Checklist for external audit example. Quality audit. Internal audit of the QMS

The scope of the need for control depends on the structure and type of activity specific organization... To properly check the work of the company must be carried out regularly. This procedure is simply impossible without a correctly drawn up checklist.

Internal audit checklist

An audit checklist may be required to check the entire activities of an organization, or a single industry, process or department. This document was previously filled out in the form of a paper medium, later electronic versions in Word and Excel began to appear. There are specialized applications for now, but the previous methods are still valid.

The standard form of an audit checklist contains 6 columns:

  1. Number line.
  2. Verifiable ISO requirement.
  3. Detailed questions.
  4. A method for evaluating a verified requirement.
  5. Checkout result.
  6. Auditor or panel comments.

The very concept of a checklist literally translates as a "checklist" and can even be used to audit the activities of 1 employee of the company.

Legal and regulatory framework

According to the Federal Law of December 30, 2008 No. 307 "On Audit", the preparation of checklists is regulated different typesbut this is about external audit. It is legally allowed to conduct internal audits by outsourced companies. Management can invite an employee to conduct an audit, rather than create a commission from their own employees.

Article 19 Federal law "On accounting" dated December 6, 2011 obliges to conduct an internal audit. This concerns the audit of the accounting area, other areas of activity are controlled according to the personal preferences of the organization.

Document functions

The main tasks of the checklist are to control and structure information about the current processes of any kind of activity. This is a kind of checklist of questions that allows you to conduct a systematic analysis and identify gaps in the work of a particular link in the organization.

In addition to the controlling function, based on the checklist data, it is possible to draw up a further development plan or change the company's structure. Also, based on the results of internal audit, it is permissible to assess the competence of employees of the audited department of the company or the whole.

The stages of filling out the checklist for internal audit of the QMS with examples are described below.

Filling stages

In the process of control, the structure of the checklist is important. When developing it, it is necessary to take into account a logical sequential procedure that excludes a constant return to the aspects already considered. This will allow you to build the correct structure of not only the checklist itself, but also help in filling it out correctly.

In fact, filling out a well-designed checklist is very simple.

  • The first step is to delve into the content of the checkpoint, read the question, or familiarize yourself with the controlled criterion.
  • Further, the assessment method should be clarified and carried out in accordance with this paragraph. This could be an inspection, interview, survey, study of documentation, or some other way of assessing.
  • At the third stage, it is necessary to enter or write down the control results in the appropriate column of the checklist.
  • Also in a number of documents there is a clause with the auditor's comments. If it appears on the checklist, it must be completed before moving on to the next question.

You can download a sample checklist for internal audit.

Sample checklist for internal audit

Sample checklist for internal audit - 1

Sample checklist for internal audit - 2

Sample Checklist for Internal Audit - 3

Sample Checklist for Internal Audit - 4

Sample checklist for internal audit - 5

Roman Isaev

Organizational Development and Process Management Expert

Partner of the Group of Companies "Modern Management Technologies"

Head of organizational and corporate development projects

Professional business coach and specialist in Business Studio

The final article of the cycle devoted to the functioning of the quality management system (QMS) in commercial bank (for the beginning see: MMK, 2010, No. 11-12 "Typical quality management system of a commercial bank and its architecture", part 1 and part 2). In a series of articles in this cycle, the processes (stages) of the QMS development are considered in detail: planning and building the QMS (see: MMK, 2011, No. 1), management of each QMS process (see: MMK, 2011, No. 2), internal audit of the QMS, analysis of the QMS by the bank's management, as well as practical examples and recommendations from the experience of various banks. The author demonstrates how to ensure the stable and effective functioning of the QMS in the bank over a long period of time.

Internal audit of the bank's QMS

Audit - a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively in order to determine the extent to which the audit criteria are being met.

The object of the audit can be: QMS (upper level), process, department, information system and etc.

A model of this process is shown in Scheme 1.

Scheme 1. Internal audit of the QMS

When conducting an internal audit of a bank's QMS, it is recommended to use the ISO 19011 "Guidelines for the audit of quality management systems and / or environmental management systems."

The templates of documents that are necessary for the audit of the bank's QMS and audit of the bank's processes are given in.

see schemes 2 and 3, MMK, 2011, no. 1, p. 6-7), then the internal audit of the QMS includes two corresponding stages, as well as the general stage "Preparing for the audit":

  1. Preparing for the audit. Contractor: quality service;
  2. Internal audit of the QMS (top level). Contractor: quality service;
  3. Process audit. Executor: process team.

