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Audit Checklist (Preview)
Quality Management System conformance to ISO 9001:2015 requirements
ISO 9001:2015
Clause
1

Auditor’s tips (recommendations)

Conforms

Questions

Verified Process
Yes/ No

2

What is being verified (explanations)?

3

1 Scope

4

5

Management

This clause does not contain any requirements.

review

A good practice is to initiate management
response to the question:
‘What goals are set (expected) by Management
for the QMS?’

Any answer is acceptable (e.g., the need for
certification, customer satisfaction improvement,
increase of efficiency, and so forth).


6.1 Actions to

1. How the QMS risks and

address risks

opportunities are distributed?

and
opportunities

2. How the risks and

management

QMS could be regulated:
- by the availability of elements of the risk -

QMS Processes

audited process?

Audit Checklist (Preview)
QMS conformance to ISO 9001:2015 requirements

Actions to address risks and opportunities in the

opportunities are defined in the

How often they are reviewed?

Quality

management system in accordance with the
principles and guidance of ISO 31000;
- in the ‘Actions to address risks and
opportunities’ QSP;
CBG Inc. © 2016

1

4 questions. eliminating the process? source of risk.com Verified Process Yes/ No What is being verified (explanations)? .Supporting the work of Quality Professionals ™ http://www.1 questions to the sec. © 2016 2 . distributing the risk or retaining the risk based on the decision made. addressing new customers. opening 4. accepting opportunities in the audited risk to use the opportunity. 3. changing the probability or the How often the results of actions ☐ are evaluated? consequences.via personnel risk management training. launching of new products. How and how often the actions ☐ new markets.4. Audit of Monitoring and measuring resources Audit Checklist (Preview) QMS conformance to ISO 9001:2015 requirements CBG Inc. It is beneficial to link sec. use of new technology and other desirable and viable options to address the needs of the organization or consumers.com Auditor’s tips (recommendations) Conforms ISO 9001:2015 Questions Clause training@c-bg.c-bg. to address risks and opportunities in the verified process are evaluated? business partnership.5 Important: Monitoring 1. What illustrates the results of ☐ An illustration of actions to address risks and actions to address risks and opportunities could be: avoiding risk.1. Actions taken to address risks and opportunities should correspond to the possible effect on the conformity of products and services. … 7.6. Opportunities may lead to the adoption of new How the evaluation is conducted? ☐ practices.

© 2016 3 . section (working category requirements). etc.c-bg. . .com Auditor’s tips (recommendations) Conforms ISO 9001:2015 Questions Clause training@c-bg.Under the provision of subdivisions (for the managers). When auditing monitoring and measuring resources. .Approved measuring techniques. In which QMS documents the required staff competence is defined? ☐ The required staff competence can be defined: . … 7. measuring 2.Prepared (trained) personnel carrying out the measurement. Competence personnel training and experience. Audit Checklist (Preview) QMS conformance to ISO 9001:2015 requirements CBG Inc.In the technology. 1. .Equipment and measuring media. the following should be verified: resources . labor instructions.In the job description section (for all employees). including software.Supporting the work of Quality Professionals ™ http://www.com Verified Process Yes/ No What is being verified (explanations)? and should be linked to the national metrology legislature.2 Control of The components of competence are: education.

.com training@c-bg. How the competence is ☐ The competence of persons who are not ensured for the persons who are employees but perform work under the control of not employees but perform work the organization can be ensured via work under the control of the permits. and conducting interviews. if necessary. for example.c-bg.The procedure of competitive recruitment.com Auditor’s tips (recommendations) Conforms ISO 9001:2015 Questions Clause 2. including audit records of education. How in the QMS the Verified Process Yes/ No What is being verified (explanations)? ☐ The requirements for the competence of persons requirements for the competence who are not employees but perform work under of persons who are not the control of the organization (for example. Wherein it is necessary to evaluate the effectiveness of training and make changes to the training program. in ‘Annual staff training CBG Inc. organization? 5. How and on what basis the necessary competence (training. © 2016 4 .Supporting the work of Quality Professionals ™ http://www.Development and testing of the training program. training and experience. How the staff competence is ☐ ensured? Competence of employees can be ensured via: . 4. 3. employees but perform work equipment start-up) can be defined by internal under the control of the or external regulatory documents or in the organization are defined? contract. Audit Checklist (Preview) QMS conformance to ISO 9001:2015 requirements ☐ Acquiring of the necessary competence can be planned.

