary to consider interests of various parties, including:
Expectations of customers:
- quality (production, hardware, software, services);
· reliability (observance of promises);
· maintenance;
· influence on health, ecology, health;
· accounting of "spirit of the age" (fashion, design);
· trouble-free utilization.
Interests of employees:
· appeal of a workplace;
· extent of material remuneration;
· guarantee of safety and preservation of health;
· convenient working hours;
· satisfaction with work;
· recognition;
· possibility of growth.
Interests of the enterprise:
· minimum costs of process;
· increase of a turn and profit;
· expansion twist parts of the market;
· image of firm;
· reduction of terms of turnover of means;
· recognition in the market;
· quality of suppliers;
· satisfaction and health of employees;
· satisfaction of customers;
· maintenance of commitment to a trademark.
Interests of suppliers:
· long partnership;
· reliability of economic relations;
· readiness of the customer to consider interests of the subsupplier.
Requirements of society:
· laws;
· norms and rules;
· modern level of equipment.
The main goal in the field of quality of the organization can be defined as stable ensuring quality of production (services) providing satisfaction of requirements, requirements and expectations of consumers.
On the basis of a main goal of the organization other purposes relating to such characteristics of production as functional suitability, operational characteristics, reliability, etc. are concretized.
3 Plans of quality
The special attention when planning activity of the organization should be paid to development of the document establishing an order of relationship with consumers.
Planning of creation, maintenance and improvement of QMS is a management process of QMS which has to is carried out by the top management.
The top management of the enterprise has to solve, by what way the objectives facing it can be achieved. Thus it is supposed that all resources will be defined and recorded in the relevant documents necessary for achievement of these is more whole. This decision has to include development and documentary registration of process of planning of the quality corresponding features of the accepted system of management.
Planning of quality has to begin with the processes entering QMS. For the existing processes planning of quality can is carried out with use of the techniques applied at the enterprise. New kinds of activity, contracts or projects can demand special plans of quality.
Plans of quality can be same short, as well as cards of processes and to contain references to other components of system.
The plan of quality can also submit the official agreement between the organization and the consumer which contents has to be agreed prior to action of the contract.
The head of the organization is responsible also for working capacity maintenance
The existing system of QMS in process of entering of changes into it. It is necessary to provide that modification of system took place under control. Similar changes can concern the organization of works, the applied processes, production and services.
It is necessary to paint structure of management of development and deployment of QMS accurately. Thus areas of responsibility and powers of each performer have to be established.