Audit Report - Oman Green Ready Mix
Audit Report - Oman Green Ready Mix
Audit Report
General Information
Certification Scheme
Single site certification
Multiple Site Certification
Multi-site Certification based on sampling
Certification Transfer
Combined/integrated Certification
Specified Audit
Transition Audit (ISO 9001:2008 to ISO 9001:2015)
Audit Report Number – BQSR-C-1258
Others (Specify)
Specific Information about client
The organisation is a product manufacturer in data communications industry with manufacturing/assembly location with high Speed Test and
Measurement Equipment manufacturing. It provides high-value test solutions for high-speed IO markets that enable next generation
interconnect technologies and exceed customer expectations.
Audit Objectives
Topic Changes
Management System/Documented Information None
Yes
Scope of Certification None
Yes
Number of Employees None
Yes
Others None
Yes
Topic Changes
Audit Report Number – BQSR-C-1258
Deviations from the audit plan None
Yes
Significant issues impacting the audit program (Planned activities for the certification cycle) None
Yes
Changes in the audit objectives or audit criteria None
Yes
Other particulates None
Yes
The audit team evaluated the corrective actions taken for the non-conformities/areas of concern from the previous
audit. Effective
Non-Effective
In the case of RA/Re-Certification audits, the audit team considered the audit reports for the last two audits the (MNC or NC)
audit planning/performance of the audits and in particular checked the nonconformities/areas of concerns Not Applicable
(MNC or NC)
The corrective actions were found to be
Certification Area Major Non- Minor Non- Opportunities of Positive Aspect (P)
Conformity (NC) Conformity (MiN) Improvement (I)
ISO 9001:2015 – Quality Management System 0 2 4 Multiple
Observations (O)
Comments
An audit cannot cover each and every detail of the management system. Therefore, there may still be nonconformities not addressed by the
auditors in the closing meeting or the audit report. Audit results are always evaluated on the basis of the following classification.
Audit Report Number – BQSR-C-1258
Non-conformities failure to fulfil one or more requirements of the management system standard or in situations that rises
(NC): significant doubt about the ability of client’s management system to achieve its intended outputs
(Classification: Non-Conformities)
• Corrective actions of the audit findings are to be implemented
• the causes of the identified nonconformities shall be analysed
• corrective actions for causes of the nonconformity shall be effectively implemented prior to the
addition of certification issue.
• auditor generally verifies the effectiveness of the corrective action in an on site/online re audit unless
verification is possible on basis of submitted new documentation
Minor Non- in individual cases some of the requirements of the management system standard are not fulfilled completely.
Conformities (MiN) however this does not jeopardise the effectiveness of the management system element.
• Corrective actions of the audit are to be implemented.
• The causes of the identified nonconformity shall be analysed.
• for the cause of nonconformity within 14 days prior to the decision one certificate issue.
• The submitted corrective actions and confirms acceptance. the implementation of the corrective action
will be verified in the next audit.
Opportunities for Aspect that would lead to management system optimization with respect to a requirement of the standard.
Improvement (I)
Positive Aspects (P) positive aspects of the management system meeting special mention.
Action List
The following table shall be used for all findings recorded by the audit team during an audit(Certification, change , repeat, sample,
special or surveillance).
Nonconformities
Clause Process Findings Results of Root Cause Intended Corrective Evaluation of CA
No. Description Type Analysis Action (CA) Date Accepted Evidence
provided
Audit Report Number – BQSR-C-1258
*The intended corrections and implemented corrective actions have to be verified. the auditor shall evaluate "effective" (E) in the case of NC and “Accepted” in the
case of corrections for MiN findings, if appropriate.
General
If Minor nonconformities identified in the last audit are not closed in an acceptable manner, they must be rated as nonconformities
(re-audit required).
The management representative of the office must check whether systematic corrective actions to close a root cause can be applied
in a preventive manner to the other affected sites. This is required for findings from internal and external audits.
In sampling certification the auditor will select and audit other sites in the next audit cycle and consequently cannot verify on site the
effectiveness of the corrective action from the last audit cycle.
Given this during the next internal audits carried out at the sites concerned, the management representative of the office must verify
on site the effectiveness and acceptance of corrective actions taken to address non-conformities, minor non-conformities,
opportunities for improvement, if any.
