Certification of quality systems
8.1 Purposes and conditions of carrying out certification of quality systems
Main objectives of carrying out certification of quality systems are:
- confirmation of compliance of the quality system and its elements (processes)
to the requirements established in the relevant normative documents;
- confirmation of the opportunities declared by producers steadily
to let out production (works, services) the planned quality in
the terms established by contracts (contracts) and in the planned
volumes;
- creating favorable conditions for certification of production;
- creation of confidence at consumers of production (works, services),
managements of the organizations manufacturers and other interested parties
in possibility of manufacturers to provide with production (works, services),
conforming to the established requirements.
Works on certification of quality systems carry out the accredited bodies for certification of quality systems and the certified experts.
Objects of check and assessment of the quality system are:
- activities for management and ensuring quality;
- condition of a production system;
- quality of production (service).
Verification of the quality system is carried out by the commission consisting of several or one experts depending on the scale of the checked organization or other conditions. The head of body for certification (or the administrative director) appoints the chief expert responsible for all stages and results of check. For the purpose of providing the qualified assessment the commission can include experts in certification of production, production certification experts, consultants, experts in the field of metrology, tests, etc.
The structure of the commission can include observers, specialists of the Technical center of the register. The commission has to be approved by body for certification, the chief expert and the checked organization. The commission is formed so that its participants in total possessed basic knowledge by the form of production, to standard requirements to it and the production technology.
The expert has to be prepared in such areas, as:
- the knowledge and understanding of standards, on compliance which can be carried out verification of quality systems;
- methods of survey, poll, carrying out estimation and preparation of the report;
- has to have the skills necessary for the management of check, such as planning, the organization, communication and management.
The expert bears responsibility for:
- compliance to requirements imposed to checks;
- statement and explanation of requirements to checks;
- the qualified and effective planning and implementation of the duties assigned to it;
- documentary statement of results of supervision;
- check of efficiency of the correcting influences undertaken by results of check (on request of body for certification at the request of the applicant);
- maintenance in an order and safety of the documents concerning check;
- submission of documents on request of the chief expert;
- ensuring confidentiality of information and the documents received and generalized as a result of check.
Experts have to:
- to carry out work within area of purpose of check;
- to carry out expertize objectively;
- to collect and analyze the facts which have a direct bearing on check and are sufficient to draw conclusions concerning a condition of the checked quality system or its elements.
The chief expert bears full responsibility for all stages of check. The chief expert has to:
- to form the commission (group of experts);
- to develop the program of checks;
- to establish requirements to each task of the program for check, including requirements to qualification of experts;
- to present the group of experts to the management of the checked organization;
- to direct preparation of briefs;
- to provide the constant management of experts in the course of verification of the quality system;
- to report to the checked organization about all considerable and insignificant discrepancies and notices;
- to report to the management to the checked organization and body for certification about any serious obstacles which the commission faced when carrying out check;
- to state results of check clearly, convincingly and rather briefly;
- in time to submit acts and reports on check;.
Consultants have to:
- to carry out an assessment objectively;
- to be extremely exact at an assessment of any data obtained during check which can affect results of check;
- to inform the group of experts on all the supervision concerning discrepancies or possible discrepancies concerning quality of production, technological processes, monitoring and test methods, observance of standard documentation, etc.
The observer has to:
- to know the purposes, tasks and rules of carrying out check;
- to know responsibility and duties of members of the commission;
- to provide supervision over carrying out certification of quality systems.
The applicant is obliged:
- to define need and the purpose of certification;
- to define certification area, the standard or the document for the quality system, on compliance to which it has to be carried out;
- to issue and submit the application for carrying out certification of the quality system;
- to inform the corresponding officials and the staff of the organization on the purposes and area of certification;
- to agree on the program of carrying out check;
- at the request of experts to provide them access to necessary objects of check (to the equipment, the personnel, documentation, etc.);
- to produce to body for certification the evidence of that implementation of requirements of the normative document declared on certification is provided;
- to carry out the correcting actions on the basis of the act and the report on check.
8.2 Carrying out certification of quality systems
Certification of quality systems includes the organization of works (precertified stage) and three stages of certification:
I - preliminary estimate of the quality system;
II - check and an assessment of the quality system in the organization;
III - inspection control of the certified quality system.
Organization of works (precertified stage)
Registration of the demand (letter of appeal).
The demand from the organization applying for certification of the quality system in the register comes to the Technical center of the register which registers the arrived demand taking into account the offer of the organization (applicant), determines the body capable to realize it and by specialization and area of accreditation directs the demand to this body.
