ISO 9001:2015 Clause Wise Audit Questionnaire 9001:2015 Clause Wise Audit Questionnaire ISO 9001:...

ISO 9001:2015 Clause Wise Audit Questionnaire

ISO 9001: 2015

Clause

Requirement

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4. Context Of the Organization

4.1 Understanding the Organization and its context

1) Have you determine external and internal issues in the Quality management system (QMS)?

2) Does this issues are relevant to its purpose and ability to achieve intended outcome of to take Quality management system (QMS)?

3) Have you considered the context of the organization’s overall business activities? Does QMS scope cover all the activities or any exclusion for any areas or functions?

4.2 Understanding the needs and expectations of interested parties

1. How many interested parties are identified by you and are relevant to your Quality management system in implementing ISO 9001-2015?

2. What is the requirements of interested parties in Quality management system? What procedure or process is followed to understand interested parties requirements?

3. Have you defined any other quality requirements in the organization?

4.3 Determining the scope of the Quality management system

Have you determine the boundaries and applicability of the Quality management system?

Have you documented the scope of the organization considering below details?

a)

Have you determining this scope of the organization and considered external and internal issues?

b) Do you considered any requirement of interested parties in the scope?

c)

Have you considered interfaces and dependencies between activities perform by the organization and other organization?

Have you prepared documented QMS scope?

4.4 Quality management system and its process

Have you established and implemented QMS in accordance of ISO 9001-2015?

How do you establish the QMS?

How do you maintain QMS in your organization? What kind of documentations structure is made by you?

How do you bring continual improvement in Quality management system in accordance of this international standard?

Dose the organization determine processes for quality management system and their application throughout the organization for inputs required and the outputs expected from the processes? Have you identified the sequence and interaction of the processes?

How do you define criteria, methods inclusive measurements & related performance indicators to ensure effective operation and control of these processes? How do you determine resources needed and ensure their availability?

Who is given assignment of the responsibilities and authorities?


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How do you identify the risks and opportunities and plan to implement the appropriate actions to address them? Have you define the methods for monitoring, measuring as appropriate and evaluation of processes and if needed, the changes to processes to ensure that they achieve intended results ? How do you Improve the processes of QMS?

Have you maintain Documented information to support operation of processes? How it is kept? How do you ensure by documented information that the processes are carried out as planned?

5. Leadership

5.1 Leadership and Commitment

How the top management demonstrate leadership & commitment for QMS?

a)

Does the Top Management have signed and establish an quality policy? Does he approved QMS objectives? Is he active in formulation of quality policy and Objectives? Does the QMS objectives are in line with strategic direction of the organization?

b) How do you ensure the integration of the Quality management system requirement with the organization Processes?

c)

How do you ensure resources related to Quality management systems (QMS are available? If any resources are lacking then whom do you contact? What is a formal process for getting approval of resources? How do you carry out capacity planning and budget approval to get management approval for resources related to Quality management system?

d) Have you communicated in the organization related QMS system requirements? How do you communicate the importance of effective Quality management system implementation and benefits? What is the methods followed for communication?

e) How do you ensure QMS achieves its intended outcome

f) How many people are directing and supporting to contribute the effectiveness of QMS system? Have you define QMS Supporting Team?

g) How do you promote for continual improvement?

h) What are the roles of the management? How do you support and demonstrate leadership for QMS? How do you demonstrate your leadership and commitment for ISO 9001 QMS system?

5.2 Policy

Have you establish quality policy?

Does quality policy appropriate to the purpose and context of organization?

Who has define the organization's Quality policy? What is the framework for setting up the QMS objectives? Where do you documented QMS objectives?

Have you included the commitment to satisfy applicable requirements related to quality in the quality policy?

Do you include quality policy to ensure commitment for continual improvement of the Quality management system? How do you track the continual improvements? What benefits are achieved by you by implementing this ISO 9001-2015 standards?


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How do you communicate quality policy within the organization?

Have you prepared quality policy and kept it on notice board/ Is it available as documented information for all the employees and interested parties? How is it made available? How do you provide the Quality policy to the interested parties?

