Escolar Documentos
Profissional Documentos
Cultura Documentos
Systems: QMS ISO 9001 (2015) & EMS ISO 14001 (2015)
Assessment Report/Checklist
Form 009
CLIENT‐ORGANIZATION (NAME): Safi Aran
PHYSICAL LOCATION(s): No. 16, Block 61, Ali Abad INd. Town, Khavaran
Road, Tehran, Iran
Stage II Audit Date(s): 16 – 17 July 2016
Stage I Audit Date(s): 2 July 2016
NAICS (or NACE) CODE 17.29
NAICS : North America Industry Classification System (if you operate within the EC you may use NACE)
ISO 9001 EXCLUSIONS: 8.3 Design
Assessment objectives: Third party assessment of requirements of QMS ISO
9001:2015, is met in companies management system,
as well as legal requirements
ASSESSMENT TEAM INFORMATION
Assessment Team Leader, ATL Mojtaba Ramezani
Assessor 2
Assessor 3
Assessor 4
Assessor 5
Assessor 6
Note: Adjusting the language within this form to the type of activity and nature of the organization is acceptable.
Reference Clause Observation
We pursuit to assure that client‐organization adheres to the protection of communities and consumers. This is to
1 follow the intent to the substitution of the word “identify” to the word “determine” as part of the importance to
the processes being capable of achieving desired outputs (including consumer’s well‐being).
2 Scope of activities Food and pharmaceutical grade paper filter
BRSM requires that the organization’s legal obligations and regulatory are met.
Legal status Technical supervisor is main responsible for executing and monitoring of these
3 regulations ok
Obligatory applicable
standard which N/a
organization has to follow
4 Context of the organization
The organization has determined External and Internal issues relevant to its purpose /
strategic direction, affecting its ability to achieve the intended result(s) of its quality
Understanding the management system. Internal Issues: resources to fulfill the objectives, such as financial and
organization and its time allocated for projects while staff are busy with their routine tasks. External Issues:
4.1
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context Rivals in the industry, price of paper, lack of competent human resource in the industry,
QMS/EMS trade rules between Iran and China. The organization monitors and reviews information
about internal and external issues. Above information was documented, Type of document :
Manual, Code /ID: QM/00, Approved by: R Kafili, Date issued: Jan 2016,
The interested parties relevant to Quality management system, to meet customer and
applicable statutory and regulatory requirements have been determined (while in stage I it
Understanding the was not identified); The requirements of these interested parties relevant to the quality
management system. has been determined External Issues: GMP requirements by MoH and
needs and
industrial ministry and DoE. The Internal issues have been determined. The organization
4.2 expectations of
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monitors and reviews information about these interested parties and their relevant
interested parties requirements. Above information was documented, Type of document : Instructions/Codes,
QMS/EMS Code /ID: SP‐ Pr‐ 1393‐ 0011, Approved by: FDO, Date issued: April 2016, sample of matters
considered in the expectations; Increase of controls over factories by authorities has led to
increase of monitoring and control costs
Following Clause(s) has/have been Not applicable from the QMS; 8.3 Design and
Determining the development; ‐ Exclusions and their justifications have been defined in the QMS. The scope
of activities has been defined considering: the external and internal issues, the requirements
scope of the
of relevant interested parties, the products and services of the organization Scope of
4.3 quality/
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activity: Food and pharmaceutical grade paper filter. The organization has determined the
management role(s) undertaken by the organization under the applicable regulatory requirements.
