Review of possible impact of ISO 9001:2015

The CD version is released and in a routine pace, this will pass through the usual process of DIS, FDIS before release. The standard as such is not  only having some minor corrections , but has new concepts.

Risk, Process approach, Context & Development process are some major aspects in the standard. This will bring in major change in the understanding, documenting and implementing the standard. All such changes will bring in the quality management approach risk prevention, sustainability. The standard is in line with ISO 9004 guidelines published some time back.

From the business perspective let us analyze the changes:

This is now a management standard : With more focus on risk, prevention, strategy and accountability of top management, the standard clarifies the tasks for top management. In the earlier versions, the linkage between vision- strategy, policy, objective was not mentioned , though expected. Here it is direct linkage and there by onus will be more on management. This means management can not handover to MR and remain aloof.

Focus on sustainability: The context of organization identifies business related external & internal aspects , risks. The impact and counter actions are part of review. Hence this document will be guiding document and this will help organization to improve.

Focus on Prevention rather than QA/QC: The current  standard was clear on product monitoring and  has clear requirements related to process monitoring, product monitoring. The new standard uses risk approach, strategy, Knowledge management, process approach &  context of organization. This will bring in more focus on how to se all these to prevent product failures . The standard has no change as far as current requirements of product monitoring.

Better quality documentation: The process approach , the risk, knowledge management will ensure that the documentation will be pertaining to the organization’s size and purpose.

There are few areas which are different and made more generic in order to accommodate service sector. These can have some impact especially , clause on calibration , Management representative role are  more simplified.

Let us see the  not so positive impact :

a.       This standard will further add some documentation. Though useful , but may lead  a debate that earlier standard was more flexible, while this calls for more, structured documentation.

b.      The small organizations will find it difficult to prepare for unless some guidelines are released. At the same time, big organizations will find it very useful, only confidentiality can be an issue.

c.       The management clauses , context, and strategy  have some elements where there can be debate as to what extent organization would want to document the details. Adequacy, findings  may not be acceptable to the management.

d.      The same clauses when evaluated differently , may lead to consultancy.

e.      The time required for the audit is likely to go up – as documentation review, top management, planning function need to be audited to the requirements.

Positive  Impacts:

a.       Increased involvement of top management.

b.      More of management audit, hence success rate , sustainability of the organization will be better.

c.       Flexibility in the areas of monitoring, calibration.

d.      Better understanding of preventive actions, risk, strategy, improvements