ISO 9001 Training - Key Explanation Points and Tips:
Clause 7.1 is essentially a repeat of clause 4.1, butapplied
specifically toproductrealizationprocesses(see clause 4.1
explanation points - COPs). The focus is on controls governing
themaking of product to meet customer requirements and all the QMS
processes that, directly or indirectly,make this happen.
Productrealization processes may include - customer related
processes (sales and marketing); design and development;
production; shipping; receiving; packaging; measurement and
monitoring of product and processes, etc., whether performed onsite
or off-site.
Some of the support processes that come to bear on product
realization include- document control; record control; human
resources; infrastructure provision and maintenance; IT; purchasing
and materials management; laboratory services and control of
monitoring and measuring devices, business planning; etc.
The output of product realization planning may be implemented in
many different ways. It does not necessarily have to be all in one
document, but may sometimes include several documents (drawings;
machine set-up; inspection criteria; process sheets; etc.). These
must be readily available to those performing realization
processes.
You may also consider using specific product, contract or
project quality plans to accomplish this. Your quality plans should
include the processes needed; process sequence and control
parameters; specific resources needed to make, verify and deliver
product; product acceptance criteria and quality objectives;
product and process monitoring and measurement controls; plans to
control and correct any product or process nonconformities;
reference to support processes; documents needed (such as work
instructions or engineering specifications, etc.) and details of
records to be kept.7.1 Planning of Product Realization- Cont'd
7 Product Realization
7.1 Planning of Product Realization
The organization shall plan and develop the processes needed for
product realization. Planning of product realization shall be
consistent with the requirements of the other processes of the
quality management system (see 4.1).
In planning product realization, the organization shall
determine the following, as appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes and documents, and to provide
resources specific to the product;
c) required verification, validation, monitoring, measurement,
inspection and test activities specific to the product and the
criteria for product acceptance;
d) records needed to provide evidence that the realization
processes and resulting product meet requirements (see 4.2.4).
The output of this planning shall be in a form suitable for the
organization's method of operations.
NOTE 1: A document specifying the processes of the quality
management system (including the product realization processes) and
the resources to be applied to a specific product, project or
contract can be referred to as a quality plan.
NOTE 2: The organization may also apply the requirements given
in 7.3 to the development of product realization processes.
Understanding ISO 9001:2008Requirements for Quality Management
Systems
7.2 Customer Related Processes
7 Product Realization
7.2 Customer-Related Processes
7.2.1 Determination of Requirements Related to the Product
The organization shall determine:
a) requirements specified by the customer, including the
requirements for delivery and post-delivery activities,
b) requirements not stated by the customer but necessary for
specified or intended use, where known,
c) statutory and regulatory requirements applicable to the
product, and
d) any additional requirements considered necessary by the
organization.
NOTE Post-delivery activities include, for example, actions
under warranty provisions, contractual obligations such as
maintenance services, and supplementary services such as recycling
or final disposal.
7.2.2 Review of Requirements Related to the Product
The organization shall review the requirements related to the
product. This review shall be conducted prior to the organization's
commitment to supply a product to the customer (e.g. submission of
tenders, acceptance of contracts or orders, acceptance of changes
to contracts or orders) and shall ensure that:
a) product requirements are defined,
b) contract or order requirements differing from those
previously expressed are resolved, and
c) the organization has the ability to meet the defined
requirements.
Records of the results of the review and actions arising from
the review shall be maintained (see 4.2.4).
Where the customer provides no documented statement of
requirement, the customer requirements shall be confirmed by the
organization before acceptance.
Where product requirements are changed, the organization shall
ensure that relevant documents are amended and that relevant
personnel are made aware of the changed requirements.
NOTE: In some situations, such as internet sales, a formal
review is impractical for each order. Instead the review can cover
relevant product information such as catalogues or advertising
material.
