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ISO 9001:2015 has now been released and introduces new concepts, terminology and current thinking, in order to satisfy your very important customers.

ISO 9001:2015 has now been released and is a major revision to the previous edition issued in 2008. This revision introduces new concepts, terminology and current thinking, in order to satisfy your very important customers.

All management system Standards of the future will have the same high level structure, identical core text, as well as common terms and definitions.

ISO 9001:2015 Section 1: Scope

The scope sets out the intended outcomes of the management system. The outcomes are industry specific and should be aligned with the context of the organisation (clause 4).

ISO 9001:2015 Section 2: Normative references

Provides details of the reference Standard ISO 9000:2015.

ISO 9001:2015 Section 3: Terms and definitions

Because the definitions were so poorly written in the 2008, 2000 and 1994 versions, another attempt has been made to describe the terms and definitions that are now found in ISO 9000:2015.

Sections 4 – 10 are the auditable parts.

ISO 9001:2015 Section 4: Context of the organisation

Section 4 comprises four clauses:

4.1 Understanding the organisation and its context

4.2 Understanding the needs and expectations of interested parties

4.3 Determining the scope of the managements system

4.4 Quality management system and its processes.

The organisation needs to identify internal and external issues that can impact on its intended outcomes, as well as all interested parties and their requirements. In other words you need to know what you do and who your customers are. You also need to document its scope and set the boundaries of the management system – all in line with the business objectives.

ISO 9001:2015 Section 5: Leadership

Section 5 comprises three clauses:

5.1 Leadership and commitment

5.2 Policy

5.3 Organisational roles, responsibilities and authorities.

The new high level structure places particular emphasis on leadership. This means top management now has greater accountability and involvement in the organisation’s management system. In other words they must take ISO 9001 seriously:

  • Open the purse strings and provide adequate resources to achieve its planned outcomes.
  • Describe the business philosophy in their own words.
  • Encourage employee awareness and involvement. Assign employees with responsibilities and give them the authorities needed to do their jobs effectively.

Section 6: Planning

Section 6 includes three clauses:

6.1 Actions to address risks and opportunities

6.2 Quality objectives and planning to achieve them

6.3 Planning of changes.

Section 6 brings risk-based thinking to the fore. Once the organisation has highlighted risks and opportunities in Section 4, it needs to plan how it will address risks and take advantage of opportunities. The planning phase looks at what, who, how and when these risks must be addressed. This proactive approach replaces preventive action and reduces the need for corrective actions later.

  • When planning how to achieve its objectives, the organisation will need to consider:
  • What is to be done,
  • What resources will be required,
  • Who will be responsible,
  • When it will be completed, and
  • How the results will be evaluated.

Section 7: Support

Organisations will need to consider the support needed to meet their goals and objectives. This includes resources, targeted internal and external communications, as well as documented information.

Section 7 consists of five clauses:

7.1 Resources

7.2 Competence

7.3 Awareness

Persons doing work under the organisation’s control need to be aware of:

  • The quality policy,
  • Their contribution to the organisation (i.e. why their job is important), including the benefits of improved quality performance, and
  • The implications of not conforming to requirements (i.e. loss of job, reputation or customer, and incurring unnecessary expenses).

7.4 Communication

The organisation shall determine the need for internal and external communications relevant to the quality management system including:

  • On what it will communicate,
  • When to communicate, and
  • With whom to communicate.

Management have to ensure there are formal processes for communication. A suggestion box won’t make the grade.

7.5 Documented information.

Documented information replaces previously used terms such as documents, documentation and records. Documented information may include drawings, procedures, specifications, presentations, etc.

Section 8: Operation

Section 8 has many clauses:

8.1 Operational planning and control

8.2 Requirements for products and services

8.3 Design and development of products and services

8.4 Control of externally provided processes, products and services

8.5 Production and service provisioning

8.6 Release of products and services

8.7 Control of nonconforming outputs.

Clause 8 addresses both internal and outsourced processes and requires adequate criteria to control these processes, as well as ways to manage planned and unintended change. An organisation must plan, implement and control it processes and work practices needed to meet requirements by:

  • Establishing criteria for the processes,
  • Implementing control of the processes in accordance with the criteria,
  • Keeping documented information to demonstrate that processes have been carried out as planned,
  • Ensuring your suppliers are competent before you purchase their goods or services,
  • Managing change to mitigate the consequences of any adverse effects.

