ISO 9001 Training - Key Explanation Points and Tips:

Clause 7.1 is essentially a repeat of clause 4.1, but applied specifically

toproduct realization processes (see clause 4.1 explanation points - COPs). The focus is on
controls governing the making of product to meet customer requirements and all the QMS
processes that, directly or indirectly, make this happen.
Product realization 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 9001:2008
Requirements 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 postdelivery 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 postdelivery 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 9001:2008
Requirements 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 reevaluation 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 customerdesignated 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, rustproofing, 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 CMMcoordinate 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-MeasuringEquipment-2.html