7.2.3 Customer Communication
The organization shall determine and implement effective
arrangements for communicating with customers in relation to:
a) product information,
b) enquiries, contracts or order handling, including amendments,
and
c) customer feedback, including customer complaints.
7.2 Customer Related Processes - Continued
7 Product Realization
7.2 Customer-Related Processes
7.2.1 Determination of Requirements Related to the Product
The organization shall determine:
a) requirements specified by the customer, including the
requirements for delivery and post-delivery activities,
b) requirements not stated by the customer but necessary for
specified or intended use, where known,
c) statutory and regulatory requirements applicable to the
product, and
d) any additional requirements considered necessary by the
organization.
NOTE Post-delivery activities include, for example, actions
under warranty provisions, contractual obligations such as
maintenance services, and supplementary services such as recycling
or final disposal.
7.2.2 Review of Requirements Related to the Product
The organization shall review the requirements related to the
product. This review shall be conducted prior to the organization's
commitment to supply a product to the customer (e.g. submission of
tenders, acceptance of contracts or orders, acceptance of changes
to contracts or orders) and shall ensure that:
a) product requirements are defined,
b) contract or order requirements differing from those
previously expressed are resolved, and
c) the organization has the ability to meet the defined
requirements.
Records of the results of the review and actions arising from
the review shall be maintained (see 4.2.4).
Where the customer provides no documented statement of
requirement, the customer requirements shall be confirmed by the
organization before acceptance.
Where product requirements are changed, the organization shall
ensure that relevant documents are amended and that relevant
personnel are made aware of the changed requirements.
NOTE: In some situations, such as internet sales, a formal
review is impractical for each order. Instead the review can cover
relevant product information such as catalogues or advertising
material.
7.2.3 Customer Communication
The organization shall determine and implement effective
arrangements for communicating with customers in relation to:
a) product information,
b) enquiries, contracts or order handling, including amendments,
and
c) customer feedback, including customer complaints.7.3.1 Design
& Development Planning
7 Product Realization
7.3 Design and Development
7.3.1 Design and Development Planning
The organization shall plan and control the design and
development of product.
During the design and development planning, the organization
shall determine:
a) the design and development stages,
b) the review, verification and validation that are appropriate
to each design and development stage, and
c) the responsibilities and authorities for design and
development.
The organization shall manage the interfaces between different
groups involved in design and development to ensure effective
communication and clear assignment of responsibility.
Planning output shall be updated, as appropriate, as the design
and development progresses.
NOTE: Design and development review, verification and validation
have distinct purposes. They can be conducted and recorded
separately or in any combination, as suitable for the product and
the organization.
7.3.2 Design & Development Inputs
7 Product Realization
7.3.2 Design and Development Inputs
Inputs relating to product requirements shall be determined and
records maintained (see 4.2.4). These inputs shall include:
a) functional and performance requirements,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar
designs, and
d) other requirements essential for design and development.
The inputs shall be reviewed for adequacy. Requirements shall be
complete, unambiguous and not in conflict with each other. 7.3.2
Design & Development Outputs
7 Product Realization
7.3.3 Design and Development Outputs
The outputs of design and development shall be in a form
suitable for verification against the design and development input
and shall be approved prior to release.
Design and development outputs shall:
a) meet the input requirements for design and development,
b) provide appropriate information for purchasing, production
and service provision,
c) contain or reference product acceptance criteria, and
d) specify the characteristics of the product that are essential
for its safe and proper use.
NOTE Information for production and service provision can
include details for the preservation of product. 7.3.5 Design and
Development Verification
7.3.6 Design and Development Validation
7.3.7 Control of Design and Development Changes
7 Product Realization
7.3.5 Design and Development Verification
Verification shall be performed in accordance with planned
arrangements (see 7.3.1) to ensure that the design and development
outputs have met the design and development input requirements.
Records of the results of the verification and any necessary
actions shall be maintained (see 4.2.4).