Section 9: Performance evaluation

Organisations need to determine what, how and when things are to be monitored, measured, analysed and evaluated. An internal audit is part of this process to ensure the organisations processes conform to its own requirements as well as the Standard, and is successfully implemented and maintained

Section 9 comprises three clauses:

9.1 Monitoring, measurement, analysis and evaluation

9.2 Internal audit

9.3 Management review.

Section 10: Improvement

You have to demonstrate improvement by setting unrealistic targets (objectives), self-preservation of the quality team (internal audits), mental gymnastics (analysis and evaluation), effective use of the internal complaint system (corrective action) and occasional meeting not on the golf course (management review). Section 10 looks at ways to address nonconformities and corrective action, as well as strategies for improvement. It includes the following clauses:

10.1 General

10.2 Nonconformity and corrective action

When nonconformity occurs:

  • React to the nonconformity, and take action to control and correct it, and
  • Deal with the consequences.
  • Evaluate the need for to do anything further by:
  • Reviewing the nonconformity
  • Determining the causes of the nonconformity,
  • Determining if similar nonconformities exist, or could potentially occur,
  • Implement any action needed,
  • Review the effectiveness of any action taken,
  • Make changes to the organisation if necessary.

10.3 Continual improvement.

Identify and improve any areas of underperformance.

ISO 9001:2015 and the Auditor

The Standard is written for the benefit of organisations, not auditors. There are likely to be many challenges for auditors to understand and recognise the evidence that would be acceptable to confirm compliance to the 2015 requirements.


Quality Standard ISO 9001:2015 is published

Since it was first published in 1987, ISO 9001 has proved to be the most popular ISO standard with nearly 1.2 million organisations certified to this standard worldwide. It is clear why so many organisations have decided to become certified to this standard; it demonstrates to their customers that they can consistently deliver high quality products and services which meet their expectations. Along with helping to demonstrate quality, this framework allows certified organisations to streamline their processes in order to become more efficient.

ISO revise their published standards every five to seven years to ensure that they are up-to-date, reflect current business practice, and stay relevant for the near-future. The revision process usually takes around three years to complete. The 2015 revision has brought new and exciting changes.

Main changes to with ISO 9001:2015 include:

  • ISO 9001:2015 will follow Annex SL like other recently-published ISO standards. This will give a consistent look and feel in terms of structure and sequencing to all of the ISO standards.
  • Risk-based thinking will be integrated into the standard, in the hope of preventing undesirable outcomes.
  • Steps you can take to prepare for the new version:
  • Review your current approach.
  • Engage with management to inform them of how the proposed changes will affect them.
  • Review your approach to identification, management and control of your processes.
  • If you are certified to more than one standard, start to consider the benefits to be gained from management system integration.


1. Certification to ISO 9001:2008 will continue to be recognised by certification bodies and can be audited to before being withdrawn at the end of the three year transition period (September 2018). After this period, organisations will only be able to achieve certification to ISO 9001:2015.

2. Organisations can upgrade to ISO 9001:2015 from September 2015 during a re-certification provided their system meets all the requirements outlined in ISO 9001:2015.


A total of 1,609,294 ISO related certificates were issued worldwide in 2014, an increase of 448,846 from 2013.

A total of 1,609,294 ISO related certificates were issued worldwide in 2014, an increase of 448,846 from 2013. This moderate growth confirms the trends from the past two years that most ISO management system standards have now reached a steady implementation speed which endorses their current and future longevity in the market. The global share of certification to ISO 9001 and ISO 14001 have stabilised with overall growth of 1% and 7% respectively, the publication of the 2015 editions of these standards are expected to give both standards a new lease of life. ISO 50001 and ISO 22000 have proven to be the strongest performers with an overall growth of 40% and 14% respectively.

