Author Archives: Jack Bogle

Cybersecurity Maturity Model Certification

The Office of the Under Secretary of Defense for Acquisition and Sustainment (OUSD(A&S)) recognizes that security is foundational to acquisition and should not be traded along with cost, schedule, and performance moving forward. The Department is committed to working with the Defense Industrial Base (DIB) sector to enhance the protection of controlled unclassified information (CUI) within the supply chain.

The CMMC will encompass multiple maturity levels that ranges from “Basic Cybersecurity Hygiene” to “Advanced”. The intent is to identify the required CMMC level in RFP sections L and M and use as a “go / no go decision.”

  • The CMMC will review and combine various cybersecurity standards and best practices and map these controls and processes across several maturity levels that range from basic cyber hygiene to advanced. For a given CMMC level, the associated controls and processes, when implemented, will reduce risk against a specific set of cyber threats.
  • The CMMC effort builds upon existing regulation (DFARS 252.204-7012) that is based on trust by adding a verification component with respect to cybersecurity requirements.
  • The goal is for CMMC to be cost-effective and affordable for small businesses to implement at the lower CMMC levels.
  • The intent is for certified independent 3rd party organizations to conduct audits and inform risk.

The CMMC effort builds upon existing regulation, specifically,

  • 48 Code of Federal Regulations (CFR) 52.204-21 and
  • Defense Federal Acquisition Regulation Supplement (DFARS) 252.204-7012, and
  • incorporates practices from multiple sources such as the National Institute of Standards and Technology (NIST) Special Publication (SP) 800-171 rev 1 & Draft NIST SP 800-171B,
  • the United Kingdom’s Cyber Essentials, and Australia’s Essential Eight [11,12,47,4].

ABCI Consultants provide cyber security guidance, implementation and personnel training services, which focus on Information Security Management Systems (ISO 27001) and regulatory compliance (NIST 800-171).

Risk Assessments and Management Methods for ISO Management Systems

Important enhancements have been made to the QMSCAPA™ software module for Risk Assessments and Management.

The QMSCAPA Risk Assessment (RA) module consist of:

  • Table of Risk Assessments (current and historical assessments)
    • A sub-table of specific aspects of the risk assessments
    • A look-up table of the risk impact values with regard to the
      • Probability (P) {likelihood}
      • Severity (S) {impact}
      • Detection (D) {overall detection ability reduces risk
    • Five user-defined boundaries, e.g. Very Low, Low, Medium, High, Very High.

The impact values are used to calculate the Risk Priority Number (RPN) for each aspect.

RPN = (P * S * D)

The module is developed around the concepts typically found in a Failure Mode Effects Analysis (FMEA).

The single-user version of QMSCAPA software may be downloaded free of charge, simply click here to join the QMSCAPA users-group.

The Risk Assessments browse table can store a large number of current and/or historical assessments.

  1. The browse window contains sort tabs for instant viewing of data according to the key value of the Tab.
  2. Risk assessments can be performed and recorded for virtually any type of risk related to the organization, relevant interested parties, product, service, staff, logistics, transportation, and cost, including environmental, health and safety.
  3. View RiskAspects button: Opens a sub-table of related aspects to the highlighted risk assessment may be viewed, added, edited or deleted as needed.
  4. RIP icon button: Access the Relevant Interested Parties table (RIP).
  5. Print Assessment button: Use the button to print a Risk Assessment, which includes all aspects and impacts recorded.
  6. Copy Assessment or Template button: The copy button control copies the currently highlight assessment record.
  7. The tab 10) Templates applies a filter that only shows the Risk Assessments designed to be templates.

The Risk Aspect module form is configured with 4 main Tabs or sections:

  1. The General Tab contains information about the failure (generic for incident, breach, non-conformance). The assessment calculation tool (pre and post mitigation results) is designed for rating or assessing a specific aspect of the Risk identified and associated in the Risk Assessment Table. Therefore, a one to many relationship exist between the Risk (parent table) and the Aspects (child table).
  2. Tab 2) contains fields for additional consequences.
  3. Tab 3) contains fields for mitigation or risk treatment actions.
  4. Tab 3) contains a method of generating risk impact statement based upon availability, confidentiality, integrity and financial effect.