7.3.6 Design and Development Validation
Design and development validation shall be performed in
accordance with planned arrangements (see 7.3.1) to ensure that the
resulting product is capable of meeting the requirements for the
specified application or intended use, where known. Wherever
practicable, validation shall be completed prior to the delivery or
implementation of the product. Records of the results of validation
and any necessary actions shall be maintained (see 4.2.4).
7.3.7 Control of Design and Development Changes
Design and development changes shall be identified and records
maintained. The changes shall be reviewed, verified and validated,
as appropriate, and approved before implementation. The review of
design and development changes shall include evaluation of the
effect of the changes on constituent parts and product already
delivered. Records of the results of the review of changes and any
necessary actions shall be maintained (see 4.2.4). Understanding
ISO 9001:2008Requirements for Quality Management Systems
7.4.1 Purchasing Process
7 Product Realization
7.4 Purchasing
7.4.1 Purchasing Process
The organization shall ensure that purchased product conforms to
specified purchase requirements. The type and extent of control
applied to the supplier and the purchased product shall be
dependent upon the effect of the purchased product on subsequent
product realization or the final product.
The organization shall evaluate and select suppliers based on
their ability to supply product in accordance with the
organization's requirements. Criteria for selection, evaluation and
re-evaluation shall be established.
Records of the results of evaluations and any necessary actions
arising from the evaluation shall be maintained (see 4.2.4).
ISO 9001 Training - Key Explanation Points and Tips:
Clause 7.4 covers the following purchasing activities:
Requirements to control purchased product (clauses 7.4.1 and
7.4.3)
Requirements to control suppliers you buy from (7.4.1)
Requirements to control your buying process (7.4.2)
Purchased product includes raw materials, components,
subassemblies, supplies, tooling, machinery and equipment,
sequencing, sorting, rework, testing, calibration, maintenance,
etc.
Note that clause 7.4 requirements apply to items that - go into
the product, manufacture the product, check the product or deliver
the product; whether paid for or customer provided.
These may include materials, production equipment; tooling;
measuring and test equipment; facilities; transport vehicles;
returnable packaging; intellectual property (drawings,
specifications or proprietary information); product returned for
servicing under warranty, product sent for outsourced work;
etc.
You must have specifications/criteria for purchased product.
These specifications may come from your organization, customer,
regulatory bodies, supplier or industry. As documents, these
specifications must be controlled as per clause 4.2.3
Many times the customer may require the use of pre-approved
purchased products and suppliers. The onus is still on you to
ensure that purchased product from customer-designated sources
meets all requirements.
You must control both, the product you buy, as well as the
supplier or subcontractor you buy from. Your controls must
primarily be based on prevention of nonconformities in both product
and supplier/subcontractor performance.
Determine how important the purchased product is to design,
manufacture, assemble and maintain your end product. If you recall
from product design input (clause 7.3.2) we considered factors such
as - targets for product quality, life, reliability, durability,
maintainability, and cost. You must apply similar criteria to
purchased product as well as outsourced processes for work going
into your end product. Your objective must be to proactive and
downstream specified controls to ensure product quality. You are
paying for quality product. You want to minimize or eliminate
rework, incoming inspection or material or product returns.
Your purchasing process should include all the controls for
outsourced work. Refer to clause 4.1 for how outsourced needs to be
identified and controlled.
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product
7 Product Realization
7.4 Purchasing
7.4.2 Purchasing Information
Purchasing information shall describe the product to be
purchased, including, where appropriate:
a) requirements for approval of product, procedures, processes
and equipment,
b) requirements for qualification of personnel, and
c) quality management system requirements.
The organization shall ensure the adequacy of specified purchase
requirements prior to their communication to the supplier.
7.4.3 Verification of Purchased Product
The organization shall establish and implement the inspection or
other activities necessary for ensuring that purchased product
meets specified purchase requirements.
Where the organization or its customer intends to perform
verification at the supplier's premises, the organization shall
state the intended verification arrangements and method of product
release in the purchasing information.
