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- Keshav Ram Singhal
Blog on 'Quality Concepts and ISO 9001: 2008 Awareness' at http://iso9001-2008awareness.blogspot.in

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Sunday, December 28, 2014

Documentation Requirements in ISO/DIS 9001

Documentation Requirements in ISO/DIS 9001

Keshav Ram Singhal

Documentation and record keeping have been important aspects of ISO 9001 quality management system. Clause 4.2 of ISO 9001:2008 QMS standard has specifically provides documentation requirements, however, clause 7.5 of ISO/DIS 9001 provides requirements for documentation information. Further the terms 'document' and 'record' used in ISO 9001:2008 QMS standard are changed to 'documentation information' in ISO/DIS 9001. The term 'documentation information' is defined in ISO/DIS 9001. It means meaningful data (information) required to be controlled and maintained by an organization and the medium on which it is contained. No specific source, format or media is specified for documentation information in ISO/DIS 9001. It can be in any format (such as language, software version, graphics etc) and media (such as paper, electronic) and from any source. It has been clarified that documentation information can refer to the quality management system including related processes, meaningful data (information) created for the organization to operate and evidence of results achieved.

ISO/DIS 9001 requires documentation information to be available and maintained/retained for the following:
- scope of the quality management system stating (i) products and services covered, and (ii) justification for any instance where a requirement of ISO/DIS 9001 cannot be applied (clause 4.3)
- to the extent necessary to (i) support the operation of processes, and (ii) have confidence that the processes are being carried out as planned (clause 4.4)
- quality policy (clause 5.2.2)
- quality objectives (clause 6.2.1)
- monitoring and measurement resources as evidence of fitness (clause 7.1.5)
- evidence of competence (clause 7.2)
- documentation information of external origin determined by the organization (clause
- result of the review of requirements related to products and services (clause 8.2.3)
- confirmation that design and development requirements have been met (clause 8.3.2)
- design and development outputs (clause 8.3.5)
- design and development changes (clause 8.3.6)
- results of evaluations, monitoring of the performance and re-evaluations of the external providers (clause 8.4.1)
- traceability (clause 8.5.2)
- results of the review of changes, personnel authorizing the change and any necessary action for production and service provision (clause 8.5.6)
- traceability to the person(s) authorizing release of products and services for delivery to the customer (clause 8.6)
- actions taken on nonconforming process, outputs, products and services including any concessions obtained and person/authority made decision regarding dealing with the nonconformity (clause 8.7)
- evidence of results for monitoring, measurement, analysis and evaluation (clause 9.1.1)
- evidence to implement internal audit programme and the internal audit results (clause 9.2.2)
- results of management review (clause 9.3.2)
- evidence of the nature of nonconformities and any subsequent actions taken and results of any corrective action (clause 10.2.2)
- controlled conditions to control production and service provision to include, as applicable, the availability of documentation information defining the characteristics of the products and services, and the activities to be performed and the results to be achieved (clause 8.5.1)

In addition to the above, organization's quality management system needs to include documentation information determined by the organization as being necessary for the effectiveness of the quality management system (clause 7.5.1 b).

Creating and updating of documented information

Clause 7.5.2 of ISO/DIS 9001 provides requirements for creating and updating of documented information. At the time of creating and updating documented information the organization needs to ensure as appropriate:
- suitable identification and description of documented information by marking a title, date, author or reference number
- format of the documented information, such as language, software version, graphics etc
- media of the documented information, such as paper (hard copy), electronic
- review and approval of the documented information for suitability and adequacy

Control of documented information

Clause 7.5.3 of ISO/DIS 9001 provides requirements to control documentation information. As per requirements of ISO/DIS 9001 documented information required by the quality management system and by ISO/DIS 9001 must be controlled to ensure:
- its availability and suitability for use, where and when it is needed,
- its adequate protection so that there is no (i) loss of confidentiality, (ii) improper use, or (iii) loss of integrity,

The organization needs to address the following activities, as applicable, to control documentation information:
- distribution
- access (that imply a decision regarding permission to view the documented information only, or the permission or authority to view and change the documented information)
- retrieval and use
- storage and preservation, also preservation of legibility
- control of changes, such as version control
- retention and disposition

The organization needs to identify as appropriate, and control the documented information of external origin determined by the organization

Is quality manual required in ISO/DIS 9001?

ISO/DIS 9001 no longer includes the requirement of a documented quality manual, where ISO 9001:2008 QMS standard requires a documented quality manual. Although there is no explicit requirement for the quality manual in ISO/DIS 9001, however its clause 7.5.1 (b) states to include documented information determined by the organization as being necessary for the effectiveness of the quality management system. Accordingly, most organizations would determine a manual (or description book or instruction manual) that may define and provide clear direction to the organization people regarding implementing ISO/DIS 9001 in the organization.

Note: The ISO 9001 revision process moves on to the next stage, as such readers should note that there may be some changes in the requirements in the next stage of revision process. The above article is for academic purpose. Readers' comments are invited. Thanks.

Sunday, December 14, 2014

ISO DIS 9001 Gets Approved, Proceeds to FDIS Stage

Please read the link article "ISO DIS 9001 Gets Approved, Proceeds to FDIS Stage" of Christopher Paris, VP Operations at Oxebridge Quality Resources International LLC.

Monday, November 17, 2014

News from ISO - ISO 9001 revision moves on to final stage

News from ISO

ISO 9001 revision moves on to final stage

- Maria Lazarte, Communication Officer and Social Media Manager
Communication Services, International Organization for Organization
(5 November 2014)

A recent vote approved the latest draft of the revised ISO 9001 on quality management systems. The document can now progress to the next stage of the ISO standard development process.