5.3 Organizational roles, responsibilities and authorities

Have you assigned and communicated job description including responsibilities and authorities for roles relevant to EMS? How?

In the job description have you defined clearly the authority and responsibility of all concern person for how they contribute meet the requirements of ISO 9001- standard? Is the clarity of roles are defined in job description to avoid conflict?

Have you define responsibilities and authorities for reporting performance of the QMS within organization? Do you reporting the performance of the Quality management system to top management? How it is reported and who is responsible?

Who has to ensure provision of resources for implementation of Quality management system? Which resources are required to include?

Who is appointed as a QMS coordinator? What is the defined roles, responsibilities and authority for QMS coordinator?

In the job description have you defined clearly the authority and responsibility of all concern person for how they contribute meet the requirements of ISO 9001-2015 standard? Is the clarity of roles are defined in job description to avoid conflict? Is the authority and responsibility communicated to concern employees?

Have you define responsibilities and authorities for reporting performance of the QMS within organization? Do you reporting on the performance of the Quality management system to top management? How it is reported and who is responsible?

How you ensure that promotion of customer of focus throughout organization?

6. Planning

6.1 Action to address risks and opportunities

Have you establish, implement and maintain process for EMS planning? Can you explain how it is followed.? How do you determine the risks and opportunities that need to be addressed to:

a)

How do you ensure the Quality management system can achieve its intended outcome?

b) How do you prevent, or reduce, undesired effects related to risk?

c) How do you achieve continual improvement?

How do you plan actions to address these risks and opportunities? How do you integrate and implement these actions into its Quality management system processes?

How do you evaluate actions for the effectiveness of the actions related to risk and opportunity?


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What do you evaluate to ensure the effectiveness action?

How do you define a quality risk assessment process?

6.2 Quality objectives and Planning to achieve them

How do you establish Quality objectives at relevant functions and levels? Where does it documented? Who monitor it?

a) Does these Quality objectives consistent with the Quality policy?

b) Is your Quality objective measurable? Show me. Are there any objectives not measurable?

c) How do you communicate the Quality objectives?

What frequency do you update the Quality objectives?

Where does objectives documented? Who monitor it?

How do you retain documented information on the quality objectives?

Do you have plan for how to achieve quality objectives?

Have you considered the below things in planning the objectives

What will be done?

What resources will be required?

Who will be responsible to plan the objectives and implement the task?

When it will be completed?

How the results of quality objectives are evaluated?

How do you establish, implement and maintain documented Quality objectives? How?

Have you considered compliance obligations and risk and opportunities in framing this

objectives?

Which type of objectives are defined? What parameters needs to be taken in to account

while establishing and reviewing objectives?

Have you done any planning for how to achieve the Quality objectives? Does this plan

cover what will be done, resource details and responsibilities, target date? How the

results are evaluated including indicators for achievement of these objectives?

6.3 Planning of changes

Have you determines the needs and opportunities for change to the QMS?

How can you carried out the change in organization?

What are the things you consider at the time of change in organization?

Have you consider the availability of resources at the time of change in organization?

Have you consider the purpose of the change and their potential consequences?

Have you consider the allocation or reallocation of responsibilities and authorities at the time of change in organization?

7. Supports

7.1 Resources


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Have you determine and provide resources needed for

Establishment

Implementation

Maintenance and

Continual improvement

Who is responsible for providing resources?

Have you provide the infrastructure necessary for the operation?

What is formal process for budget approval? How the capacity planning is done and resources are provided? Do you get timely resources or delay to get resources? Due to un availability of resources does your work affected?

Have you provide the environment necessary for the operation of your process?

How do you ensure that resources are suitable for the specific type of monitoring and measurement activities? How do you maintain and ensure that resources are continuing fitness for their purpose?

Have you determine how to acquire or access any necessary additional knowledge and require when addressing changing needs and trends? Who is appointed as an QMS coordinator? What is the defined roles, responsibilities and authority for QMS coordinator?

