Schedule of carrying out internal audits of QMS of the enterprise
| No. of a payment order | The checked organization (division, department, group, BP) | Date of audit (check) | Auditors (internal) |
| Section A Planned inspections | |||
| Subsection A.1 the Top management | |||
| Subsection A.2 of Division (departments and sectors) | |||
| Section B. MT | |||
| Section B. Unscheduled inspections |
Notes -
1 The schedule of carrying out internal audits can be formed and be approved according to sections and on subsections is independent.
2 The schedule of carrying out internal audits according to the section A is formed and approved by December 20 of the current year the next year.
3 Unscheduled inspections connected with carrying out external audit according to claims of consumers and on other circumstances are formed independently and is part of the uniform program of internal audit.
Head of qaulity (signature, date) I.O Surname.
Appendix Zh
Form. 06Zh
Record code by ISO 9001: 6.2.2, 8.2.2
List of internal auditors of QMS of the enterprise
№ ___
____ ________ 200 __.
Instead of No. ___ from ___ _________ 200 __.
| No. of a payment order | Surname, name, middle name | No. of a personal leaf of the accounting of the auditor | Division in which the auditor is registered |
Representative of a quality manual _____________________________
(signature, Surname)
Appendix I
Sheet 1 form 06I
Record code by ISO 9001: 6.2.2, 8.2.2
Personal leaf of the accounting of the auditor No. ____
Surname ________________
Name ____________________
Middle name ________________
It is begun _____________ It is ended _____________ the termination Reason ___________
Birth date and birth place ____________________________________
Work place
Post
Training:
| No. of a payment order | The name of the training course | Who / what organization provided training | Training period/term | The document about confirming listening of a course | Notes |
Sheet 2 form 04-002
Participation in internal checks (audits):
| No. of a payment order | Date / period of carrying out check | Planned / not planned inspection | Object of check | Notes (it is filled with the head of group of auditors) |
Personal signature of the auditor __________________________________
(signature, Surname)
Representative of a quality manual ________________________________
(signature, Surname)
Appendix K
Form 06K
Record code by ISO 9001: 8.2.2
Auditor questionnaire
| Major factors for the analysis of a condition of the QMS elements | The considered documents | Responsible person | |||||||
| 4.1. General requirements | |||||||||
| 1. Whether the processes and their interaction necessary for QMS are defined. 2. Whether the sequence and interaction of these processes is defined. 3. Whether necessary methods are defined, both at implementation, and at management of these processes. 4. Whether resources and information support for support of these processes and their assessment are allocated. 5. Whether monitoring, measurement and the analysis of these processes is carried out, whether measures are taken for continuous improvement of these processes (it is described in subsection 8.1 and point 8.2.3). 6. Whether management of the allocated processes transferred for performance to the third-party organizations is provided. | Quality manual the Documents regulating performance of processes and procedures; other existing documents Protocols of the analysis from the management | ||||||||
| 4.2 Requirement to documentation | |||||||||
| General provisions | |||||||||
| 1. Existence of policy in the field of quality and the purpose in quality area (it is described in subparagraph 5.3 and section 5.4.1) 2. Existence of a quality manual and necessary documents on management of processes 3. Existence of protocols of quality | Quality manual the Documents regulating performance of processes and procedures of the Obligation for continuous improvement Protocols of quality Documentary procedure of management of the documents Documentary Procedure for Management of Records about Quality (protocols of quality) Documentary procedure for internal audits Documentary procedure for management of inappropriate production Documentary procedure for management of the correcting and warning actions | ||||||||
| 4.2 Requirement to documentation | |||||||||
| General provisions | |||||||||
| 1. Existence of policy in the field of quality and the purpose in quality area (it is described in subparagraph 5.3 and section 5.4.1) 2. Existence of a quality manual and necessary documents on management of processes 3. Existence of protocols of quality | Quality manual the Documents regulating performance of processes and procedures of the Obligation for continuous improvement Protocols of quality Documentary procedure of management of the documents Documentary Procedure for Management of Records about Quality (protocols of quality) Documentary procedure for internal audits Documentary procedure for management of inappropriate production Documentary procedure for management of the correcting and warning actions | ||||||||