ISO 9001 is undergoing the periodic revision standards generally go through every 3 to 5 years to ensure they are relevant and up-to-date. The new edition, expected in 2015, will feature some important changes.

The latest draft (Draft International Standard – DIS) was put to vote according to ISO procedures and received nearly 90% approval, which is enough for it to progress to the next stage: Final Draft International Standard (FDIS).

Experts in the ISO subcommittee revising the standard will now go through all the comments received during the DIS vote in order to produce a final draft which will then be put forward for voting. Once approved, the standard can then be published.

"We are on the right track, and we are on schedule for publication,"says Nigel Croft, Chair of the ISO subcommittee revising the standard. He adds, "The new version is very strongly based on three basic core concepts: that process approach which was very successful in the 2008 version of the standard superimposed on that system of processes is the plan-do-check act methodology, and a third core concept which is new in the 2015 version is risk based thinking, aiming at preventing undesirable outcomes."

ISO 9001 is one of ISO’s most well-known standards, with more than 1.1 million certificates worldwide. It provides requirements to help companies demonstrate that they can offer their customers consistent, good quality products and services. It also provides a framework to help them streamline their processes and become more efficient at what they do. ISO 9001 can be used by organizations of all types and sizes. The standard has inspired a series of documents for sector-specific applications including for the automotive sector, the medical sector, local governments and more.

Courtesy Source - ISO Website (http://www.iso.org/iso/news.htm?refid=Ref1905)

Monday, October 20, 2014

What's New? A Look at the Changes in ISO/DIS 9001

International Organization for Standardization (ISO) had issued ISO/CD 9001 on 03 June 2013 for review and comments as a part of the revision process of ISO 9001 QMS Standard. Now the International Organization for Standardization (ISO) has issued ISO/DIS 9001 on 8 May 2014 for voting to be begin on 10 July 2014 and terminate on 10 October 2014. ISO/DIS 9001 is the formal draft of the forthcoming ISO 9001:2015 that describes the potential requirements of the revised version of ISO 9001 and it should be noted that this is not the final version, however this DIS version provides an idea on what might be included in the forthcoming standard. Further changes are possible in the ISO/DIS 9001 before final publication of ISO 9001:2015 that currently scheduled to be published in the fourth quarter of 2015. Those interested to procure a copy of ISO/DIS 9001 should contact ISO. A copy of ISO/DIS 9001 can be purchased at the ISO website (http://www.iso.org/iso/catalogue_detail?csnumber=62085).

The significant changes proposed in ISO/DIS 9001 relate to:
- Structure and terminology
- Internal and external context of an organization's QMS and risk-based approach (Clause 4 and 6)
- QMS requirements (Clause 5, 7 to 10)
- Incorporation of Annex A, B and C

Annex A provides clarification of new structure, terminology and concepts. Annex B provides details of seven quality management principles on which the ISO QMS Standards portfolio are based. Annex C describes the ISO 10000 portfolio of quality management standards that can provide assistance to organizations in establishing or improving their QMS, processes or activities

ISO/DIS 9001 contains following changes in the terminology:
- The term 'product' used in ISO 9001:2008 standard is changed to 'product and service' in ISO/DIS 9001. ISO 9001:2008 QMS Standard used the term 'product' to include all output categories. ISO/DIS 9001 uses the term 'products and services' that includes all output categories (hardware, services, software and processed materials). The specific inclusion of 'services' is intended to highlight the differences between products and services.
- The terms 'document' and 'record' used in ISO 9001:2008 standard are changed to 'documented information' in ISO/DIS 9001.
- The term 'work environment' used in ISO 9001:2008 standard is changed to 'environment for the operation of processes' in ISO/DIS 9001.
- The term 'supplier' used in ISO 9001:2008 standard is changed to 'external provider' in ISO/DIS 9001.
- The term 'purchased product' used in ISO 9001:2008 standard is changed to 'externally provided products and services' in ISO/DIS 9001

Clause 1.2 of ISO 9001:2008 standard mentions concession to organization for exclusion of any requirement(s). Now this requirement is not included in clause 1, the scope, of ISO/DIS 9001. However, clause 4.3 of ISO/DIS 9001, determining the scope of the quality management system, mentions the requirement for stating the justification for any instance where a ISO/DIS 9001 requirement cannot be applied. ISO/DIS 9001 no longer makes specific reference to 'exclusions' when determining the applicability of its requirements to the organization's quality management system.

ISO/DIS 9001 mentions new requirements with regard to the context of the organization - clause 4.1 - understanding the organization and its context, and clause 4.2 - understanding the needs and expectations of interested parties. Now as per ISO/DIS 9001, an organization establishing a quality management system needs to understand the organization and its context by determining relevant internal and external issues, understand the needs and expectation of interested parties, determine the scope of the quality management system, and determine risks and opportunities.

It is an opinion that ISO 9001:2008 standard has a inward-focusing methodology approach, while ISO/DIS 9001 has a external-focusing methodology approach to develop and implement quality management system. ISO/DIS 9001 now requires organization to determine interested parties and their requirements. ISO/DIS 9001 is closely aligned to the adoption of risk-based approach.

ISO 9001:2008 standard clause 8.5.3 contains requirements for preventive action, however with inclusion of risk-based approach now ISO/DIS 9001 does not mention specific clause on preventive action.

We will post more articles on changes and forthcoming standard to create awareness.

- Keshav Ram Singhal