a) Opening Meeting

 List of attendance - Keep the attendance list for report purpose.

 Perform an introduction and purpose of the visit/audit
 Said the audit/visit generally followed the agenda provided Any clarification needed?? Perform
explanatory on the audit scope?? – Agenda to provide prior visit
 Explanatory on audit structure – definition on term, corrective action needed, way of corrective action
implementation, and any requested docs/report not presented prior audit closing will consider not
available.
 Confidential statement – Audit report will shall not disclose to 3 rd parties without agreement of both
parties
 Stress that although the audit generally for Quality however HSE will also investigate at minimum.
 Report will be sending to client however any findings throughout the audit will be discusses and
clarify during audit closing.
 Advise any restriction on shop floor (HSE, photograph allowed??)
 Vendor presentations (overall, HSE, etc...) – jot down their company overall business, pass experience,
design capabilities, code, standard and specification references, shop capabilities, shop capacity, shop
overall progress (current) - workload, in house equipment’s capabilities (crane capacity, assembly
capacity, load out from inside shop, welding capabilities – material related, inspection & test capacity
(hydrostatic water sources for big volume and PWHT especially) loading/shipping area and limitation,
mode of transport and packaging. Need suitable to the scope undertaken. Asked copy of
presentation if needed for report purpose.
 Jot down vendor working time (from when to when, day, shift etc..)
 Jot down vendor total employees with detail breakdowns (i.e.. Manager??top management?? CEO??
QA?? QC ??)

b) Management Structure
 Asked vendor general organization chart. Did key department/personnel available to cover the scope
(i.e..engineering/design, procurement, production, quality (independent from other department??),
and etc) ( keep the chart for report purpose)
 Asked vendor number of employee (permanent/contract/on job basis) roughly following by key
department?? (i.e...Management, QC personnel, supervisor, engineer, coordinator, NDT personnel,
welder, fitter, helper etc...)

c) Management System (9001/14001/18001 (45001) EN

1090/ASME/PED/ABSA/AISC/CSA/Regulatory)
 Asked vendor certifications/accreditations (ISO/ASME/PED/EN 1090/ABSA/AISC/AWS/CSA etc...)
Check if the certification scopes cover work undertaken?? (Keep certificates for report purpose)
 Asked vendor certification body use?? (i.e. For ASME their ASME AI, for PED their NoBo etc...)
 Asked vendor quality manual and their related procedure and work instruction – 2015 ISO 9001 may
or may not have the quality manual and certain documentations. Check others
standard/regulatory/construction code require manual? Did manual authorize by top
management??? (signed, date, named) (Keep first page of QM, table of content, policy, objective,
procedure table of contents, and work instruction table of contents for report purpose.)
 Vendor manual, procedure, work instruction written language??English and/or native??If English only
did all employee well versed in English?? If not in English did vendor able to produce in English or dual
language if needed??
 Vendor manual, procedure, work instruction accessibility??Hard copy or soft copy??If hard copy how
many copies been made?? (Keep distribution list for report purpose)
d) Control of Documentations
 Cross check quality manual revision/management system procedure/work instruction is the latest
version available and being use??cross check again their index and distribution. Jot down the
procedure number being check for report purpose.
 Vendor management system document control procedure?? Jot down procedure no??
Incoming/outgoing transmittal??Working on latest revision?? Crosscheck during shop visit on docs
available at shop floor?? All drawing, procedure is approved for construction?? (Keep transmittal
for report purpose)
 Vendor documentation produces according to contract requirements?? Random review on contract
specific procedure (i.e..RT procedure conformance to ASME V)
 Vendor documentation written languages?? English and/or native??If English only did all employee
well versed in English?? If not in English did vendor able to produce in English or dual language??
Minimum procedures i.e..( ITP, wed plan, weld map, WPS/PQR, WPQR, NDT (RT/UT/PT/MPI), Ferrite,
PMI, PWHT, Hardness, Hydrostatic test, Pneumatic test, pickling and passivation, handling (material &
consumable), packing, coating etc…)
 Vendor code, standard, specification availability?? Is it latest and or per contract requirement??Is it
well control and authorize for vendor?? – Code and standard must be the one buy by vendor and not
downloadable or sharable available on the internet.
 Vendor record retention?? 3, 5, 10 years??Check previous MDR (ABSA MDR, ARH Dossier, PED
Technical File, EEHA dossier and etc…) related to the scope undertaken?? (Keep approved table of
content for report purpose)
 Vendor record retention soft copy or hardcopy??where it being keep if hard copy??If soft copy how??
how does this soft copy being protect (backup server, antivirus etc..)??