| Quality manual | |||||||||
| 1. Whether the scope, including justifications of exceptions is specified (it is described in subsection 1.2). 2. Whether processes of quality management and their interaction are described. | Quality manual | ||||||||
| Management of documentation | |||||||||
| 1. Whether an inspection of documents on adequacy before their release and mailing is carried out. 2. Whether the analysis, updating and, necessarily, reapproval is carried out. 3. Whether it is identified the status of revision of documents and changes. 4. Whether existence of the relevant documents in places of their application is provided. 5. Whether unhindered reading and easy for identification of documents is provided. 6. Whether identification and management of documents of an external origin is provided. 7. Whether identification and prevention of inadvertent use of outdated editions of documents is carried out. | Documentary procedure for management of documentation. Quality manual. Lists of revision of the status of documents. Lists of mailing Documents on places. | ||||||||
| Management of protocols of quality | |||||||||
| Whether provide actions for management of protocols of quality: - readability; - identification; - storage / warehousing; - protection against damage; - restorability; - period of storage; - existence; - availability. | Quality manual Documentary procedure for management of records about quality (protocols of quality) Acts of acceptance of the Confirmation of Relevance of Documents Documentation of Internal Audits Documentation of Confirmation of Monitoring and Management projects Protocols on purchases | ||||||||
| 5. Responsibility of the management | |||||||||
| 5.1 Obligation of the management | |||||||||
| 1. Whether existence of quality management system, its effectiveness and improvement of productivity is confirmed (it is described in subsection 8.4 and point 8.5.1). 2. Whether importance of implementation of requirements of consumers, and also implementation of legislative and other obligatory requirements is brought to the attention of the organization (it is described in subsection 5.2). 3. Whether are developed policy and the purposes in quality area (it is described subsection 5.3 and subsection 5.4) 4. Whether the analysis and an assessment of quality management system of management (it is described in subsection 5.6) 5 is carried out. Whether functioning of quality management system is provided with necessary resources (it is described in section 6) | The analysis of data from the management Plans for training and preparation of the certificate on training Information for employees (bulletin board) Protocols on intentions Plans of projects Production meetings | ||||||||
| 5.2. Orientation to the consumer | |||||||||
| Whether requirements, requirements and expectations of consumers are defined (it is described in points 7.2.1, 8.2.1) | The analysis and assessment of polls of consumers the Analysis of the market the Analysis of documents according to claims of Record about validation of production Definition of requirements to production the Analysis of satisfaction of consumers | ||||||||
| 5.3 Policy in the field of quality | |||||||||
| Whether 1 the policy Answers the purpose of the organization. Whether 2 obligations of continuous increase of productivity of quality management Are reflected (it is described in point 8.5.1). 3 Are set and whether the objects in quality area are analyzed. Whether 4 the policy Is brought to the attention of the personnel. Whether 5 the analysis on constant suitability Is kept. | Quality manual of the Politician in the field of quality Plans for training and preparation, certificates on preparation passing Information for employees (a bulletin board, etc.). The analysis from the management Internal audits Production meetings | ||||||||
| 5.4 Planning | |||||||||
| 5.4.1 Purposes in quality area | |||||||||
| Whether 1 the purposes Will be coordinated with policy in the field of quality. Whether 2 it Will be coordinated the purposes with requirements to production (it is described in subsection 7.1a). | The quality manual Internal and external coordination is more whole Target plans of quality | ||||||||
| 5.4.2 Planning of quality management system | |||||||||
| 1. Whether it is provided performance of the purposes and requirements in the field of quality (it is described in subsection 4.1). 2. Whether integrity of quality management system at introduction remains of changes in it. | Quality manual Strategic plans Production plans Plans of use of resources and their confirmation Description of processes and procedures | ||||||||
| 5.5 Responsibility, powers, exchange of information | |||||||||
| 5.5.1 Responsibility and powers | |||||||||
| Whether 1 It is defined and whether responsibility and powers is brought to the attention of the personnel of the organization | Quality manual of Provision on divisions Duty regulations | ||||||||
| 5.4.2 Planning of quality management system | |||||||||
