ISO 9001 is the world’s most used management system standard, and all eyes are on this revision.

The impact it has had in shaping how organizations manage the issue of quality correctly, is huge. No organization can afford to let their standards slip and the new ISO 9001 encompasses the changing needs of businesses. In this article we’ll look at how ISO 9001 has evolved over the years and the changes related to the Final Draft International Standard (FDIS).

ISO 9001 started life in 1992 as BS 5750, driven by the Ministry of Defense which specified how manufacturing processes should be managed, instead of looking at what was manufactured. In 1987, ISO adopted BS 5750 and it became ISO 9001. The 1994 version of the standard particular emphasis on product assurance using preventive actions, instead of just checking the final product and also required documented procedures.

The radical change came in the 2000 version when it placed quality and process management at its core. It aimed to first understand the client’s requirements before designing processes that would help deliver these. It also looked at how to continuously improve processes and track customer satisfaction. Where previous versions focused on quality control, ISO 9001:2000 was built on quality management. ISO 9001:2008 only made the existing requirements clearer.

So why the need for change now?

Since 2000 the way we do business has changed enormously. We all have instant access to information and higher expectations of organizations we work with, whilst having to deal with more complex supply chains and a globally competitive economy. ISO 9001:2015 has been revised to take this into account and the key changes are.

• Greater emphasis on building a management system suited to each organization’s particular needs

• A requirement that those at the top of an organization be involved and accountable, aligning quality with wider business strategy

• Risk-based thinking throughout the standard makes the whole management system a preventive tool and encourages continuous improvement

• Less prescriptive requirements for documentation

• Alignment with other key management system standards through the use of a common structure and core text

ISO 9001:2015 brings quality management and continual improvement into the heart of an organization. The new standard is an opportunity for organizations to align their strategic direction with their quality management system and means that it can be used to help enhance and monitor the performance of an organization.

So what has changed specifically?

ISO 9001:2015 is based on Annex SL – the new high level structure. This is a common framework for all ISO management systems and helps to keep consistency, align different management system standards, offer matching sub-clauses and apply common language across all standards. There are 10 clauses within the standard and these are the changes:

Clause 1 is very similar to the 2008 version covering the scope of the standard and there has been very little change to this clause.

Clauses 2 and 3 cover normative references and term and definitions, both these clauses reference ISO 9000, Quality Management System - Fundamental and vocabulary which provides valuable guidance.

The remainder of the clauses include some new key elements which need to be considered when implementing the new standard.

Clause 4: Context of the Organization

This is a new clause that establishes the context of the QMS and how the business strategy supports this. The ‘context of the organization’ is the clause that underpins the rest of the new standard.

The organization will need to determine external and internal issues that are relevant to its purpose and would have an impact on what the organization does. Secondly an organization will also need to identify the “interested parties” that are relevant to their QMS. Each organization will identify their own unique set of “interested parties” and over time these may change.

Next the scope of the QMS must be determined which should consider any outsourced functions or processes if they are relevant.

The final requirement of Clause 4 is to establish, implement, maintain and continually improve the QMS.

Clause 5: Leadership

This clause places requirements on “top management” which is the person or group of people who directs and controls the organization at the highest level. It is no longer the responsibility of an individual or to have a “Management Representative” who is responsible for the QMS.

Top management now have greater involvement in the management system and must ensure the requirements are integrated into the organization’s processes and it is compatible with the strategic direction of the organization. The quality policy should be a living document, at the heart of the organization.

There is also a greater focus on top management to enhance customer satisfaction by identifying and addressing risks and opportunities that could affect this.

Clause 6: Planning

Planning has always been a familiar element of ISO 9001, but now there is an increased focus on ensuring that it is considered with Clause 4.1 ‘context of the organization’ and Clause 4.2 ‘interested parties’.

The organization will need to plan actions to address both risks and opportunities, how to integrate and implement the actions into its management system processes and evaluate the effectiveness. Actions must be monitored, managed and communicated across the organization.

Another key element of this clause is the need to establish measurable quality objectives. This retains some of the requirements contained in Clause 5.4 of the 2008 version but is more specific.

Clause 7: Support

Clause 7 ensures there are the right resources, people and infrastructure to meet the organizational goals. Simply expressed, this is a very powerful requirement covering all QMS resource needs and now covers both internal and external resources.

Organizational knowledge is a new requirement which deals with requirements for competence, awareness, and communication of the QMS. Personnel must not only be aware of the quality policy, but they must also understand how they contribute to it and what the implications of not conforming are.

There is a key requirement to maintain the knowledge held by an organization to ensure conformity of products and services.

Finally there are the requirements for “documented information”. This is a new term, which replaces the references in the 2008 standard to “documents” and “records”. Organizations need to determine the level of documented information necessary to control the QMS.

Clause 8: Operation

This clause deals with the execution of the plans and processes and includes much of what was previously referred to in Clause 7 of the 2008 version However, there is a greater emphasis on the control of processes especially planned changes and review of the consequences of unintended changes, and mitigating any adverse effects as necessary.

The revised version of the standard also acknowledges the trend towards greater use of subcontractors and outsourcing, whose performance should be monitored.

There is also a new clause which covers post-delivery activities. This could include activities such as maintenance programs, and activities covering final disposal or recycling of the product.

Clause 9: Performance Evaluation

Performance evaluation covers many of the areas previously featured in Clause 8 of the 2008 version. Requirements for monitoring, measurement, analysis and evaluation are covered and organizations will need to consider what needs to be measured, methods employed, when data should be analyzed and reported on and at what intervals.

There is now an emphasis on directly seeking out information that relates to how customers view the organization. Organizations must actively seek out information on customer perception. There is now an explicit requirement that organizations must show how the analysis and evaluation of this data is used, especially with regards to the need for improvements to the QMS.

Internal audits must also be conducted and this is largely unchanged from those in the 2008 version. Management reviews are still required but there are additional requirements including the consideration of changes in external and internal issues that
are relevant to the QMS.

Clause 10: Improvement

The final clause starts with a new section that organizations should determine and identify opportunities for improvement. There is also a need to actively look for opportunities to improve processes, products and services, and the QMS, especially with future customer requirements in mind.

Due to the new way of handling preventive actions, there are no preventive action requirements in this clause. However, there are some new corrective action requirements.

The requirement for continual improvement has been extended to cover the suitability and adequacy of the QMS as well as its effectiveness, but it no longer specifies how an organization achieves this.

In summary, there will be a number of new areas that organizations need to consider when implementing the new standard, but it provides a great opportunity to review your current approach and spring clean where appropriate.

This could help your business grow, increase customer satisfaction, and increase profitability. It is now a powerful business improvement tool for organizations of all sizes and in manufacturing or service industries to use to help them remain resilient and achieve sustainable growth.

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