system Organization role: Manufacturer. Above information was documented, Type of document :
Manual, Code /ID: QM/00, Approved by: R Kafili, Date issued: April 2016
FORM‐009_V4_QMS‐EMS Issued: July 9, 2003 Revised: June 2016 Page 2 of 14
Reference Clause Observation
The processes needed for QMS/EMS and their application throughout the organization has
been defined effectively. the sequence and interaction of these processes has been
Determined effectively with a risk based approach. the criteria and methods has been
determined to ensure that both the operation and control of these processes are effective
resources and information are available to support and monitor processes the Organization
Monitors, measures and analyses all its processes the organization follows actions necessary
to achieve planned results and to maintain the effectiveness of these processes the
organization evaluated changes/improvements in processes for their impact on the quality
management system and products produced by related QMS; the organization controls
Quality changes to processes against current International Standard and applicable regulatory
management requirements; 'QC', with process indicator/index: 'External NCs', acceptance level/criteria:
4.4
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system and its 'less than 7%', Owner of the Process: 'Quality manager', and 'Production' is input to this
processes process . Output from this process is used in ‘improvements’ .next process is 'production',
with process indicator/index: 'off‐times', acceptance level/criteria: 'less than 15 hours per
month', Owner of the Process: 'production manager', and 'production plan' is input to this
process. Output from this process is used in 'data analysis' .The organization has
determined the inputs required and the outputs expected from its processes; The
organization has assigned the responsibilities and authorities for its processes; Above
information was documented, Type of document : Isolated Paper : Sequence and order of
the processes, Code /ID: QA/00, Approved by: R Kafili, Date issued: Feb 2014
5 Leadership
5.1 Leadership and commitment
the Top Management, Mr. Ruhollah Kafili demonstrates leadership and
commitment with respect to the quality management system by: taking
accountability for the effectiveness of the quality management system; ensuring
that the quality policy and quality objectives are established for the quality
management system and are compatible with the context and strategic direction of
the organization; ensuring the integration of the quality management system
requirements into the organization’s business processes; promoting the use of the
5.1.1 process approach and risk‐based thinking; ensuring that the resources needed for
General
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qms the quality management system are available; communicating the importance of
effective quality management and of ","conforming to the quality management
system requirements; ensuring that the quality management system achieves its
intended results; engaging, directing and supporting persons to ","contribute to the
effectiveness of the quality management system; promoting improvement;
supporting other relevant management roles to demonstrate their leadership as it
applies to their areas of responsibility.")
5.1.2
Customer focus management demonstrated leadership and commitment with respect to customer focus
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qms
5.2 Policy
FORM‐009_V4_QMS‐EMS Issued: July 9, 2003 Revised: June 2016 Page 3 of 14
Reference Clause Observation
Quality Policy has been established in documented information, with ID: QP/00, Version: 0
Issued: Feb 2014 Approved by, Ruhollah Kafili. Is appropriate to the purpose and context of
the organization and supports its strategic direction; provides a framework for setting
Establishing the
5.2.1 quality objectives; includes a commitment to satisfy applicable requirements; includes a
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quality
commitment to continual improvement of the quality management system. The policy is
reviewed every year. Policy: increase of awareness, commitment to control and reduce of
pollutions, increase of recycling and reducing disposing wastes.
Policy has been established in documented information, with ID: QP/00, Version: 0 Issued:
Feb 2014 Approved by, Ruhollah Kafili. Quality policy was communicated to staff, as staff
Communicating the
5.2.2 was asked they were aware of the policy. Staff asked; Majid Bashiri . Sample of Policy items:
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quality policy
increase of quality bar, increase of customer satisfaction and market developement. The
policy is available to relevant interested parties. Such as: Contractor.
Top management has defined responsibilities and authorities which are
documented and relevant roles are assigned and communicated and understood
within the organization (organization chart). Performance of the quality
management system and opportunities for, improvement is being reported in
particular to top management; the integrity of the quality management system is
maintained when changes to the quality management system are planned and
Organizational roles,
implemented Top management has established the interrelation of all personnel
5.3 responsibilities and
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authorities
affecting quality, with independence and authority necessary to perform their
tasks.. Top Management has appointed Reza Bashiri as Management
representative. some of the main job duties of MR are as follows: , Establish and
Implement processes needed for the QMS/EMS and maintained, Report to top
management on the performance of the quality management system and any need
for improvement , promotion of awareness of regulatory and customer
requirements throughout the organization.