| 1. Whether it is provided performance of the purposes and requirements in the field of quality (it is described in subsection 4.1). 2. Whether integrity of quality management system at introduction remains of changes in it. | Quality manual Strategic plans Production plans Plans of use of resources and their confirmation Description of processes and procedures | ||||||||
| 5.5 Responsibility, powers, exchange of information | |||||||||
| 5.5.1 Responsibility and powers | |||||||||
| Whether 1 It is defined and whether responsibility and powers is brought to the attention of the personnel of the organization | Quality manual of Provision on divisions Duty regulations | ||||||||
| 5.5.2 Representative of a quality manual | |||||||||
| Whether 1 powers of the representative of a quality manual in quality management system Are defined. Whether the representative of a quality manual Is appointed 2 and whether he carries out the duties. | Quality manual Structure of the organization the Official document on appointment of the representative of a quality manual (order) Situation about the representative of a quality manual the Description of functions and powers of the representative of the management Reports about the state / analysis of quality management Reports for internal audit Reports on a situation in the field of quality | ||||||||
| 5.5.3 Internal exchange of information | |||||||||
| Whether 1 communication processes in the organization Are established. Whether 2 exchange of information about productivity of quality management system Is conducted. | Protocols and reports of discussions at operational meetings Group instructing and other meetings of the Bulletin board, Electronic means Reports on productivity of quality management system | ||||||||
| 5.6 The analysis from the management | |||||||||
| 5.6.1 General provisions | |||||||||
| 1. Whether the regular analysis of quality management system 2 is carried out. Whether the analysis of opportunities of improvement of policy and the purposes in area of quality 3 is kept. Whether the analysis of need for changes in quality management system is kept | Reports of the management Reports on quality Analysis of suppliers | ||||||||
| 5.6.2 Entrance data for the analysis | |||||||||
| Whether it is carried out from the management the analysis: - results of audits; - feedback with consumers; - functioning of processes and compliance of production; - the status of the warning and correcting actions; - the subsequent actions, the changes following from the previous analysis of reviews of management which could affect quality management system; - recommendations about improvement (it is described in subsections 8.1, 8.2, 8.4, 8.5); | Reports of the management the Analysis of satisfaction of consumers the Analysis of processes Confirmation of the correcting and warning actions the Planned need for resources and plans for use of the Risk Analysis Reports resources of internal audit Audits of processes Reports of audit inspections of production Reports on actions | ||||||||
| 5.6.3 Output data of the analysis | |||||||||
| Whether include results of the analysis the following decisions and actions: - increase of productivity of quality management system and its processes - improvement of production - definition of necessary resources | The report of the management the Business plan Strategic plans Personal plans of employees Statement of the new is more whole the List of Actions Projects | ||||||||
| 6. Management of resources | |||||||||
| 6.1 Providing with resources | |||||||||
| Whether are defined and the resources demanded for are provided: - introduction and maintenance in working order and continuous increase of productivity of quality management system; - ensuring satisfaction of consumers; | Quality manual Operating plans on: - to the personnel - the equipment - to devices - subcontract to the organizations - natural persons | ||||||||
| Whether the corresponding competence, preparation, skills and experience of the personnel performing the work influencing quality of production is provided | Quality manual Description of official and functional duties Employment contracts Plans for training of the personnel Qualification descriptions Recording of conversations with employees Certification of employees | ||||||||
| 6.2.2 Competence, awareness and preparation | |||||||||
| 1. Whether necessary preparation of the personnel 2 is defined. Whether the corresponding training 3 is provided. Whether the assessment of productivity of training 4 is carried out. Whether the awareness of the personnel on activity of the organization and on the purposes 5 is provided. Whether the relevant protocols are kept | Records of qualification requirements the Description of official and functional duties Plans of introduction courses for new workers Recording of conversations with employees Plans of preparation of Confirmation of passing of preparation of Confirmation of an assessment of productivity of preparation: - to the training purposes - advantage of preparation - productivity of preparation - benefit for the Productivity Assessment organization of the taken measures for preparation of Conversation with employees | ||||||||