1) General tab

(A) In the form image below/right, Describe the failure and the failure mode.

(B) Describe what may cause the failure and the failure effect.

(C) The impact values for calculating the Risk Priority Number (RPN) (pre-mitigation treatments); see the look-up table for impact values:

  • RPN = Probability (P) * Severity (S) * Detection

(D) The impact values for calculating the Risk Priority Number (RPN) (post-mitigation treatments);

(E) Look-up Tables for Response to Risk Aspect and the current/last Status of the Risk Aspect.

(F) The RPN can report the pre or post-mitigation action [√] RPN Post Mitigation Action is check-box.

Additional QMSCAPA risk assessment and management information has been published at

Information Security Requirements for Controlled Unclassified Information (CUI)

 ISO 27001 Information Security Management System (ISMS) provides essential framework for compliance to NIST 800-171

Controlled Unclassified Information (CUI) supports federal missions and business functions that affect the economic and national security interests of the United States. Non-federal organizations (e.g. colleges, universities, state, local and tribal governments, federal contractors and subcontractors) often process, store, or transmit CUI.

Executive Order 13556, as issued November 10, 2010, designated the National Archives and Records Administration (NARA) as the Executive Agent to implement the CUI program. NIST Special Publication 800-171 defines the security requirements for protecting CUI in non-federal information systems and organizations.

Security Requirements for Protecting the Confidentiality of CUI

NIST Special Publication 800-171 contains fourteen families of security requirements (including basic and derived requirements) 18 for protecting the confidentiality of CUI in nonfederal information systems and organizations.

The security controls from NIST Special Publication 800-53 associated with the basic and derived requirements are also listed in Appendix D. Organizations can use Special Publication 800-53 to obtain additional, non-prescriptive information related to the CUI security requirements (e.g., supplemental guidance related to each of the referenced security controls, mapping tables to ISO/ IEC 27001 ISMS, Annex A (security objective & controls), and a catalog of optional controls that can be used to help specify additional CUI requirements if needed).

The security requirements identified in 800-171 are intended to be applied to the non-federal organization’s general-purpose internal information systems that are processing, storing, or transmitting CUI. Some specialized systems such as medical devices, Computer Numerical Control (CNC) machines, or industrial control systems may have restrictions or limitations on the application of certain CUI requirements and may be granted waivers or exemptions from the requirements by the federal agency providing oversight.



Basic Security Requirements:

1.1 Limit information system access to authorized users, processes acting on behalf of authorized users, or devices (including other information systems).

1.2 Limit information system access to the types of transactions and functions that authorized users are permitted to execute.

Derived Security Requirements:

1.3 Control the flow of CUI in accordance with approved authorizations.

1.4 Separate the duties of individuals to reduce the risk of malevolent activity without collusion.

1.5 Employ the principle of least privilege, including for specific security functions and privileged accounts.

1.6 Use non-privileged accounts or roles when accessing nonsecurity functions.

1.7 Prevent non-privileged users from executing privileged functions and audit the execution of such functions.

1.8 Limit unsuccessful logon attempts.

1.9 Provide privacy and security notices consistent with applicable CUI rules.

1.10 Use session lock with pattern-hiding displays to prevent access/viewing of data after period of inactivity.

1.11 Terminate (automatically) a user session after a defined condition.

1.12 Monitor and control remote access sessions.

1.13 Employ cryptographic mechanisms to protect the confidentiality of remote access sessions.

1.14 Route remote access via managed access control points.

1.15 Authorize remote execution of privileged commands and remote access to security-relevant information.

1.16 Authorize wireless access prior to allowing such connections.

1.17 Protect wireless access using authentication and encryption.

1.18 Control connection of mobile devices.

1.19 Encrypt CUI on mobile devices.

1.20 Verify and control/limit connections to and use of external information systems.

1.21 Limit use of organizational portable storage devices on external information systems.

1.22 Control information posted or processed on publicly accessible information systems.


Basic Security Requirements:

2.1 Ensure that managers, systems administrators, and users of organizational information systems are made aware of the security risks associated with their activities and of the applicable policies, standards, and procedures related to the security of organizational information systems.

2.2 Ensure that organizational personnel are adequately trained to carry out their assigned information security-related duties and responsibilities.