The uptake of ISO 9001 has slowed on a global level due to the fact that many of the world’s largest companies are already certified to this standard and are branching out to more specific standards outside of quality. The uptake may have slowed also as companies may have been waiting to get certified to the 2015 version of the standard, instead of implementing ISO 9001:2008 and then transitioning to the new standard.

ISO/TS 9002, Guidelines for the application of ISO 9001:2015, has just been published.

A new technical specification for ISO 9001 has just been published that is set to benefit organisations that want to get the most out of the quality management standard.

ISO/TS 9002, Guidelines for the application of ISO 9001:2015, provides clause-by-clause guidance and examples to enable users, regardless of the size of the organisation, to implement their own quality management system.

The new technical specification will complement ISO 9001:2015, which provides the requirements for a quality management system. Because ISO 9001 is designed to be applicable to all kinds of organisations, irrespective of size or context, the requirements of the standard are quite broad. ISO/TS 9002 provides guidance supported by in-depth explanations and examples to help organisations fully benefit from the implementation of their own quality management system.ISO/TS 9002 is ideal for organisations that want a more detailed understanding of the requirements of ISO 9001:2015, while reaping the benefits of the standard.

ISO/TS 9002 is part of ISO’s family of standards on quality management and quality management systems. The standard does not provide any additional requirements, but provides useful examples of what organisations can do so as to apply the clauses of ISO 9001 most effectively.

Key changes in ISO9001:2015

ISO 9001:2015 is the first major revision to the standard since the 2000 version. The intent of the 2015 revision was simple:

  • •Consider recent the technological changes in business and other organisations,
  • •Develop requirements that could be dynamic enough to adjust when additional changes occur in industry, and
  • • Include requirements that could be audited for conformance.

Any changes in requirements should enhance a customer’s confidence in the organisation’s quality management system (QMS) and help the organisation achieve intended results. A common criticism of past versions of ISO 9001 was that organisations could meet the standard’s requirements but deliver product and services that didn’t meet customer requirements. ISO 9001:2015 includes requirements that focus on achieving intended results i.e. meeting the needs of the customer.

By making the standard less prescriptive and more reliant on risk-based thinking to determine the level of complexity needed for an organisation’s QMS, ISO 9001:2015 accomplishes what many users have requested. This introduces new challenges and for this reason ISO 9001:2015 includes an annex that provides the rationale for some of the changes.

Here are some of the key changes in ISO 9001:2015.

Change: structure

The structure of ISO 9001:2015 changed due to a decision by the ISO Technical Management Board to adopt a standardised format and common core text and terms for use in all new and revised ISO management system standards. This is to promote greater ease of use for organisations that want to integrate the requirements of multiple management system standards such as ISO 9001, ISO 14001, and ISO 50001. This standardized format is referred to as Annex SL, which is simply the alphanumeric indication of the index from the ISO Directives.

Understanding the change

Before getting too caught up in the structure of the revised standard, it’s important to read subclause 0.4, Relationship with other management system standards, and Annex A. Subclause 0.4 introduces the Annex SL high-level structure, explains the rationale of the structure, and highlights some of the changes in ISO 9001:2015. Specifically, it indicates that the structure relates to the framework developed by ISO to approve alignment among management system standards.

Subclause A.1 (located within Annex A), Structure and terminology, provides details that should help organisations understand the requirements related to structure. Subclause A.1 specifically states that there is no requirement for organisations to adopt the ISO 9001:2015 structure in their own QMS, nor do organisations have to change the terminology used in their QMS.

If an organisation wants to ensure that it has addressed any new requirements in ISO 9001:2015, it should develop a cross-reference of compliance methods such as implemented processes or documented procedures from whatever structure it’s using to the requirements in the revised standard. A cross-reference of ISO 9001:2008 requirements to ISO 9001:2015’s requirements is available to the public at no charge at: .

