ISO 9001:2008 vs. ISO 9001:2015 (2013 CD)
A Focus on Clause 4
A direct clause by clause comparison of ISO 9001:2008 vs. ISO 9001:2015 is difficult at best. Eight clauses in the 2008 version are replaced by ten in the 2013 committee draft.
Clauses 1 through 3 have the least changes, sans the word ‘continual’. Clause 4 is a major rewrite and suggest a new approach to documentation and planning requirements. The process model and role is expanded to included expected output, risks of conformity for goods and services. Plus, customer satisfaction if unintended outputs are delivered or process interaction is ineffective.
ISO 9001:2008 |
ISO 9001:2015 |
4 Quality Management System4.1 QMS: General RequirementsThe organization will establish, document, implement, maintain and continually improve a Quality Management System (QMS). This is where we find the Requirement to identify processes that need to be controlled, and determine how they interrelate. The organization must also determine how to control any outsourced processes.Steps that need to be taken are:
This section does not address the documentation of the processes. It focuses on the development and implementation of the process and goes on to require that they are managed and continually improved. 4.2 Documentation Requirements4.2.1 GeneralQuality management system documentation must include:
The standard only identifies six places where a documented procedure is The only documented procedures specifically required by ISO 9001:2008
However, this does not mean that they are the only procedures required. You will need to document your key processes. Key processes must be From the list of key processes, additional needed documentation must be 4.2.2 Quality Manual (does not appear in the 2013 CD)The standard also requires a documented quality policy and objectives. A quality manual must be created and maintained that includes : A description of the sequence and interaction of the processes included in the quality management system (QMS) Identification of permissible exclusions 4.2.3 Control of documentsYou must have a system in place to control your documents- your quality Establish a process to approve documents, control the revision and You must make sure that people are working from the current, correct Quality records must be controlled and protected, quality records are Have a process in place that identifies what quality records you have, Most companies will use a “Master List” to list the current revision and Recording the distribution of documents is important; if a document is Documents must be reviewed on a regular basis to make sure they are up This could be with regular use, and during internal audits. If employees In other words, if staff are using the system as it is designed, 4.2.4 Control of recordsRecords established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. A table works well for listing all your quality records, where they are The procedure must address storage, retention times and disposition. If ISO does not specify how long you have to keep your records, but |
4 Context of the organization4.1 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 outcome(s) of its quality Management system. The organization shall update such determinations when needed. When determining relevant external and internal issues, the organization shall consider those arising from: a) changes and trends which can have an impact on the objectives of the organization; b) relationships with, and perceptions and values of relevant interested parties; c) governance issues, strategic priorities, internal policies and commitments; and d) resource availability and priorities and technological change.Note 1 Note 2 4.2 Understanding the needs and expectations of interested partiesThe organization shall determine a) the interested parties that are relevant to the quality management system, and b) the requirements of these interested partiesThe organization shall update such determinations in order to understand and anticipate needs or expectations affecting customer requirements and customer satisfaction. The organization shall consider the following relevant interested parties: a) direct customers; b) end users; c) suppliers, distributors, retailers or othersinvolved in the supply chain; d) regulators; and e) any other relevant interested parties. Note: Addressing current and anticipated future needs can lead to the identification of improvement and innovation opportunities. 4.3 Determining the scope of the quality management systemThe 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, and b) the requirements referred to in 4.2.The scope shall be stated in terms of goods and services, the main processes to deliver them and the sites of the organization included. When stating the scope, the organization shall document and justify any decision not to apply a requirement of this International Standard and to exclude it from the scope of the quality Note: An external provider can be a supplier or a sister organization (such as a headquarters or alternate site location) that is outside of the organization’s quality management system. The scope shall be available as documented information. 4.4 Quality management system4.4.1 GeneralThe organization shall establish, implement, maintain and (continual deleted) improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard. 4.4.2 Process approachThe organization shall apply a process approach to its quality management system. The organization shall: a) determine the processes needed for the quality management system and their application throughout the organization; b) determine the inputs required and the outputs expected from each process; c) determine the sequence and interaction of these processes; d) determine the risks to conformity of goods and services and customer satisfaction if unintended outputs are delivered or process interaction is ineffective; e) determine criteria, methods, measurements, and related performance indicators needed to ensure that both the operation and control of these processes are effective; f) determine the resources and ensure their availability; g) assign responsibilities and authorities for processes; h) implement actions necessary to achieve plannedresults; i) monitor, analyse and change, if needed, these processes ensuring that they continue to deliver the intended outputs; and j) ensure continual improvement of these processes. |