7.2 Competence

a)

Does the organisation determine necessary competence for personnel performing activities affecting QMS? How do you determine competency? Do you prepare the competency matrix related to QMS activity?

Have you ensure that the necessary competence has been achieved? If any areas the competency is not achieved then what action is taken?

b)

Do you provide training or take other actions to achieve the necessary competence? Have you define what is appropriate education, training and experience for different category of persons? Where do you maintain such documented information?

c)

Have you ensure that the necessary competence has been achieved? What actions are taken to acquire the necessary competence? How do you evaluate the effectiveness of action taken for example written test, mock trail, review of effectiveness of training etc? What action was taken to upgrade the competence of people?

d) Are you maintaining appropriate information and documented information of education, training, skills and experience and qualifications as an evidence of competence?

What are the parameters covered under competence? How are you maintaining training

records of all employees? What is the mechanism of identification and providing training

needs of all employees? Are all employees trained for ISO 9001 QMS requirements?

What are the training provided by you to all employees? Show me your training records?

How do you plan and impart training? Are you having list of in house trainer? What is the

mechanism of providing induction training to new employees? What is the mechanism of

providing induction training to new employees? What is your training plan for next six


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months?

7.3 Awareness

a) Do your employees are aware of quality policy and Quality objective? How do you contribute your work to implement the quality policy in your work area?

b) How do you contribute to Quality management system? What benefits are achieved by implementing the QMS? What is your improved quality performance?

c) Does the employee aware for what is the implication of not conforming with QMS requirements and for not fulfilling Quality obligations? How do you provide such awareness to all concern persons?

7.4 communication

How do you determine the needs of internal and external communication relevant to QMS? Do you have any communication plan?

a) What do you communicate related QMS?

b) When do you communicate related QMS?

c) Whom do you communicate related QMS?

d) How do you communicate related QMS?

e) Who will communicate related QMS?

Do you respond to relevant communication on its Quality management system? Is there any documented information of this communication?

Have you internally communicate information relevant to QMS at various levels and functions? How?

Do you ensure such communication enables persons to contribute for continual improvement? How

Have you externally communicate information relevant to QMS? Show us what kind of communication is done by you externally? Does it covers all information required by all applicable compliance obligations?

7.5 Documented Information

7.5.1 General

a) Do you require information documented as per ISO 9001:2015?

b) How do you decide the need of the effective documentation information?

c) Do you documented requirement Paper copy or electronic copy?

1) What is your documented information for competence of person?

2) Have you documented related like quality policy and QMS objectives?

3) Have you documented scope of the QMS?

5) Have you any documented information compliance to ISO 9001:2015 requirements?


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7.5.2 Creating and Updating

a) Have you created and updated documented information covering proper identification and description of the title, date, author or reference number?

b) Do you made format for documented information including identification, language, software version, and graphics and media like paper copy and electronic copy?

c) Who is reviewing and updating and re-approved documented, information?

d)

Have you approved information for adequacy and suitability prior to issue ? Who is authorized to approve and review the documented information? How do you ensure documented information is adequate and suitable for the purpose? Where did you defined such authority for approval and review of documented information

7.5.3 Control of documented information

a) Have you defined any control mechanism for documented information? How do you ensure documented information is available for use when it is required?

b) How do you protect documented information? How do you adopt system like confidentiality, improper use, or loss of integrity?

c)

Does the documents required by the QMS is protected and controlled? How? Who is authorised to control QMS documents? How do you distribute the documented information? Have you prepared authorized copy holder list to understand who is having access of information? How do you retrieve documented information and use it?

d)

Are documented information established and maintained to provide evidence of conformity to requirements and the effective operation of the QMS? How do you store and preserve the documented information? How do you ensure it is legible?

e)

Is it protected and controlled? How do you change the documented information? How do you establish version control for your documented information? Are you using any automated tool for such version control and configuration management?

f)

Is there a documented information define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of documented information? Have you define the retention period for various types of documented information? How do you dispose of such documented information in hard copy as well as soft copy?