e) Management review
How to Make the Quality Objectives Work for You
After deciding which things to monitor, measure and improve, the important thing is to make the
Quality Objectives effective in addressing what needs to be improved. The objectives should be
designed to be S.M.A.R.T (specific, measurable, achievable, realistic and time-based) and
should have relevance at all levels of the company, meaning that each employee should
understand how their job supports meeting the Quality Objectives. To do this, the following
should be addressed:

Specific. For the best results, an objective needs to be clear and specific. Instead of saying “to
improve non-conforming product,” a specific Quality Objective would be “to reduce non-
conformances on the third widget line,” if the third widget production line is showing data as the
most troublesome area for non-conforming product.

Measurable. If an objective can’t be measured, how will you know if it has been obtained? In
order to make a Quality Objective effective, it needs to be measurable, so this means that having
an objective “to reduce non-conformances on the third widget line from 15% to 5%” is much more
effective than saying “to improve quality of the products on the third widget line.” You can
measure the defects being made, and therefore make plans to reduce the number of defects, but
a vague measure of “quality” is more ephemeral and very hard to plan improvements for.

Agreed. For an objective to be agreed it first needs to be created and approved by top level
management. Once management agrees on the objective it needs to be communicated to each
level of the organization that will be required to implement the plans to achieve the objective, and
the people at these levels of the organization need to agree that the plan is achievable. Without
this buy-in they may not fully work towards the goal and the plan may be doomed to failure.

Realistic. Being realistic with an objective will make selling it within your organization easier. If
you tell your employees that you want to reduce defects from 50% to 2%, they will not be able to
see how this is possible, especially if the plans around the object do not support the
improvement. It is better to set realistic goals and overachieve than it is to set unrealistic goals
and always fall short of the expectation.

Time-Based. To be truly effective, an objective needs to have a time associated with it. To say
“reduce non-conformances on the third widget line from 15% to 5% in the next year” allows for
better planning, since a plan needs to have dates in order to be properly tracked. Again, having
the time associated will allow you to monitor how close you expect to be in achieving your goals.

7.1.5 Monitoring and Measuring Resources

7.1.5.1 General
The organization should determine and provide the resources needed for valid
and reliable monitoring and measuring results, where monitoring or measuring is
used for evidence of conformity of products and services to specified
requirements. The organization should ensure that the resources provided are
suitable for the type of monitoring and measurement activities being undertaken
and are maintained to ensure continued fitness for their purpose. The
Organization should retain appropriate documented information as evidence of
fitness for the purpose of monitoring and measurement resources.
7.1.5.2 Measurement Traceability
Where measurement traceability is a requirement(statutory or regulatory  or
customer or relevant interested party expectation) or considered by the
organization to be an essential part of providing confidence in the validity of
measurement results,  measuring instruments must be verified or calibrated at
specified intervals or prior to use against measurement standards traceable to
international or national measurement standards. The organization must retain
the basis used for calibration or verification as documented information if no
such standard exists as documented information. Measuring instruments
must be identified in order to determine their calibration status; It must be
safeguarded from adjustments, damage, or deterioration that would invalidate
calibration status and subsequent measurement results. The organization
should determine if the validity of previous measurement results has been
adversely affected when an instrument is found to be defective during its
planned verification or calibration, or during its use, and take appropriate
corrective action as necessary.

