Understanding ISO 9001:2008 Quality Management System

Understanding ISO 9001:2008 Quality Management System

Chapter – 6

PRODUCT REALIZATION

Author – K. R. Singhal

There are following clauses under this section:
7.1 – Planning of product realization
7.2 – Customer-related processes
7.3 – Design and development
7.4 – Purchasing
7.5 – Production and service provision
7.6 – Control of monitoring and n measuring equipment

Planning of product realization
(Please refer to Clause 7.1 of ISO 9001:2008)

The organization must plan the processes needed for product realization and the organization must develop such processes.

Planning of product realization must be consistent with the requirements of the other processes of the QMS. In this connection, a reference to clause 4.1 of ISO 9001:2008 is needed.

In planning product realization, the organization must (as appropriate) determine the following:
quality objectives for the product
requirements for the product
the need to establish processes
the need to establish documents
the need to provide resources specific to the product
required verification activity specific to the product
required validation activity specific to the product
required monitoring activity specific to the product
required measurement activity specific to the product
required inspection activity specific to the product
required test activity specific to the product
the criteria for product acceptance
records needed to provide evidence that the realization processes and resulting product meet requirements

A reference to clause 4.2.4 of ISO 9001:2008 is needed for control of records.

The output of planning of product realization must be in a form suitable for method of operations of the organization.

There are two notes at the end of clause 7.1 of ISO 9001:2008.

Note 1 clarifies the term quality plan. A quality plan is a document specifying:
the process of the quality management system (including the product realization processes), and
the resources to be applied to a specific product, project or contract.

Note 2 clarifies that those requirements given in clause 7.3 (design and development) to the development of product realization processes may be applied by the organization.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we find that the requirement in clause 7.1 (b) has been reframed being editorial change. In clause 7.1 (c), the word ‘measurement’ has been added, accordingly, the organization needs to also determine required measurement activities, as appropriate, specific to the product and the criteria for product acceptance.

Customer-related processes
(Please refer to Clause 7.2 of ISO 9001:2008)

There are following clauses under this clause:
7.2.1 – Determination of requirements related to the product
7.2.2 – Review of requirements related to the product
7.2.3 – Customer communication

Determination of requirements related to the product
(Please refer to Clause 7.2.1 of ISO 9001:2008)

The organization must determine:
customer requirements,
requirements for delivery and post-delivery activities,
requirements, necessary for specified or intended use of the product, although not stated by the customer,
applicable legal (statutory and regulatory) requirements related to the product,
any other requirements, that are considered necessary by the organization.

Note at the end of this clause clarifies the term post-delivery activities. Actions under warranty provisions, contractual obligations (such as maintenance services) and supplementary services (such as recycling, final disposal) are part of post delivery activities.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we find that requirement has been slightly re-worded. The word ‘related’ has been changed to ‘applicable’. The wordings of clause 7.2.1 (d) that ‘any additional requirements determined by the organization’ (in ISO 9001:2000 Standard) have been changed to ‘any additional requirements considered necessary by the organization’ (in ISO 9001:2008). Accordingly, now the organization must determine any additional requirements considered necessary by the organization.

A note has been added at the end of sub clause 7.2.1 in ISO 9001:2008 clarifying the post delivery activities to include actions under warranty provisions, contractual obligations (such as maintenance services) and supplementary services (such as recycling and final disposal). Old version did not clarify what post delivery meant; now the new version has clarified the same.

Review of requirements related to the product
(Please refer to Clause 7.2.2 of ISO 9001:2008)

The organization must review, the requirements related to the product, prior to the organization’s commitment to supply a product to the customer. Accordingly, the organization must review the requirements related to the product before submission of tenders, acceptance of contracts, acceptance of orders, acceptance of changes to the contracts, or acceptance of changes to orders.

The organization must also ensure the following:
to define product requirements,
to resolve contract or order requirements differing from those previously expressed,
the organization has the ability to meet requirements that are defined.

The organization must maintain following records:
results of the review, and
actions arising from the review.

Sometimes customer provides its requirements verbally (not written requirements), in such situation, the organization must confirm such customer requirements before acceptance to supply the product to the customer.