6 Planning
The organization has considered the issues affecting its strategies and directions
and their requirements and has determined the risks and opportunities that need
to be addressed. Sample of risks: risks related to failure in preventing bigger objects
passing through the filter, and causing problem for the device/machine. Sample of
opportunities: new markets are thirsty of the product in middle east. The
organization has planed actions to address risks and opportunities; The organization
Actions to address has integrated and implemented the actions into its quality management system
6.1
nc
risks and
processes. The organization has evaluated the effectiveness of the actions. Actions
opportunities
taken to address risks and opportunities are proportionate to the potential impact
on the conformity of products and services. Above information was documented,
Type of document: Procedure: risk assessment, Code /ID: W02, Approved by: R
Kafili, Date issued: Feb 2014 up Dated in October 2015, Changes needed to the
quality management system has been implemented. NC: risks and opportunities
determined during planning have not been updated
FORM‐009_V4_QMS‐EMS Issued: July 9, 2003 Revised: June 2016 Page 4 of 14
Reference Clause Observation
Quality Objectives have been documented, Issued: august 2015 Approved by,
Hussein Haghighi. Objectives cover all QMS requirements, as follows: Quality
objectives are in line with quality policy. The objectives are measureable. The
objectives take into account applicable requirements. The objectives include
product conformity/customer satisfaction. The objectives are being monitored. The
objectives are communicated to staff involved. The objectives will be updated if
necessary.
Quality objectives Sample objectives: increasing quality of products, Time to fulfill the objective:
6.2
August 2016, Objective indicator: number of NC products, Objective
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and planning to
6.2.1
achieve them acceptance/goal: less than 100 per 10000, Time to fulfill the objective: August 2016,
Objective indicator: number of NC products, Responsible people to fulfill the
objective: Reza Bashiri, Objective acceptance/goal: less than 100 per 100000,
Evaluation method: counting of NCs during the period.
Another Sample: Control of effect of activities , Time to fulfill the objective: end of
2016, Objective indicator: number responsible people to fulfill the objective: Mr.
Bashiri
Change to MS is carried out in planned manner. Changes are planned to be
reviewed periodically every 2 years. Planning of changes cover all MS requirements,
Planning of changes
6.3 as follows: the purpose of the changes and their potential consequences; the
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Achieve objectives integrity of the quality management system; the availability of resources; the
allocation or reallocation of responsibilities and authorities. To cover the standard
7 Support
7.1 Resources
The infrastructure necessary for the operation of its processes and to achieve
conformity of products and services includes: buildings and associated utilities;
information and communication technology. Preventive maintenance of machines
affecting quality is directed by Preventive Maintenance procedure with Document
ID/version of W03 issued in March 14, approved by R Kafili. The document includes
requirements to prevent product mix‐up and orderly handling of product. Records
of Planned maintenance and services needed for Machines affecting quality
7.1.3
Infrastructure observed during audit; PREVENTIVE MAINTENANCE PLAN. Each machine has a
nc
qms
record of the history of repairs and services done for it Each machine is identified
when are out of work Sample of Machines taken as evidence during audit. Name of
the machine/device reviewed: Furnace, This machine/device is used for Cooking
paper. Planned Services considered for this machine observed during audit: doors
seam insulators, Planned intervals: every 2 Years. Records of repairs done in May‐
16, observed during audit: Sensor changed.
Oil spilled on the floor during maintenance and based on the effect.
The organization has determined, provided and maintained the
7.1.4 for the operation of socially/psychologically and physically necessary for the operation of its processes
nc
FORM‐009_V4_QMS‐EMS Issued: July 9, 2003 Revised: June 2016 Page 5 of 14
Reference Clause Observation
7.1.5 Monitoring and measuring resources
Equipments are suitable for the specific type of monitoring and measurement
Equipments are maintained to ensure their continuing fitness for their purpose. The
7.1. organization has established documented information as evidence of fitness for
5.1 General purpose of the monitoring and measurement resources, Procedure name:
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qms Calibration procedure, Procedure code: P05, Approved by: Hussein Haghighi, Dated:
May‐16.