This clause is specifically about monitoring product and service for conformity.  This
clause replaces old clause 7.6 on Control of Monitoring and Measuring Equipment
and is one of the structural changes in the 2015 revision. the use of the term
“equipment” has been changed to “resources”. It needs evidence of the fitness for
purpose of the resources. Humans may carry out the activity without
equipment. Calibrated equipment now termed “instruments”.   Monitoring and
measuring the quality system has a whole clause (9 Performance Evaluation)
dedicated to it.  This clause is sticking only with monitoring and measuring devices
and equipment used to monitor the product (or service).  So,  the organization must
ensure they have identified and put in place the appropriate resources including
(7.1.2 People, 7.1.3 Infrastructure, 7.1.4 Environment) and now 7.1.5 Monitoring and
measuring resources.

Requirements for what needs to be measured and the acceptance criteria may come
from the customer, regulatory, industry and your own organization. Product
realization planning must determine the following what specific product and process
characteristics need to be monitored and measured, the criteria for product
acceptance, the type of Monitoring and Measurement Device needed, frequency i.e.
at what stages of realization to do it, sample size, etc. You must then determine what
Monitoring and Measurement Device is appropriate for each measuring or
monitoring requirement. Consideration must be given to the measurement capability
(precision) of the Monitoring and Measurement Device which may have to be several
times greater than the tolerance criteria for product measurement.  This would
depend on the industry you are in and the criticality of end use for the product for
e.g. the precision requirements for ball bearings may be much greater than say for
cutting cloth to make a shirt. Personnel using Monitoring and Measurement Device’s
must have competence and training in the use of Monitoring and Measurement
Devices in terms of their function, range, and precision of measurement, reliability,
use, and maintenance. Monitoring and Measurement Devices may include
measurement and testing tools, equipment, hardware, and software. They may be
owned by your organization, your employees or the customer. Monitoring and
Measurement Devices may be used to verify product as well as to measure process
conformity for e.g. a temperature controller on an oven.  Besides Monitoring and
Measurement Device’s used for product conformity, you may need to calibrate and
control certain Monitoring and Measurement Device’s used in related and peripheral
processes such as production equipment, tooling, maintenance, etc. To ensure valid
measurement and monitoring results, Monitoring and Measurement Device’s must
be controlled. A process is required, to control the identification of monitoring
measurement,  selection, purchase, status, identification, calibration, verification,
adjustment or readjustment, use, handling, maintenance and storage, training,
handling of nonconforming  Monitoring and Measurement Device’s, etc. You must
keep appropriate records to demonstrate effective operation and control of your
Monitoring and Measurement Device processes. These records must include
calibration and verification records traceable to national, international or other
benchmark used for calibration.

All Monitoring and Measurement Device’s used for product verification must be
capable of being calibrated, verified or both. Calibration is setting or correcting a
Monitoring and Measurement Device, usually by adjusting it to match or conform to a
dependably known and traceable standard for e.g. adjusting a micrometer or caliper
to conform to master blocks traceable to national standards. Verification is
confirming that the Monitoring and Measurement Device is meeting or performing to
acceptable national measurement standards and does not involve any correction or
adjustment for e.g. verifying a ruler or tape measure against a calibrated ruler that
has been calibrated to a national standard. A ruler or tape measure is generally not
capable of being calibrated and when it gets out of calibration its use must be
discontinued. There are Monitoring and Measurement Device’s that are capable of
being both calibrated and verified for e.g. a CMM- coordinate measuring machine
and may require both to be done in specific situations based on the frequency of use
and criticality of measurement. This requirement also applies to the use of computer
software whose capability and calibration status must be established prior to initial
use and reconfirmed (verified) at defined intervals.