7.4.2 Purchasing Information
ISO 9001 Training - Key Explanation Points and Tips:
Your purchase documents (purchase order, contract, blanket
order, your organizations supplier quality manual, etc.) must
specify your requirements for the purchased product; controls for
the suppliers/subcontractors QMS and any other initial or on-going
controls you deem necessary for ensuring consistent supplier
performance.
You must define how you ensure the adequacy of these documents
before you communicate them to your supplier or subcontractor. A
review of adequacy of purchasing documents may include their
completeness, accuracy, correctness, quantity, timing, cost,
approval, etc., by one or more functions; computerized controls,
etc.
In larger organizations, this may be a separate process on-site
or off-site. In either case, it must be identified and controlled
as per clause 4.1 along with 7.4.2.
While clause 7.4.2 does not specify keeping of records, you must
show evidence of carrying out (issue purchase documents) and review
of these documents (see clause 7.1d and 4.2.4 first sentence).
7.4.3 Verification of Purchased Product
Key Explanation Points and Tips:
Verification of purchased product can range from doing no
verification to 100% verification. You have flexibility in
determining the scope of purchased product verification.As
indicated earlier in 7.4.1, you can apply different controls for
different suppliers and products depending on your initial supplier
evaluation and their ongoing product quality and delivery
performance. In any case these controls must be included or
referenced in your quality or inspection plans.
To the extent that you decide to do verification of purchased
product, you also have flexibility in when you do the verification.
You can do it on receipt, prior to use in production, during
production and in some situations after production. Obviously, the
earlier the control is exercised, the more preventive it is and
will reduce the extent of post production verification and rework.
Make sure you appropriately control un-inspected material or
product. This may include identification and storage to prevent
unintended use.
Consider using supplier quality plans, inspection plans, etc.,
to verify that purchased product meets specified purchase (product
and QMS) requirements.
Your inspection process must define and document the acceptance
criteria and sampling plan for product conformity and what
measurement tools needed. and records needed to show effective
control of purchased product quality and supplier performance.7.5.2
Validation of Processes For Production and Service
7 Product Realization
7.5 Production and Service Provision
7.5.2 Validation of Processes for Production and Service
Provision
The organization shall validate any processes for production and
service provision where the resulting output cannot be verified by
subsequent monitoring or measurement and, as a consequence,
deficiencies become apparent only after the product is in use or
the service has been delivered.
Validation shall demonstrate the ability of these processes to
achieve planned results.
The organization shall establish arrangements for these
processes including, as applicable:
a) defined criteria for review and approval of the
processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures,
d) requirements for records (see 4.2.4), and
e) revalidation.
ISO 9001 Training - Key Explanation Points and Tips:
Validation is usually required where product cannot be verified
without damaging or destroying the product, e.g. some types of
welding, heat-treating; electroplating, rust-proofing, etc. In such
instances, the quality of these activities may only be discovered
during or after use. This would generally not be acceptable due to
safety (e.g. weld) or aesthetic (evidence of rust or dullness of
chrome) reasons.
In the case of a service (such as pizza delivery within 30
minutes of order placement), if the timeliness of delivery is not
verifiable, then validation would be required. However, most
service-oriented businesses (e.g. delivery; call center) have some
form of monitoring during service execution to ensure service
quality and on-time delivery.
Validation involves conducting capability studies using a
combination of resources - technology, equipment; materials;
environment; competent personnel; and production and testing
methods that consistently result in a quality product or
service.
Document the specific procedures; methods; and combination of
resources that achieve this capability, and keep records of ongoing
studies to show that you are maintaining this capability.
Validation may also require customer or regulatory approval of the
process ( e.g. certain types of welding for certain types of
products that have a safety risk).
You must keep appropriate records of process validation showing
both the achievement of planned results as well as the ongoing
maintenance of such capability.
