Main objectives of documentation of the organization irrespective of, it is introduced on it or not official QMS are given below:
a) Informing
- as instrument of transfer and finishing information. The type and volume of documentation depends by nature production and processes of the organization, degree of formality of communication, level of skills of communication in the organization and organizational culture.
B) Proof of compliance
- providing the proof of the valid performance planned.
C) Exchange of knowledge
- for distribution and preservation of experience of the organization. A typical example is the specification which can be taken as a basis at design and development of new production.
The list of widely used terms connected with documentation is presented in appendix A (ISO 9000:2005). It is necessary to emphasize that, according to Art. 4.2 "Requirement to documentation" of ISO 9001:2008 documents, can be submitted in any form and on any carrier, in definition "document" in Art. 3.7.2 of ISO 9000:2005 the following examples are given:
- paper
- magnetic carrier
- electronic or optical computer disk
The additional management is presented to ISO/TR 10013 "Guidelines on documentation of systems of quality management".
2 Requirements to documentation of ISO 9001:2008
Art. 4.1 of ISO 9001:2008 "General requirements" demands from the organization "establishment, documentation, introduction and maintenance of quality management system and continuous increase of its efficiency according to requirements of the present international standard". In Art. 4.2.1 "General" speaks that documentation of quality management system includes:
a) the documentary statement of policy is also more whole than quality;
b) quality manual;
c) the documentary procedures demanded by the present international standard;
d) documents necessary for the organization for ensuring efficiency of planning, work and control of its processes;
e) the records demanded by the present international standard.
In notes to Art. 4.2 it is explained that where the standard specifically demands "documentary procedure", procedure needs to be established, documentary to issue, enter and support. It is emphasized also that documentation volume, can vary from the organization to the organization, depending on:
- size of the organization and type of its activity;
- difficulties of processes and their interaction;
- competences of the personnel.
All documents forming part of QMS have to be controlled according to Art. 4.2.3 of ISO 9001:2008 or, in a special case of conducting records, according to Art. 4.2.4.
Guide to Art. 4.2 of ISO 9001:2008
The following comments are intended to help users of ISO 9001:2008 to understand purpose of the general requirements of the international standard to documentation.
A) Documentary statements for policy and tasks in the field of quality:
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- Requirements to policy of quality are defined in Art. 5.3 of ISO 9001:2008. The documentary policy of quality has to be controlled according to requirements of Art. 4.2.3. Perhaps, some organizations reconsider the policy of quality for the first time, for the purpose of satisfaction to requirements of ISO 9001:2008 therefore they need to pay special attention to Art. 4.2.3 (c), (d) and (g).
B) Quality manual:
- In Art. 4.2.2 of ISO 9001:2008 minimum content of a quality manual makes a reservation. The form and structure of the management gets out the organization depending on the size, structure and complexity of the organization. Some organizations can use a quality manual in other purposes, besides simple documentation of QMS.
- the Small organization can include the description of all QMS in one management including all documentary issued procedures demanded by the standard.
- some managements at the world, national or regional levels and difficult hierarchy of documentation can be necessary for the Large multinational companies.
- the Quality manual is a document which needs to be controlled according to requirements of Art. 4.2.3.
c) Documentary procedures:
- ISO 9001:2008 specifically demands from organization "documentation of procedures" for the following six kinds of activity:
- 4.2.3. Control of documents
- 4.2.4. Control of records
- 8.2.2. Internal audit
- 8.3. Control not of the corresponding production
- 8.5.2. Remedial actions
- the Warning actions
- These procedures have to be controlled according to requirements of St.
4.2.3. - Some organizations can find convenient a procedure combination several works in one documentary issued procedure (for example, the remedial and warning actions). Others can choose documentation of a separate kind of activity by means of one documentary issued procedure (for example, internal audit).
Are acceptable both options.
- to Some organizations (especially large or with the complicated processes) can be demanded additional documentary the issued procedures (especially that are connected with realization processes production) for the purpose of introduction of effective QMS.
- additional procedures too can be required for Other organizations, but the size and/or culture of the organization allow to enter them not less effectively without obligatory documenting. However, for demonstration compliances of ISO 9001:2008the organization has to be capable to provide the objective proof (not necessarily documentary issued) effective introduction of the QMS.