The results must be recorded and submitted to the auditor at the next audit to ensure the auditor can verify the effectiveness of the
corrective actions initiated.
Describe corrections for NC & MiN taken under intended correction and corrective action, provide evidences that actions were
planned taken and are effective.
Have the appropriate root causes being identified? Consider the following:
Recommendation
The organization has fulfilled the audit objective requirements for Stage I with observations that need to be provided with corrective
actions post which Stage II audit process shall be initiated.
Recommendation
The organization has fulfilled the audit objective requirements for Stage II with observations that conforms to QMS requirements
and is recommended for certification.
Audit Report Number – BQSR-C-1258
Audit Findings
d) Can Top Management demonstrate how they Various appointment letters were The compliance is evidenced C
promote the process approach? evidenced during the audit to
demonstrate the responsibility and
authorities being provided to
employees to implement the
process approach
e) Can Top Management demonstrate how they Risk assessment for ready mix has The compliance is evidenced C
promote risk-based thinking? been evidenced
f) Can Top Management demonstrate that it has The organization has established The Compliance is evidenced C
provided resources needed for the QMS? policy and procedures for resource
requirements requests
g) Does Top Management engage, direct, Yes the intention of the top The organisation conducts the management C
communicate, support, and contribute to management has been evidenced review meeting which covers all inputs as
achieve the intended quality system results? to contribute towards QMS system required by standard and also provide
relevant outputs
5.1.2 Customer Focus
a) Can Top Management demonstrate how they The organization has established The organisation is complaint to the required C
ensure that customer requirements are numerous practices like customer clause requirements
determined, understood, and consistently delivery procedure, customer
met? complaints, Customer Satisfaction
questionnaire has been evidenced
b) Does Top Management ensure that risks and Procedure for risk Management The risk register has addressed all required C
opportunities that can affect conformity of has been evidenced, risk and opportunities in its business activities
products & services, and the ability to
Audit Report Number – BQSR-C-1258
enhance customer satisfaction are determined
and addressed?
5.2 Policy
5.2.1 Establishing the Quality Policy
a) Is the quality policy statement appropriate to Quality policy has been evidenced The Quality Policy has all inclusions as per the C
the purpose and context? clause requirement of ISO 9001:2015
b) Is the quality policy statement defined in a Quality policy has been evidenced the quality policy has commitments statement C
way allowing for setting and reviewing quality towards objective oriented and continual
objectives? improvement factors required for
effectiveness of QMS
c) Does the quality policy include commitment to Quality policy has been evidenced The quality policy includes customer satisfying C
satisfy requirements? requirements statement
d) Does the quality policy include commitment to Quality policy has been evidenced The quality policy includes its commitment C
continual improvement of the quality statement towards continual improvement of
management system? quality management system
e) Is there planning to monitor and review Quality policy has been evidenced The quality policy provides commitment C
Quality Objectives at reasonable intervals? statement on review and monitoring of
quality objectives the review of the quality
objective shall be performed during internal
audit
5.2.2 Communicating the Quality Policy
a) Is the Quality policy documented or / and Quality policy has been evidenced The evidence has been complaint with the C
posted within the organization? requirement of the clause
b) Do staff members understand the Quality Quality policy has been evidenced The Quality Policy has been communicated to C
Policy? all employees through physical display and
emails
c) Has the quality policy been communicated to Quality policy has been evidenced The evidence has been complaint with the C
each interested parties? requirement of the clause
5.3 Organizational Roles, Responsibilities and Authorities
a) Is there a company Organizational chart with The organization chart has been the organisation chart covers the required C
position/title, and does the organizational established and cross verification position and title.
Audit Report Number – BQSR-C-1258
chart match with the process map to ensure of positions and personnel’s was
conformance to ISO 9001? performed and evidenced.
b) Are Job descriptions documented with The Organization practices defined In Compliance C
responsibilities to deliver intended outputs? roles and responsibilities –
c) Are Job description documented with The Organization practices defined The requirement has been evidenced and is C
responsibilities to report on performance, and roles and responsibilities – satisfactory
need for change if applicable?
