On July 9th 2015, the ISO/FDIS 9001:2015 was issued in 28 pages, the last stage in the ISO 9001 revision process. This is the final draft international standard (FDIS) before the final publication of the standard scheduled on September 23, 2015. The overall opinion is that very little to no change will be taking place between the final draft and the published standard.
Let’s begin our journey by reviewing some of the revised terms and definitions between the current standard and the FDIS.
ISO 9001:2008 |
ISO 9001:2015 |
Exclusions |
As Applicable… |
Products |
Products and Services |
Quality Manual, Documented Procedures |
[Maintain] Documented Information |
Records |
[Retain] Documented Information |
Work Environment |
Environment for the Operation of Processes |
Purchased Products |
Externally Provided Products and Services |
Supplier |
External Provider |
What’s important to understand here is that Annex A of the FDIS states that organizations can use terms which suit their operations. For example, using records, or documentation rather than “documented information”, or supplier, or vendor rather than “external provider”. There is no requirement to mirror the structure (clause sequence) and the terminology of the new ISO 9001 International Standard.
New Terms and Concepts
“The organization shall maintain documented information and control to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned.”
- “maintain” infers procedure
- “retain” infers record
Further eliminated terms include the Quality Manual. This does not preclude the need and value of a Quality Manual. Your Quality Manual and its content should be viewed and utilized as company policies.
Unfortunately, in many cases the Quality Manual is considered a necessary evil of certification compliance, and not valued. An effective quality manual is one that is used for internal and external policy communication, and new employee training source – use it and improve it. Multiple procedures which are valued and have been proven to improve operational effectiveness and reduce operating costs are a resource – use them and improve them. “Documented information to the extent necessary to have confidence”.
Content of the Organization Clause
The Why, How and What of Your Business Purpose and Objectives. What is the Combination of internal and external factors that can have an effect on an organization’s approach to its products and services …and interested parties?
Determine your issues and requirements that can impact on the planning of the Quality Management System… within the scope of the QMS.
What is relevant is whether or not it has impact on the organization’s ability to consistently provide products and services that meet customer and applicable regulatory requirements; or the organization’s aim to enhance customer satisfaction.
Interested Party Clause
Person or organization that can affect, be affected by, or perceive themselves to be affected by a decision or activity…and their relevant interests.
Examples can be: Customers, Owners, Employees, Suppliers, Regulators, Partners, Community, and Competitors.
Content of the Organization + Interested Party Requirements = Scope of the QMS
Risk- effect of uncertainty on an expected result.
The risks and opportunities and the appropriate actions to address them..
“When planning for the QMS, the organization shall consider the issues referred to in 4.1 [Organization and Context] and the requirements referred to in 4.2 [Interested parties] and determine the risks and opportunities that need to be addressed…”
The organization shall plan actions to address these risks …”
i.e. avoiding, taking, eliminating, changing likelihood or consequence, sharing, retaining.
Let’s now take a look at integration of Clause 4 Context of the Organization
ISO/DIS 9001 Clause 4.1 Understanding the organization and its context.
“The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system. The organization shall monitor and review the information about these external and internal issues.”
Interpretation: What is your company purpose and direction? This requires you to know yourself inside and outside, including the strategic organizational direction. What are your external and internal business factors affecting you? A much broader look at the role of the management system is now required, and its relative processes. Moving Quality out of the Quality Department is expanding. The Quality Manager as sole responsibility for definition and control will not be sufficient for compliance.
ISO/DIS 9001 Clause 4.2 Understanding the needs and expectations of interested parties
Due to their impact or potential impact on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:
a) the interested parties that are relevant to the quality management system;
b) the requirements of these interested parties that are relevant to the quality management system.
The organization shall monitor and review the information about these interested parties and their relevant requirements.
Interpretation: Identify and take interested parties into consideration (e.g. customers, owners, employees, suppliers, and partners) and their requirements relevant to the QMS, incorporate into the QMS, and monitor information and requirements.
Together these clauses require the organization to determine the issues and requirements that can impact on the planning of the quality management system.
ISO/DIS 9001 Clause 4.3 Determining the scope of QMS
The organization shall determine the boundaries and applicability of the quality management system to establish its scope.
When determining this scope, the organization shall consider:
a) the external and internal issues referred to in 4.1;
b) the requirements of relevant interested parties referred to in 4.2;
c) the products and services of the organization.
Interpretation: The company scope remains required, however with added clarity for boundaries and applicability. The documented information and integration of 4.1 and 4.2 determination will be part of the QMS scope. Products and services referenced could be at a high-level.
We will continue in our September newsletter with further information on ISO 9001:2015. Stay tuned for information on our future ISO 9001:2015 Training and Supporting Services to ensure your company makes a successful and measurable transition.
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