Changes in ISO 9001:2015 Not Based on Annex SL

by Dave Moskal

As seen in previous articles, some of the changes are based on the published  Annex SL standard which causes consistency among management system standards.  Changes in these areas can be predicted quite reliably, however, there are some changes to ISO 9001:2015 that don’t originate in these areas of the standard.  These changes relate specifically to quality and are currently only at the committee draft stage of development.  In this article I’ll briefly discuss three of the changes that were suggested in this committee draft to occur in the Product Realization sections of the standard.

First of all, the name of the section itself will be changing from “Product Realization” to “Operation.” As the change in the section title implies the focus has shifted from being primarily on products that are physically produced to an equal focus on the production of goods and the provision of services that are provided. This new emphasis will ensure that the processes for the provision of services that are provided by companies are planned and implemented using a process approach and with the same importance and focus that goods are in the current revision of the standard.

Development

So to start let’s take a closer look at ISO 9001:2015 section 8.5 ‘Development of Good and Services’. This section relates directly to 7.3 ‘Design and Development’ in 9001:2008. The first thing that is noticed is that the section has been condensed and has only the three sub-sections of 8.5.1 ‘Development Processes’ , 8.5.2 ‘Development Controls’, and 8.5.3 ‘Development Transfer’, instead of the previous seven sub-sections. Additionally the word “design” has been removed from the standard. This doesn’t mean that goods produced no longer need to go through a controlled design process. By removing “design” from the standard the perception that the process is only applicable to physically produced goods is also removed and therefore opens the requirement to the development of services that are to be provided.

Section 8.5.1 ‘Development processes’ has essentially combined sections 7.3.1 ‘Planning’, 7.3.2 ‘Inputs’, and 7.3.3 ‘Outputs’ of 9001:2008 with the focus being on the development of both goods and services using the process approach. While customer, statutory and regulatory requirements still need to be taken into account, standards or codes of practice that the organization has committed to implement need to be taken into account as well. Risks and opportunities for the goods and services developed including the potential consequences of failure will also need to be accounted for.

Section 8.5.2 ‘Development controls’ is essentially a combination of sections 7.3.4 ‘Review’, 7.3.5 ‘Verification’, 7.3.6 ‘Validation’, and 7.3.7 ‘Changes’ from 9001:2008. While the words “verification” and “validation” have been removed, controls will still need to be established to ensure that the outputs are consistent with the inputs and that the objective of the development activity has been met. While the control of development changes is currently a requirement in 9001:2008, configuration management is not required. Unlike the current change control processes in some organizations, the configuration management process will require that a process be developed and implemented to not only approve the version of individual components and determine the effects of changes on constitute parts before the implementation of the change but to also identify the revisions and compatibility for each of the components in the completed goods provided or services provisioned that have been or are to be delivered to the customer.

Finally, section 8.5.3 ‘Development Transfer’ also relates to 7.3.6 ‘Validation’ from 9001:2008 in that the organization only releases the goods or services once it has ensured that the they are capable of meeting the specified requirements. However 9001:2015 goes a bit farther than that and also requires that the organization will only transfer the development to production or service provision when all outstanding or arising actions from development have been completed or are otherwise managed to ensure that there is no adverse impact on the organization’s ability to consistently meet customer requirements, statutory or regulatory requirements or to enhance customer satisfaction.

Production

Now let’s move on to see how section 8.6 ‘Production of Goods and Provision of Services’ in 9001:2015 relates to section 7.5 ‘Production and Service Provision’ in 9001:2008. Following the same theme as Development, Production of goods and provision of services has increased the focus on the provision of services. Section 8.6.1 ‘Control of Production of Goods and Provision of Services’ includes the requirements of sections 7.5.1 ‘Control of Production and Service Provision’ and 7.5.2 ‘Validation of Processes’ in 9001:2008. While none of the requirements have been removed from either of these sections, there has been a subtle and minor change in the requirement for the controlled conditions to include the competence of personnel or their qualifications to not only be applicable when deficiencies that only become apparent after the product is in use of the service has been delivered, but will also be applied to the control of all of the applicable realization processes. There is also a new requirement for the prevention of nonconformity due to human error, such as unintentional mistakes and intentional rule violations. Although there have been some wording changes to the requirements of sections 7.5.3 ‘Identification and Traceability’, 7.5.4 ‘Customer Property’ and 7.5.5 ‘Preservation of Product’ in 9001:2008 to clarify the provision of services, the intents have remained the same.

Calibration

Lastly we’ll cover the differences between section 7.1.4 ‘Monitoring and Measuring Devices’ in 9001:2015 to the current requirements in section 7.6 ‘Control of Monitoring and Measuring Equipment’ in 9001:2008. The most notable change is that the section has been reduced to only two requirements. The first requirement “The organization shall determine, provide and maintain the monitoring and measuring devices needed to verify the product requirements and shall ensure that the devices are fit for purpose” is essentially the same as the current requirement in 9001:2008. However the second requirement in 9001:2015 has included and generalized the remaining requirements of 7.6 in 9001:2008. In 9001:2015 it’s currently stated as “The organization shall retain appropriate documented information as evidence of fitness for purpose of monitoring and measuring devices.” While the requirements for the adjustment or re-adjustment, identification, safeguarding from adjustments, protection from damage or deterioration, the assessment and recording of the validity of previous measuring results when equipment is found not to conform to requirements, and taking appropriate action on equipment and product affected will no longer be specified in the requirements, the organization will still need to “retain appropriate documented information as evidence.” The best way to provide the evidence “of fitness for purpose” will be with equipment that has been identified and have calibration certifications traceable to national or international standards and impact investigations when found out of tolerance. It is also important to mention that note 2 of clause 7.1.4 for 9001:2015 states that “Monitoring and measurement devices can be calibrated or verified, or both, at specified intervals, or prior to use, against standards traceable to national or international measurement standards.” Although the notes themselves are not a requirement the words “appropriate documented information as evidence” will drive the auditor to look for the documented information that is contained in note 2.

Conclusion

Although there are differences from the current version to the upcoming version of ISO 9001, organizations that are already in conformance with the Product Realization process in 9001:2008 will mainly need to review their system to ensure that they will still be in conformance with Operation process that will be in 9001:2015. The primary differences in the 2015 update to ISO 9001 for the Operation process is the increased focus on the development and provision of services and the configuration management of the goods produced and services provided. This focus on services however will not reduce the responsibilities of organizations to ensure that the development and production of goods are planned, implemented, and controlled using a process approach. Both goods that are produced and services that are provided will have similar focus and require that controls are developed and implemented for their realization.

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