Calibration plan is recorded/planned in: Calibration Log. Calibration status is
recorded in: Tag on the device box. Calibration status is identified, Name of the
tool/device reviewed: Furnace Sensor Thermometer This device is used for
Measuring temperature in furnace, calibration status: Calibrated. last date of
calibration: November 15. Next due date of calibration: 2016‐November. The device
is calibrated externally by Laksar, . All measuring devices observed have been
7.1.
Measurement calibrated in range required by standard and application. Calibrations are traceable
5.2
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traceability to international applicable standards. Measuring devices are safeguarded from
qms
adjustments that would invalidate the measurement results. Measuring devices are
protected from damage and deterioration during handling, maintenance and
storage. When equipment is found out of calibration, all previous measurements
are called invalid and they get verified again. The organization takes appropriate
action on the equipment and any product affected by out of calibration measuring
device.
The organization has determined the knowledge necessary for the operation of its
processes and to achieve conformity of products and services. The knowledge is
maintained and made available.
7.1.6 Organizational Operators are trained based on previous experience gained from the service and
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qms knowledge product, such as the mixers operators or furnace operators who have been trained
for operating of the machine, managers attend the seminars in their area of their
work as an example participating in paper recycling seminar in 2014 in Chalooos
university.
FORM‐009_V4_QMS‐EMS Issued: July 9, 2003 Revised: June 2016 Page 6 of 14
Reference Clause Observation
Training and competence of staff affecting quality is directed by Training / HR
procedure with Document ID/Version of P10 issued in March 14 , approved by Mr.
Haghighi. records of qualifications and competence needed for positions affecting
quality observed during audit; training plan/matrix . records of trainings conducted
for positions affecting quality observed during audit; training plan F01‐P10. records
of trainings evaluations for training conducted observed during audit; evaluation
training form . The organization keeps the educational records of staff affecting
quality, Type of Record: Diploma and License. The organization keeps the Training
records of staff affecting quality, Type of Record: Training Certificates. The
organization keeps the Experience and skills records of staff affecting quality, Type
of Record: Resumes. for sample, following evidence has been reviewed during HR
7.2 Competence audit; Name of the staff profile reviewed ,Bahram Akbari, Position: QC. Education
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record was in place: High school Diploma. Training planned observed during audit
for clamping and attaching papers on regal, Planned in 16‐jan‐16. Records of
Training conducted in 17‐jan‐16, observed during audit for clamping and attaching
papers on regal. Records of Training effectiveness evaluation done in 25‐jan‐16
observed during audit for clamping and attaching papers on regal, evaluation result:
0.67. Name of the staff profile reviewed, Ali Allayari, Position: warehouse manager.
Education record was in place: Associate degree. Training planned observed during
audit for Pressing paper filters, Planned in 13‐May‐16. Records of Training
conducted in 18‐May‐16, observed during audit for Pressing paper filters. Records
of Training effectiveness evaluation done in 25‐May‐16, observed during audit for
Pressing paper filters, evaluation result: 0.87.
Quality policy was communicated to staff, as staff was asked they were aware of
the policy. Staff asked; Majid Bashiri . Sample of Policy items: increase of
awareness. Quality objectives were communicated to staff, as staff were asked they
7.3 Awareness were aware of the related objective to their job staff asked; Majid Bashiri . Related
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objective: CRM Project. Staff is aware of their contribution to the effectiveness of
the quality management system and the implications of not conforming to the
quality management system requirements are not feed backed to staff.
The organization has determined the internal and external communications
relevant to the quality management system. The communication includes following
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criteria: 'on what who communicates, when, how and to whom', Internal
communications are mostly; verbally, Face to Face, In writing, and external
communications are mostly formal. The communication is effective and efficient
7.4 Communication
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according to the complications and size of organization. Sample of communication
observed: subject of communication: feedback from client, on what circumstance :
complaint by customer, who initiated the communication : Sales department, to
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whom : quality department, method of communication : letter was forwarded
7.5 Documented information
Documented information required by current International Standard(s); has been
determined: Such as: Quality Manual. Documented information by the organization
7.5.1 General
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as being necessary for the effectiveness of the quality management system has
been determined: Such as: Quality Manual.