In the absence of the accredited body for certification of quality systems with the corresponding area of accreditation or big removal of the accredited bodies from applicants in order to avoid rise in price of works on certification the Technical center of the register has the right independently or on representation of one of bodies to appoint the authorized expert certified for certification of the corresponding quality systems, having the bases on individual work and to send it the demand, to charge to create the commission and to carry out works on certification of the quality system according to requirements of documents of the register.
The body for certification registers the demand and notifies the organization which submitted the application:
- about adoption of the order;
- about need of payment by the applicant of a registration contribution to the Technical center of the register;
- about the direction to the applicant (after payment made by it) a set of the materials necessary to start works on certification.
At the same time the body for certification directs the copy of the specified notice to the Technical center of the register for registration information.
The organization (applicant) after obtaining the notice from body for certification pays a registration contribution to the Technical center of the register. After registration of the copy of the payment order the Technical center of the register charges to body for certification to begin works on certification at the applicant.
At the request of the Technical center of the register the body for certification directs (transfers) to the applicant the following materials:
- a set of initial forms of documents for carrying out a preliminary estimate of the quality system;
- the list of the documents submitted on certification of the quality system.
The precertified stage comes to an end with the written notice of the applicant of adoption of the order for certification of the quality system and further actions or of refusal in certification.
Refusal in certification of the quality system can be caused by the objective reasons, for example:
- the declared area of certification does not correspond to area of accreditation of body for certification;
- the declared model of the quality system is chosen unsuccessfully therefore compliance of the quality system to requirements of the declared standard cannot guarantee stable quality of products and, therefore, the certificate of conformity of the quality system cannot be issued;
- there are other reasons for refusal which the body for certification is obliged to prove accurately.
At the positive decision by results of consideration of the materials received from the applicant on possibility of adoption of the order for certification of the quality system between body for certification and the applicant the contract for carrying out a preliminary estimate of the quality system is signed. Preliminary revenues to the account of body for certification of all sum of payment prior to works are provided in the contract. The contract is sent to the applicant along with the notice of adoption of the order. After signing of the contract the chief expert is appointed and the commission is formed. Distribution of duties between members of the commission is made by the chief expert at coordination with the interested members of the commission (experts, consultants).
Preliminary estimate of the quality system - a stage I
The preliminary estimate of the quality system is carried out for the purpose of definition of degree of readiness of the checked organization for certification of the quality system and expediency of further work on certification.
The preliminary estimate consists, as a rule, in preliminary and the analysis and an assessment of the description of the quality system in documents of the checked organization. If necessary, in coordination with the applicant, the body for certification can send the representative for carrying out on a familiarity place with the quality system of the checked organization or the solution of controversial issues.
The commission carries out the analysis of the initial documents and materials received from the applicant for a preliminary estimate of his readiness for certification of quality systems. Along with the analysis of the data which arrived from the applicant, the commission can organize, if necessary, collecting and the analysis of additional data on quality of production on which the quality system, from independent sources extends (bodies of the state supervision and control, territorial authorities of Gosstandart of Russia, societies of consumers, guarantee workshops, etc.).
The stage of a preliminary estimate of the quality system comes to the end with preparation of the written conclusion about possibility of carrying out the second stage of certification of the quality system. The conclusion by results of a preliminary estimate of the quality system is signed by the chief expert, experts who were carrying out expertize and approves the management of body for certification.
At the positive conclusion on the I stage of certification the body for certification directs to the applicant "The conclusion by results of a preliminary estimate of the quality system" and the draft agreement on carrying out check and an assessment of the quality system in the organizations. In the contract define the purpose, volume and terms of the carried-out works. Responsibility of the parties, and also procedure for payment of works on check and assessment of the quality system. Preliminary revenues to the account of body for certification of all sum of payment prior to the beginning of the II stage of check are provided in the contract.
Check and assessment of the quality system in the organization - a stage II
The program of check is developed by the chief expert. Experts and consultants of the commission and the checked organization have to be acquainted with the program. Objections of the applicant against any points of the program have to be brought to the attention of the chief expert. Disagreements are allowed between the chief expert and the applicant's representative having appropriate authority prior to carrying out check.
The program of check has to contain the following sections:
- name of the organization (applicant), check venue;
- purposes and area of check;
- time of carrying out check;
- structure of the commission;
- the list of reference documents (the standard, to which is checked for compliance the quality system, a quality manual of the checked organization, etc.);
- objects of check (activities for providing and quality management, production system, quality of production);
- identification of the checked divisions of the organization;
- fixing of experts and representatives of the checked organization for objects of check;
- main actions for check and terms of their carrying out;
- requirements to confidentiality;
- the instruction on check language;
- addresses of mailing of the act.
