Looking for significant changes in the 2015 revision of ISO 9001
By Ir William S K WONG
The current edition of ISO 9001¹ was published in 2008. The ISO standard has a defined mechanism for reviewing every standard regularly. According to the previous pattern, ISO 9001 is updated approximately every seven to eight years. The review of the standard is now in progress. A new revision is targeted for issue at the end of 2015. According to the committee draft² issued in June 2013, the proposed changes in the new revision is huge, even more significant than the revision made in the 2000 version. The new revision is not only a structural change, but also includes some fundamental changes. This paper introduces some of these significant changes.
To cope with the introduction of Annex SL³ (previously ISO Guide 83), the structure of the standard also will be changed. The main elements are described in five sections (section 4 to section 8) in the current edition. In the new revision, the main elements will be described in seven sections (section 4 to section 10). An individual section is developed for "planning". It is also noted that some rationalisations will be made; for example, "control of measuring device" is moved from "process control" to "support".
Starting from the 2000 edition, ISO 9001 has been developed based on the eight quality management principles. In the 2015 revision, the number of quality management principles will be reduced to seven. "System approach to management" will be removed. It may be because the standard itself is demonstrating a systems approach, so there is no need to re-emphasise. Another quality management principle, "Mutually beneficial supplier relationships", will become "Relationship management". Starting from the first edition of ISO 9001, the standard has focused on describing the relationship between customers, the organisation and suppliers. However, in the new revision, there is a fundamental change in the scope, which will be extended to cover interested parties too. This change implies a transition of the standard from a quality management standard to a business management standard.
Under Note 1, clause 8.2.1 of the proposed revision, the term "customer" refers to an existing customer or potential customer. It implies that an organisation should manage not only the interactions with existing customers (that is, sales activities) but also interactions with potential customers (that is, marketing activities). However, someone may also query whether a person or party approaching the organisation which is not in the targeted customer segment should be classified as a potential customer or not.
The proposed revision adds two clauses at the beginning of the standard:
4.1 Understanding the organisation and its context
4.2 Understanding the needs and expectations of interested parties
Introduction of these two clauses provides more specific guidelines for reviewing an organisation's external and internal competitive environments, in order to enhance the planning of its quality management system and identify opportunities for improvement and innovation. These two clauses also extend the scope of the standard from a focus on customer satisfaction to considering the needs and expectations of interested parties, including direct customers, end users, suppliers, distributors, retailers, others involved in the supply chain and regulators, etc.
There are also a number of statements made, in the new revision, requiring an organisation to determine and address risks and opportunities. These requirements include clauses 4.4.2(d), 5.1.2(a), 6.1, 6.3, 8.3(b), 8.4.2(a), 8.5.1(e), 8.6.5(a), 9.1.1, 9.2.2(a) and 10.2(c). However, there is no specific requirement for a formal risk assessment.
ISO 9001:2008 promoted the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system. The proposed revision to the standard makes this more explicit by including "process approach" (clause 4.4.2) in the core text. It implies that the adoption of a process approach is not a choice, but a requirement.
Another significant change in the new revision is the documentation requirement. In the new revision, the documentation requirement will be reduced to minimal. There is no specific requirement for any 'documented procedure' in the new revision. Even the requirement for a 'quality manual' will be deleted. In the new revision, only three items must be documented, which are:
- Scope (4.3)
- Policy (5.2)
- Quality objectives (6.2)
Organisations can determine the extent of their quality system documentation according to their situations (7.5.1). Since by definition an 'audit' should be a documented process, an 'internal audit' is the only process that must be documented according to the new revision. The terms 'document' and 'record' have both been replaced throughout the requirements text by 'documented information'. Therefore, the requirements, "Control of documents" (4.2.3) and "Control of records" (4.2.4), will also be combined as a new requirement, "Control of documented information" (7.5.3).
Starting from the 2000 edition, the standard carries an "exclusion" clause (clause 1.2) which allows an organisation to exclude some clauses under certain circumstances. The "exclusion" clause was originally introduced following the decision to withdraw ISO 9002 and ISO 9003 in 2000. This clause still exists in the committee draft. However, as the committee draft has taken a different approach to the way in which its requirements are stated, when compared to the earlier editions of ISO 9001, the technical committee considers that there should no longer be any technical reasons for an organisation's quality management system not to be able to meet all the requirements of the future standard. Therefore, the technical committee is also considering the possibility of removing this "exclusion" clause.
The term "monitoring and measuring devices" as stated in ISO 9001: 2000 was changed to "monitoring and measuring equipment" in ISO 9001: 2008. It is interesting that the proposed revision will go back to "monitoring and measuring devices" again. Whether "survey" should be considered as a measuring device or not is a debatable topic. In the proposed revision, there is a note that clearly states that monitoring and measuring devices can include assessment methods such as surveys. It implies that surveys, such as customer opinion surveys, should be verified or calibrated before being used in the future. It can also further imply that the clause may also be applicable to other subjective assessment methods, such as personal judgement or visual inspection, which is quite debatable.
More specific and new requirements
It is well known that quality objectives should be measurable. Although it is implied, there is no specific requirement in ISO 9001: 2008 for quality objectives to be monitored. In the proposed revision, it is clearly stated, in clause 6.2(e), that quality objectives should be monitored. Moreover, more specific requirements are stated for planning to achieve quality objectives. It is clearly stated that actions, resources, responsibilities, timeframe for completion and evaluation method should be determined.
The requirements for authorities and responsibilities will also be changed. The term, "management representative", is removed. Instead, it is clearly stated, in clause 5.3 of the proposed revision, that top management is accountable for the effectiveness of the quality management system. The top management should assign responsibility and authority for managing the quality management system. However, there is no statement requiring these responsibilities and authorities to be assigned to a single person or a member of management.
The proposed revision will introduce a new requirement about knowledge management (clause 7.1.5) which will require an organisation to determine, maintain, protect and make available the necessary knowledge.
In conclusion, the proposed changes are significant and ambitious. Due to the degree of changes proposed, the transition period for users of ISO 9001:2008 to transfer to the new revision has been set for three years. As it is only a committee draft, the changes have not been finalised yet. Another consideration is that ISO 14001 will probably be amended in 2015. The changes of these two standards, which are the two standards that are most widely adopted, will surely have a significant impact on the business community.
1. ISO 9001: 2008
2. ISO/TC 176/SC 2/N1147 Committee Draft of ISO 9001 dated 3 June 2013
3. ISO/IEC Directives, Part 1 - Consolidated ISO Supplement - Procedures specific to ISO, 4th Edition, 2013
About the author: Ir William S K Wong is the principal consultant of Knowledge Workshop and is a registered quality management system lead auditor of the International Register of Certificated Auditors.