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- Keshav Ram Singhal
krsinghal@rediffmail.com
keshavsinghalajmer@gmail.com
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Thursday, July 30, 2015

VOTE STARTS ON ISO/FDIS 9001:2015





We informed our readers vide our earlier post that ISO/FDIS 9001:2015 has been issued by the International Organization for Standardization (ISO) and the revision to ISO 9001 standard has reached to final stage of the revision process.

Now ISO member countries have less than 2 months to form a national position and vote on the latest draft of the standard before the 9 September deadline.

With best wishes,

Keshav Ram Singhal

Sunday, July 26, 2015

ISO/DIS 9001 - OPERATION - Determination of requirements for products and services - Customer communication


ISO/DIS 9001 - OPERATION - Determination of requirements for products and services - Customer communication

Keshav Ram Singhal


Requirements in clause 8.2.1 of ISO/DIS 9001 are similar to clause 7.2 of ISO9001:2008 QMS standard, however now organization needs to establish the processes for customer communication.

As per requirements of ISO/DIS 9001, the organization needs to establish processes for communicating with customers for
- products and services information,
- enquiries,
- contracts,
- order handling,
- changes with regard to enquiries, contracts, order handling,
- obtaining customer views,
- obtaining customer perceptions,
- obtaining customer complaints,
- handling of customer property, if applicable,
- handling treatment of customer property, if applicable,
- contingency actions' specific requirements, when relevant.

Effective customer communication plays a important role in all above activities. Make sure that the organization understand the importance of customer communication. The organization can meet customer's requirements in a better way when it has effective customer communication processes.
Effective customer communication can be done by establishing processes for providing product information, catalogues, specifications, samples etc. Product information may also be communicated in hard copy or soft copy. For handling enquiries, contracts, order handling and obtaining customer's views, perceptions, complaints, the organization must establish processes for dealing them.

ISO/DIS 9001 has also included the significance of establishing processes for handling and treating customer property and also for contingency (a future or possible event or circumstance which is possible but cannot be predicted with certainty) actions.


.... to be continued


Friday, July 24, 2015

ISO/DIS 9001 - OPERATION - Operational planning and control



ISO/DIS 9001 - OPERATION - Operational planning and control

Keshav Ram Singhal


Clause 8 of ISO/DIS 9001 provides requirements related to the operation. All phases, involved in the development of products and services, come under operation.

The relevant sub-clauses are as under:

8.1 - Operation
8.1.1 - Operational planning and control

8.2 - Determination of requirements for products and services
8.2.1 - Customer communication
8.2.2 - Determination of requirements related to products and services
8.2.3 - Review of requirements related to products and services

8.3 - Design and development of products and services
8.3.1 - General
8.3.2 - Design and development planning
8.3.3 - Design and development inputs
8.3.4 - Design and development control
8.3.5 - Design and development outputs
8.3.6 - Design and development changes

8.4 - Control of externally provided products and services
8.4.1 - General
8.4.2 - Type and extent of external provision
8.4.3 - Information for external providers

8.5 - Production and service provision
8.5.1 - Control of production and service provision
8.5.2 - Identification and traceability
8.5.3 - Property belonging to customers or external providers
8.5.4 - Preservation
8.5.5 - Post-delivery activities
8.5.6 - Control of changes

8.6 - Release of products and services

8.7 - Control of nonconforming process outputs, products and services

Operational planning and control

Requirements in this clause are similar to the requirements as mentioned in clause 7.1 of ISO 9001:2008 QMS standard under the heading 'Planning of product realization', however ISO/DIS 9001 requires more emphasis on control of processes. According to the requirements, the organization needs to plan, implement and control all determined processes that are needed to (i) meet requirements for the provision of products and services, and (ii) implement the determined actions to address identified risks and opportunities. For controlling all determined processes, the organization needs to:
- determine requirements for products and service,
- establish criteria for all processes,
- establish criteria for acceptance of products and services,
- determine the resources needed to operate and control processes so as to achieve conformity to products and service requirements, and
- implement control of processes according to the established criteria.

The organization is also required to retain documented information that provides evidence and confidence that (i) processes have been carried out as per planning, and (ii) products and services are as per requirements.

The output of planning must suit to organization's operations.

The organization is also required to control planned changes, review the results or effects of unintended changes and take necessary action to reduce the gravity of any adverse effects.

The organization is also required to control outsourced processes as per requirements mentioned in clause 8.4 of ISO/DIS 9001.