Does the master list for documented information with revision no. Made and updated?

Show us latest revision of Quality Manual and other documented information? How do

you maintain master list of page-wise amendment? How do you inform all the persons

for changes in any documented information? Who is responsible for approval and

control of different types of documents? Are you changing whole document or page-wise

amendment? How do you get information for changes in the documented information?

How do you inform to all the concerned person?

How documented information are identified for control / uncontrolled and obsolete?


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Do you preserve obsolete documents? Where do you preserve it?

8.0 Operation

8.1 Operational Planning and control

Have you plan, implemented processes as per ISO 9001:2015 QMS system Standard?

Do you implement action from risks and opportunities?

How do you determine the requirement for products and services? Have you establish the criteria for the processes and acceptance of product and services?

Do you have any documented information carried out as per plan?

How do you document information to have confidence for processes have been carried out as planned? Where do you keep such information? Based on such information if any delay happens then what actions are taken?

How can you ensure that implemented control of the processes is as per defined criteria?

How do you Control planned changes and review the consequences of unintended changes? Who is responsible for the same?

How do you ensure that outsourced process is controller or influenced. What type and extent of control or influence is applied to the Process is defined within the QMS for such outsourced process? Have you establish system for selection of vendors and outsourced activities and how do you communicate such controls to them?

What is to be considered as operational control? Which operations needs to be covered

under operational control plan?

Have you prepared defined operational control parameters for the identified process?

Which processes are covered?

8.2 Requirements for products and services

8.2.1 Customer communication

How do you determine and implement effective arrangements for communicating with customers in relation to:

a) Information related to products and services?

b) Enquiries, contracts or order handling, including changes?

c) Customer feedback, including customer complaints?

d) Control of customer property?

e) Establish specific requirements for contingency actions?

8.2.2 Determining the requirements related to product & services

How do you determine Statutory and regulatory requirements applicable to the product

& services? Have you identified any additional requirements considered necessary

by the organisation?

Dose the organization has capability and can meet the claims for the products and

services it offers? How do you ensure it?


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8.2.3 Review of requirements related to the products and services

How do you review the requirements related to the product and services?

Does the review ensure that:

a) Requirements specified by the customer, including the requirements for

delivery and post delivery activities?

b) Requirements not stated by the customer but necessary for specified or

intended use, where known?

c) Any additional requirements specified by the organisation?

d) Statutory and regulatory requirements applicable to the product & services?

e) Contract or order requirements differing from those previously expressed?

How do you ensure that product and services requirements are defined? Who ensure contract or order requirements differing from those previously expressed are resolved? How it is communicated? Show us related documented information.

Are documented information of the results of the review and any new requirements for

the products and services maintained? How?

Where the customer provides no documented statement of requirement, are the customer requirements confirmed by the organisation before acceptance? How?

Where product requirements are changed, does the organisation ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements? Show us evidence.

8.3 Design and development of products and services

8.3.1 General

Have do you establish, implement and maintain a design and development process to ensure the subsequent provision of product and services?

8.3.2 Design and development (D&D) planning

How do you plan and control the design and development of product?

During the design and development planning, do you consider:

a) The nature, duration and complexity of design and development activities?

b) The design and development stages?

c) The review, verification and validation that is appropriate to each design and

development stage?

d) The responsibilities and authorities for design and development?

e) Internal and external resource needs for the development of products and

services?

f) The need to control interfaces between persons involved in the design and

development process?

g) The need for involvement of customers and users in the design and

development process?

h) The requirements for subsequent provision of products and services?

i) The level of control expected for the design and development process by

customers and other relevant interested parties?


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j) The documented information needed to demonstrate that design and

development requirements have been met?

8.3.3 Design and development Inputs

Are inputs relating to product requirements determined and documented information maintained?

In preparing design and development inputs do you consider:

a) Functional and performance requirements?

b) Applicable statutory and regulatory requirements?

c) Where applicable, information derived from previous similar designs?

d) Other requirements essential for design and development?

e) Standards or codes of practice that the organization has committed to

implement?

f) Potential consequences of failure due to the nature of products and

services?