There may be instances when product requirements are changed, in such situation, the organization must ensure that relevant documents are amended and information about the changed requirements is made aware to relevant personnel.

A note at the end of the clause provides clarification that a formal review of requirements is impractical for organization and customer in some situations, as in the case of internet sales. In such cases, the review of requirements can cover relevant product information, such as catalogues and adverting material.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.2.2.


Customer communication
(Please refer to clause 7.2.3 of ISO 9001:2008)

The organization must determine and implement effective arrangements for communicating with customers in relation to:
product information,
enquiries,
contracts or order handling,
amendments, if any,
customer feedback,
customer complaints, if any.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.2.3.

Design and development
(Please refer to clause 7.3 of ISO 9001:2008)

There are following clauses under this clause:
7.3.1 – Design and development planning
7.3.2 – Design and development inputs
7.3.3 – Design and development outputs
7.3.4 – Design and development review
7.3.5 – Design and development verification
7.3.6 – Design and development validation
7.3.7 – Control of design and development changes

Design and development planning
(Please refer to clause 7.3.1 of ISO 9001:2008)


The organization must plan and control the design and development of product.

During the planning of design and development, the organization must determine:
the stages of design and development,
the review, verification and validation (appropriate to each design and development stage), and
responsibilities and authorities for design and development.

The organization must manage the interfaces between different groups involved in design and development. The purpose is to ensure effective communication and clear assignment of responsibility.

During the progress of design and development, planning must be updated, as appropriate.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) a note added in the sub-clause 7.3.1 (Design and development planning) in ISO 9001:2008 clarifies that design and development review, verification and validation are separate activities having distinct purposes and these may be conducted and recorded separately or in combination as suitable for the product and the organization.



Design and development inputs
(Please refer to clause 7.3.2 of ISO 9001:2008)

The organization must determine design and development inputs relating to product requirements and maintain records. The design and development inputs must contain:
functional requirements,
performance requirements,
applicable legal (statutory and regulatory) requirements,
other requirements necessary for design and development.

The organization must review design and development inputs for adequacy. Requirements must be:
complete,
unambiguous, and
not in conflict with each other.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is editorial change in the wordings of sub-clause 7.3.2 (Design and development inputs), no change in the requirement.


Design and development outputs
(Please refer to clause 7.3.3 of ISO 9001:2008)

The outputs of design and development must be such that are suitable for verification against the design and development inputs and outputs must be approved prior to release.

Design and development outputs must:
meet input requirements for design and development,
provide appropriate information for purchasing,
provide appropriate information for production and service provision,
contain product acceptance criteria or its reference, and
specify characteristics (essential for safe and proper use) of the product.

Note at the end of the clause clarify that information for production and service provision may include details for preservation of product.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), in this clause, the word ‘provided’ mentioned in old version has been removed and the phrase ‘suitable for’ (in new version) replaces ‘that enables’ (of the old version). The word ‘for’ (service provision) has been removed. A new note (added in ISO 9001:2008) in the sub clause 7.3.3 clarifies that information for production and service provision may include details for the preservation of product.

The old version requires making sure that design and development process generate outputs information that must have to meet certain thing, but the new version also requires that design and development outputs could include information that must explain how product to be preserved during production and service provision..


Design and development review
(Please refer to clause 7.3.4 of ISO 9001:2008)

The organization must perform systematic design and development review at suitable stages in accordance with planned arrangements:
to evaluate the ability of the results of design and development to meet requirements, and
to identify any problems, and
to propose necessary actions.

Participants in such reviews must be from the functions concerned with the design and development stage / stages that are being reviewed. The organization must maintain records of the results of the reviews and any necessary actions.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.3.4.

Design and development verification
(Please refer to clause 7.3.5 of ISO 9001:2008)

The organization must perform design and development verification in accordance with planned arrangement to ensure that the design and development outputs have met the design and development input requirements. The organization must maintain records of the results of the verification and any necessary actions.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.3.5.

Design and development validation
(Please refer to clause 7.3.6 of ISO 9001:2008)

The organization must perform design and development validation in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use of the product, where known. Where it is possible (practicable), design and development validation must be completed prior to the delivery or implementation of the product. The organization must maintain records of the result of validation and any necessary action.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.3.6.