Subclause 4.4, Quality management system and its processes, should also be considered when reviewing requirements related to the structure. Organisations that have taken a minimal approach to this requirement may need to make some changes in how they identify and control their processes. Organisations that have embraced the process approach will not only find that the transition to ISO 9001:2015 is simpler, but also that the integration of any new requirements into their QMS is easier to accomplish.

Change: terminology

Ever since the first of edition of ISO 9001 was published, there has been feedback from some users that the standard is difficult to apply to all types of industries, specifically the service sector. For that reason, the language in ISO 9001 was modified to make it easier to use across all sectors.

Products and services

One way that ISO 9001:2015 has been made more generic is by replacing the word “product” with “products and services.” Using “products and services” helps to emphasize that the standard can be applied to all types of organisations. In addition, some requirements have been specifically changed to emphasize this point. This includes subclause 7.1.5, Control of monitoring and measuring resources, which was made easier to apply to service industries by changing the words “monitoring and measuring equipment” to “monitoring and measuring resources” and incorporating requirements related to monitoring and measuring as applicable to the service sector.

Interested parties

Some of ISO 9001:2015’s new requirements are practices that most organisations already do, but may cause some discussion regarding implementation. This is partially due to the new terminology in ISO 9001:2015 related to “interested parties.”

ISO 9001 has always been and remains a customer-focused standard. The high-level structure and common text that is required to be used by Annex SL uses the term “interested parties” instead of “customers.” Specifically, subclauses 4.1, Understanding the organisation and its context, and 4.2, Understanding the needs and expectations of interested parties, require you to focus on these aspects. These requirements were implied in subclause 0.1, General, in ISO 9001:2008, which indicated that the QMS is influenced by the environment that the organisation operates in, including changes and risks.

To eliminate the potential for the term “interested parties” to be interpreted beyond the intent of ISO 9001:2015, subclause A.3, Understanding the needs and expectations of interested parties (located in Annex A), explains subclauses 4.1 and 4.2. Specifically, ISO 9001:2015 doesn’t require an organisation to consider interested parties that aren’t relevant to its QMS. Organisations will need to determine what is relevant for them based on whether the interested party has an effect on the organisation’s ability to meet customer, statutory, and/or regulatory requirements. Some organisations may choose to expand the interpretation of the requirement, but this is at their discretion and where it can be determined that such an application can add value. A list of examples of interested parties is included in ISO 9000:2015.

Applicability (Exclusions)

In ISO 9001:2008, exclusions allowed an organisation to exclude a requirement of clause 7 of the standard as long as it doesn’t affect the organisation’s ability to meet customer, statutory, and/or regulatory requirements or provide a product or service that conformed to such requirements.

With the introduction of the core Annex SL text, which includes a different structure, the standard has been made more generic. Therefore, it’s easier to apply the standard’s requirements. This change focuses ISO 9001:2015 on the application of the requirements and not on the exclusion of requirements. ISO 9001:2015 requires organisations to apply the requirements where they can.

Subclause 4.3, Determining the scope of the quality management system, still requires an organisation to justify any instance where a requirement cannot be applied. However, it isn’t limited to certain clauses of ISO 9001:2015 like it was in the previous two versions of the standard. The required justification for not applying a requirement of ISO 9001:2015 will assist with establishing the framework of an organisation’s QMS. This will be helpful not only to the organisation, but also to any third-party auditors who will be reviewing the organisation’s QMS.

Understanding the change

Subclause A.5, Applicability (located in Annex A), outlines the new concept of “application not exclusion.” It specifically addresses the idea that not all requirements have to be applied by an organisation due to the nature of the product or service that it provides. Other influences might be the size of the organisation, the management model it adopts, and/or its risks and opportunities.

Organisations that are already taking exclusion to a requirement in their ISO 9001:2008-based QMS should be able to determine if the requirement continues to no longer appliy when they transition to ISO 9001:2015.

Risk-based thinking

Another concept that has been integrated into ISO 9001:2015 is risk-based thinking. Although risk was implied in previous versions of ISO 9001, the word “risk” is now actually used in ISO 9001:2015. Using risk-based thinking allows an organisation to determine the level of controls needed for certain requirements, thereby reducing some requirements that were seen as more prescriptive than others.