D) Documents necessary for the organization for ensuring efficiency of planning, work and control of its processes:
- to show efficiency of introduction of the QMS, the organization can be necessary to develop other documents besides documentary procedures. Anyway in ISO 9001:2008it is concrete only the following documents are specified:
- to show efficiency of introduction of the QMS, the organization can be necessary to develop other documents besides documentary procedures. Anyway only the following documents are specifically specified in ISO 9001:2008:
- Policy of quality (Art. 4.2.1.a)
- Problems of quality (Art. 4.2.1.a)
- Quality manual (Art. 4.2.1.b)
- V ISO 9001:2008 is presented some requirements according to which the organization could add the value of the QMS and show, by means of preparation of other documents, compliance to the standard in spite of the fact that specifically it does not demand it. For example:
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- Cards of processes, schemes of sequence of operations and/or description of processes
- Organizational schemes
- Specifications
- Working and/or test instructions
- the Documents regulating internal exchange of information
- Production plans
- the Approved list of suppliers
- Test and inspection plans
- Plans (programs) of quality
- All these documents have to be controlled according to requirements Art. 4.2.3 and, necessarily, Art. 4.2.4.
e) Records:
- Examples of the records which are specifically demanded ISO 9001:2008 are given below.
- the Organizations are free in development of other records which can to be necessary for demonstration of compliance of their processes, production and system of management kachestva.9001:2000.
- Requirements to control of records differ from requirements to another to documents therefore all records have to be controlled in compliance with Art. 4.2.4 of ISO 9001:2008.
Documentation of QMS is a description (documented) processes and procedures of quality management system of the organization in the volume showing and proving effective functioning and control of QMS.
Main objectives of documentation of QMS:
- Informing - as the instrument of transfer and finishing information on QMS. The type and volume of documentation depends on a type of products, processes of the organization, culture.
- The proof of compliance - providing the proof of the valid performance planned
- an exchange of knowledge - for distribution and preservation of experience of the organization
Structure of documents QMS
Documentation of QMS has to include:
- documentary issued applications for policy and the purposes in quality area;
- quality manual
- the documented procedures demanded by the RK ISO 9001:2001 ST standard
- documents necessary for ensuring effective planning of implementation of processes, works and managements of its processes
- the records about quality demanded by the standard.
3 Structure of documents QMS
Documentation of QMS consists of 4 levels:
| 1 level Quality manual |
| 2 level Documented procedures |
| 3 level I, PO, DI, TI, RI, I |
| 4 level Quality records |
Records about quality
4 Levels belong to documents records about quality.
Records is the document containing the reached results or the evidence of the carried-out activity.
Entries which are made on the work course, are confirmation of performance of this work.
Records about quality is a confirmation of compliance of production to the established requirements, compliances are more whole than processes to the purposes of the organization, confirmation of achievement of the established purposes, continuous improvement and efficiency of actions of the quality system.
Example:
- the completed reports of results of the analysis of QMS from the management, protocols of meetings, orders, instructions, orders.
- data recording about the equipment, training, preparation, skills and experience of the personnel;
- the records necessary for providing the proof of that processes of life cycle of production conform to the established requirements (cards of technological processes, magazines of orders, the completed reports of implementation of the plan of the correcting and warning actions, entries in magazines of sampling and analytical control, etc. And as soon as the organization makes the decision to keep these data for any term, they become records on quality.
What documents QMS at us belong to the 3rd level
Methodical instructions, regulations on structural divisions, official instructions, working instructions, control instructions, technological instructions.
The methodical instruction is the document establishing requirements to construction, registration, the contents and introduction of documents of quality management system. Example: MI on development, coordination and the adoption of Provision on divisions, MI on development, coordination and the approval of technological instructions, working instructions, control instructions, duty regulations, processes of QMS.
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The provision on structural divisions is the document QMS distributing behind divisions responsibility and powers in the course of performance of the main objectives and functions including in the field of quality. The provision on structural divisions includes the following sections:
- general provisions;
- main objectives;
- organizational structure;
- functions;
- rights;
- responsibility
Example: to tell specifically about Position of the structural division
The duty regulations are the main organizational and legal document defining tasks, functions, fundamental obligations, the rights and responsibility of the employee of the enterprise at implementation of office activity by it according to a post. DI contains the following sections:
- general provisions;
- qualification requirements;
- duties;
- rights;
- responsibility.
Working instruction
It is a component of documentation of QMS and contains the most important excerpts from normative documents, technological processes and instructions which define the main criteria, the modes, parameters providing quality of performance of process by the working personnel.
RI develops on each profession, each category.
Control instruction
KI is the component of documentation of QMS representing rules and procedures of monitoring procedure and tests. KI is developed on each control operation, irrespective of a kind of activity.
KI contains the following sections:
- purpose
- scope
- norms for monitoring procedure
- definitions and reductions
- qualification of the performer
- description of monitoring procedure
- designation of the status of control
- control devices
- monitoring procedure conditions
- volume of selection and sampling
- monitoring procedures
- registration of results of control
- assessment of results of control
- actions with inappropriate production
Technological instruction
TI is the component of documentation of QMS representing the description of the main stages of processes of life cycle of production (production) according to the established requirements.