Control of design and development changes
(Please refer to clause 7.3.7 of ISO 9001:2008)

The organization must identify design and development changes and maintain records. The organization must review, verify and validate design and development changes, as appropriate, and approve such changes before implementation. The design and development changes’ review must include evaluation of the effect of the changes on constituent parts and product already delivered. The organization must maintain results of the review of changes and any necessary actions.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.3.7. There is editorial change, no text change. Two Para of old version merged to one Para in new version.


Purchasing
(Please refer to clause 7.4 of ISO 9001:2008)

There are following clauses under this clause:
7.4.1 – Purchasing process
7.4.2 – Purchasing information
7.4.3 – Verification of purchased product

Purchasing process
(Please refer to clause 7.4.1 of ISO 9001:2008)

The organization must ensure that purchased product conforms to specified purchase requirements. The type and extent of control (on the supplier and the purchased product)must be dependent upon the effect of the purchased product on subsequent product realization or the final product.

The organization must evaluate and select supplier. Such evaluation and selection must be based on the ability of suppliers to supply product in accordance with the organization’s requirements. The organization must establish:
criteria for selection,
criteria for evaluation, and
criteria for re-evaluation.

The organization must maintain records of the results of evaluations and any necessary actions arising from the evaluation.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.4.1.


Purchasing information
(Please refer to clause 7.4.2 of ISO 9001:2008)

Organization’s purchasing information must describe the product to be purchased. Where appropriate, following must be included in the purchasing information:
requirements for approval of product,
requirements for approval of procedures,
requirements for approval of processes,
requirements for approval of equipment,
requirements for qualification of personnel, and
any other quality management system requirements.

The organization must ensure adequacy of specified purchase requirements prior to their communication to the supplier.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.4.2.

Verification of purchased product
(Please refer to clause 7.4.3 of ISO 9001:2008)

The organization must establish and implement the inspection and other activities necessary to ensure that purchased product meets specified purchase requirements.

Where the organization or its customer wishes to perform verification at supplier’s premises, the organization must state the intended verification arrangements and method of product release in the purchasing information.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 7.4.3.

Production and service provision
(Please refer to clause 7.5 of ISO 9001:2008)

There are following clauses under this clause:
7.5.1 – Control of production and service provision
7.5.2 – Validation of processes for production and service provision
7.5.3 – Identification and traceability
7.5.4 – Customer property
7.5.5 – Preservation of product

Control of production and service provision
(Please refer to clause 7.5.1 of ISO 9001:2008)

The organization must plan and carry out production and service provision under controlled conditions. Controlled condition must include, as applicable, the following:
the availability of information about the product characteristics,
the availability of work instructions, as necessary,
the use of suitable equipment,
the availability and use of monitoring and measuring equipment,
the implementation of monitoring and measurement, and
the implementation of product release, delivery and post-delivery activities.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), the term ‘monitoring and measuring devices’ (mentioned in ISO 9001:2000 QMS Standard) has been replaced by the term ‘monitoring and measuring equipment’ (in ISO 9001:2008). It is now clearly mentioned in the new standard that release (mentioned in old version) is product release.

Validation of processes for production and service provision
(Please refer to clause 7.5.2 of ISO 9001:2008)

The organization must 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 must demonstrate the ability of these processes to achieve planned results.

The organization must establish arrangements for these processes including, as applicable, the following:
defined criteria for review of the processes,
defined criteria for approval of the processes,
approval of equipment,
approval of qualification of personnel,
use of specific methods and procedures,
requirements for records, and
revalidation.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), in clause requirement, there is editorial change and accordingly as per new version, the organization must validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring and measurement and as a consequences deficiencies are known only after the product is in use or service has been delivered.


Identification and traceability
(Please refer to clause 7.5.3 of ISO 9001:2008)

Where appropriate, the organization must identify the product by suitable means throughout product realization process.

The organization must identify the product status with respect to monitoring and measurement requirements throughout product realization.

Where traceability is a requirement, the organization must control the unique identification of the product. The organization must also maintain such records.