Derived Security Requirements:

2.3 Provide security awareness training on recognizing and reporting potential indicators of insider threat.


Basic Security Requirements:

3.1 Create, protect, and retain information system audit records to the extent needed to enable the monitoring, analysis, investigation, and reporting of unlawful, unauthorized, or inappropriate information system activity.

3.2 Ensure that the actions of individual information system users can be uniquely traced to those users so they can be held accountable for their actions.

Derived Security Requirements:

3.3 Review and update audited events.

3.4 Alert in the event of an audit process failure.

3.5 Correlate audit review, analysis, and reporting processes for investigation and response to indications of inappropriate, suspicious, or unusual activity.

3.6 Provide audit reduction and report generation to support on-demand analysis and reporting.

3.7 Provide an information system capability that compares and synchronizes internal system clocks with an authoritative source to generate time stamps for audit records.

3.8 Protect audit information and audit tools from unauthorized access, modification, and deletion.

3.9 Limit management of audit functionality to a subset of privileged users.


Basic Security Requirements:

4.1 Establish and maintain baseline configurations and inventories of organizational information systems (including hardware, software, firmware, and documentation) throughout the respective system development life cycles.

4.2 Establish and enforce security configuration settings for information technology products employed in organizational information systems.

Derived Security Requirements:

4.3 Track, review, approve/disapprove, and audit changes to information systems.

4.4 Analyze the security impact of changes prior to implementation.

4.5 Define, document, approve, and enforce physical and logical access restrictions associated with changes to the information system.

4.6 Employ the principle of least functionality by configuring the information system to provide only essential capabilities.

4.7 Restrict, disable, and prevent the use of nonessential programs, functions, ports, protocols, and services.

4.8 Apply deny-by-exception (blacklist) policy to prevent the use of unauthorized software or deny-all, permit-by-exception (whitelisting) policy to allow the execution of authorized software.

4.9 Control and monitor user-installed software.


Basic Security Requirements:

5.1 Identify information system users, processes acting on behalf of users, or devices.

5.2 Authenticate (or verify) the identities of those users, processes, or devices, as a prerequisite to allowing access to organizational information systems.

Derived Security Requirements:

5.3 Use multifactor authentication for local and network access to privileged accounts and for network access to non-privileged accounts.

5.4 Employ replay-resistant authentication mechanisms for network access to privileged and non-privileged accounts.

5.5 Prevent reuse of identifiers for a defined period.

5.6 Disable identifiers after a defined period of inactivity.

5.7 Enforce a minimum password complexity and change of characters when new passwords are created.

5.8 Prohibit password reuse for a specified number of generations.

5.9 Allow temporary password use for system logons with an immediate change to a permanent password.

5.10 Store and transmit only encrypted representation of passwords.

5.11 Obscure feedback of authentication information.


Basic Security Requirements:

6.1 Establish an operational incident-handling capability for organizational information systems that includes adequate preparation, detection, analysis, containment, recovery, and user response activities.

6.2 Track, document, and report incidents to appropriate officials and/or authorities both internal and external to the organization.

Derived Security Requirements:

6.3 Test the organizational incident response capability.


Basic Security Requirements:

7.1 Perform maintenance on organizational information systems.24

7.2 Provide effective controls on the tools, techniques, mechanisms, and personnel used to conduct information system maintenance.

Derived Security Requirements:

7.3 Ensure equipment removed for off-site maintenance is sanitized of any CUI.

7.4 Check media containing diagnostic and test programs for malicious code before the media are used in the information system.

7.5 Require multifactor authentication to establish nonlocal maintenance sessions via external network connections and terminate such connections when nonlocal maintenance is complete.

7.6 Supervise the maintenance activities of maintenance personnel without required access authorization.


Basic Security Requirements:

8.1 Protect (i.e., physically control and securely store) information system media containing CUI, both paper and digital.

8.2 Limit access to CUI on information system media to authorized users.

8.3 Sanitize or destroy information system media containing CUI before disposal or release for reuse.

Derived Security Requirements:

8.4 Mark media with necessary CUI markings and distribution limitations.25

8.5 Control access to media containing CUI and maintain accountability for media during transport outside of controlled areas.

8.6 Implement cryptographic mechanisms to protect the confidentiality of CUI stored on digital media during transport unless otherwise protected by alternative physical safeguards.

