ISO 9000 Family

International Organization of Standardization

 

The ISO 9000 family of quality management systems standards is designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service.  ISO 9000 deals with the fundamentals of quality management systems,  including the seven quality management principles upon which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill.

Third-party certification bodies provide independent confirmation that organizations meet the requirements of ISO 9001. Over one million organizations worldwide are independently certified, making ISO 9001 one of the most widely used management tools in the world today. However, the ISO certification process has been criticized as being wasteful and not being useful for all organizations.

 

Background:  ISO 9000 was first published in 1987 by ISO. It was based on the BS 5750 series of standards that were proposed to ISO in 1979.  However, its history can be traced back some twenty years before that, to the publication of government procurement standards, such as the US Department of Defense mil-spec standards of the late 1950’s.  Large organizations which supplied government procurement agencies often had to comply with a variety of quality assurance requirements for each contract awarded which led the defense industry to adopt mutual recognition of NATO APQP, MIL-Q and Def Stan standards. Eventually, ISO 9000 was adopted as a suitable option, instead of forcing contractors to adopt multiple – and often similar – requirements.

 

Reasons for use:  The global adoption of ISO 9001 may be attributable to a number of factors. In the early days, the ISO 9001 (9002 and 9003) requirements were intended to be used by procuring organizations, as the basis of contractual arrangements with their suppliers. This helped reduce the need for “supplier development” by establishing basic requirements for a supplier to assure product quality. The ISO 9001 requirements could be tailored to meet specific contractual situations, depending the complexity of product, business type (design responsibility, manufacture only, distribution, servicing etc) and risk to the procurer. If a chosen supplier was weak on the controls of their measurement equipment (calibration), and hence QC/inspection results, that specific requirement would be invoked in the contract. The adoption of a single Quality Assurance requirement also lead to cost savings throughout the supply chain by reducing the administrative burden of maintaining multiple sets of quality manuals and procedures.

A few years later, the U.K. Government took steps to improve national competitiveness following publication of cmd 8621, and Third Party Certification of Quality Management Systems was born, under the auspices of the National Accreditation Council of Certification Bodies (NACCB) which has become the United Kingdom Accreditation Service (UKAS) .

In addition to several stakeholders’ benefits, a number of studies have identified significant financial benefits for organizations certified to ISO 9001, with a 2011 survey from the British Assessment Bureau showing 44% of their certified clients had won new business. Certified organizations achieved superior Return On Assets compared to otherwise similar organizations without certification.  ISO 9001 certification resulted in superior stock market performance and suggested that shareholders were richly rewarded for the investment in an ISO 9001

system.  While the connection between superior financial performance and ISO 9001 may be seen, the improvement is partly driven by the fact that there is a tendency for better performing companies to seek ISO 9001 certification.

The mechanism for improving results has also been the subject of much research to include:  cycle time reduction, inventory reductions) as following from certification.  Internal process improvements in organizations lead to externally observable improvements.  The benefit of increased international trade and domestic market share, in addition to the internal benefits such as customer satisfaction, interdepartmental communications, work processes, and customer/supplier partnerships derived, far exceeds any and all initial investment.

 

Global adoption:  The increase in ISO 9001 certification is shown in the table below showing the Top 10 Countries for ISO 9001 certifications as of 2014

Rank Country No. of certificates
1 China 342,800
2 Italy 168,960
3 Germany 55,363
4 Japan 45,785
5 India 41,016
6 United Kingdom 40,200
7 Spain 36,005
8 United States 33,008
9 France 29,122
10 Australia 19,731

ISO 9000 series Quality Management Principles

The ISO 9000 series are based on seven quality management principles:

  • QMP 1 – Customer focus
  • QMP 2 – Leadership
  • QMP 3 – Engagement of people
  • QMP 4 – Process approach
  • QMP 5 – Improvement
  • QMP 6 – Evidence-based decision making
  • QMP 7 – Relationship management

 

Principle 1 – Customer focus

Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.

Principle 2 – Leadership

Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.

Principle 3 – Engagement of people

People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.

Principle 4 – Process approach

A desired result is achieved more efficiently when activities and related resources are managed as a process.

Principle 5 – Improvement

Improvement of the organization’s overall performance should be a permanent objective of the organization.

Principle 6 – Evidence-based decision making

Effective decisions are based on the analysis of data and information.

Principle 7 – Relationship management

An organization and its external providers (suppliers, contractors, service providers) are independent and a mutually beneficial relationship enhances the ability of both to create value.

 

ISO 9001:2015 Quality management systems — Requirements is a document of approximately 30 pages which is available from the national standards organization in each country. Only ISO 9001 is directly audited against for third party assessment purposes.  Contents of ISO 9001:2015 are as follows:

  • 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

Essentially the layout of the standard is similar to the previous ISO 9001:2008 standard in that it follows the Deming Wheel (Plan, Do, Check, Act) cycle in a process based approach, but is now further encouraging this to have risk based thinking. (section 0.3.3 of the introduction) The purpose of the quality objectives is to determine the conformity of the requirements (customers and organizations), facilitate effective deployment and improve the quality management system.