Are the inputs reviewed for adequacy?

Are requirements complete and not in conflict with each other? How do you ensure that?

How do you retain documented information on Design and development Inputs?

8.3.4 Development controls

How do you establish controls applied to the design and development process ? Where do you define the result to be achieved by the development activities? How the reviews are conducted to evaluate the ability of the results of D&D to meet requirements?

What verification activities are conducted to ensure that outputs meet the input requirements? How Validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use? What actions are taken on problems determined during the reviews, or verification and validation activities? How do you maintain Documented information for design and development controls ?

8.3.5 Design and development outputs

How do you ensure design and development outputs is adequate for the subsequent processes for the provision of products and services? do you ensure design output meet the input requirements for design and development? How do you ensure it?

Where do you include or reference monitoring and measuring requirements, and acceptance criteria, in your D&D outputs?

How do you specify the characteristics of the product that are essential to its safe and proper use?

8.3.6 Design and Development changes

Are design and development changes identified, reviewed and controlled by

organization to ensure that there is no adverse impact on conformity of requirements?

Is documented information of the results of the review of changes, authorization of the

changes and any necessary actions to prevent adverse impacts maintained?

8.4 Control of externally provided processes, products and services


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8.4.1 General

How do you ensures that externally provided processes, products, and services conform to specified requirements?

Have you determine the controls to be applied on externally provided products and services when;

a) Products and services are provided by external providers for incorporation into the organization’s own products and services?

b) Products and services are provided directly to the customer(s) by external providers on behalf of the organization?

c) A process or part of a process is provided by an external provider as a result of a decision by the organization to outsource a process or function?

Have you determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers in accordance with requirements?

8.4.2 Type & extent of control – external provision

What controls are established for externally provided processes, products and services which adversely affect the organization’s ability to consistently deliver conforming products and services to its customers?

How do you ensure that externally provided processes remain within the control of its QMS? Where do you define the controls that it intends to apply to an external provider and those it intends to apply to the resulting output

How do you ensure the effectiveness of the controls applied by the external provider and what mechanism is checked to ensure the same?

What kind of verification, or other activities, is determinate to ensure that the externally provided processes, products and services meet requirements? Show us evidence.

8.4.3 Information for external providers

Does the organization has Communicate to external providers applicable requirements for the following;

a. The processes, products and services to be provided?

b. The approval of products and services; methods, processes & equipment and

the release of products and services?

c. Competence of personnel, including necessary qualification?

d. The external providers interactions with organization?

e. The control and monitoring of the external provider’s performance to be applied?

f. Verification or validation activities that the organization, or its customer, intends to perform at the external provider’s premises?

8.5 Production and service provision

8.5.1 Control of production and service provision

Does the organisation carry out the production and service provision under controlled conditions/

Where do you keep the information that describes the characteristics of the product and the results to be achieved? How do you ensure that same is available with related person? Have you identify the use of suitable monitoring and measuring resources? How do you ensure it is suitable? How do you ensure implementation of


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monitoring and measurement activities at appropriate stages?

Who ensure the use and control of suitable infrastructure and environment? How does he ensure it? How do you ensure the appointment of competent persons, including any required qualification? How do you ensure validation and periodic revalidation for special processes? What actions are taken for implementation of actions to prevent human error? What process is followed for implementation of product release, delivery and post delivery activities?

8.5.2 Identification and traceability

How do you identify the output by suitable means throughout product and service provision? Does the organization identify the product status with respect to monitoring and measurement requirements throughout product and service provision? How do you establish inspection and test status for inspected by, rejected etc.

Where traceability is a requirement, does the organization control the unique identification of the product and retain documented information? How do you establish such traceability?

8.5.3 Property belonging to customers (CSP) or external providers

How do you exercise care with customer property while it is under the organization's control or being used by the organization?

How do you identify, verify, protect and safeguard customers or external provider’s

property provided for use or incorporation into the product and services?