FORM‐009_V4_QMS‐EMS Issued: July 9, 2003 Revised: June 2016 Page 7 of 14
Reference Clause Observation
It provides a method of revision status identification (including changes) and
prevention of obsolete document to be used. Method of identification: List of
approved documents F02‐P01. , Obsolete documents are kept in In file, physically
Creating and
7.5.2 kept in old file in the drawer. Method of identification: List of approved documents
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updating
F02‐P01. , Obsolete documents are kept in In file, physically kept in old file in the
drawer. Documents are in Persian Language. The media used for documents is:
paper and electronically.
7.5.3 Control of documented information
Documents are always available at the point of access as in Furnace, Furnace work instruction and method of
7.5.3.1 drying filters was available. all sample reviewed documents are Legible and Readily identifiable. All sample
reviewed documents are distributed according to confidentiality consideration.
Method of defining distribution: green and red stamp. Method of retrieving of records: backup of raw electronic
file. Method of disposing of records: when a new record is in place the old one is collected and disposed. as
evidence records of Quality Check of Filter press paper seen issued at: 23‐June‐15 which is kept on paper.
7.5.3.2 Applicable national or local regulations were identified. Sample of applicable local and national documents are in
control: Water discharge code. External documents were identified. Applicable external documents were listed
in distribution matrix F02‐P01. Sample of external documents listed: STANDARD 1295‐ 1.
8 Operation
The organization has planned, implemented and controlled the processes needed
to meet the requirements for the provision of products and services, and to
implement the actions determined in by: Determining the requirements for the
products and services, Establishing criteria for the processes, and the acceptance of
products and services, Determining the resources needed to achieve conformity to
the product and service requirements, Controlling of the processes in accordance
Operational
with the criteria, Determining, maintaining and retaining documented information
8.1 planning and
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to the extent necessary, criteria established for the processes, and the acceptance
control
of products and services, The output of this planning is suitable for the
organization’s operations.
Sample taken: The furnace is adjusted time to time, and checked at the beginning of
each shift, the company reviews the change to the process to monitor the
compliance with environment limits.
8.2
Requirements for products and services
qms
Requirements met in communication with customers are as follows: providing
information relating to products and services; handling enquiries, contracts or
8.2.1 Customer
orders, including changes; obtaining customer feedback relating to products and Ok
qms communication
services, including customer complaints; handling or controlling customer property;
establishing specific requirements for contingency actions,
FORM‐009_V4_QMS‐EMS Issued: July 9, 2003 Revised: June 2016 Page 8 of 14
Reference Clause Observation
The organization has determined product and service requirements, Such as:
Determining the
applicable statutory and regulatory requirements; considered requirements
8.2.2 requirements for
necessary by the organization, Approved by: FDO have been reviewed and ok
qms products and
considered. Sample record for product requirements observed, Document name:
services
catalogue Issued: 11‐jan‐15.
The organization reviews product requirements, Such as: requirements specified by
the customer, requirements for delivery and post‐delivery activities, Requirements
not stated by the customer but necessary for specified or intended use, applicable
regulatory requirements related to the product, requirements specified by the
Review of the organization, The company reviews the product requirements through formal
8.2.3 requirements for documented communications with customer. The documented record observed
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qms products and during assessment for product requirement was; Contract no.2348845‐3, dated 23
services July 2016, for customer: Khodayar Razavi, sample of requested product
requirements: paper press filter, Results of the reviews are recorded and
maintained, in: as in contract above. And also The company reviews the product
requirements through informal communications or verbally with customer.
customer can select from items in catalogue and buys it from the company
Changes to , where product requirements were changed, the organization had not ensured that
8.2.4 requirements for relevant documents were amended and consequently the relevant personnel were
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qms products and made aware of the changed requirements.