| 6.3 Infrastructure | |||||||||
| It is defined, provided and whether the infrastructure, for example is supported in working order: - buildings, working space and related means of labor and equipment; - equipment for implementation of processes (both technical, and program) services of providing (for example, transport, communication); | Studying of workplaces Plans of carrying out maintenance and repair, protocols of the carried-out works Protocols of the analysis of suppliers (including producers of services) | ||||||||
| 6.4 Production environment | |||||||||
| Are defined and whether the factors influencing the production environment for the purpose of creation of the production environment necessary for achievement of compliance to requirements to production cope | Confirmations on implementation of legislative and other obligatory requirements or norms Plans of carrying out maintenance and repair (protocols) Studying of workplaces | ||||||||
| 7. Processes of life cycle of production | |||||||||
| 7.1 Planning of processes of life cycle of production | |||||||||
| 1. Whether planning and development of the processes necessary for ensuring life cycle of production is conducted. 2. Whether the following considers this planning: - purposes in area of quality and requirement to production; - need for development of processes, documents and resources; - necessary activities for verification and validation, monitoring, control and tests, and also criteria of acceptance of production; 3. Whether there is corresponding documentation testifying that processes of life cycle of production and the made production meet the requirements. | The concept of the planned strategy Target plans of quality Methods of monitoring and management Definition of risks and reduction of risks | ||||||||
Appendix L
Form 06L
ISO 9001 code: 4.2.4, 7.1, 7.2.3, 8.2.2, 8.3
Plan of audit
| The checked organization | Date | Type of check (planned - P, unplanned - VP) | Auditors |
| AUDIT PURPOSES: 1 Check of compliance of the performed works to requirements of ST RK ISO 9001:2009, quality manual and other firm standards used by division. 2 Check of productivity of introduction and maintenance of procedures and processes of QMS used by division. 3 Assessment of compliance to the carried-out activity to requirements of the Consumer. 4 Check of performance and efficiency of the correcting measures taken by results of the previous check. 5 Assessment of compliance to the carried-out activity to legislative, standard requirements. 6 Identification of areas of potential improvement of QMS. | |||
| AUDIT AREA (coverage): location, organizational structure, kinds of activity, the procedures and processes used by the organization in checked time period. | |||
| CRITERIA of AUDIT: Policy and purposes in area of quality, ST RK ISO 9001:2009, procedure and processes QMS, standard documentation, requirements of contracts. |
Appendix L
Form 06L
ISO 9001 code: 4.2.4, 7.1, 7.2.3, 8.2.2, 8.3
Plan of audit
| The checked organization | Date | Type of check (planned - P, unplanned - VP) | Auditors | |||
| AUDIT PURPOSES: 1 Check of compliance of the performed works to requirements of ST RK ISO 9001:2009, quality manual and other firm standards used by division. 2 Check of productivity of introduction and maintenance of procedures and processes of QMS used by division. 3 Assessment of compliance to the carried-out activity to requirements of the Consumer. 4 Check of performance and efficiency of the correcting measures taken by results of the previous check. 5 Assessment of compliance to the carried-out activity to legislative, standard requirements. 6 Identification of areas of potential improvement of QMS. | ||||||
| AUDIT AREA (coverage): location, organizational structure, kinds of activity, the procedures and processes used by the organization in checked time period. | ||||||
| CRITERIA of AUDIT: Policy and purposes in area of quality, ST RK ISO 9001:2009, procedure and processes QMS, standard documentation, requirements of contracts. | ||||||
| The LIST of the DOCUMENTS which are SUBJECT to OBLIGATORY CHECK: 1 Provision on division. 2 Duty regulations. 2 the Used documents QMS (procedures, processes, methodical instructions). 3 Records on quality. 4 List of the standard documentation used by division. METHOD AND PROCEDURE of CARRYING OUT AUDIT: carrying out introduction meeting, studying of documentation, interview of experts, supervision on workplaces, the analysis of results of audit, final meeting. | ||||||
| Head of group of auditors: Date of the previous audit | Date of the previous audit | |||||
| With the PLAN of AUDIT it is ACQUAINTED: The head of the checked organization: | ||||||
| Position: | I.O surname. | Signature | Date | |||
Appendix M
Form 11M
Record code by ISO 9001:
7.4.3, 8.2.2, 8.3