d) Is there a backup person with the same The Organization chart describes Organizational chart was evidenced and is C
qualification and authority for each possible the hierarchical position where in found to be in compliance
significant position? the next reporting position is
capable to assist the organization
during requirement of replacement
6 Planning
6.1 Actions to Address Risks and Opportunities
6.1.1 Determining Risks and Opportunities
a) Are techniques / methods used to identify Procedure for risk and opportunity The risk management procedure contains the C
risks and opportunities? has been evidenced required methodology for risk assessment and
is found to be in compliance.
b) Are risks and opportunities categorized per Procedure for risk and opportunity The severity of the risk due to occurrence has C
their severity of their impact? has been evidenced been captured and residual risk calculation
post control implementation is also
evidenced.
c) Has the organization considered risks from Procedure for risk and opportunity The organization has considered risks from C
internal and external issues (4.1) they face has been evidenced internal and external issues during risk
which are relevant of interested parties (4.2)? assessment
d) Is there an established plan/method detailing Procedure for risk and opportunity Actions to be implemented have been I
the actions to be taken to address risks and has been evidenced demonstrated by the organization as all risks
opportunities? and actions are not implemented
e) Is there evidence that consideration of risk Procedure for risk and opportunity Internal and External opportunities and risks C
and opportunities from internal and external has been evidenced have been evidenced.
issues (4.1) has been integrated in the QMS?
Audit Report Number – BQSR-C-1258
f) Are the actions adequate? Can actions Procedure for risk and opportunity Is found to be in compliance C
appropriately assess the compliance of the has been evidenced
risks and opportunities?
6.2 Quality Objectives and Planning to Achieve Them
a) Are the Organization Quality Goals & The Quality objectives are The objectives for quality management system I
Objectives documented? Are Quality evidenced and found to be in needs to be improvised the Objectives must
Objectives measurable and consistent with compliance cover all departments and organizational goals
the quality policy?
b) Are quality objectives communicated in any Not in Compliance Non – Complaint NC
sort of media/form?
c) Has the Organization defined a plan or Not in Compliance The Quality objectives cover the responsibility
strategy to meet the Quality Goals and of achievement, timeline and measurable C
Objectives? aspects of objective
d) Are Quality Objectives monitored and The organization has regular Found to be in compliance NC
reviewed at reasonable intervals? intervals of monitoring but
improvement in communication
objectives is essential.
6.3 The Planning of Changes
a) Has the organization identified and Procedure for Change The organization identifies the changes to C
documented potential changes? Management is evidenced documentation, products and services,
personnel as primary changes
b) Is the purpose of changes defined? Procedure for Change Has been defined and found to be in C
Management is evidenced compliance
c) Are potential consequences / risks The potential risks and In compliance C
documented and analysed prior to applying opportunities are addressed prior
the changes? to applying changes
d) Is there a prevision / plan of how to Procedure for Change prevision / plan of how to implement changes C
implement changes to ensure the integrity of Management is evidenced to ensure the integrity of the QMS is
the QMS evidenced in this document
e) Are resource available to implement the Yes the resources are available C
change?
Audit Report Number – BQSR-C-1258
f) Are changes communicated to relevant Yes, the changes are The changes are communicated to relevant C
people? changed responsibilities communicated parties as per communication procedure that
is evidenced
7 SUPPORT
7.1 Resources
a) Has the organization determined and provided The organization has determined The organization maintains organizational C
persons / responsible necessary for the the human resource requirements chart, roles and responsibility description of
establishment, maintenance and continual and assigned roles and personnel’s and periodically assessment of
improvement of the QMS (7.1.1)? responsibilities accordingly efficiency is performed
b) Has the organization determined and provided The organization maintains The effectiveness is evaluated through C
persons responsible for the effective organizational chart, roles and internal audit and regular assessments
implementation of its QMS (7.1.2)? responsibility description of
personnel’s and periodically
assessment of efficiency is
performed
c) Has the organization determined, provided The organization has established Found to be in compliance C
and maintained infrastructure for the various request procedures and
operation of its processes to achieve forms where in required
conformity of product and services (7.1.3)? infrastructure is established by
management to ensure process to
achieve conformity of products.
d) Has the organization determined, provided The organization has established Found to be in compliance C
and maintained the environment necessary various controls and one such
for the operation of its processes and to examples are
achieve conformity of products and services Temperature/humidity checklist
(7.1.4)?
e) Has the organization determined and provided The organization has established C
resources for monitoring and measuring of various parameters and checklists
conformity of products and services (7.1.5)? for monitoring and measuring of
products.
f) When addressing changing needs and trends, In Compliance The procedure evidenced considers the input C
has the organization considered its current requirements and analysis of all requirements
Audit Report Number – BQSR-C-1258
knowledge and determined how to acquire or during development of new or change in
access any necessary additional knowledge product
and required updates (7.1.6)?