If any customer property is lost, damaged or otherwise found to be unsuitable for use,

how do you report this to the customer or external provider and retain documented

information?

8.5.4 preservation of goods and services

How do you preserve output during production and service provision in order to

maintain conformity to requirements?

Does this preservation include identification, handling, contamination control, packaging,

storage, transportation and protection?

8.5.5 Post – delivery activities

How do you meet requirements for post-delivery activities associated with the products and services?

In determining the extent of post-delivery activities how do you consider;

a) Statutory and regulatory requirements?

b) The potential undesired consequences associated with its products and services?

c) The nature, use and intended lifetime of its products and services?

d) Customer requirements?

e) Customer feedback?

Does the Post-delivery activity include warranty provisions, contractual obligations like maintenance and supplementary service like recycling or final disposal? how such things are taken care and show us evidences.

8.5.6 Control of changes

How do you review and control unplanned changes essential for production or service provision to the extent necessary to ensure continuing conformity with specified requirements?


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8.6 Release of products and services

What is the procedure to release of products and services to the customer?

Is the products and services approved by a relevant authority / customer before release?

Have you implement the planned arrangements at appropriate stages to verify that product and service requirements have been met?

Does the company retain documented information which includes evidence of conformity with the acceptance criteria and traceability?

8.7 Control of nonconforming outputs

Does the organization ensure that product which does not conform to product

requirements is identified and controlled to prevent its unintended use or delivery?

Does the organisation deal with nonconforming product by one or more of the following

ways:

a) By correction? b) By segregation, containment, return or suspension of provision of products and

services? c) By informing the customer? d) Obtaining authorization for acceptance under concession?

Are documented information of the nature of the nonconformities and any subsequent

actions taken including concessions obtained maintained? How it is maintained and who

is authorized for disposal of such nonconformity?

9.0 Performance evaluation

9.1 Monitoring, measurement and analysis and evaluation

9.1.1 General

a)

How do you monitor and measure quality processes?

Do you have any document information control? Who is authorised to control of process? What is monitored and measured?

b) How do you monitor, measurement, data analysis and evaluate it? How do you ensure to get valid result? When the monitoring and measurement is performed?

c) How do you ensure that result from monitoring & measuring instrument is adequate? Have you analyzed and evaluated result?

d) Who is authorized to approve, analyse and evaluate these results?

e) How do you maintain evidence for monitoring and measurement of results?

What methods for monitoring, measurement, analysis and evaluation is followed to ensure valid results? What are the parameters covered under the monitoring and measurements? When do you monitor it?

Which equipment needs to be calibrated under the monitoring and measurement? Show us the evidence that instrument is calibrated?

9.1.2 Customer satisfaction


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How do you Monitor customer perceptions of the degree to which their needs and

expectations have been fulfilled? Have you determine the methods for obtaining, monitoring and reviewing this information?

9.2 Internal Audits

Have you conducted Internal audit? What is the frequency to carry out internal audit?

How do you perform audits to ensure Organizations requirements for Quality management systems is maintained ? When and how?

How do ensure during internal audit that ISO 9001 requirements as well as international standard requirements are implemented by the organization?

How do you ensure during the audit that QMS is implemented & maintain effectively?

Have you any establish plan, implement & maintain audit programme? Who is the authorised person reporting for audit and to whom it is reported? How do you ensure Processes & Audits result mention in Internal audit is implemented effectively?

How do you define audit criteria and scope of internal audit?

How do you select auditors and conduct audits to ensure objectivity and impartiality of the audit process? Are identified employees/ functional heads trained for internal auditor? Are you having list of trained Auditor?

Who is authorised person to review results of the audits?

How do you maintain evidence of the audit programme and the audit results ? Where? Who has access to such documented information?

Do you have list of trained auditors? Who has given training to them as per ISO 9001

QMS? How many days? Have you made audit plan? During auditing do the auditor

check and monitor results of Objectives reported by the functional heads? Does all the

NCR’s communicated to respective function heads? Are they closed? Have you

prepared plan for internal audit for whole year? How do auditors carry out internal audit?