Let's consider these stages in more detail.

1. Preparing for the audit

Assumes the following procedures and actions.

Development, coordination and approval of the internal audit program. This document contains a list of all types of audits with names (for the next year). For each audit, the following is indicated: a list of audit objects, full name. the head of the audit, the timing of the audit.

Formation and training (if necessary) of a group of internal auditors of the bank. In parallel with the development of the audit program, the need for auditors is determined, a group of auditors is formed and trained (if necessary), auditors are appointed for each process team, auditors are appointed to audit the top-level QMS, and the chief auditor is approved.

Preparation and publication of an order for conducting internal audits. The bank's order approves the audit program, the composition of the group of auditors and their duties, the duties of the members of the process teams, heads of departments and bank employees during audits.

Preparation of teaching materials on internal audit.

Development of a single checklist for auditing the process.
A checklist is a table that is used by the auditor to check that established requirements are met. A fragment of the checklist (three columns of the table) for auditing the process is given in table. 1.

The checklist consists of six columns:

  • Line number;
  • Checked requirement;
  • Clarifying questions (if necessary);
  • A method for assessing the fulfillment of a requirement (study of documentation, observation, survey, etc.);
  • Compliance / non-compliance mark;
  • Audit evidence (auditor's record and comments).

Table 1. Checklist for process audit (fragment)

A single process audit checklist is necessary to ensure that all process teams and auditors conduct process audits for the same requirements.

2. Audit of the QMS (top level)

Consists of the following procedures and actions.

Development of a checklist and plan for the audit of the QMS (top level). A sample checklist (fragment) for the audit of the QMS (top level) is presented in table. 2.

Table 2. Checklist for internal audit of the QMS (top level)

It lists the general requirements for the QMS components (top level). These requirements should be detailed and supplemented with requirements iSO standard 9001 (one might say, with quotes from this standard) and the bank's own requirements.

For example, the requirement “1.1. The list (completeness) of documentation - compliance with ISO 9001 requirements ”is detailed to the requirements of Sec. 4.2 of ISO 9001 "Requirements for Documentation", which specifies the composition of the required documentation:

“The quality management system documentation should include:

  • Documented statements of quality policy and objectives;
  • Quality quide…" .

Based on the checklist, a QMS audit plan is developed.

The audit plan has five columns:

  • Line number;
  • Checklist number or section (group of checked requirements) of the checklist;
  • FULL NAME. auditor;
  • Date and time of check;
  • FULL NAME. and the position of the person in charge of the process team members / process executors.

The auditor chooses the requirements from the checklist and prescribes in the plan when, how and with the help of whom he will check them.

For example, to check the requirement “1.2. Relevance of the documents ”the auditor schedules several interviews with the bank employees responsible for these documents, and writes it down in the plan.

Conducting an audit of the QMS (top level) according to the plan and filling out the checklist. The auditor evaluates the fulfillment of each requirement from the checklist using the selected assessment method (interviews bank employees, examines the documentation, monitors the bank's activities). Then he puts a mark on compliance / non-compliance and indicates the evidence that confirms this.

Preparation of a report on the results of the internal audit of the QMS (top level). The report on the results of the internal audit of the QMS combines all completed checklists in the order of the requirements. The total number of identified inconsistencies, conclusions and conclusions are indicated.

Development of corrective and preventive actions based on audit results.

Implementation of prompt corrective and preventive actions.
The most urgent and important actions are performed immediately after development. Actions requiring the involvement of significant labor and financial resources are performed during the next period of the QMS operation.

3. Process audit

The rules for auditing the process are similar to the rules for auditing the QMS (top level), only the process becomes the object of audit. Therefore, we give a list of procedures and actions without additional comments.

For a process audit to be performed by the process team in a methodically correct and effective manner, it must include a qualified auditor from the quality department.

So, the process team during the audit:

  • Get acquainted with the documentation on internal audit;
  • Develops a process audit plan;
  • Audits the process according to the plan and fills in the checklist;
  • Prepares a report on the results of the process audit and submits it to the quality service;
  • Develops corrective and preventive actions based on audit results;
  • Carries out prompt corrective and preventive actions.

For example, in one bank there was a completely normal and cost-effective “Salary projects” process. However, the audit revealed many inconsistencies. Some of them were not even known to the owner and functional managers of the process. Eliminating inconsistencies doubled the performance and quality of the process.