8.7 Control the use of removable media on information system components.

8.8 Prohibit the use of portable storage devices when such devices have no identifiable owner.

8.9 Protect the confidentiality of backup CUI at storage locations.


Basic Security Requirements:

9.1 Screen individuals prior to authorizing access to information systems containing CUI.

9.2 Ensure that CUI and information systems containing CUI are protected during and after personnel actions such as terminations and transfers.

Derived Security Requirements: None.


Basic Security Requirements:

10.1 Limit physical access to organizational information systems, equipment, and the respective operating environments to authorized individuals.

10.2 Protect and monitor the physical facility and support infrastructure for those information systems.

Derived Security Requirements:

10.3 Escort visitors and monitor visitor activity.

10.4 Maintain audit logs of physical access.

10.5 Control and manage physical access devices.

10.6 Enforce safeguarding measures for CUI at alternate work sites (e.g., telework sites).


Basic Security Requirements:

11.1 Periodically assess the risk to organizational operations (including mission, functions, image, or reputation), organizational assets, and individuals, resulting from the operation of organizational information systems and the associated processing, storage, or transmission of CUI.

Derived Security Requirements:

11.2 Scan for vulnerabilities in the information system and applications periodically and when new vulnerabilities affecting the system are identified.

11.3 Remediate vulnerabilities in accordance with assessments of risk.


Basic Security Requirements:

12.1 Periodically assess the security controls in organizational information systems to determine if the controls are effective in their application.

12.2 Develop and implement plans of action designed to correct deficiencies and reduce or eliminate vulnerabilities in organizational information systems.

12.3 Monitor information system security controls on an ongoing basis to ensure the continued effectiveness of the controls.

Derived Security Requirements: None.


Basic Security Requirements:

13.1 Monitor, control, and protect organizational communications (i.e., information transmitted or received by organizational information systems) at the external boundaries and key internal boundaries of the information systems.

13.2 Employ architectural designs, software development techniques, and systems engineering principles that promote effective information security within organizational information systems.

Derived Security Requirements:

13.3 Separate user functionality from information system management functionality.

13.4 Prevent unauthorized and unintended information transfer via shared system resources.

13.5 Implement subnetworks for publicly accessible system components that are physically or logically separated from internal networks.

13.6 Deny network communications traffic by default and allow network communications traffic by exception (i.e., deny all, permit by exception).

13.7 Prevent remote devices from simultaneously establishing non-remote connections with the information system and communicating via some other connection to resources in external networks.

13.8 Implement cryptographic mechanisms to prevent unauthorized disclosure of CUI during transmission unless otherwise protected by alternative physical safeguards.

13.9 Terminate network connections associated with communications sessions at the end of the sessions or after a defined period of inactivity.

13.10 Establish and manage cryptographic keys for cryptography employed in the information system.

13.11 Employ FIPS-validated cryptography when used to protect the confidentiality of CUI.

13.12 Prohibit remote activation of collaborative computing devices and provide indication of devices in use to users present at the device.

13.13 Control and monitor the use of mobile code.

13.14 Control and monitor the use of Voice over Internet Protocol (VoIP) technologies.

13.15 Protect the authenticity of communications sessions.

13.16 Protect the confidentiality of CUI at rest.


Basic Security Requirements:

14.1 Identify, report, and correct information and information system flaws in a timely manner.

14.2 Provide protection from malicious code at appropriate locations within organizational information systems.

14.3 Monitor information system security alerts and advisories and take appropriate actions in response.

Derived Security Requirements:

14.4 Update malicious code protection mechanisms when new releases are available.

14.5 Perform periodic scans of the information system and real-time scans of files from external sources as files are downloaded, opened, or executed.

14.6 Monitor the information system including inbound and outbound communications traffic, to detect attacks and indicators of potential attacks.