services
8.3
Design and development of products and services
qms
8.3.1
General Not applicable e
qms
Design and
8.3.2
development Not applicable e
qms
planning
Design and
8.3.3
development Not applicable e
qms
inputs
Design and
8.3.4
development Not applicable e
qms
controls
Design and
8.3.5
development Not applicable e
qms
outputs
Design and
8.3.6
development Not applicable e
qms
changes
8.4
Control of externally provided processes, products and services
qms
FORM‐009_V4_QMS‐EMS Issued: July 9, 2003 Revised: June 2016 Page 9 of 14
Reference Clause Observation
: Suppliers evaluation and selection, Approved by: Hussein Highlight The
organization evaluates and selects suppliers based on their ability to supply product
in accordance with the organization’s requirements, the Criteria for selection,
8.4.1 evaluation and re‐evaluation has been established . , The organization evaluates
General ok
qms suppliers periodically, every 12 months. The evaluation of suppliers includes 'ability
and performance of supplier', 'effect of the purchased product on the quality of the
product' and is proportionate to the risk associated. Sample of criteria: distance ‐
price ‐ equipment ‐ a ‐ b ‐ c. . sample of criteria: distance
The organization ensures that externally provided processes remain within the
control of its quality management system;
,The organization defines both the controls it intends to apply to an external
provider and those it intends to apply to the resulting output;
The organization evaluates the effectiveness of the controls applied by the external
provider;
8.4.2 Type and extent of
The organization has established inspection and verifies purchased products meet ok
qms control
specified purchase data requirements, records of the purchase verification and
controls are provided in F03‐ P06, The extent of verification activities is based on
the supplier evaluation results and proportionate to the risks associated with the
purchased product. When the organization becomes aware of any changes to the
purchased product, the organization determines whether these changes affect the
product realization process or the product.
Purchasing information describing the product specification and criteria, suppliers
qualifications and QMS, to be purchased is in place , records of the purchase
information is provided in F03‐ P06, sample of purchase data for purchased item:
Bearing with following specification; With CE Mark,, specified dimensions,,
observed.
8.4.3 Information for All requirements met in Information for external providers as follows: products and
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qms external providers services; acceptance: sample of the acceptance data observed. Methods, processes
and equipment for approval100 % qc control. the method of release of products
and services; after approval by QC manager. Competence, including any required
qualification of persons; qc people have trainings in controlling the production. The
external providers’ interactions with the organization; the MR of the supplier in
touch with organization.
8.5
Production and service provision
qms
FORM‐009_V4_QMS‐EMS Issued: July 9, 2003 Revised: June 2016 Page 10 of 14
Reference Clause Observation
All requirements met in Control of production and service provision as follows: the
characteristics of the products to be produced, the services to be provided, or the
activities to be performed; the results to be achieved; the availability and use of
suitable monitoring and measuring resources; the implementation of monitoring
and measurement activities at appropriate stages to verify that criteria for control
Control of
8.5.1 of processes or outputs, and acceptance criteria for products and services, have
production and ok
qms been met; the use of suitable infrastructure for the operation of processes; the
service provision
appointment of competent persons, including any required qualification; the
validation, and periodic revalidation, of the ability to achieve planned results of the
processes for production and service provision, where the resulting output cannot
be verified by subsequent monitoring or measurement; the implementation of
actions to prevent human error;
Organization controls and records the unique identification of the product. Sample
product taken: 'paper filter', serial number: 931128‐Osf1000ag, Date produced:
8.5.2 Identification and
may 16. Final product is traceable to following items: Purchased Material, for the ok
qms traceability
sample taken it is tracked to The organization ensures that output returned to the
organization are identified and distinguished from conforming ones.
The organization identifies, verifies, protects and safeguards customer property
Property belonging provided. When the property of a customer or external provider is lost, damaged or
8.5.3
to customers or otherwise found to be unsuitable for use, the organization reports this to the ok
qms
external providers customer or external provider and retains documented information on what has
occurred.
The company has following storages: Raw material, Final product. Preservation
method includes: Identification, Handling, Packaging, Storage and protection.