7.2 Competence
a) Is adequate Manpower provided for quality The requirements of personnel are The organization has provided required C
activities? established by the organization and personnel for the activities, the process
has been established and owners are required to request for additional
evidenced force through human resource request that
are communicated with management
b) Has the organization identified training needs training program which is regularly updated C
and developed a documented training plan? has been evidenced.
c) Are individual training records well The induvial training records have Found to be complying C
established and been evidenced
d) Has the effectiveness of training been Training program includes such The requirements are found to be complying C
evaluated through any type of examination requirements and has been
or test evaluated and evidenced
7.3 Awareness
a) Is adequate Manpower provided for quality The requirements of personnel are The organization has provided required C
activities? established by the organization personnel for the activities, the process
owners are required to request for additional
force through human resource request that
are communicated with management
b) Has the organization identified training needs Procedure for training and training program which is regularly updated MiN
and developed a documented training plan? awareness is evidenced has been evidenced. the improvement in
training programme is needed
c) Are individual training records well The induvial training records have Expect the organization to establish training C
established and been evidenced calendar and training programme to enhance
the ISO compliance
d) Has the effectiveness of training been Procedure for training and The effectiveness of the training is not MiN
evaluated through any type of examination awareness is evidenced captured in any feedback form and has to be
or test evidenced.
7.4 Communication
Audit Report Number – BQSR-C-1258
a) Is critical information identified to be shared Procedure for communication is Found to be complying C
internally? established
b) Is critical information identified to be shared Communication matrix is Found to be in compliance C
externally? evidenced.
c) Is information communicated in a timely Yes is evidenced Found to be in compliance C
manner?
d) Has the organization identified all the internal Communication matrix is The communication procedure addresses the C
interested parties to whom information will evidenced. internal party and its communication
be communicated to? methodologies
e) Does the organization identify all the external Communication matrix is The communication procedure addresses the C
interested parties to whom information will evidenced. External party and its communication
be communicated to? methodologies
f) Is there an established method to Communication matrix is Internal audits and management review C
communicate information relevant to quality evidenced. meetings are some examples of mediums for
management system? communication on QMS requirements and
Trainings
g) Has the organization nominated a The head of department or process External communication is well defined in the C
person/department in charge of owner is responsible for all procedures on responsibility and authorities.
communicating information internally and communication monitoring as
externally? mentioned in communication
procedure.
7.5 Documented Information
7.5.2 Creating and updating
a) Are quality system procedures & work The documented information Document identification needs to be I
instructions documented and identified? needs improvement in terms of improvised and should follow a set format.
identification, version controls and
others
b) Is there a documented procedure in place The documented information Found to be complying, Needs improvement I
that describes approval, distribution and needs improvement in terms of in recording change history
change control for internal documents. identification, version controls and
others
Audit Report Number – BQSR-C-1258
C) Is there evidence that approval, distribution The documented information The change management procedure describes I
and change of documents are properly needs improvement in terms of the evidence of approval, distribution and
followed as described in the procedure? identification, version controls and change of documents in procedure form
others
d) Is any form of media (Paper, electronical) Electronic medium of document Relevant folders and control of access is also C
used as a method to document procedures / establishment is primarily been evidenced.
work instructions? evidenced
e) Is there is a master list of all controlled Master list is to be updated. The document list tracker is evidenced and is I
documents that includes current revision updated at regular intervals or when changed
and distribution information as per change management procedure
f) Is a documented procedure in place that External origin document list is It maintains the details of the external origin C
describes control for external documents evidenced and found to be documentation,
and is there evidence that it is being compliance
followed.
g) Are quality system procedures & work Yes they have been evaluated and C
instructions documented and identified? found to be in compliance
7.5.3 Control of Documented Information
a Is appropriate documented information Yes the documents are accessible Found to be complying C
available at all locations where they are used and awareness on documentation
existence is been communicated
and recorded
b In which location is documented Complaint, QA-FM-15 describes Found to be complying C
information stored, are there easy to find? the location of availability
c Are Procedures in place defining the type, Yes in compliance Found to be complying C
location, protection, retrieval, retention
period and disposal of documented
information?
d Are changes to the documented information Yes the approvals are clearly Found to be complying C
reviewed and approved by an individual in the described in the organization and is
same function or organization that performed in practice
the original review and approval.