14.7 Identify unauthorized use of the information system.


(14 DERIVED FROM 800-53)


Access Control Access Control
Awareness and Training Awareness and Training
Audit and Accountability Audit and Accountability
Configuration Management Configuration Management
(Not required by NIST 800-171) Contingency Planning
Identification and Authentication Identification and Authentication
Incident Response Incident Response
Maintenance Maintenance
Media Protection Media Protection
Personnel Security Personnel Security
Physical Protection Physical Protection and Environmental Protection
(Not required by NIST 800-171) Planning
(Not required by NIST 800-171) Program Management
Risk Assessment Risk Assessment
Security Assessment Security Assessment and Authorization
System and Communications Protection System and Communications Protection
System and Information Integrity System and Information Integrity
(Not required by NIST 800-171) System and Services Acquisitions

The development of the CUI security requirements and the expectation of federal agencies in working with nonfederal entities include:

  • Nonfederal organizations have information technology infrastructures in place, and are not necessarily developing or acquiring information systems specifically for the purpose of processing, storing, or transmitting CUI;
  • Nonfederal organizations have specific safeguarding measures in place to protect their information which may also be sufficient to satisfy the CUI security requirements;
  • Nonfederal organizations can implement a variety of potential security solutions either directly or through the use of managed services, to satisfy CUI security requirements; and
  • Nonfederal organizations may not have the necessary organizational structure or resources to satisfy every CUI security requirement and may implement alternative, but equally effective, security measures to compensate for the inability to satisfy a particular requirement.

We have a Program to assist Suppliers to the Federal Government with meeting the requirements for Compliance with Executive Order 13556 and NIST 800-171

Our professional services include assisting with:

  • Initial Risk Assessments for Controlled Unclassied Information (CUI)
  • Preparation of a CUI Security Plan and Statement of Applicability
  • Preparation of Policies, Procedures and Control Objectives
  • Personnel Awareness Training
  • Auditing for Compliance to NIST 800-171 and ISO 27001

Contact Us | Request a Proposal

Quality Management Evolves from Good to Great

The ISO 9001 Quality Management Standard continues to evolve.

IMO the 2008 version was very good and the 2013 ISO committee draft for the 2015 version has the potential to be great.

The main changes in the new draft relate to its approach to documentation, and format and an increased importance on risk versus preventive action. These include:

  • A high-level structure used by other management system standards which will help companies implementing more than one standard,
  • the identification of risk and risk control as requirements in the standard,
  • the requirement of top management to take a more active role in aligning quality policies with business needs, and
  • a focus processes and the interaction of processes with each other.

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.  Through a series of post we will reveal ISO 9001:2015 clause by clause and attempt to make a useful comparison.

Click here for ISO 9001:2015 Clause 4.



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.

ISO 9001:2008 Compared to ISO 9001:2015 (2013 Committee Draft)

ISO 9001:2015 Part 1: Quality Management Principles


This document introduces the seven quality management principles (QMP) on which the quality management system standards of the ISO 9000 series are based and the essential importance for establishing communications for nonconformity and corrective actions.

The principles were developed and updated by international experts of ISO/TC 176, which is responsible for developing and maintaining the ISO 9000 series on quality management standards. This guidance document provides a “statement’ describing each principle and a “rationale’ explaining why an organization should address the principle.

QMP 1 — Customer Focus

a)      Statement – The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations.

b)      Rationale – Sustained success is achieved when an organization attracts and retains the confidence of customers and other interested parties on whom it depends. Every aspect of customer interaction provides an opportunity to create more value for the customer. Understanding current and future needs of customers and other interested parties contributes to sustained success of an organization.

QMP 2 — Leadership

a)      Statement – Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the quality objectives of the organization.

b)      Rationale – Creation of unity of purpose, direction and engagement enable an organization to align its strategies, policies, processes and resources to achieve its objectives.

QMP 3 — Engagement of People (involvement in 2008)

a)      Statement – It is essential for the organization that all people are competent, empowered and engaged in delivering value. Competent, empowered and engaged people throughout the organization enhance its capability to create value.

b)      Rationale – To manage an organization effectively and efficiently, it is important to involve all people at all levels and to respect them as individuals. Recognition, empowerment and enhancement of skills and knowledge facilitate the engagement of people in achieving the objectives of the organization.

QMP 4 — Process Approach

a)      Statement – Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system.

b)      Rationale – The quality management system is composed of interrelated processes. Understanding how results are produced by this system, including all its processes, resources, controls and interactions, allows the organization to optimize its performance.

QMP 5 — Improvement (continual improvement in 2008)

a)      Statement – Successful organizations have an ongoing focus on improvement.

b)      Rationale – Improvement is essential for an organization to maintain current levels of performance, to react to changes in its internal and external conditions and to create new opportunities.