The system of tests providing directly or indirectly control of all characteristics of production on compliance to the requirements provided by obligatory certification of this production has to be object of check without fail. The program of check is approved by the management of body for certification and agreed with the checked organization. When carrying out check concrete functional divisions of the checked organization and concrete elements of the quality system are allocated to each expert.
Briefs apply to simplification, streamlining and increase of efficiency of check and documentary registration of the inspection statement and the report. Preparation of briefs is conducted by experts under the leadership of the chief expert.
Briefs are among:
- lists of control questions for an assessment of elements of the quality system;
- forms for documenting of the auxiliary data confirming expert opinions, etc.
Check includes the following procedures:
- preliminary meeting;
- inspection of the checked organization;
- drawing up inspection statement;
- final meeting.
Participants of preliminary meeting are members of the commission, the head of the checked organization, heads of structural divisions who according to the program of check are surveyed, the chief and leading experts of the checked organization.
The purposes of preliminary meeting are:
- representation of members of the commission to representatives of the checked organization;
- short message on the purposes, area and program of check;
- a summary of the methods and procedures used when checking;
- establishment of official procedures of interaction between members of the commission and staff of the checked organization.
Inspection of the checked organization is carried out by collecting and the analysis of actual data and registration of supervision during check.
Collecting actual data is made as follows:
- poll of the personnel;
- the analysis of the used documents;
- analysis of processes of production;
- analysis of activity of functional divisions;
- analysis of activity of the personnel;
- studying and an assessment of the held events for ensuring quality of production.
If impose requirements, obligatory for observance established in state standards or other normative documents during the checking and an assessment of the quality system and its separate elements to production, including system of tests, check ability of the organization to provide observance to these requirements by the analysis:
- design documentation:
- technological documentation;
- standard documentation;
- methodical documentation (technique of work, instruction and so forth);
- working and analytical documentation (protocols and reports of tests, plans of control, working magazines, forms of registration of supervision and so forth);
- compliances and conditions of control devices and measurement of parameters of processes and production;
- compliances of the personnel, etc.
The data indicating existence of discrepancies have to be fixed for the purpose of additional inspection and the analysis.
In the course of check the chief expert in coordination with the representative of the checked organization can make changes to the program of check and distribution of duties between members of the commission if it is necessary for optimum achievement of the objectives of check.
After inspection of objects of check members of the commission under the leadership of the chief expert consider results of the supervision to solve what of them have to be presented as discrepancy.
Results of supervision are considered by the chief expert and the representative of the management of the checked organization. About all supervision testifying to existence of discrepancies, the management of the checked organization is informed.
The supervision made during check are differentiated in forms:
- "discrepancy";
- "notice"
Discrepancies are subdivided on:
- the considerable:
- the insignificant.
The found discrepancies and notices are registered in special forms where specify:
- check area (object, element, process);
- the concrete section of the standard to which this requirement belongs;
- the detailed description of discrepancy or the notice, including the name and number of the document, material and to what category this discrepancy belongs.
The authorized representative of the management of the checked organization appends the signature on forms with discrepancies (notices), than confirms acceptance of this discrepancy (notice).
Discrepancy is removed by the chief expert in the following cases:
- if during discussion from the checked organization is produced the additional evidence of that the discrepancy found by the expert is not reasonable, thus the issued form of registration of discrepancy is cancelled;
- the found discrepancy is eliminated during check.
Discrepancy can be transferred by the chief expert from category considerable to category insignificant in case of representation by the checked organization of objective proofs.
The quality system recognize conforming to the standard on system in the absence of considerable discrepancies or with 10 or less insignificant discrepancies.
The discrepancies eliminated during check do not include in total of discrepancies, but and estimates of the quality system specify in the inspection statement. Existence of notices does not influence the decision on certification of the quality system or refusal in it.
Results of check, conclusions and recommendations of the commission make out in the form of the act of results of check and an assessment of the quality system. The commission specifies in the act, corresponds or the checked quality system does not conform to the declared standard, makes the recommendation of body for certification of delivery or refusal in issue of the certificate of conformity and about elimination of the revealed insignificant discrepancies in agreed time frames if they are available.
When carrying out certification of quality systems in the inspection statement and estimates the conclusion about existence in the checked organization of the system of tests providing control of all characteristics of production on compliance to the requirements provided by certification of this production surely becomes.
The act is issued in triplicate.
Are applied to the act:
- program of check:
- sheets with data on discrepancies:
- sheets with data on notices.
One copy of the act remains at the checked organization, one - in body for certification, one goes to the Technical center of the register.