In alignment with risk-based thinking, ISO 9001:2015 doesn’t use the term “preventive action.” The language in the standard looks at how an organisation determines the risks and opportunities that need to be addressed as part of an effective QMS. Subclause 6.1, Actions to address risks and opportunities, includes requirements to ensure that the QMS can achieve its intended outputs. It also addresses taking action appropriate to the potential effect of conformity of products and services and preventing the occurrence of potential issues.

Understanding the change

Subclause 6.1 includes a note that provides clarification of the options that can be used to address risks and opportunities, including the idea that risks and opportunities aren’t always negative. The organisation can take actions to avoid risks or actions to pursue an opportunity.

Subclause A.4, Risk-based thinking (located in Annex A), emphasizes the point that there is no requirement to implement a specific, formal risk-management system. Instead, ISO 9001:2015 focuses on the potential risks and opportunities associated with the implementation of a specific requirement and the level of implementation required.

In addition, subclause 0.3.3, Risk-based thinking, includes the consideration of risks and the potential consequences for different types of organisations, which allows the application of requirements based on those consequences.

Documented information

In ISO 9001:2015 the terms “documents” and “records” have been replaced with the term “documented information.” In addition, in previous versions of ISO 9001 the requirements for documents and records were kept in separate clauses. They are now included in subclause 7.5, Documented information.

It’s important to understand that this new terminology has been introduced because the way we control documented information today is vastly different than it was when ISO 9001 was first released. Despite this fact, there had been little change to the requirements in past revisions.

Understanding the change

Subclause A.1, Structure and terminology (located in Annex A), identifies some of the biggest terminology changes in ISO 9001:2015. It states that although the terms have been changed, organisations aren’t required to use the same terminology used by ISO 9001:2015 in their QMS. Furthermore, subclause A.6, Documented information (located in Annex A), includes clarifying information related to when the term “documented information” is used. It states, “Where ISO 9001:2008 used specific terminology such as ‘document’ or ‘documented procedures,’ ‘quality manual’ or ‘quality plan,’ this edition of this International Standard defines requirements to ‘maintain documented information.’

“Where ISO 9001:2008 used the term ‘records’ to denote documents needed to provide evidence of conformity with requirements, this is now expressed as a requirement to ‘retain documented information.’ ”

The annex goes on to explain that when the word “information” is used without “documented,” there is no requirement that the organisation maintain documented information unless the organisation determines it’s necessary.

Organisational knowledge

Subclause 7.1.6, Organisational knowledge, requires organisations to determine what knowledge is necessary for the operation of their processes to meet product or service requirements. This is one of ISO 9001:2015’s new requirements, but it’s something that most organisations already have in place, even if informally.

This requirement is frequently confused with the requirements for employee competence. Organisational knowledge relates to the organisation; competence relates to the degree an employee understands and applies their knowledge.

Understanding the change

Subclause A.7, Organisational knowledge (located in Annex A), addresses this requirement. It specifically relates that the organisation needs to safeguard against loss of knowledge through employee turnover. It also provides examples of methods for acquiring knowledge, such as benchmarking or sharing lessons learned.

Control of externally provided products and services

This is another aspect of ISO 9001:2015 where the terminology has changed. In ISO 9001:2000, the term “vendor” was changed to “supplier.” In ISO 9001:2015, the term “supplier” has been replaced with “external provider.” This is because not all products or services are obtained through a traditional purchasing process. For example, some organisations receive parts or services from an associate company.

Understanding the change

Using the term “supplier” limited the organisation’s ability to see that there might be the need for controls for providers other than suppliers. With the understanding that the controls for a traditional “supplier” might be different than those for an associate company, subclause A.8, Control of externally provided processes, products, and services (located in Annex A), provides clarification that the organisation can take a risk-based approach to determine the type and extent of controls needed for each external provider based on the products and services to be provided.