You must define the frequency and method of calibration for each type and level i.e.
whether used in the shop floor, laboratory or standard of Monitoring and
Measurement Device. Your calibration records must identify what standard you used
for calibration and show traceability of the standards you use at your facility to
national or international standards. In rare circumstances, national or international
standards may not exist for calibrating a specific Monitoring and Measurement
Device. In such situations consider using industry, manufacturer or even your own
organizational standard to validate the accuracy and reliability of your Monitoring and
Measurement Device. Consult with your customer if the contractual circumstances
require it.  Your quality plan must define the measurement and monitoring required
and the type of Monitoring and Measurement Device needed for it, including the
frequency of measurement and acceptance criteria. Depending on the risk and
precision and reliability of measurements needed, you might consider doing
statistical studies on Monitoring and Measurement Device’s referenced in your
quality plans. Ensure that personnel performing such statistical studies are trained
and competent to do so. A multitude of software tools is available to manage and
control Monitoring and Measurement Devices. There are many acceptable methods
to identify Monitoring and Measurement Device’s and their calibration status. The
methods you select must consider the manufacturers recommendations, frequency
of use, environment the Monitoring and Measurement Device is used in, risk in
misuse or incorrect tool being used, etc. Where a Monitoring and Measurement
Device is found to be out of calibration, you must take appropriate corrective action
to contain and re-verify the product affected, to the extent practical. This is in
addition to containing, repair and recalibration of the defective Monitoring and
Measurement Device.  Customer or internal engineering changes may result in a
change in product measurement, requirements and/or the Monitoring and
Measurement Device to be used.  These changes would normally be reflected in
your quality plan. If you use external calibration services, you are still expected to
impose the specific control requirements of this clause to the external organization.
Performance indicators such as the monthly trends in  the number of out of
calibration Monitoring and Measurement Device’s, or the number of Monitoring and
Measurement Device’s past their calibration due date, number of Monitoring and
Measurement Device’s being used and not controlled, reduction in untrained
personnel found using Monitoring and Measurement Device’s, etc. Use these
indicators to tighten and improve the effectiveness of your Monitoring and
Measurement Device process. You could use a product quality plan, documented
procedure or other combination of specific practices, procedures, documents, and
methods. Look at the risks related to your product, processes, and resources in
determining the extent of documented controls you need to have.