If you change any part of the proven process capability (e.g.
materials, equipment or personnel, etc.), you must revalidate
(re-prove) the changed process. It is up to each organization to
determine what combination of resources and methods will provide
the required consistent process capability and quality of product
or service. Include as appropriate, these validation controls in
your quality plans.
If the nature of your product or service is such that it does
not require validation (e.g. where product can always be verified
by subsequent monitoring or measurement prior to delivery), then
you must clearly state this exclusion to your QMS scope, in your
Quality manual.
Performance indicators to measure the effectiveness of processes
that validate production processes may include reduction in -
defect rates, PPMs (defective parts per million); validation cycle
time; revalidations; etc.7.5.4 Customer Property
7.5.5 Preservation of Product
7 Product Realization
7.5 Production and Service Provision
7.5.4 Customer Property
The organization shall exercise care with customer property
while it is under the organization's control or being used by the
organization. The organization shall identify, verify, protect and
safeguard customer property provided for use or incorporation into
the product. If any customer property is lost, damaged or otherwise
found to be unsuitable for use, the organization shall report this
to the customer and maintain records (see 4.2.4).
NOTE: Customer property can include intellectual property and
personal data.
7.5.5 Preservation of Product
The organization shall preserve the product during internal
processing and delivery to the intended destination in order to
maintain conformity to requirements. As applicable, preservation
shall include identification, handling, packaging, storage and
protection. Preservation shall also apply to the constituent parts
of a product.
7.5.4 Customer Property
ISO 9001 Training - Key Explanation Points and Tips:
Customer property may include material; production equipment;
tooling; measuring and test equipment; facilities; transport
vehicles; returnable packaging; intellectual property (drawings,
specifications or proprietary information); product returned for
servicing under warranty, product sent for outsourced work;
etc.
All customer property is exposed to the risk of being damaged,
lost, misused; misplaced; stolen, become unsuitable or obsolete for
use. You must establish controls for each of these risks. Notify
the customer in writing if their property is lost, damaged or
otherwise found to be unsuitable (perishable past its shelf life,
e.g. paint) for use.
Control to minimize the risks to customer property include -
inventory management; preservation and storage; identification,
status and traceability indicators; maintenance; notification;
traffic flow; authorized use; restricted access; etc. Marking
customer property with a unique identification number that can be
traced to a record that provides details of ownership is one of
many acceptable controls.
This clause requires records to be kept of customer property
that is lost, damaged or otherwise found to be unsuitable for use.
This implies tracking the storage and use of and quality status, of
customer property.
While this clause does not call for a specific documented
procedure, these controls may be included in your product
realization processes through your product quality plans; work
instructions and other specific documentation. Many of the controls
needed for clause 7.5.3 Identification and traceability and clause
7.5.5 Preservation of product apply to customer property. The
processes, controls and documentation for these other clauses could
be expanded to include customer property.
If the nature of your business does not require the use of any
customer property, then you must clearly state this exclusion to
your QMS scope, in your Quality manual.
Performance indicators (to measure the effectiveness of
processes that control customer property) may include - reduction
in identification errors and omissions; loss due to damage or
unsuitability; scrap; rejects; etc., as well as increased customer
property turnover rates.
7.5.5 Preservation of Product
Key Explanation Points and Tips:
All raw materials, work in progress; finished product; supplies;
customer provided materials or product; product sent for outsourced
work; etc, are subject to risk of being damaged, lost, misused;
misplaced; stolen, become unsuitable (perishable) or obsolete (past
shelf life) for use. This could occur during receipt, handling;
storage; use in production; transportation to the customer,
etc.
Controls include - identification, status and traceability
indicators; inventory cycle counts and condition evaluation; stock
rotation methods such as FIFO; just in time; tracking shelf life;
MRP systems for tracking requirements and usage; special, controls
for restricted access; handling and storage of hazardous materials,
climate and environment; maintenance procedures; bar codes;
training; use of special equipment for handling; condition reports;
etc.