Sample product: filter press paper. Identification method for the sample taken:
8.5.4 931128‐Osf1000ag, Storage and protection method for the sample taken: in cartons
Preservation ok
qms and closed bags to protect from dust. There is sufficient inventory stock of the
sample taken as required in the system. There is currently 3500 number of filter
press paper in the storage. Minimum inventory stock /order point for this product is
2000.
8.5.5 Post‐delivery
Not Applicable e
qms activities
The organization reviews and controls changes for production or service provision,
8.5.6 to ensure continuing conformity with requirements. Results of the review of
Control of changes ok
qms changes, have been recorded in: management review. Ruholla Kafili is responsible
to authorize the changes.
Records of conformity with the acceptance criteria observed in: f01‐p04, for
Release of product/service: filter press paper, Date released: 34‐ May 16the person(s)
8.6
products and authorizing the release is traceable to each time release.Mr. Bashiri is authorized to ok
qms
services release. There has been no circumstance till now that the product has been
released before all arrangements being satisfactory fulfilled.
FORM‐009_V4_QMS‐EMS Issued: July 9, 2003 Revised: June 2016 Page 11 of 14
Reference Clause Observation
Controls and related responsibilities and authorities for dealing with
nonconforming product have been defined. Mr Reza Bashiri is authorized to deal
with non‐conforming products. The organization deals with non conformities in
Control of following ways: The organization releases the non‐conforming product if it meets
8.7
nonconforming regulatory requirements .Sample non‐conforming products/records observed: ok
qms
outputs failed filters. Nature of Non‐conformity of the product: out of dimensions. The non‐
conforming product observed in: 'final product storage'. The non‐conforming
products are identified by: labels. The non‐conforming products are properly
identified throughout the process.
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
All requirements met in Monitoring, measurement, analysis and evaluation ,as
follows: Items needed to be measured, such as; processes, quality controls,
objectives, the methods used for monitoring, measurement, analysis and evaluation
9.1.1 General to ensure valid results; such as; statistical methods, data gathering, when the ok
monitoring and measuring is performed; every 6 months, when the results from
monitoring and measurement is analyzed and evaluated; before internal audits
Above information was documented, Type of document : Form : Process measuring.
The organization monitors information relating to whether the organization has
9.1.2 Customer
met customer requirements. Source of customer requirements fulfillment ok
qms satisfaction
monitoring: complaints 80.80% of customer’s satisfaction.
Process name: 'QC', Process index: 'External NCs', Process criteria: 'less than 7%',
Process outcome/result: '6%'. Process name: 'production', Process index: 'off‐
times', Process criteria: 'less than 15 hours per month', Process outcome/result:
'2:50'. With comparison of characteristics and trends of processes with previous
9.1.3 Analysis and results the system is proved to be improving.
Qms evaluation of All requirements met MS as follows: conformity of products and services; the
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compliance degree of customer satisfaction; the performance and effectiveness of the quality
management system; if planning has been implemented effectively; the
effectiveness of actions taken to address risks and opportunities; the performance
of external providers; the need for improvements to the quality management
system.
The responsibilities and requirements for planning and conducting audits, is
9.2/ Internal audit
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provided in a documented method; audit procedure, code and version: P03. The
9.2.1 General
audit report is recorded in: audit report from, code and version: F03‐P03. Latest
internal audit was conducted in August 2015. Latest internal audit was conducted
by Mr Bahsiri‐ Mr Kafili. In latest internal audit, auditors did not audit their own
Internal audit work. Corrective action followed up after the NCs rose in latest internal audit, The
9.2.2
programme latest audit result was reported to all staff related and needed to be involved. Audit
program has been considered to be conducted every year, in form F01‐P03, Audit
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planned in F02‐P03
9.3 Management review
FORM‐009_V4_QMS‐EMS Issued: July 9, 2003 Revised: June 2016 Page 12 of 14
Reference Clause Observation
The intervals of management review meeting have been determined in QMS; every
12 Months The latest management review was conducted in: 29‐ September ‐15.
9.3.1 General ok
Participants in the latest Management review session: Ruholla Kafili and Ali AllaYari
and Seyed Mohsen Hashemi and Mehdi Akbari.