Before the certification body can issue or renew a certificate, the auditor must be satisfied that the company being assessed has implemented the requirements of sections 4 to 10. Sections 1 to 3 are not directly audited against, but because they provide context and definitions for the rest of the standard, not that of the organization, their contents must be taken into account.

The standard no longer specifies that the organization shall issue and maintain documented procedures, however ISO 9001:2015 requires the organization to document any other procedures required for its effective operation. The standard also requires the organization to issue and communicate a documented quality policy, a quality management system scope, and quality objectives. The standard no longer requires compliant organizations to issue a formal Quality Manual. The standard does require retention of numerous records, as specified throughout the standard. New for the 2015 release is a requirement for an organization to assess risks and opportunities (section 6.1) and to determine internal and external issues relevant to its purpose and strategic direction (section 4.1). The organization must demonstrate how the standard’s requirements are being met, while the external auditor’s role is to determine the quality management system’s effectiveness. More detailed interpretation and implementation examples are often sought by organizations seeking more information in what can be a very technical area.

 

Certification

The ISO does not certify organizations itself. Numerous certification bodies exist, which audit organizations and, upon success, issue ISO 9001 compliance certificates. Although commonly referred to as “ISO 9000” certification, the actual standard to which an organization’s quality management system can be certified is ISO 9001:2015 (ISO 9001:2008 will expire by around September 2018). Many countries have formed accreditation bodies to authorize (“accredit”) the certification bodies. Both the accreditation bodies and the certification bodies charge fees for their services. The various accreditation bodies have mutual agreements with each other to ensure that certificates issued by one of the accredited certification bodies (CB) are accepted worldwide. 

An organization applying for ISO 9001 certification is audited based on an extensive sample of its sites, functions, products, services and processes. The auditor presents a list of problems (defined as “nonconformities”, “observations”, or “opportunities for improvement”) to management. If there are no major nonconformities, the certification body will issue a certificate. Where major nonconformities are identified, the organization will present an improvement plan to the certification body (e.g., corrective action reports showing how the problems will be resolved); once the certification body is satisfied that the organization has carried out sufficient corrective action, it will issue a certificate. The certificate is limited by a certain scope (e.g., production of golf balls) and will display the addresses to which the certificate refers.

An ISO 9001 certificate is not a once-and-for-all award, but must be renewed at regular intervals recommended by the certification body, usually once every three years. There are no grades of competence within ISO 9001: either a company is certified (meaning that it is committed to the method and model of quality management described in the standard) or it is not. In this respect, ISO 9001 certification contrasts with measurement-based quality systems.

 

Evolution of ISO 9000 standards

The ISO 9000 standard is continually being revised by standing technical committees and advisory groups, who receive feedback from those professionals who are implementing the standard.

1987 version:  ISO 9000:1987 had the same structure as the UK Standard BS 5750, with three “models” for quality management systems, the selection of which was based on the scope of activities of the organization:

  • ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products.
  • ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products.
  • ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.

ISO 9000:1987 was also influenced by existing U.S. and other defense standards (“MIL SPECS”), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management, which was likely the actual intent.

1994 version:  ISO 9000:1994 emphasized quality assurance via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures. As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actually be impeded by the quality system.

2000 version:  ISO 9001:2000 replaced all three former standards of 1994 issue, ISO 9001ISO 9002 and ISO 9003. Design and development procedures were required only if a company does in fact engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing front and center the concept of process management (the monitoring and optimization of a company’s tasks and activities, instead of just inspection of the final product). The 2000 version also demanded involvement by upper executives in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal was to improve effectiveness via process performance metrics: numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit.  ISO 9000 Requirements include:  a) Approve documents before distribution; b) Provide correct version of documents at points of use; c) Use your records to prove that requirements have been met; and d) Develop a procedure to control your records.

2008 version:  ISO 9001:2008 in essence re-narrates ISO 9001:2000. The 2008 version only introduced clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There were no new requirements. For example, in ISO 9001:2008, a quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version.  ISO 9001 is supplemented directly by two other standards of the family:  a) ISO 9000:2005 “Quality management systems. Fundamentals and vocabulary”; and b) ISO 9004:2009 “Managing for the sustained success of an organization. A quality management approach”

ISO9001-2015 version:  In 2012, ISO TC 176 – responsible for ISO 9001 development – celebrated 25 years of implementing ISO 9001, and concluded that it is necessary to create a new QMS model for the next 25 years. This is why they commenced the official work on creating a revision of ISO 9001, starting with the new QM principles. This moment was considered by important specialists in the field as “beginning of a new era in the development of quality management systems.” As a result of the intensive work from this technical committee, the revised standard ISO 9001:2015 was published by ISO on 23 September 2015. The scope of the standard has not changed; however, the structure and core terms were modified to allow the standard to integrate more easily with other international management systems standards.