While this clause does not call for a specific documented
procedure, these controls may be included in your product
realization processes through your product quality plans; work
instructions and other specific documentation. Many of the controls
needed for clause 7.5.3 Identification and traceability apply to
preservation of product.
Performance indicators (to measure the effectiveness of
processes that control preservation of product) may include -
reduction in obsolete and spoint materials an product (e.g., fresh
produce, fruits, or frozen foods), identification errors and
omissions; rejects; waste; scrap; etc., and increase in inventory
turnover and material/product availability; and product safety.7.6
Control of Measurement and Monitoring Equipment
7 Product Realization
7.5 Production and Service Provision
7.6 Control of Monitoring and Measuring Equipment
The organization shall determine the monitoring and measurement
to be undertaken and the monitoring and measuring equipment needed
to provide evidence of conformity of product to determined
requirements.
The organization shall establish processes to ensure that
monitoring and measurement can be carried out and are carried out
in a manner that is consistent with the monitoring and measurement
requirements.
Where necessary to ensure valid results, measuring equipment
shall:
a) be calibrated or verified, or both, 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 recorded (see 4.2.4);
b) be adjusted or re-adjusted as necessary;
c) have identification in order to determine its calibration
status;
d) be safeguarded from adjustments that would invalidate the
measurement result;
e) be protected from damage and deterioration during handling,
maintenance and storage.
In addition, the organization shall assess and record the
validity of the previous measuring results when the equipment is
found not to conform to requirements. The organization shall take
appropriate action on the equipment and any product affected.
Records of the results of calibration and verification shall be
maintained (see 4.2.4).
When used in the monitoring and measurement of specified
requirements, the ability of computer software to satisfy the
intended application shall be confirmed. This shall be undertaken
prior to initial use and reconfirmed as necessary.
NOTE: Confirmation of the ability of computer software to
satisfy the intended application would typically include its
verification and configuration management to maintain its
suitability for use.
ISO 9001 Training - Key Explanation Points and Tips:
Requirements for what needs to be measured (see clause 4.1c
& e; 7.1c) and the acceptance criteria (see clause 7.2.1; 7.1c;
7.3.3c) may come from the customer, regulatory, industry and your
own organization.
Product realization planning (see clause 7.1) must determine the
following - what specific product and process characteristics needs
to be monitored and measured; the criteria for product acceptance;
the type of monitoring and measurement equipment (MME) needed;
frequency - at what stages of realization to do it; sample size;
etc.
You must then determine what MME is appropriate for each
measuring or monitoring requirement. Consideration must be given to
the measurement capability (precision) of the MME 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 (e.g. the precision requirements for
ball bearings may be much greater than say for cutting cloth to
make a shirt).
Personnel using MME must have competence and training in the use
of MME in terms of their function, range and precision of
measurement, reliability, use and maintenance.
MME may include measurement and testing tools; equipment;
hardware and software. They may be owned by your organization; your
employees or the customer. MME may be used to verify product as
well as to measure process conformity (e.g. a temperature
controller on an oven).
Besides MME used for product conformity, you may need to
calibrate and control certain MME used in related and peripheral
processes such as production equipment; tooling; maintenance;
etc.
To ensure valid measurement and monitoring results, MME must be
controlled. A process is required, to control - the identification
of monitoring measurement; selection; purchase; identification;
status; calibration; verification; adjustment or re- adjustment;
use; handling; maintenance and storage; training; handling of
nonconforming MME; etc.
You must keep appropriate records to demonstrate effective
operation and control of your MME processes (see clause 4.2.4).
These records must include calibration and verification records
traceable to national, international or other benchmark used for
calibration.
All MME used for product verification must be capable of being
calibrated, verified or both. Calibration is setting or correcting
an MME, usually by adjusting it to match or conform to a dependably
known and traceable standard (e.g. adjusting a micrometer or
caliper to conform to master blocks traceable to national
standards).