Receiving and aggregating reports on process audits from process teams. Reports on the results of all audits should be collected together for further work with them.

Analysis of the QMS by the bank's management

The model of the sub-process "Analysis of the quality management system by the bank's management" is shown in diagram 2.

Scheme 2. Analysis of the QMS by the bank's management

The process is launched according to the frequency established by the bank (at least twice a year) or by decision of the bank's management. The director for quality is in charge of the collection and preparation of information for the analysis of the QMS, the development of plans for improving the QMS. The responsible executor of work in the framework of the preparation of the QMS analysis is the head of the QMS department. Those responsible for the process of analyzing the QMS within the framework of the processes are process teams (process owner).

Insofar as qMS architecture consists of two levels (see Diagrams 2 and 3, MMK, 2011, No. 1, pp. 6-7), then the analysis of the QMS by the management has two components:

  • Preparation by process teams and analysis by management (process and quality committee) of consolidated reports on all QMS processes;
  • Preparation by the quality service and analysis by the management (process and quality committee) of reports on the upper level of the QMS.

Note that the analysis of the QMS by the bank's management, as well as the internal audit of the QMS of the bank, is recommended to be carried out using software products class "Business Modeling" (for example, Business Studio). They allow you to store all information and documents on the QMS, integrate (establish and maintain relationships) with other components of the QMS (processes, departments, goals and indicators, projects), automatically generate QMS documents that are obtained at the outputs of processes (reports, protocols, records, etc. etc.).

More detailed information on the use of these software products in the performance of all processes / stages of the bank's QMS operation is presented in.
The process consists of the following procedures and actions.

Sending information and inquiries to process teams. Process teams should analyze and audit their processes, prepare and submit to the quality service a summary report on the process. Process commands may be prompted for additional Information by a process that is not included in the summary report.

Receiving, checking and aggregating summary reports on processes from process teams. All reports should be checked and then combined into a single process report.

Preparation and aggregation of reports on the upper level of the QMS include reports:

  • Based on the results of the internal audit of the QMS;
  • On the implementation of corrective / preventive actions for the upper level of the QMS;
  • Analysis of customer complaints (summary);
  • On the implementation of the plan for the development, updating and improvement of the QMS;
  • On the implementation of actions approved by the results of the previous analysis of the QMS by the management;
  • By analyzing the factors of external and internal environment, changes significantly affecting the bank's QMS.

For more information on these reports, as well as their samples, see.

Development of a report on the functioning and effectiveness of the QMS. This report includes, as annexes, reports on the upper level of the QMS, summary reports on processes. It should contain conclusions and conclusions on the functioning and effectiveness of the QMS (each component) over the past period.

Development of corrective and preventive actions. Corrective and preventive actions are developed by the quality service for both process teams and the top level of the QMS.

Preliminary study of the report, plans, preparation of comments and proposals. The bank's management (process and quality committee) must familiarize themselves with all documents and send their comments and suggestions to the quality service.

Collecting and processing comments and suggestions from members of the process and quality committee

Organization of the committee, presentation of the final version of the report and plans for the committee meeting (performed by the quality service).

Preparation, presentation of the report and presentation of the report. The Quality Director at the meeting of the Processes and Quality Committee makes a report on the functioning and effectiveness of the QMS over the past period, makes presentations of the prepared reports and plans.

Discussion and approval of the report, plans and decisions. When discussing the report and plans at a meeting of the process and quality committee, necessary adjustments and additions are recorded for them. On the basis of reports and plans, the committee must assess the effectiveness and quality of each component of the QMS (in accordance with the architecture - see schemes 2 and 3, MMK, 2011, No. 1, pp. 6-7). There may be the following solutions / estimates:

  • Excellent. All planned results have been achieved. There were no glitches, errors, inconsistencies. The component does not require improvement or corrective action;
  • Satisfactorily. Not all planned results have been achieved. There were minor glitches, errors, inconsistencies. Some improvements and corrective actions are required;
  • Unsatisfactory. The planned results have not been achieved. There were significant glitches, errors, inconsistencies. Significant changes are required.

In the course of the meeting, a protocol of the analysis of the quality management system by the management is drawn up, which indicates decision for each QMS document / component considered by the committee.

Adjustment and approval of plans based on the results of the QMS analysis by the management (performed by the quality service).