Note at the end of the clause clarifies that in some industry sectors identification and traceability are maintained by configuration management.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), Para 2 of this sub-clause has been modified and organization needs to identify the product status with respect to monitoring and measurement requirements throughout product realization. In Para 3 of this sub-clause, there is slight modification in wordings and maintaining records is a requirement instead of just recording the unique identification of the product (as mentioned in ISO 9001:2000 QMS Standard). There is no change in the requirement to control the unique identification of the product, where traceability is a requirement.

Customer property
(Please refer to clause 7.5.4 of ISO 9001:2008)

The organization must exercise care with customer property while the customer property is under the control of the organization or being used by the organization. The organization must 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 must report this to the customer and maintain records.

Note at the end of this clause clarifies that the customer property can include intellectual property and personal data.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), there is no change in the requirement and maintaining records has been made clearer in this sub-clause. There is editorial change in this sub-clause. A note at the end of sub clause 7.5.4 has been made clearer to include ‘personal data’ as customer property.

Preservation of product
(Please refer to clause 7.5.5 of ISO 9001:2008)

In order to maintain conformity to requirements, the organization must preserve the product during:
internal processing, and
delivery to the intended destination.

As applicable, preservation must include:
identification,
handling,
packaging,
storage, and
protection.

Preservation must apply to the constituent parts of a product.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), the terms ‘conformity to requirements’ and ‘as applicable’ have been added to provide more clarity. Accordingly, now as per ISO 9001:2008, the organization needs to preserve the product (earlier ISO 9001:2000 QMS Standard mentioned ‘the conformity of product’) during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, preservation must include identification, handling, packaging, storage and protection. Preservation must also apply to the constituent parts of a product.

Control of monitoring and measuring equipment
(Please refer to clause 7.6 of ISO 9001:2008)

The organization must 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.

To ensure performing monitoring and measurement consistent with requirements the organization must establish processes.

Where necessary to ensure valid results, measuring equipment must:
be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards,
be adjusted or re-adjusted as necessary,
have identification in order to determine its calibration status, be safeguarded from adjustments that would invalidate the measurement results,
be protected from damage and deterioration during handling, maintenance and storage.

Where no international or national standards exist, the basis used for calibration or verification must be recorded.

The organization must also assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization must take appropriate action on the equipment and any product affected.

The organization must maintain the results of calibration and verification.

When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application must be confirmed. This must be undertaken prior to initial use and reconfirmed as necessary.

Note at the end of this clause clarifies that 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.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that the term ‘devices’ (of the old version) has been replaced by the term ‘equipment’ (in the new version). Thus the title of this clause is also revised. The requirement of this clause has been reworded to bring in more clarity. Reference to see 7.2.1 has been deleted. The words ‘or both,’ have been added after the words ‘be calibrated or verified,’ in clause 7.6 (a). In 7.6 (c), instead of ‘be identified to enable the calibration status to be determined’ (mentioned in ISO 9001:2000 QMS Standard) the requirement now says ‘have identification in order to determine its calibration status’ (in ISO 9001:2008). A new Para 5 in this clause has been made (in ISO 9001:2008) from the Para 4 of this clause (in ISO 9001:2000 QMS Standard), this Para 4 of ISO 9001:2000 QMS Standard is converted in two Para (Para 4 and Para 5) in ISO 9001:2008. Para 5 of this clause (in ISO 9001:2000 QMS Standard) is now Para 6 of this clause (in ISO 9001:2008). The note at the end of this clause (in ISO 9001:2000 QMS Standard) ‘See ISO 10012-1 and ISO 10012-2 for guidance’ has been deleted. Explanatory notes have been added at the end of this clause regarding the use of computer ‘software to satisfy the intended application typically includes its verification and configuration management to maintain its suitability for use.

Questions

What are the key changes in clause 7.1 (Planning of product realization) in ISO 9001?
What are the key changes in clause 7.2 (Customer related processes) in ISO 9001?
What are the key changes in clause 7.3 (Design and development) in ISO 9001?
What are the key changes in clause 7.4 (Purchasing) in ISO 9001?
What are the key changes in clause 7.5 (Production and service provision) in ISO 9001?
What are the key changes in clause 7.6 (Control of monitoring and measuring devices) in ISO 9001?

Note from the author

The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.

The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.