QMP 6 — Evidence-based Decision Making (factual approach to decision making)

a)      Statement – Decisions based on the analysis and evaluation of data and information are more likely to produce desired results.

b)      Rationale – Decision-making can be a complex process, and it always involves some uncertainty. It often involves multiple types and sources of inputs, as well as their interpretation, which can be subjective. It is important to understand cause and effect relationships and potential unintended consequences. Facts, evidence and data analysis lead to greater objectivity and confidence in decisions made.

QMP 7 — Relationship Management (mutually beneficial supplier relationships in 2008)

a)      Statement – For sustained success, organizations manage their relationships with interested parties, such as suppliers.

b)      Rationale – Interested parties influence the performance of an organization. Sustained success is more likely to be achieved when an organization manages relationships with its interested parties to optimize their impact on its performance. Relationship management with its supplier and partner network is often of particular importance.

Essential to the seven QMPs is the organization should establish an effective communications method for notifying the organization of nonconformities.

System approach to management, which appears in the 2008 version has been somewhat commingled into the 2015 seven principles.


QMSCAPA v1.8.43 is Available for Download

In this release of QMSCAPA, our popular Quality Management Software, we have included several important enhancement that are design to provide support for multilingual installations.

Essentially are providing an end-user with the tools to change (translate) the field and window prompts of most QMSCAPA windows. In addition to the global feature we have included the following new features and fixes:

  1. Released user-definable help system (F1 Key) and question-mark button [ ? ] to allow for multilingual support.
  2. Enhanced the CAPA, Documents, training programs (plus more) browse tables to allow users more options to arrange and sort columns.
  3. In the Document Management Module we increased user-defined Document Id field to 40 characters.
  4. Added CAPA Task List table linked to each CAPA.
  5. Added CAPA Task Reporting.

Join Our User Group

QMSCAPA™ is quality management software designed by a user group of quality professionals, including assessors, auditors, consultants and quality managers for quality management systems. If you have an idea or new feature that you would like to see in QMSCAPA please join our user group by completing our web form.

License Free

The single user version of QMSCAPA is license free, which means it is free to use and fee to share.

Quality Management System Software

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ISO-9001 & ISO-14001 Certification for Exporters of Recycled Materials to China

One of the largest exports from North America to China is recycled materials. Metals, plastics, paper, and other materials are in high demand in China, and an ample supply is generated in North America. It is a happy combination, but he process is carefully regulated by the Chinese Government by the AQSIQ, the General Administration of Quality, Supervision and Quarantine, who issues the licenses to import products. One of the requirements to obtaining an AQSIQ license is to have an accredited ISO-9001 certification for the quality management system of the company exporting the product to the Chinese buyers.

The accrediting organization for ISO certifying bodies in the US is an industry known as ANAB, a partnership organization of the American National Standards Institute (ANSI) and the American Society for Quality (ASQ), also known as the ANSI/ASQ National Accreditation Board. The ANAB derives its authority form the International Accreditation Forum, the only ISO licensee for accrediting certifying bodies. For the AQSIQ to accept your ISO-9001 Certification, it must have the logo of the Certifying Body and the ANAB.

genuine iso certification

Always insist on an ISO 9001 Certification by an Accredited Certification Body (CB)

ISO-9001:2008 is the latest version of the international Quality Management System standard. It is scalable from a one-person operation through an organization with thousands of employees across multiple locations. It is truly an all-encompassing Quality Management System that covers all phases of a business, not just a product quality or inspection system. It breaks down all business operations into processes, identifies how these processes interact, determines the criteria for effectiveness of the processes, and establishes a method to measure, monitor and improve each of these processes. The continual measurement, monitoring and improvement of the business processes is what makes the system so powerful. Companies implementing ISO-9001 find their operations, efficiencies, customer satisfaction continually improving resulting in increased profitability and improved relations with their customers, both existing and potential new customers.

Obtaining ISO-9001 certification is not a difficult task, but it must be embraced by the management of the company seeking certification. It is not something that can merely be purchased and administered. It requires effective implementation. It will be examined by the certifying body auditor and all aspects of the standard must be functioning in the organization being certified. The ISO standard touches on all aspects of the business, so all employees require training and engagement for the system to function.