8.3 Final meeting
The main objective of final meeting - to present to the management of the checked organization, the chief and leading experts and heads of the checked divisions results of check and an assessment of the quality system in available to them forme:.
The chief expert represents:
- the conclusion of the commission about compliance or discrepancy of the checked quality system to requirements of the declared standard or other normative document;
- recommendations of the commission to body for certification and the Technical center of the register about delivery or refusal in issue of the certificate of conformity of the quality system in the form of final part of the act of results of check and an assessment of the quality system.
One of 3 options can be result of check and an assessment of the quality system:
- the system completely conforms to the declared standard and other documents, on compliance which check was carried out;
- the system in general conforms to the standard and other documents, on compliance which check was carried out, but separate insignificant discrepancies on elements of system are found;
- the system contains considerable discrepancies.
At positive results the body for certification makes out the draft of the certificate of conformity of the quality system of the established sample and the project of permission to application of a mark of conformity. The specified documents with the cover letter are submitted to the Technical center of the register together with the act of results of verification of the quality system.
At the same time the body for certification and the organization sign the contract for carrying out inspection control.
On the basis of the presented materials the Technical center of the register makes a final decision on registration of the certificate of conformity of the quality system and sends the signed documents with the notice of the made decision to the applicant or body for certification for sending to their applicant.
The copy of the certificate of conformity has to be sent to body for certification. Period of validity of the certificate of conformity of the quality system, as a rule, 3 years.
Check comes to the end with representation to the applicant (the checked organization) of the approved report on check in one copy.
The report has to contain the following sections:
- general information about body for certification and the checked organization;
- purposes and areas of check;
- data on documents, on compliance which an inspection was carried out;
- the program of check, data on members of the commission and staff of the checked organization and dates of check;
- supervision, remarks and conclusions about discrepancies;
- an assessment of degree of compliance of activity and documentation of the quality system of the checked organization to requirements of the declared standard of the quality system;
- recommendations about certification;
- data on confidentiality of information provided in the report.
The report on check has to be prepared in the time coordinated with the applicant (but no more than 2 months after completion of check), is signed by the chief expert and approved by the management of body for certification. The body for certification submits the report on verification of the quality system to the top management of the applicant.
The body for certification ensures safety of reports and acts, and also the confidential information containing in them within 5 years after the termination of period of validity of the certificate of conformity of the quality system and a mark of conformity, and in case of the negative decision on results of verification of the quality system - within 5 years after carrying out check.
8.4 Inspection control of the certified quality system - the III stage
Inspection control of the certified quality systems establish for the entire period of action of the certificate and carry out not less once a year. Specialists of the Technical center of the register can take part in inspection control. Unplanned inspection control is carried out in the following cases:
- receipt of information on claims to quality of production of the organization having the certificate of conformity of the quality system;
- essential changes of a design of a product or production technology;
- essential changes of organizational structure of the checked organization, its personnel structure, a financial position or elements of the quality system.
When carrying out inspection control experts surely check the correcting actions and their result on data of the previous checks on the basis of remarks on discrepancies. The checked organization bears responsibility for carrying out the correcting actions necessary for correction of discrepancies.
The expert is responsible only for identification and definition of category of discrepancy by the rules established by the document.
The correcting actions and the subsequent control checks carry out within the period of time coordinated by body for certification with the checked organization.
Positive conditions for making decision on confirmation of actions of the certificate are:
- lack of considerable discrepancies of the quality system to requirements of the standard, on compliance to which it is certified;
- lack of violations of the rules of use of the certificate;
- carrying out the correcting actions for all discrepancies revealed at the previous check.
At detection of insignificant discrepancies the body for certification confirms action of the certificate of conformity of the quality system after receiving from the applicant of the written obligation about elimination of discrepancies during the coordinated period.
An inspection of the actual elimination of insignificant discrepancies can be carried out at once after the termination of an agreed time frame (within unplanned inspection control) or within blizhay shy planned inspection control.
At negative results of inspection control the body for certification prepares the draft decision on stay or cancellation of action of the certificate of conformity of the quality system and sends it to the Technical center of the register.
Control questions:
1 Purpose of internal audit
2 Give definition to the terms "audit", "criteria of audit", "plan of audit", "checked organization"
3 List duties of the representative of a quality manual to carrying out internal audit
4 Tell about the main stages of carrying out internal audits
5 List and tell about the main requirements to internal auditors
6 Requirements to resources when carrying out internal audits
7 Tell about criteria of measurement of efficiency and productivity of the booked internal audit
8 What methods of monitoring and management of process of internal audit exist