For example, in one bank, after studying all the QMS reports, the management remained so quite transparent and efficient in the activities under their control that they allocated the quality service three separate spacious offices equipped with the latest technology, next to the office of the bank's board chairman.

Conclusion

So, the secret of the stable and effective functioning of the bank's QMS for a long time lies in strict adherence to the processes and procedures described in this work, as well as in the use of standard and best practices in the field of quality management (for example, a typical bank quality management system).
Thus, the bank's QMS will be ready for repeated successful certification and will be able to constantly bring the bank both financial (increased profits, reduced costs for poor-quality processes) and non-financial effects (increased reputation, customer loyalty).

List of used literature

ISO 9000: 2005. Quality management systems. Fundamentals and vocabulary
Typical quality management system of a commercial bank (as part of a comprehensive standard business model of a commercial bank)
ISO 9001: 2008. Quality management systems. Requirements
Isaev R. A. Business engineering and management in a commercial bank. - M .: GOLOS-PRESS, 2009 .-- 318 p .: ill.

Remember we highlighted two parts iSO requirements 9001: 2015 to internal audits. We just talked about the first part just now. It will be more difficult to verify the practical implementation of the remaining provisions of ISO 9001 at the enterprise. However, this task is within the reach of anyone. Depends on the specifics of the particular process being checked, of course. As you know, many companies use Key Performance Indicators (KPIs) to evaluate their performance, including when they achieve compliance with ISO 9001: 2015. by measuring a specific indicator of which one can confidently draw conclusions about the state of the process.

I say this to the fact that if your KPIs are implemented and supported by the process owners, then the assessment of the effectiveness of the QMS based on the existing KPIs can be included as one of the elements of the internal audit checklist. If KPIs are not included in the practice of the audited company, then it would be good to include in the checklist a question for the process owner: how he determines for himself that his process is effective. Finding this out will help you achieve more from the internal audit process.

For more information on KPIs, visit the "" page.

In the journal No. 4 (28) 2013 on page 52. we published an article by our author, general director group of companies "International Management, Quality, Certification" under the title "Main trends and results of audits of security management systems food products". As an appendix to this material and in order to help beginner internal auditors, we suggest that you familiarize yourself with the EXTENDED version of the checklist (which is given in the article in Table 4), which they can use to improve the effectiveness of the system.