The export of some materials to China also requires certification to ISO-14001. This is an environmental management system. ISO-14001 requires the identification and evaluation of the possible environmental effects of the business operations. Like ISO-9001, it is scalable, implemented throughout the business operations of a company, and contains some of the same principles of business effectiveness:  objectives, monitoring, measuring and improvement, management review, and so on to achieve the environmental goals of the business.

For a company exporting recycled materials to China, the risks of not following sound quality and environmental management principles can be substantial. Facing the responsible disposal of a large shipment of products that does not meet the import standards, half a world away, can be devastating to the business responsible for supplying and getting the product there. The use of effective Quality Management and Environmental Management systems such as ISO-9001 and ISO-14001 goes a long way in mitigating those risks by providing a methodology to ensure customer requirements (as well as legal and regulatory requirements) are met verified prior to the product ever leaving the supplier.

What’s the importance of an accredited Certification Body?

ISO Certification by an Accredited Certification Body Equals Increased Credibility

“You can fool some of the people all of the time, and all of the people some of the time, but you cannot fool all of the people all of the time.”  –Abraham Lincoln, (attributed)

Is your ISO Standards based Management System certified by an ‘accredited certification body’?

Acquiring your certification for your ISO management system through an accredited Certification Body is essential if you wish to be recognized as having a genuine Certification for your ISO Standards based system. However, certification is not a requirement of any of ISO’s management system standards. This section provides a basic understanding of what certification and related terms like accreditation, and registration mean.

Certification – the provision by an independent body of written assurance (a certificate) that the product, service or system in question meets specific requirements. Certification is very often referred to as ‘registration’ in North America.

Registration‘ often means that the certifying body (aka Registrar) records the certification in its client register. So, the organization’s management system has been both certified and registered.

Accreditation – the formal recognition by an independent body, generally known as an Accreditation Body (AB), that a Certification Body (CB) is capable of carrying out the certification audit process in accordance with the International Standard ISO 19011:2011.

ISO 19011:2011 provides guidance on auditing management systems, including the principles of auditing, managing an audit program and conducting management system audits, as well as guidance on the evaluation of competence of individuals involved in the audit process, including the person managing the audit program, auditors and audit teams.

ISO 19011:2011 is applicable to all organizations that need to conduct internal or external audits of management systems or manage an audit program.

Accreditation is not obligatory but it adds another level of confidence, credibility, and integrety, as ‘accredited’ means the certification body has been independently checked to make sure it operates according to International Standard. In the context of ISO 9001:2008 or ISO 14001:2004 and other ISO Standards, ‘certification‘ refers to the issuing of written assurance (the certificate) by an independent external body that it has audited a management system and verified that it conforms to the requirements specified in the standard.

Therefore, in the ISO 9001:2008 or ISO 14001:2004 context, the difference between the two terms is not significant and both are acceptable for general use. “Certification” is the term most widely used worldwide, although registration is often preferred in North America, and the two are used interchangeably.

On the contrary, using ‘accreditation’ as an interchangeable alternative for certification or registration is a mistake, because it means something different.

In the ISO Standards context, accreditation refers to the formal recognition by a specialized body – an accreditation body – that a certification body is competent to carry out a audit for certification in specified business sectors.

In simple terms, accreditation is like certification of the certification body. Certificates issued by accredited certification bodies are perceived on the market as having increased credibility.

The International Accreditation Forum (IAF) is one of the world associations for Conformity Assessment Accreditation Bodies and other bodies interested in conformity assessment in the fields of management systems, products, services, personnel and other similar program of conformity assessment. Its primary function is to develop a single worldwide program of conformity assessment which reduces risk for business and its customers by assuring them that accredited certificates may be relied upon. Accreditation assures users of the competence and impartiality of the body accredited.


Nationally Recognized Testing Laboratory: UL or CSA

The “CSA” or Canadian Standards Association has recently been certified by the United States Occupational Safety and Health Administration (OSHA) as a “Nationally Recognized Testing Laboratory” (NTRL), just like Underwriters Laboratories (UL). Therefore, since both the UL and CSA are now recognized by all US federal, state, provincial and local authorities to test and certify product-safety in the U.S. and Canada, your products may use either approval.