ISO 9001:2008 vs. ISO 9001:2015 (2013 CD)

ISO-9001-2015-COMPAREDA 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 System

4.1 QMS: General Requirements

The 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:

  • Identify the processes needed for the QMS
  • Determine the sequence and interaction of these processes
  • Determine criteria and methods required to ensure the effective operation and control of these processes
  • Ensure the availability of information necessary to support the operation and monitoring of these processes
  • Measure, monitor and analyze these processes and implement action necessary to achieve planned results and continual improvement

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 Requirements

4.2.1 General

Quality management system documentation must include:

  • Documented procedures required by the standard
  • Documents required by the organization for effective operation and process control
  • Quality policy and objectives

The standard only identifies six places where a documented procedure is
required. The organization determines if additional documentation is

The only documented procedures specifically required by ISO 9001:2008
are procedures for:

  • Document Control (now appears in 7.5.3)
  • Control of Quality Records
  • Internal Quality Audits
  • Control of Nonconformity
  • Corrective Action
  • Preventive Action

However, this does not mean that they are the only procedures required.
You must identify what else is required in your organization. In 4.1,
the standard asks organizations to Identify key processes and their

You will need to document your key processes. Key processes must be
identified early in your transition to the new revision. This will help
you identify procedures and work instructions needed for effective
operation and control of key processes.

From the list of key processes, additional needed documentation must be
developed to meet each organization’s needs.

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 documents

You must have a system in place to control your documents- your quality
manual, procedures and work instructions

Establish a process to approve documents, control the revision and
distribution of the documents, and control changes to the documents

You must make sure that people are working from the current, correct

Quality records must be controlled and protected, quality records are
your evidence of complying with your quality system

Have a process in place that identifies what quality records you have,
where they are kept, how long they are kept, how they are protected from

Most companies will use a “Master List” to list the current revision and
location of each document. Online systems work very well for document
control if electronic files are protected from change.

Recording the distribution of documents is important; if a document is
revised all previous revisions of the document must be replaced. This is
only possible if you know where all those copies are.

Documents must be reviewed on a regular basis to make sure they are up
to date. Some organizations may choose to review all documents on a
regular basis. For example, annually. However, there is not a
requirement to do it on a regular basis, but “as necessary”.

This could be with regular use, and during internal audits. If employees
are using the documents they should be watching for documents that need
updating, and submitting document change requests. The internal audit
program measures compliance with documentation requirements (along with
other requirements) and should identify required revisions.

In other words, if staff are using the system as it is designed,
documents are continually updated, reviewed and revised and an annual
review step is not necessary to build into the system.

4.2.4 Control of records

Records 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
generated and stored, how long they are stored and who is responsible
for them. Include a requirement in your procedure that says quality
records must be legible.

The procedure must address storage, retention times and disposition. If
you archive records either on-site or off-site include your process in
your procedure.

ISO does not specify how long you have to keep your records, but
remember that the auditor will want to see six months to a year worth of

4 Context of the organization

4.1 Understanding the organization and its context

The terms ‘document’ and `record’ have both been replaced throughout the requirements text by ‘documented information’. The word ‘shall’ appears 133 times; the word ‘documented’ appears 47 times.

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
Understanding the external context can be facilitated by considering issues arising from legal, Technological, competitive, cultural, social, economic and natural environment, whether international, national, regional or local.

Note 2 
When understanding the internal context the organization could consider those related to perceptions, values and culture of the organization.

4.2 Understanding the needs and expectations of interested parties

The organization shall determine

a) the interested parties that are relevant to the quality management system, and
b) the requirements of these interested parties

The 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 others
involved 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 system

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, 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
management system. Any such exclusion shall be limited to clause 7.1.4 (Monitoring and measuring devices) and 8 (Operations) and shall not affect the organization’s ability or responsibility to assure conformity of goods and services and customer satisfaction, nor can an exclusion be justified on the basis of a decision to arrange for an external provider to perform a function or process of the organization.

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 system

4.4.1 General

The 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 approach

The 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 planned
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.