Audit Report Number – BQSR-C-1258
e Are approved changes communicated to the Yes the communication email to Found to be complying C
appropriate personnel in a timely manner. management has been evidenced
f Is the retention period of each record defined Yes the procedure for documents C
in the procedure? has been evidenced for this
requirement has been evidenced
g Are records that are required to be destroyed The records are maintained for a The practice has been evidenced and is in C
after a period of time identified? time interval of six months post compliance with requirements
change of the document as per
retention procedure
8 OPERATION
8.1.1 Operational Planning and Control
a) Has the organization planned a process for Yes defined procedures are C
operation? evidenced for each activity
b) Has the organization identified risks and Yes in each project risks are The risk management procedure has been C
opportunities on operational processes (using established and evaluated evidenced and contains the risks related to
risk- based thinking)? operational processes
c) Is the plan for the control of this process? The procedures have defined
controls at required steps
8.2 Requirements for products and services (Inputs)
8.2.1 Customer Communication
a) Is there a plan to communicate with Procedure for communication has The communication procedure has a C
customers in timely manner about products been evidenced. description of communication with customers
and services? and describes the communication
requirements like stages, responsibility to
communicate and content of communication
b) Does the order review identify the risk of not The risk management procedure Found to be complying C
making on-time deliveries, and include action has been evidenced and contains
to eliminate the risk? the risks related to operational
processes
c) Has the organization established contingency Non-conformity has been The risk management and risk log address the C
actions in case something goes wrong? established and application of NCR action plans in case of emergency or non-
procedure is crucial for such cases. conformities
Audit Report Number – BQSR-C-1258
8.2.2 Determining the requirements for products and services
a) Is there an authority to determine customer EN-PD-01 dated 17/12/2020 The product developer is responsible to C
requirements before launching product version 2 is evidenced determine the customer requirements prior to
development or production? launch of development of product.
b) Due to the nature of your product, are there There are external standards that C
"other" standards such as BS EN…, or ISO, not the organization refers to for its
stated by the customer, but to which this product development and
product should adhere? maintenance.
c) Due to the nature of your product, are there The product has clear description I
statutory and regulation requirements on the use and environment of use
determinate for health and safety of users,
and for environmental protection?
d Does the organization have established The organization has demonstrated The organization needs to implement the ITP MiN
Internal test Plan or any quality control for a general ITP for products, but the and project related quality requirements for
products detailed project wise ITP has not customer
been evidenced
8.2.3 Review of the requirements for products and services
a) Is there an authority to review requirements Sales and Business Development The requirement has been established C
for products and services? department will be the authority
for such activities.
b) Is there a procedure/system for order review The system is described is The procedure for order review has been C
before development or production? evidenced verified and all validation, verification and
approvals are evidenced.
c) Is there procedure/system for monitoring of The system is described and is The requirement has been established and is C
order changes? evidenced. complaint.
8.2.4 Changes to requirements for products and services
Does the order review procedure define how Change requirements has been has been evidenced as the forms supporting C
order changes are processed / approved? Is evidenced various forms were also the practice of the system.
there evidence of proper implementation? evidenced
Is there a procedure established to notify has been evidenced for The requirements for communication of C
relevant personnel of any changes applied to communication of changes changes to product has been evidenced in the
products and services? procedure.
Audit Report Number – BQSR-C-1258
8.3 Design and Development of Products and Services
8.3.2 Design and development planning
a) Is there a process for establishment, NOT APPLICABLE – Included in NOT APPLICABLE – Included in Exclusion
implementation and maintenance of Design Exclusion
and Development activities?
b) Does the organization determined the nature, NOT APPLICABLE – Included in NOT APPLICABLE – Included in Exclusion
duration and complexity of design and Exclusion
development?
c) Are responsibilities and authorities defined for NOT APPLICABLE – Included in NOT APPLICABLE – Included in Exclusion
the design and development process? Exclusion
d) Is there a Plan for Design & Development? Is NOT APPLICABLE – Included in NOT APPLICABLE – Included in Exclusion
there evidence of implementation? Exclusion
e) Is the Design & Development transfer stage NOT APPLICABLE – Included in NOT APPLICABLE – Included in Exclusion
planned? Exclusion
f) Is the method for the control of Design & NOT APPLICABLE – Included in NOT APPLICABLE – Included in Exclusion
Development change throughout the product Exclusion
design and life cycle defined in the procedure?