evaluated? .Evidence of education .Accreditation of subdivisions. development) is planned to be acquired? 6. ☐ verified process operators.records of work experience. © 2016 5 . diplomas. . What are the requirements to preserve processes’ outputs Audit Checklist (Preview) QMS conformance to ISO 9001:2015 requirements ☐ Production and The requirements to preserve processes’ outputs service (including products) are included in design and CBG Inc.Evidence of experience .5. ‘Internship Program’.com Auditor’s tips (recommendations) Conforms ISO 9001:2015 Questions Clause training@c-bg. . … 8.Employees testing.Personnel certification. reference letters.certificates. etc.c-bg.com Verified Process Yes/ No What is being verified (explanations)? continuous professional plan’.Supporting the work of Quality Professionals ™ http://www. How the effectiveness of The effectiveness of measures on the acquisition ☐ measures on the acquisition of competence can be evaluated via: (increase) of competence is . 7. graduation certificates.4 1. letters of recommendation. . Please.Evidence of training – continuous professional development certificates. provide the QMS processes Examples of the documented information: documented information as + Control of evidence of competence of the personnel .

What monitoring and ☐ Verify carrying out monitoring and measuring of measuring activities are carried storage conditions characteristics.8. which are part out to ensure processes’ outputs of the requirements for the process outputs preservation requirements? preservation.com ISO 9001:2015 Clause Preservation Auditor’s tips (recommendations) Conforms Questions training@c-bg.8.5.c-bg.3. and protection.4 should be linked to the Design and development outputs question #4– sec.5.7. humidity.com Verified Process Yes/ No (including products)? What is being verified (explanations)? provision development outputs.5.2 should be checked. packing. storage. In this regard. 3. Do the methods used for ME storage conditions measuring ☐ Questions #1 – 3 on measurement traceability – sec.Supporting the work of Quality Professionals ™ http://www. transmission or transportation. Preservation can include activities to identify. transfer (including loading and unloading operations). and others. 2. where the requirements for the processes’ outputs preservation appear. Such characteristics may be temperature. and monitoring correspond to the measurement traceability requirements? Audit Checklist (Preview) QMS conformance to ISO 9001:2015 requirements CBG Inc. the question#1 sec.1. © 2016 6 .

where the questions should be attributed. How the parameters are training@c-bg.com Auditor’s tips (recommendations) Conforms ISO 9001:2015 Questions Clause 4.Supporting the work of Quality Professionals ™ http://www. Purchase the complete document for $109. Moreover the Process names are specified in accordance with good practices and may differ from the actual names of the Organization's processes. when temperature is reduced below regulated if the characteristics of the acceptable level the air can be heated.com Verified Process Yes/ No What is being verified (explanations)? ☐ For example. the storage conditions are out of range? … Notes: 1. To do this. The audit program is usually compiles based on the QMS processes (or structural subdivisions of the Organization. © 2016 7 . QMS audit is the compliance spot check. Important – if column #4 says ‘QMS Processes’. In this case it is beneficial to assemble questions from different section of this ‘Checklist’. so when planning internal audits. column #4 contains Process name. those questions should be asked when auditing all QMS processes! 2. the questions can be spread into several audits.c-bg. that refer to the verified Process (or structural subdivision).00 More info… Related ISO 9001:2015 Products QMS Transition Program (to the New Version of ISO 9001:2015) Quality Manual Template (updated to ISO 9001:2015 requirements) Control of Documented Information in ISO 9001:2015 Clauses A complete List of ISO 9001:2015 Documents and Templates Audit Checklist (Preview) QMS conformance to ISO 9001:2015 requirements CBG Inc.