Critical areas

Works

Work with providers
1. List of approved suppliers
2. All suppliers have implemented FSMS and have been certified according to ISO 22000 (BRC, IFS, FSSC 22000)
3.All new suppliers are assessed using the PRP procedure, significant ones are audited
Acceptance
4 Are employees aware of food safety concerns when accepting incoming products?
5. When answering questions, staff demonstrate knowledge of basic food safety factors when inspecting a food delivery vehicle
6. All purchases from approved suppliers
7. There is a description of all purchased raw materials according to 7.3.3. ?
8. Are these records available in the receiving area?
9. Acceptance records demonstrate compliance with written procedures?
10. Is the temperature of all refrigerators and freezers monitored?
11. Are the products stored at the required temperature and humidity?
12. Are all requirements documentation available?
13. Regular monitoring is carried out vehicledelivering food?
14. Is the transportation requirements documentation available?
15. All delivery forms are completed
Wood and glass policy
16. Is there no glass and wood in the production area?
Labeling and traceability
17. All perishable products for storage are clearly marked, the date of purchase is reflected, and they are used until the expiration date
18. All pre-prepared products and work-in-process products are clearly labeled in case of storage.
Storage
19. In all warehouses, is food stored off the floor or in contact with the surface of the walls?
20. Are all products in storage containers closed and labeled with product name, production date?
21. Is all package in good condition?
22. Are all products shipped by FIFO (First In, First Out)?
23. Is there enough storage space?
24. Is there a dedicated area for potentially unsafe or recalled products?
25. Temperature and humidity in warehouses comply with regulatory requirements, monitoring, recording?
26. Are foods stored to prevent cross contamination from raw to cooked products in storage areas?
27. There are no opportunities for cross-contamination of finished products from raw materials?
28. Are all food with allergens stored separately?
29. Warehouse infrastructure in good condition, i. E. no cracks in the walls, impervious floor, no condensation from air conditioners?
30. Are the equipment door seals in good condition?
31. Corrective actions have been developed for all previously identified nonconformities, are there appropriate records?
32. Are chemicals and detergents stored separately and restricted?
33. Are there any signs of pests in the warehouses?
34. All necessary equipment verified and calibrated?
35. Records for OPRP points are maintained, all CDs are completed in a timely manner, there are records after the problem is eliminated
Cleaning (cleaning)
36. Is the cleaning schedule in an accessible place and is everyone familiar with it?
37. The PRP of cleaning performance includes all the necessary information: Instructions for preparing detergents, frequency, list of chemicals to be used, list of equipment to use, who is responsible for what, etc.?
38. Are all cleaning schedules completed on time?
39. Is there all the appropriate equipment and facilities to carry out cleaning effectively?
40. Is the cleaning equipment clean, in good condition, stored in accordance with specifications?
41. Are there disinfectants for work surfaces and are they always available for use during food preparation?
42. Are cleaning chemicals used correctly?
43. Are chemical safety certificates available?
44. Is cleaning performance verified regularly? Does the lab take swabs? Do you have an express analysis?
45. All chemical substances for cleaning are stored in a separate warehouse from food?
46. \u200b\u200bAre all chemicals stored in their containers and signed?
47. All new equipment is included in PRP
48. Dishwashers are working properly and are serviced on schedule. The contacting surfaces are washed with clean water
Maintenance of devices and equipment
49. Is all equipment in good condition and repaired in a timely manner?
50. Timely maintenance of lighting, ventilation, drainage is carried out
51. All requests for equipment repairs are completed on time
52. Broken equipment is separated from working
53. Fittings are in working order, there are no gaps
54. In organizations catering the dishes are clean and free of chips
55. All major equipment such as refrigerators, oven freezers, heat treatment equipment, temperature control devices
56. All equipment involved in monitoring the cash register is verified
57. All devices are in working order, the surface is free of chips and cracks
58. Are there programs for preventive inspection and repair of buildings, structures and equipment?
59. All lamps are covered with shatterproof protection
Pest control
60. Eat PRP to pests
61 Pest control records are kept
62. There is a contract with a specialized service
63. There is a map of baits (traps)
64 Places of baits (traps) known to workers
65. All poison is certified
Waste
66. Is there a PRP for waste?
67. Is the waste removed at a certain% of the tanks filling? Are the tank locations determined?
68. Are waste containers different in color and shape from containers for good products?
69. Are waste containers tightly closed, kept clean and emptied at specified times?
70. Places of garbage (waste collection) are removed from production workshops?
Personal hygiene
71. Is there a PRP for hygiene? Is personal hygiene regularly monitored by the HACCP team leader, are all corrective actions taken immediately?
72. Are all washbasins appropriately equipped and accessible in production facilities, foot pedal or touch control?
73 Availability of warm water, liquid soap and paper towels
74. Staff use gloves
75. No jewelry, hours
76. Is smoking and eating carried out in designated areas?
77. Are production department personnel wearing protective clothing and headgear?
78. All personnel understand the responsibility and promptly report illness
84. Sick workers are not allowed to work?
79. The first aid kit is available and painted in a bright color, protected from water
80. Do all personnel comply with food safety requirements?
81. Are all personnel trained in personal hygiene and food safety management?
Training and adaptation
82. Are all personnel trained in FSMS?
83. All employees have training materials
84. All new staff went through training covering the need for disease communication, correct hand washing / correct use of gloves and personal hygiene requirements
85. All personnel have the necessary competence
86 Are training records kept regularly?
Managing Potentially Hazardous Products and Complaints