Documentary procedures
Documentary procedure is the document containing the established way of implementation of activity and process and descriptions (documented) according to requirements of the ISO standard. DP allows the organization to show or produce the objective evidence of effective functioning of the QMS.
6 obligatory documents belong to DP:
1) Process of management of QMS of documentation.
2) Process of management of organizational and administrative documentation
3) Process of management of internal audits
4) Process of management of planning to quality
5) Process of management of the warning actions
6) Process of management of the correcting actions
If the organization treats the large organizations with a large number of products, the additional documentary issued procedures can be developed: all technological processes of production of finished goods, processes of ensuring productions with raw materials, reagents, the equipment, TMTs, etc., processes of storage and the accounting of finished goods, processes of product sales, processes of planning, work and control of production, economic, financial activity of structural divisions processes of a complete set and training, processes of routine maintenance and overhaul repairs of the equipment according to PPR, processes of ensuring productions with energy resources, a car and railway transport.
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Documents QMS for ensuring productivity of scheduling and management of its processes
To show efficiency of introduction of the QMS, the organization can be necessary to develop other documents besides documentary procedures.
Some requirements according to which the organization could add the value of the QMS and show by means of preparation of other documents, compliance to the standard in spite of the fact that specifically he does not demand it are presented in ST RK ISO 9001:2009:
- protocols of meetings of heads of structural divisions, heads of services, the chief engineer, the president of the enterprise on production, economic, financial, i.e. the documents regulating an internal exchange of information;
- cards of processes, schemes of sequence of operations;
- organizational schemes;
- plans (programs) of quality;
- specifications - the documents establishing requirements;
- programs of training, curricula, plans of certification and control of knowledge.
Business processes
All administrative processes of the organization belong to business processes: the processes connected with providing and delivery of raw materials, reagents, TMTs, the equipment (work with suppliers), the processes connected with sales of products (work with consumers), processes of planning of economic, financial activity of the enterprise, processes of market researches, etc.
4 The organizations preparing for introduction of QMS
The following comments can be useful to the organizations which are in process of introduction of QMS and persons interested to meet the requirements of ISO 9001:2008.
- the Organizations which are in process of introduction of QMS or which still it is necessary to introduce it, have to focus attention on process approach of ISO 9001:2008that includes:
- definition of the processes necessary for effective introduction quality management system
- understanding of interaction between processes
- documentation of processes in the volume necessary for providing efficiency of their work and control (perhaps, will be pertinent to document processes, using cards of processes. However, documentary issued cards of processes are not requirement of ISO 9001:2008)
- management, providing resources belong to such processes, product sales and measurement: all that belongs to effective work of QMS
- according to requirements of ISO 9001:2008 a definition basis volume of documentation necessary for system of management qualities, there has to be an analysis of processes. Documentation driving force of processes is not.
5 The organizations wishing to adapt the existing QMS
The following comments are intended to help the organizations which work on QMS meeting the requirements of ISO 9001:1994 or ISO 9002:1994 in understanding of changes to documentation which can be demanded upon transition to ISO 9001:2008.
- the Organizations having QMS. It is not necessary to copy the documentation to meet requirements of ISO 9001:2008. Especially it is fair concerning such organization, which constructed effectively working QMS, using process approach. In this case the available documentation can to be adequate and on it in the reconsidered management on quality can refer simply.
- the Organization which did not apply in the past of process approach, has to pay special attention to definition of processes, them to sequence and interaction.
6 Demonstration of compliance of ISO 9001:2008
To the organizations wishing to show compliance to requirements of ISO 9001:2008 for the purpose of certification/registration, for contractual and other reasons, it is important to remember need of providing proofs of effective introduction of QMS.
- the Organization can show compliance without need for extensive documentation.
- to apply for compliance of ISO 9001:2008, the organization has to manage to provide objective proofs efficiency of the processes and the system of management qualities. In Art. 3.8.1 of ISO 2001:2000 "objective proofs" the data confirming existence are defined as "or reliability something" is also noticed that "the objective evidence can be obtained through supervision, measurements, tests and other means".
- Objective proofs not necessarily depend on existence documentary issued procedures, records or others the documents which are specifically not designated in ISO 9001:2008.
In certain cases (for example, in the Art. 7.1 (d) "Planning product sales" and in Art. 8.2.4 "Monitoring and measurement production") the organization itself solves what records are necessary for providing objective proofs.
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- If the organization has no concrete internal procedure for and it is not required to any activity on the standard (for example, Art. 5.6 "The analysis of the management"), for conducting this activity it is allowed to take the relevant article ISO 9001:2008 as a basis.
In such situations, both at internal, and at external audit, carried out for the purpose of a compliance assessment, it is possible to use the text ISO 9001:2008.
Appendix A