In addition to this terminology change, additional terminology changes are included in subclause A.1, Structure and terminology (located in Annex A). As with the previous examples outlined, there is no requirement that organisations transition to these terms. Organisations should use terms that best fit their needs regardless of their use in the standard.

Setting audit program objectives is simpler than you might think.

ISO 19011:2011 Guidelines for auditing management systems, states that it is top management’s responsibility to ensure that audit program objectives are established. To support top management, a proactive audit program manager should review the organisation’s objectives and policies to achieve their performance goals and obligations. Many policies including safety, quality, environment, and community engagement may affect the audit department.

Next, audit program objectives can be established. Audit program objectives should be consistent with, and support, the management system policies and objectives. Program objectives go beyond verifying the purpose of a business function or department. For instance, accounts payable must pay all authorised invoices may be the purpose. The objective should be more about how the purpose is carried out and improved upon.

Audit program objectives may consider the following:

  • Management priorities;
  • Commercial and other business intentions;
  • Characteristics of processes, products, and projects and any changes to them;
  • Management system requirements;
  • Legal and contractual requirements and other requirements to which the organisation is committed;
  • Need for supplier evaluation;
  • Needs and expectations of interested parties, including customers the needs and expectations of interested parties. Interested parties may include regulatory agencies, customers, suppliers, purchasing, and operations;
  • Auditee’s level of performance, as reflected in the occurrence of failures, incidents or customer complaints;
  • Risks to the auditee;
  • Results of previous audits;
  • Level of maturity of the management system being audited;
  • Auditing organisation risks;

Examples of audit program objectives include:

  • To contribute to the improvement of a management system and its performance;
  • To fulfill external requirements, e.g., certification to a management system standard;
  • To verify conformity with contractual requirements;
  • To verify that customer requirements have been met. Customers may be internal or external;
  • To obtain and maintain confidence in the capability of a supplier;
  • To determine the effectiveness of the management system;
  • To contribute to the identification of significant risks to the organisation and verification of risk treatment actions. Risks may be associated with, for example, quality, safety, environment, finance, security and reputation;
  • To evaluate the compatibility and alignment of the management system objectives with the management system policy, strategic direction, and overall organisational objectives.

The objectives should be measurable and not vague generalisations.

Plans for monitoring the achievement of program objectives will need to include determining the appropriate metrics. Some metrics will be obvious such as continued certification of the management system. Determining the metrics for other objectives such as the effectiveness of the management system may be more challenging. There may be some thought about appropriate metrics now or later as part of the monitoring performance process.

Plans should include how objectives are communicated. Objectives should be shared (note that there could be security exceptions). Informing people that need to know will only help the achievement of objectives. Communication of objectives could be done using several media options eg, posters, intranet, emails, and meetings.

Plans should take into account the need to update, delete, or replace certain objectives. Objectives need to be monitored and periodically evaluated and updated. For example, they may need to be updated due to changing organisational objectives or strategic direction or the results of monitoring the achievement of objectives. Objectives may be reviewed annually, but circumstances may require the objectives to be assessed more frequently.

When appropriate, objectives should consider the type of audit eg on-site versus remote. The audit function of an organisation may provide many different audit services beyond management system audits. Process audits are becoming increasingly popular due to the value they add to the organisation. An ever-expanding supply chain has stressed the need for greater supplier accountability.

Objectives for the audit program

There should also be objectives for conducting audits. Providing an audit service is the purpose of the audit program. These objectives may relate to efficiency, safety, auditor competence, and they should be consistent with audit program objectives. Perhaps an example objective would be to incorporate the seven lean wastes thinking when conducting the audit process to improve efficiency.

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A total of 1,609,294 ISO related certificates were issued worldwide in 2014, an increase of 448,846 from 2013.

ISO 9001:2015 has now been released and introduces new concepts, terminology and current thinking, in order to satisfy your very important customers.

Risk is the possibility of events or activities impeding the achievement of an organisation’s strategic and operational objectives

ISO 9001:2015 for Small Enterprises – What to do? has just been updated

ISO/TS 9002, Guidelines for the application of ISO 9001:2015, has just been published.

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