Inputs to latest management review meeting;
All inputs were discussed in management review meeting, as follows: ‐Changes in
external and internal issues that are relevant to the quality management system;‐
The status of actions from previous management reviews;‐Customer satisfaction
Management and feedback from relevant interested parties;‐The extent to which quality
9.3.2 ok
review inputs objectives have been met;‐Process performance and conformity of products and
services;‐Nonconformities and corrective actions;‐Monitoring and measurement
results;‐Audit results;‐The performance of external providers;‐The adequacy of
resources;‐The effectiveness of actions taken to address risks and opportunities;‐
Opportunities for improvement. Fulfillment of its compliance obligation.
Outputs to latest management review meeting;
Following outputs have been considered as follows: ‐Resource needs; as result
Management following items has been significant outputs of Management review: to change the
9.3.3 ok
review outputs Dies in the line due to their age. It was decided to plan for overhaul of the furnace
and to increase the green area.
Management review results and agenda were recorded in Management minute.
10 Improvement
in general the organization identifies and implements any changes necessary to
ensure and maintain the continued suitability, adequacy and effectiveness of the
quality management system as well as product safety and performance to the
extent reflected in this report through; meeting customer requirements and
10.1 General ok
enhancing customer satisfaction, improving products and services to meet
requirements as well as to address future needs and expectations, correcting,
preventing or reducing undesired effects, improving the performance and
effectiveness of the quality management system.
Sample corrective action: over dried filters. Nonconformity has been detected in:
28‐June 2016 and action has been taken in: 29‐june 16with no delay. Cause of
Nonconformity and
10.2 nonconformity: overheated. Action taken to monitor the heat was evaluated and it ok
corrective action
was not effective, but follow up action is in progress. Corrective actions are
recorded.
The organization continually improves the suitability, adequacy and effectiveness of
the quality management system. The organization considers the results of analysis
Continual
10.3 and evaluation, and the outputs from management review, to determine needs or ok
improvement
opportunities to be addressed as part of continual improvement to the extent
reflected in this report.
By exception we indicate the specific Strengths and weakness of the organization in light of the management system of the management system, as we
perceive and seen through processes in reference to requirements of the criteria being ascribed as these apply and relate to the assessment plan and
planning of the assessment. This aspect relates to AVA™ as it does to the protection of consumers in the client-organization’s role within their respective
supply – chain.
Disclaimers: (1) herein, we reiterate that any suggestion or opinion that the assessment team expresses does not construe to be a contractual
FORM‐009_V4_QMS‐EMS Issued: July 9, 2003 Revised: June 2016 Page 13 of 14
Reference Clause Observation
requirement. (2) The degree of certainty in conclusions increases by the competence of the assessment team as well as the attestation within the
assessment protocol, values, mission and vision under which we operate for the protection of consumers, still remains a certain level of uncertainty.
Strength Weakness
Human resources – management commitment Management system Knowledge of staff
action Request Type I Form-008 – as we indicate and that each of the RA addresses the basic four (4) questions
as seen in Form-008:
action Request Type II Form-008 – as we indicate and that each of the AR addresses the basic four (4) questions
as seen in Form-008:
Risks and opportunities determined during planning have not been updated
FORM-009 – MS Reporting,
FORM-014 – Opening Meeting Checklist
FORM-008 – RA / AR, as requires
FORM-017 – Closing Meeting Checklist
FORM-018 – OBS, as requires
FORM-005 – Participants of opening & closing meetings
FORM-010 – As requires, recommendation for CoR
FORM-004 – Assessment Plan
FORM-026 – Assessment documents check-sheet,
FORM-007 – Planning onto -004, as process determined
for guidance purpose
FORM‐009_V4_QMS‐EMS Issued: July 9, 2003 Revised: June 2016 Page 14 of 14