Explain us how do you use audit checklist? Have you done any audit summary for

department-wise / Clause-wise audit findings? How do you close NCR?

Do you maintain records for the actual audit carried out against audit planned as well as

summary of audit done? Where do you maintain such records?

How do you ensure that all departments are covered for all the clauses applicable to that

department are audited in internal audit? How do you see effectiveness of action taken

on audit NCR? Where is it recorded?

9.3 Management Review

How Top management Review the organization’s Quality management system/ what is the frequency of review to ensure its continuing suitability & adequacy? how do you ensure its effectiveness? When Do you conduct such QMS reviews?

Does this review include assessing opportunities for improvement and the need for changes to the QMS, including quality policy and quality objectives?

Do you have documented information and actions emerged from the QMS management review meetings?


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What action is taken from previous management reviews? Have you any status for

action monitoring of previous management reviews?

Do you report to Top Management for effectiveness of Quality Management System?

How do you measure effectiveness of system for working of your Organization? How do

you collect necessary information for the same? Are you getting information for

corrective action taken on the identified non–compliances and it’s effectiveness for

discussion in the management review meeting? What is the frequency of the

Management Review Meeting?

Do you review result of feedback for the quality? who is performing it? Do you take any

feedback, implemented any improvement based on nonconformities and corrective

action, monitoring and measurement of results, Results of QMS audits and reviews,

fulfillment of quality objectives etc in the management review meetings?

Have you define adequacy resources and discussed it in MRM? What do you measure

opportunities for continual improvement?

How do you plan for management review meeting and who are committee member? Do

you circulate agenda for Management review meeting in advance? Do you prepare

minutes of Management review meeting with the actions decided in management review

meeting? How do you monitor effectiveness of the system? Are you reviewing objectives

and targets in the management review? When do you review it?

Does the output of management review includes the following?

a) Do you consider Improvement opportunity as effectiveness of the QMS and documented as action plan?

b) is any need for changes in QMS?

c) Is there any requirement of recourses?

Have you identified any changes in existing QMS system or resource requirements?

10.0 Improvement

10.1 General

Have you define any improvement to meet the customer requirements?

How do you determine Opportunities for improvement and implement necessary actions

to achieve the intended outcomes of its Quality management system?

10.2 Nonconformity and corrective action

a)

How do you control non conformity and what documented information are maintained? Have any action taken of non conformity?

How do you deal with the consequences of non conformity?

b)

Who is authorised person reviewing of non conformity? Which causes applicable of the non conformity? Are you doing route cause analysis for such no conformity? how do you determine non conformities exist? Have you determine causes of non conformities and review of NCR and Correction of NCR and evaluate non conformities? What are potential occurrence non conformities?


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c) What action is taken for NCR? How do you implement action needed to meet documented Information?

d) How do you monitor effectiveness of corrective action? Who is authorised person reviewing it?

e) Have you update risks based on such investigation in documented information?

f) Have you any corrective action taken and changed in QMS for NCR?

g) How do you monitor effectiveness of results of corrective action?

What is the base for taking corrective actions? Do you take corrective action for all the

non–conformities?

What is the mechanism to take corrective action?

Are you taking corrective action for process, product, system and interested parties

complaint? When do you take corrective actions? Who review the effectiveness of

corrective action taken by concerned department? How do you monitor it?

How do you maintain documented information for nature of the Non Conformity and subsequent actions taken as well as result of corrective action? Who maintain it?

10.3 Continual improvement

How do you ensure that organization has continually improve the adequacy and suitability and effectiveness of QMS?

How do you improve the suitability, adequacy, and effectiveness of the QMS to enhance Quality performance? Have you determine is there needs or opportunities that is addressed as a part of continual improvement ?

ISO 9001:2015 Clause Wise Audit Questionnaire 9001:2015 Clause Wise Audit Questionnaire ISO 9001:...

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Transcript of ISO 9001:2015 Clause Wise Audit Questionnaire 9001:2015 Clause Wise Audit Questionnaire ISO 9001:...