8.3.3 Design and Development inputs
a) Has the organization determined functional NOT APPLICABLE – Included in NOT APPLICABLE – Included in Exclusion
and performance requirements for the specific Exclusion
types of products and services to be designed
and developed?
b) Are potential consequences of failure due to NOT APPLICABLE – Included in NOT APPLICABLE – Included in Exclusion
the nature of the products and services Exclusion
identified and documented?
8.3.4 Design and development controls
a) Are results to be achieve are clearly defined? NOT APPLICABLE – Included in NOT APPLICABLE – Included in Exclusion
Exclusion
b) Does the Design & Development include the NOT APPLICABLE – Included in NOT APPLICABLE – Included in Exclusion
requirement to conduct Reviews at various Exclusion
stages?
Audit Report Number – BQSR-C-1258
c) Are activities for verification defined in the NOT APPLICABLE – Included in NOT APPLICABLE – Included in Exclusion
Design Plan? Exclusion
d) Are activities for Validation defined and NOT APPLICABLE – Included in NOT APPLICABLE – Included in Exclusion
performed per the plan and documented? Exclusion
e) Has the organization taken necessary actions NOT APPLICABLE – Included in NOT APPLICABLE – Included in Exclusion
on problems, if any, as determined during the Exclusion
reviews, or verification and validation
activities?
8.3.5 Design and development outputs
a) Do design and development outputs meet NOT APPLICABLE – Included in NOT APPLICABLE – Included in Exclusion
requirements of inputs? Exclusion
b) Do outputs include or reference monitoring NOT APPLICABLE – Included in NOT APPLICABLE – Included in Exclusion
and measuring methods, and acceptance Exclusion
criteria, as applicable?
c) Are performance indicators to measure the NOT APPLICABLE – Included in NOT APPLICABLE – Included in Exclusion
effectiveness of operation processes available Exclusion
and controlled? Does the organization keep
records?
d) Has the organization established a procedure NOT APPLICABLE – Included in NOT APPLICABLE – Included in Exclusion
for actions to be taken to prevent human Exclusion
error from affecting the quality system?
8.5.2 Identification and traceability
a) Are there procedures that define the Procedure for Identification and Found in Compliance C
identification of product and materials at traceability has been evidenced
various places, and is there evidence of
compliance?
8.5.3 Customer or external provider property
a) Is there a procedure in place that specifies The procedure is established and is The procedure is complaint to the C
methods of handling customer or external evidenced requirements of the standard
provider property to avoid damage,
deterioration, contamination, or other
adverse effects.
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e) Is there a procedure that describes how re- QA-PD-05 dated 08/07/2020 The requirements are evidenced and found to C
work will be accomplished and documented version 00 was evidenced be complying
and is there evidence of compliance?
9 Performance Evaluation
9.1 Monitoring, measurement, analysis, and evaluation
9.1.1 General
a) Does the organization determine what needs The organisation has determined C
to be monitored and measured? monitored & measured and
procedure controls related to
monitoring and measurement is
established
b) Have methods for monitoring, measuring, The organisation has determined The requirements are evidenced and is in C
analyzing, and evaluating validity of results monitored & measured and compliance
been defined and identified? procedure controls related to
monitoring and measurement is
established
c) Are methods describe how (manually, ERP The methods of monitoring is The requirements are evidenced and is C
system…etc.), when (Daily, monthly, specified with responsibilities of complying
quarterly…etc.) and who to monitor and monitoring being described
measure Quality Goals & Objectives? Are
there evidence of implementation?