The organization should ensure that the resources provided are suitable for the
specific type of monitoring and measurement activities being undertaken. The
organization should have the right instruments and equipment on hand and they
must be capable of determining “good” from “bad”.  The word “suitable” provides the
expectation that the instruments be accurate, reliable and precise enough to make
appropriate judgments about the product (and services).  This includes the very
common disciplines of calibration, reproducibility & reliability studies, etc to ensure
the instruments used to measure product (and service) are suitable.  They should be
maintained to ensure their continued fitness for their purpose. Once the organization
has selected and confirmed the appropriate monitoring and measuring devices, they
must have a surveillance program to ensure their continued suitability. The
organization should retain appropriate documented information as evidence of
fitness for the purpose of monitoring and measurement resources. There should be
documented records of these activities. Where measurement traceability is a
statutory or regulatory requirement a customer or relevant interested party
expectation or considered by the organization to be an essential part of providing
confidence in the validity of measurement results, measuring instruments must be
verified or calibrated at specified intervals or prior to use against measurement
standards traceable to international or national measurement standards.  Where no
such standards exist, the basis used for calibration or verification shall be retained as
documented information. There must be a generally accepted calibration program
which should always include traceable standards and a schedule for
verification/calibration.  The use of traceable standards is required because simply
having something to measure your devices by does not necessarily ensure an
adequate calibration program.  For example, using old worn gauge blocks, pins,
hardness standards, etc is not a best practice.  Your standards (in addition to your
instruments) should be maintained and traceable to an international standard to
ensure the validity of your monitoring and measuring program. The devices must be
identified in order to determine their calibration status; This is the simplest thing to do
– a simple calibration sticker will suffice.  Keep in mind that it is NOT required that
stickers be on every device, but why not do it?  If each instrument has its own unique
serial number and is properly identified and can be cross-referenced to its calibration
status, that meets compliance requirements.  However, auditors just feel a better
warm and fuzzy feeling if there is a sticker including “last calibrated” or “next
calibrated”.  And even if you do have a database or master list of instruments which
tells you the status of each instrument, a quick glance at the instrument itself doesn’t
hurt to ensure your instruments are maintained 100% of the time. The devices must
be safeguarded from adjustments, damage or deterioration that would invalidate the
calibration status and subsequent measurement results. Safeguarding from damage
and deterioration is the simplest of these three.  Obviously protective cases,
protective films, filters, etc keep an instrument in its tip-top condition.  Regular
maintenance helps too – removable of dust, atomized grease, etc.  Safeguarding
from adjustments is a little more difficult, but can be easily achieved by removing
adjustment tools from general use, using seals on access panels, etc.  Most auditors
are reasonable with regard to this, however, if someone wanted to make an
adjustment to an instrument, there are many ways to work around the safeguards.  It
is unlikely to happen, and between calibration, checks can add an additional
assurance that instruments are safeguarded against adjustments.The organization
should determine if the validity of previous measurement results has been adversely
affected when an instrument is found to be defective during its planned verification or
calibration, or during its use, and take appropriate corrective action as necessary.
The addition of intermittent checks (between calibration checks) helps to mitigate the
impact should an instrument be found to be out of calibration.  For example, if a
micrometer is calibrated monthly and on today’s monthly check it is found to be out
of calibration, every measurement it has taken for the past 30 days must be
validated.  This can require isolation of product, product recall, etc in the absence of
any other evidence of compliance.  Between calibration, checks help to detect
adjustments, errors, etc. ISO9001:2008 used to include a reference to the “ability of
computer software to satisfy the intended application shall be confirmed.”  This was
an attempt to ensure that dependence on software is confirmed (rather than simply
taking a computer’s word for it).  The idea was to prove out software and use
common sense before turning it over.  For example, implementing the use of a
coordinate measuring machine requires a great deal of validation.  A poorly
programmed measuring routine can result in a software rejecting “good” parts due to
measurement or calculation errors.  This section was intended to prevent that. 
However, the language was not clear and was often met with blank stares by those
who were asked to demonstrate compliance in this area.  So the specific reference
to software was removed.  The use of the word “suitable” in the beginning of this
section applies to all monitoring and measuring equipment (including software), so
the removal of it has little or no real effect.
http://isoconsultantpune.com/iso-90012015-clause-7-by-pretesh-biswas-apb-consultant/

Mandatory documents and records required by ISO

9001:2015
Here are the documents you need to produce if you want to be compliant with ISO
9001:2015. (Please note that some of the documents will not be mandatory if the company
does not perform relevant processes.):

 Scope of the QMS (clause 4.3)

 Quality policy (clause 5.2)

 Quality objectives (clause 6.2)

 Criteria for evaluation and selection of suppliers (clause 8.4.1)

And, here are the mandatory records (note that records marked with * are only mandatory
in cases when the relevant clause is not excluded):

 Monitoring and measuring equipment calibration records* (clause 7.1.5.1)

 Records of training, skills, experience and qualifications (clause 7.2)

 Product/service requirements review records (clause 8.2.3.2)

 Record about design and development outputs review* (clause 8.3.2)

 Records about design and development inputs* (clause 8.3.3)

 Records of design and development controls* (clause 8.3.4)

 Records of design and development outputs *(clause 8.3.5)

 Design and development changes records* (clause 8.3.6)

 Characteristics of product to be produced and service to be provided (clause 8.5.1)

 Records about customer property (clause 8.5.3)

 Production/service provision change control records (clause 8.5.6)

 Record of conformity of product/service with acceptance criteria (clause 8.6)

 Record of nonconforming outputs (clause 8.7.2)

 Monitoring and measurement results (clause 9.1.1)

 Internal audit program (clause 9.2)

 Results of internal audits (clause 9.2)

 Results of the management review (clause 9.3)

 Results of corrective actions (clause 10.1)