Verification is confirming that the MME is meeting or performing
to acceptable national measurement standards and does not involve
any correction or adjustment (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.
7.6 Control of Monitoring and Measuring Equipment - Con'td
7 Product Realization
7.5 Production and Service Provision
7.6 Control of Monitoring and Measuring Equipment
The organization shall determine the monitoring and measurement
to be undertaken and the monitoring and measuring equipment needed
to provide evidence of conformity of product to determined
requirements.
The organization shall establish processes to ensure that
monitoring and measurement can be carried out and are carried out
in a manner that is consistent with the monitoring and measurement
requirements.
Where necessary to ensure valid results, measuring equipment
shall:
a) be calibrated or verified, or both, 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 recorded (see 4.2.4);
b) be adjusted or re-adjusted as necessary;
c) have identification in order to determine its calibration
status;
d) be safeguarded from adjustments that would invalidate the
measurement result;
e) be protected from damage and deterioration during handling,
maintenance and storage.
In addition, the organization shall assess and record the
validity of the previous measuring results when the equipment is
found not to conform to requirements. The organization shall take
appropriate action on the equipment and any product affected.
Records of the results of calibration and verification shall be
maintained (see 4.2.4).
When used in the monitoring and measurement of specified
requirements, the ability of computer software to satisfy the
intended application shall be confirmed. This shall be undertaken
prior to initial use and reconfirmed as necessary.
NOTE: Confirmation of the ability of computer software to
satisfy the intended application would typically include its
verification and configuration management to maintain its
suitability for use.
ISO 9001 Training - Key Explanation Points and Tips:
There are MMEs that are capable of being both calibrated and
verified (e.g. a CMM- coordinate measuring machine) and may require
both to be done in specific situations based on 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 (shop floor; laboratory or standard) of MME. 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 MME. In such situations
consider using industry, manufacturer or even your own
organizational standard to validate the accuracy and reliability of
your MME. Consult with your customer if the contractual
circumstances require it.
Your quality plan must define the measurement and monitoring
required and the type of MMD 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 MME referenced in your
quality plans. Ensure that personnel performing such statistical
studies are trained and competent to do so.
A multitude of software tools are available to manage and
control MME. There are many acceptable methods to identify MME and
their calibration status. The methods you select must consider the
manufacturers recommendations; frequency of use; environment the
MMD is used in; risk in misuse or incorrect tool being used;
etc.
Where an MME is found to be out of calibration, you must take
appropriate correction 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 MME.
Customer or internal engineering changes may result in a change
in product measurement, requirements and/or the MME 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. One way to achieve this is by requiring them
to be ISO 9001 certified or sector specific standard such as
ISO/IEC 17025.
If the nature of your business does not require the use of MME
(e.g. a financial service such as a credit counseling service),
then you must clearly state this exclusion to your QMS scope, in
your Quality manual.
Clause 4.1f requires you to continually improve your processes.
Consider using appropriate performance indicators such as the
monthly trends in - the number of out of calibration MME; or the
number of MME past their calibration due date; number of MME being
used and not controlled; etc. Use these indicators to tighten and
improve the effectiveness of your MME process.
Clause 7.6 does not require a documented procedure. However, you
must identify and document all processes addressing this clause as
part of your QMS (see clause 4.1). For these processes, you must
also identify what specific documents, controls and resources are
needed (see clause 4.2.1d. and 7.1b.).
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 (also see clause 4.2.1 notes).
Performance indicators (to measure the effectiveness of
processes that control MME) may include reduction - in MME found
past due for calibration and being used; reduction in damaged,
uncontrolled and uncalibrated MME being used; reduction in
untrained personnel found using MME; reduction in lost MME;
reduction in MME found out of calibration; etc.
http://www.askartsolutions.com/iso9001training/Control-of-Monitoring-and-Measuring-Equipment-2.html