9.1.2 Customer Satisfaction
a) Is there a procedure / system as a guideline to Customer satisfaction The requirements for customer satisfaction C
conduct customer satisfaction surveys? requirements are capture in CSS survey questionnaire has been evidenced
form
b) Are customer satisfaction surveys conducted In compliance The survey is conducted every time the C
in periodical manner as required? How many shipments of products is received by the
times a year? Is there evidence of customer. Multiple times based on orders of
implementation? customer
c) Are there follow up actions for improvement Yes, the follow up actions are being The requirements are following standards C
after the survey? evidenced clause demands
9.2 Internal Audit
Audit Report Number – BQSR-C-1258
a) Does the audit plan / scope address all areas Yes, the internal audit plan covers The audit plan covers all scope and addressed C
covered by the quality systems & cover all all the required scope and plan all areas of QMS
requirements of regulations?
b) Is there a documented procedure controlling Procedure for Internal audit has The procedure for internal quality audit has C
internal audits? Does the audit procedure been evidenced provision of re-audits if non-conformities are
contain a provision for re-audits if non- critical and needs review.
conformities are found?
c) Have Quality system audits been scheduled & Yes, has been evidenced to be as The audit was planned and conducted on C
completed and are audit documents on file? per the schedule
d) Are Internal auditors trained and are they Yes, in Compliance The internal auditors are trained and are C
independent of the areas audited? independent of any influence from other
departments
e) Are any audit findings properly documented Yes, in Compliance The Internal audit has been performed, and MiN
and is there evidence of actions taken? audit report was evidenced for the same
9.3 Management Review
a) Is there a documented management review The procedure for management The procedure for management review has C
procedure /system and is it under revision review meeting was evidenced been established and is evidenced
control.
9.3.1 Management review inputs
c) Are plans to collect inputs and related analysis All the management review inputs plans to collect inputs and related analysis of C
of actual situations defined in the procedure? as per standards has been actual situations are defined in the procedure
evidenced
d) Is there clear indication of which department Yes, it is clearly defined in the References of representation of department is C
/personnel shall be responsible for providing management review inputs evidenced
inputs?
9.3.2 management Review Outputs
a) If applicable, do the management review All the management review C
outputs include decisions and action taken outputs as per standards has been
related to opportunities of improvement, evidenced
changes needed, and/or resource needs?
10 Improvement
10.1 General
Audit Report Number – BQSR-C-1258
a) Is there a system / procedure as a guideline Procedure for objectives has been Quality Objectives which result in continual C
for identification of opportunities for evidenced. improvement is evidenced in the procedure
improvement?
b) Is there a responsible person in charge to Sandeep has been recognized as Execution of the provided responsibility is C
conduct this identification? the person in charge to conduct excellent
the identification
c) Is there any list of opportunity for Objectives list was evidenced list of opportunity for improvement approved, C
improvement approved, budget, timeline of budget, timeline of implementation is
implementation? Is evidence and the result of evidenced
such improvement visible?
10.1 Non-Conformities and corrective Actions
a) Are procedures defined as guidelines to Procedure for non-conformity has C
capture any complaint, conduct investigation been evidenced and complies
of root causes of nonconformities and to
define appropriate corrective Action to
prevent re-occurrence?
b) Does the factory maintain a list of complaints In Compliance The organization maintains corrective action C
(Internal / External)? Is there evidence that reports for register complaints
those complaints are analyzed to identify root
causes and opportunities to implement
corrective actions?
c) Is there a template/form to document the The organization follows 5 whys to The procedure documents decision making on C
decision-making process to pursue look into root cause analysis. investigation output and root cause actions
investigation and root cause corrective action?
10.2 Continual Improvement
a) Is there a procedure as a guideline for Yes, it complies, has been The procedure includes the requirement of C
continuous improvement of the QMS? evidenced Continual improvement through objective
oriented measures are verified and evidenced
b) Does the organization consider results of KPIs Yes, and redefines them eventually C
and evaluate them to determine necessity of
improvement?
Audit Report Number – BQSR-C-1258
Special Notes:
1. The organization must implement ISO 45001 and ISO 14001 for its environmental and HSE risks involved.
2. It is noted that the organization does not address many PPE, Chemical Hazards and Lifting hazards which needs to be implemented
3. The ERP is established by the integration of many requirements of QMS in ERP module such that automatic technological control is
implemented is missing, huge investment in terms of ERP is seen but effectiveness is minimal
4. Training and Awareness on complaints handling and quality analysis needs to be improved, no formal training feedback has been
evidenced.
Annex 1
Attendance List