87. Is there a mandatory documented procedure? All incidents, complaints about products are recorded and mandatory corrective actions are taken
Seizure of products
88. Is there a withdrawal procedure and all recalls and withdrawals occur according to the procedure?
89. Are all required forms being completed?
Production of products
90. Is the 2h / 4h rule used for all steps from production to freezing or distribution?
91. Are food products with allergens prepared separately?
92. Are all salads prepared before shipping?
93. All chemicals for hygiene and sanitation are listed
94. Correct use of equipment and devices to prevent contamination?
95. Documents for on-site cleaning?
96. For all the identified non-conformities, were the CA carried out?
97. Are all contact surfaces clean?
98. Are all chemicals kept separate to prevent contamination?
99. Was the ingress of foreign matter prevented?
100. Is all equipment working well?
101. Is all equipment clean?
102. Is the waste disposed of regularly?
103. Do staff understand the food safety hazards?
101. The staff knows where the CCP is, and the person in charge is trained in monitoring, knows the critical limits and CA
105. Personnel in protective clothing?
106. Does the staff comply with personal hygiene requirements?
107. Are the sick people not present at the production site?
108. Do you have the necessary hygiene products, washbasins, showers, sanitary checkpoints?
109. Are personal belongings of staff stored separately and do not come into contact with food?
Defrosting
110. Are all food thawed in the refrigerator?
111. Are all raw foods thawed separately from cooked foods?
112. Are all foods thawed covered and labeled?
113. Is the purpose, date and time of removal from the freezer compartment marked?
114. Are all foods thawed marked?
115. Are defrosted food used no later than 3 days after removing it from the freezer?
116. Have all the design documents been developed for previously identified inconsistencies?
Heat treatment
117. Does the staff know where the CCP and the journal entries are?
118. Is the monitoring column filled in?
119. Gloves in direct contact with hands?
120 Pass All PRPs to prevent contamination by microorganisms, physical and chemical hazards, allergens during heat treatment?
121. Do all personnel comply with personal hygiene requirements and know these requirements?
134. Are all heat treatment equipment clean?
122. Does the laboratory take swabs for chemical and microbiological contamination?
123. No opportunities for cross-contamination?
124. Are all staff healthy?
125. Are the temperature recording devices verified?
126. Is the risk of contamination after cooking controlled?
Cooling
127. Is the temperature regime observed in the cooling room?
128. Necessary records on control and / or monitoring are kept in KKT, OPRP. Are there cold rooms?
129. Is all the necessary documentation available?
130. Whenever possible, are all refrigerated food covered or blast chilled?
131. Are all refrigerating chambers and freezers hermetically sealed and have seals?
132. All finished products are protected from contact with raw materials
133. Are timely CA undertaken?
134. Are the temperature and cooling time correct?
135. Have all PRPs been taken to prevent contamination during refrigeration?
135. Are all containers labeled?
Packaging
137. Are the required forms completed?
138. Are records on monitoring temperature, humidity kept?
139. Does the staff know and follow the personal hygiene requirements?
140. Are corrective actions being taken immediately?
141. Are all PRPs implemented, do the staff know them?
142. Does the staff wear gloves?
143. Is the cleanliness of the packaging controlled?
144. Is pest control carried out?
Transportation
145. PRP on transportation performed
146. All food products are packed and stored at an appropriate temperature during transportation
147. Is the temperature controlled before unloading?
179. Are all products protected from contamination?
148. Are there records of control in OPRP? Are they in the vehicle?
149. Are all drivers familiar with food safety requirements?
150. Finished products and raw materials are not transported at the same time?
152. Are corrective actions being taken immediately?
152. All are identified dangerous factors during transportation?
Consumers / Internal Complaints
153. Are all inconsistencies registered?
154. Does the staff know the characteristics of the product (7.3.3.)?
155. Are responsibilities and powers for dealing with complaints clearly assigned?
156. Are staff informed about consumer complaints?
157. Are actions taken on all revealed inconsistencies and complaints?
Changes to products and processes
158. Is there a description of all products?
159. Is validation performed when changes are made to the process?
160. When changing equipment, adjustments are made to PRP, OPRP
161. When changes are made, is staff training provided?
162. Did all complaints lead to changes?
Food safety management system documentation
163. The last audit took place in the department later than 12 months
164. Are all the necessary programs being updated?
165. All documentation is approved and up-to-date
166. The scope of the system has not changed?
167. Did the HACCP team members stay the same?
168. Product description has not changed
169. Flow diagrams ( technological schemes) are relevant
170. Hazard analysis carried out
171. Are the food safety objectives being met?

Problem report

Remember, we have highlighted two parts of the ISO 9001: 2015 requirements for internal audits. We just talked about the first part. It will be more difficult to verify the practical implementation of the remaining provisions of ISO 9001 at the enterprise. However, this task is within the reach of anyone. Depends on the specifics of the particular process being checked, of course. As you know, many companies use Key Performance Indicators (KPIs) to assess their performance, including when they seek to comply with ISO 9001: 2015. by measuring a specific indicator of which one can confidently draw conclusions about the state of the process.

I say this to the fact that if your KPIs are implemented and supported by the process owners, then the assessment of the effectiveness of the QMS based on the existing KPIs can be included as one of the elements of the internal audit checklist. If KPIs are not included in the practice of the audited company, then it would be good to include in the checklist a question for the process owner: how he determines for himself that his process is effective. Finding this out will help you achieve more from the internal audit process.

For more information on KPIs, visit the "" page.