... to be continued

Thursday, July 9, 2015

ISO/FDIS 9001:2015 Released


ISO/FDIS 9001:2015 Released

FDIS = Final Draft International Standard

We are glad to inform our readers that ISO/FDIS 9001:2015 has been issued by the International Organization for Standardization (ISO) and the revision of ISO 9001 QMS standard has now reached the final stage.

Around 90% members approved the earlier released ISO/DIS 9001, however over 3,000 comments with suggestions on possible improvements were received by the committee responsible for revision. The ISO committee responsible for ISO 9001 revision has met twice, in Ireland and Lithuania, and also carried out extensive online discussions to analyze and decide on every comment received during the vote on ISO/DIS 9001. Now ISO/FDIS 9001:2015 has been issued on 09 July 2015 and ISO members will proceed with a national consultation before submitting their final vote on ISO/FDIS 9001:2015. ISO members have 2 months time to form their national position and vote the latest draft of the standard (ISO/FDIS 9001:2015) before 9 September 2015 deadline.

Compared to ISO/DIS 9001, changes in ISO/FDIS 9001:2015 are relatively minor. The terms and definitions have now been removed from the standard and these will now be part of ISO 9000. Some of the explanatory text has been moved to an informative Annex.

If you wish to read ISO/FDIS 9001:2015, you should contact national standards body in your country who is the member of ISO. In India Bureau of Indian Standards is the national standards body, who is the member of ISO.

More information in forthcoming posts.

With best wishes,

Keshav Ram Singhal
Email:
keshavsinghalajmer@gmail.com
krsinghal@rediffmail.com

Please keep visiting the blog 'Forthcoming ISO 9001:2015 QMS Revision' at http://qmsawareness.blogspot.in/.

Those interested in 'Awareness Training on Forthcoming ISO 9001:2015 QMS' may contact us by mentioning their requirements.

Thanks.




Monday, July 6, 2015

ISO/DIS 9001 - SUPPORT - Documented information ....



Continue from the last post ...

ISO/DIS 9001 - SUPPORT - Documented information ....

Keshav Ram Singhal

DOCUMENTED INFORMATION


Details, format and type of documented information related to the quality management system of one organization may differ from another organization due to various reasons and some of the reasons may be as under:
- size of the organization
- activities of the organization
- processes of the organization
- complexities and interactions of organization's processes
- products and services of the organization
- competence of the people of the organization

The organization is required to ensure appropriate measures (mentioned below) at the time of creating and updating documented information, such as:
- identification and description
- format
- media
- review and approval for suitability and adequacy

Identification of documented information means the action or process of identifying the documented information. Identification and description of documented information can be done by mentioning the classification title, date, author, reference (identification) number, page number etc.

Format of documented information means the way in which the documented information is arranged or set out. Ensure: (i) language used in the documented information, (ii) whether the documented information is in software version, (iii) whether graphics are to be used in the documented version.

Media of documented information means the means of communication used in the documented information. It can be either hard copy (paper) or Soft copy (electronic).

Review of documented information means another look at the documented information and this is a task, which should be carried out at the time of creating and updating of the documented information by the appropriate person, who is linked with the affairs of the documented information. Review of the documented information may be carried out randomly or periodically, but ISO/DIS 9001 requires review of documented information at the time of creating and updating of documented information.

Approval of documented information means that some authority has agreed the contents and data of the documented information.


The organization needs to control the documented information required by the quality management system and ISO/DIS 9001 by ensuring the following:
(i) The documented information is available and suitable for use.
(ii) The documented information is adequately protected from the loss of confidentiality, improper use and loss of integrity.
The organization needs to address the following activities for the control of documented information:
- distribution
- access (permission to view)
- retrieval
- use
- storage
- preservation including preservation of legibility

The organization needs to determine and control documented information of external origin that are necessary for the planning and implementation of the quality management system. In order to control documented information of external origin, the organization should establish appropriate process or mechanism for identification, classification, distribution and availability of such documented information.

ISO/DIS 9001 does not specify requirements to control obsolete (out of date) documented information. However, it is better to have control on such documented information, as use of obsolete documented information may lead to errors, failures or hazards, which can be an evidence of nonconformity. Sometimes superseded or obsolete documented information needs to be retained by an organization for a variety of reasons, such as legal or reference purpose, and for this the organization must have a method of identifying the status of such documented information to prevent their accidental use in place of current documented information. In practice, organizations put 'Obsolete Document' or 'Obsolete Documented Information' stamp in red ink on the face of obsolete documented information.