Forward – What’s new in the 2015 update?

In this ISO 9001:2015 resource article, we will briefly look at the changes introduced in the latest update of the standard and how it is now structured. We will then start by looking at the following sections:

Sections 1 Scope of the standard.

Section 2. Normative references.

Section 3. Terms and definitions.

If you were familiar with ISO 9001:2008, but have not yet looked at the 2015 update, some of the key changes in the new version you will need to consider are:

1. Increased emphasis on leadership requirements.
2. The adoption of a new structure (“Annex SL”) of the standard to help facilitate an integrated approach to systems.
3. An explicit requirement for risk-based thinking. (Very topical given the impact of the Coronavirus on businesses in 2020.)
4. Increased emphasis on the process approach for the Management System.
5. Less emphasis on documentation, (no longer a requirement for a Quality Manual for example.)
6. An increased requirement to define the boundaries (“scope”) of the Management System.
7. Increased emphasis on the internal and external operating environment (“context”) of the organisation and its stakeholders. (“Interested parties”).
8. Considering the knowledge held in the organisation as a resource.
9. Fewer prescribed requirements.
10. “Improved” applicability for service organisations.

ISO 9001:2015 Sections & Clauses

As discussed, the 2015 revision of the standard follows the Annex SL template for its structure. This consists of 10 sections, (which are further divided into clauses and sub-clauses.)

Section 1: Scope

Section 2: Normative references

Section 3: Terms and definitions

Section 4: Context of the organization

Section 5: Leadership

Section 6: Planning

Section 7: Support

Section 8: Operation

Section 9: Performance evaluation

Section 10: Improvement

In the following articles, we will look initially at the first sections and then at each new clause and significant sub-clauses in turn, interpret the requirements for initial implementation of ISO 9001:2015

Although these series of articles are primarily intended to help organisations to get the most benefit from their initial implementation of the standard, there are also included “Audit Check” footnotes in each article highlighting what auditors may specifically look for when auditing against the revised requirements.

Note: Prior to section 1, the Forward and Introduction in the standard, contain some useful information and explanations (in, generally speaking, plain English!) on some key topics and changes in the new standard such as the process approach, the Plan, Do, Check cycle and Risk based thinking. Worth reviewing before moving onto the main sections…

Section 1. Scope of the standard (not scope of your organisations management system!)

The overall purpose of the 2015 version of the standard was unchanged from ISO 9001:2008. The aim is still to enable organisations to apply and demonstrate their ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.

“Exclusions” have been removed from the update, as all the requirements in ISO 9001:2015 are intended to be applicable to all organisations, products and services. However, there is provision in Appendix A5 if it is not possible for an organisation to conform to a specific requirement, for it to specify the requirement as “not applicable” under its Management System scope. (The organisations Scope is required to be established and documented under clause 4.3)

Comment:

We will in a later article look at Clause 4.3, which requires the business scope to be determined in consideration of the organisations context – a new term for 2015 which we will also explore.

(The context of the organisation is itself clarified and expanded in later clauses and referenced throughout the standard, which now takes a more holistic view of the environment in which the organisation operates. ISO 9001:2015 is not just about the quality of the product or service your customers see, it defines a genuine whole Business Management System, because all the processes in a well-structured system, can ultimately impact the customer.)

Section 2. Normative references

ISO 9001:2015 cites ISO 9000, (Quality management systems — Fundamentals and vocabulary) as a normative reference as did the 2008 issue. IE: It covers the basic quality management concepts and language and is intended to be used alongside 9001 as a reference document.

Comment:

As a “Normative reference,” ISO 9000:2015 can be interpreted as a “vital or essential” companion text to the 9001 standard. ISO 9000 is certainly potentially a very useful dictionary, given the number of phrases and terms in ISO 9001:2015. (Just to add some confusion, ISO 9000 is also used to refer to a group of standards of which 9001 is a part!)

Audit Check:

Definitions and their interpretation, are often the breeding ground for animated discussions with an auditor! The use of ISO 9000 is not mandatory however, although sometimes online deals are available if you wish to purchase the 9001 & 9000 standards together. Note: Before you buy, see also “audit check” in terms and definitions below…

Section 3. Terms and definitions

All applicable terms and definitions are incorporated into ISO 9000:2015 which includes all twenty two core definitions referenced in Annex SL. As mentioned previously, ISO 9001 has been re-structured in line with Annex SL requirements, in order to improve alignment and compatibility with other management system standards such as the Environmental Management System standard ISO 14001:2015.

Comment:

The aligned structure of Annex SL is a great help for organisations planning to install Integrated Management Systems covering both Quality and Environmental for example. This is because many single business processes can cover the requirement of both standards. (Why would you want to operate two separate Corrective Action processes for example, when one can meet the requirements of both standards?)

Audit Check:

Before you enter into a “discussion” (!) with your auditor, regarding the interpretation of terms and definitions, if you do not have a copy of ISO 9000 to hand, you may be able to find what you are looking for via the ISO Online Browsing Platform (OBP) at:

https://www.iso.org/obp/ui/#iso:std:iso:9000:ed-4:v1:en:term:3.5.5