The 2015 version is also less prescriptive than its predecessors and focuses on performance. This was achieved by combining the process approach with risk-based thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization.  Some of the key changes include:

  • High Level Structure of 10 clauses is implemented. Now all new standard released by ISO will have this High level structure.
  • Greater emphasis on building a management system suited to each organization’s particular needs
  • A requirement that those at the top of an organization be involved and accountable, aligning quality with wider business strategy
  • Risk-based thinking throughout the standard makes the whole management system a preventive tool and encourages continuous improvement
  • Less prescriptive requirements for documentation: the organization can now decide what documented information it needs and what format it should be in
  • Alignment with other key management system standards through the use of a common structure and core text
  • Inclusion of Knowledge Management principles
  • Quality Manual & Management representative is now not mandatory requirements.

Auditing

Two types of auditing are required to become registered to the standard: auditing by an external certification body (external audit) and audits by internal staff trained for this process. The aim is a continual process of review and assessment to verify that the system is working as it is supposed to; to find out where it can improve; and to correct or prevent problems identified. It is considered healthier for internal auditors to audit outside their usual management line, so as to bring a degree of independence to their judgments.

Under the 1994 standard, the auditing process could be adequately addressed by performing “conformance auditing”:

  • Tell me what you do (describe the business process)
  • Show me where it says that (reference the procedure manuals)
  • Prove that this is what happened (exhibit evidence in documented records)

The 2000 standard uses a different approach. Auditors are expected to go beyond mere auditing for rote conformance by focusing on risk, status, and importance. This means they are expected to make more judgments on what is effective, rather than merely adhering to what is formally prescribed. The difference from the previous standard can be explained thus:

Under the 1994 version, the question was broad: “Are you doing what the manual says you should be doing?”, whereas under the 2000 version, the questions are more specific: “Will this process help you achieve your stated objectives? Is it a good process or is there a way to do it better?”

Industry-specific interpretations

The ISO 9001 standard is generic; its parts must be carefully interpreted to make sense within a particular organization.  Developing software is not like making cheese or offering counseling services, yet the ISO 9001 guidelines, because they are business management guidelines, can be applied to each of these. Diverse organizations like police departments, professional soccer teams, and city councils have successfully implemented ISO 9001:2000 systems.

Over time, various industry sectors have wanted to standardize their interpretations of the guidelines within their own marketplace. This is partly to ensure that their versions of ISO 9000 have their specific requirements, but also to try and ensure that more appropriately trained and experienced auditors are sent to assess them.

 

Effectiveness

Effectiveness of the ISO system being implemented depends on a number of factors, the most significant of which are:

  1. Commitment of senior management to monitor, control, and improve quality. Organizations that implement an ISO system without this desire and commitment often take the cheapest road to get a certificate on the wall and ignore problem areas uncovered in the audits.
  2. How well the ISO system integrates into current business practices. Many organizations that implement ISO try to make their system fit into a cookie-cutter quality manual instead of creating a manual that documents existing practices and only adds new processes to meet the ISO standard when necessary.
  3. How well the ISO system focuses on improving the customer experience. The broadest definition of quality is “Whatever the customer perceives good quality to be.” This means that a company doesn’t necessarily have to make a product that never fails; some customers will have a higher tolerance for product failures if they always receive shipments on-time or have a positive experience in some other dimension of customer service. An ISO system should take into account all areas of the customer experience and the industry expectations, and seek to improve them on a continual basis. This means taking into account all processes that deal with the three stakeholders (customers, suppliers, and organization); only then will a company be able to sustain improvements in the customer’s experience.
  4. How well the auditor finds and communicates areas of improvement. While ISO auditors may not provide consulting to the clients they audit, there is the potential for auditors to point out areas of improvement. Many auditors simply rely on submitting reports that indicate compliance or non-compliance with the appropriate section of the standard; however, to most executives, this is like speaking a foreign language. Auditors that can clearly identify and communicate areas of improvement in language and terms executive management understands facilitate action on improvement initiatives by the companies they audit. When management doesn’t understand why they were non-compliant and the business implications associated with non-compliance, they simply ignore the reports and focus on what they do understand.

Advantages

Proper quality management can improve business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation.  The quality principles in ISO 9000:2000 are also sound.  ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive”.  The benefits ranging from registration required to remain part of a supply base, better documentation, to cost benefits, and improved involvement and communication with management.  ISO:2015 version includes the following benefits:

  1. By assessing their context, organizations can define who is affected by their work and what they expect. This enables clearly stated business objectives and the identification of new business opportunities.
  2. Organizations can identify and address the risks associated with their organization.
  3. By putting customers first organizations can make sure they consistently meet customer needs and enhance customer satisfaction. This can lead to more repeat custom, new clients and increased business for the organization.
  4. Organizations work in a more efficient way as all their processes are aligned and understood by everyone. This increases productivity and efficiency, bringing internal costs down.
  5. Organizations will meet necessary statutory and regulatory requirements.
  6. Organizations can expand into new markets, as some sectors and clients require ISO 9001 before doing business.