ISO 9001 – 2015 CERTIFICATION
ISO 9001 – 2015 CERTIFICATION ISO standards are reviewed every five years and revised if required. This supports make sure they remain helpful tools for the market. The challenges faced by business and organizations today are very different from a few decades ago and ISO 9001 has been updated to take this new environment into account.
Both old and new standards cover effectively the same topics. However, there are some essential differences. Some of these are discussed below.
Structure of the standard
A general structure is possible because basic concepts such as management, client, needs, policy, procedure, planning, performance, objective, control, monitoring, measurement, auditing, decision making, corrective action, and nonconformity are general to all management system standards. While this will make it easier for organizations to implement multiple standards because they will all share the same basic needs, it may cause some disturbance in the short run as organizations get used to the new structure.
A common structure is possible because basic concepts such as management, customer, requirements, policy, procedure, planning, performance, objective, control, monitoring, measurement, auditing, decision making, corrective action, and nonconformity are common to all management system standards. While this will make it easier for organizations to implement multiple standards because they will all share the same basic requirements, it may cause some disruption in the short run as organizations get used to the new structure.
The new ISO 9001 2015 standard has also eliminate the long standing distinction between documents and records. Now they are both referred to as “documented information”. Why ISO chose to abandon two common sense concepts and replace them with one that is needlessly awkward and esoteric is not entirely clear.
Objects, outputs, products, and services
The definition of the term “object” is new. The introduction of the term “object” to mean anything conceivable or perceivable and its use in a variety of definitions (quality, design and development, innovation, review, traceability) appear to suggest that the new ISO 9001 standard can be applied to any object whatsoever. In theory at least, this greatly expands its scope.
What ISO 9000 2005 used to call a “product” the new standard now calls an “output”. The two definitions are the same. Since the term “output” was not defined in 2005, this shift in terminology suggests that the procedure approach is now even more central to the new standard.
And to further complicate things, the old definition of “product” has now been split into three separate definitions for the terms output, product, and service. “Output” is the general concept since both “products” and “services” are now thought of as “outputs”.
Other clarifications and modifications
While the earlier changes could be the most important ones, the new standard has also clarified some concepts and modified others. Some of these changes are listed below.
The old standard said that a “service” was a type of “product”. Now, the phrase “products and services” is used throughout the new standard and the term “service” has received its own definition. This should help out make it clear that ISO 9001 2015 applies not only to manufacturers but also to all types of service providers.
What used to be called “customer property” has been customized and greatly expanded to include products, services, and processes belonging to all types of external providers (including clientele). The new standard now expects you to control externally provided products and services if they are included in your products or services or if they are provided directly to clients.
The old definition of “continual improvement” has changed. When ISO 9001 2008 asked you to make continual improvements it was asking you to improve your ability to fulfill needs. Now, ISO 9001 2015 says it means enhancing performance (getting better results). This is an important shift.
According to the new standard, organizations must now recognize, acquire, and share the “knowledge” that personnel need in order to support procedure operations and achieve conformity of products and services.
The old concept of “product realization” is gone. Most of the material in the old product understanding section has been customized and moved to the new ISO 9001 2015 section on Operations.
The term “management representative” has been dropped. The management duties and responsibilities that were earlier assigned to someone called a “management representative” may now be assigned either to one person or to many people.
“Preventive action” has also disappeared. It’s been replaced by “risk-based-thinking”, evidently because both approaches try to achieve the same thing. Both try to prevent future problems. Once you introduce risk-based thinking, you no longer need a separate clause on preventive action. It’s redundant.
While the old standard asked you to use monitoring and measuring “equipment”, the new standard refers to monitoring and measuring “resources”. This is a more bendy approach to monitoring and measuring because it identify the fact that these activities can often be carried out without the use of equipment.
Clause by Clause Comparison
|ISO 9001: 2015||ISO 9001:2008||DISCUSSION|
|4 Context of the organization||1.0 Scope|
|4.1 Understanding the organization and its context||1.1 General||A new requirement – the organization must determine the external and internal context that affects the organization|
|4.2 Understanding the needs and expectations of interested parties||1.1 General|
|4.3 Determining the scope of the quality management system||1.2 Application 4.2.2 Quality manual||The Quality Manual is no longer mandatory. The requirement remains for determining and documenting its scope.|
|4.4 Quality management system and its processes||4 Quality management system
4.1 General requirements
|This requirements remains, the new cover risks, opportunities, and assigning authority for processes.|
|5 Leadership||5 Management responsibility|
|5.1 Leadership and commitment||5.1 Management commitment|
|5.1.1 Leadership and commitment for the quality management system||5.1 Management commitment|
|5.1.1 Leadership and commitment for the quality management system||5.1 Management commitment||The new version requires top management to become accountable for the QMS’ effectivness.|
|5.1.2 Customer focus||5.2 Customer focus||Virutally the same except the new version includes services (along with products) and also addresses government regulations.|
|5.2 Quality policy||5.3 Quality policy|
|5.3 Organizational roles, responsibilities and authorities||5.5.1 Responsibility and authority
5.5.2 Management representative
|The new version details the responsibilities, roles and authorities within the QMS.|
|6 Planning for the quality management system||5.4.2 Quality management system planning|
|6.1 Actions to address risks and opportunities||5.4.2 Quality management system planning 8.5.3 Preventive action|
|6.2 Quality objectives and planning to achieve them||5.4.1 Quality objectives|
|6.3 Planning of changes||5.4.2 Quality management system planning|
|7 Support||6 Resource management|
|7.1 Resources||6 Resource management|
|7.1.1 General||6.1 Provision of resources|
|7.1.2 People||6.1 Provision of resources|
|7.1.3 Infrastructure||6.3 Infrastructure|
|7.1.4 Environment for the operation of processes||6.4 Work environment||The 2015 version focuses the provision of resources to monitor and measure. The organization must retain the evidence monitoring and measuring resources.|
|7.1.5 Monitoring and measuring resources||7.6 Control of monitoring and measuring equipment|
|7.1.6 Organizational knowledge||New||The organization must determine the knowledge necessary to run the processes and achieve conformity of products and services|
|7.2 Competence||6.2.1 General 6.2.2 Competence, training and awareness||The old version covered both competence and awareness in the same clause. The new clause separates them.|
|7.3 Awareness||6.2.2 Competence, training and awareness||Separated for clarity and focus.|
|7.4 Communication||5.5.3 Internal communication||Internal and External communication responsibilities must be defined.|
|7.5 Documented information||4.2 Documentation requirements|
|7.5.1 General||4.2.1 General|
|7.5.2 Creating and updating||4.2.3 Control of documents 4.2.4 Control of records||Documents and records are now considered in the same category (i.e. documented information)|
|7.5.3 Control of documented Information||4.2.3 Control of documents 4.2.4 Control of records|
|8 Operation||7 Product realization|
|8.1 Operational planning and control||7.1 Planning of product realization|
|8.2 Determination of requirements for products and services||7.2 Customer-related processes||The new version emphasizes documenting the treatment of customer property.|
|8.2.1 Customer communication||7.2.3 Customer communication|
|8.2.2 Determination of requirements related to products and services||7.2.1 Determination of requirements related to the product|
|8.2.3 Review of requirements related to the products and services||7.2.2 Review of requirements related to the product|
|8.3 Design and development of products and services||7.3 Design and development|
|8.3.2 Design and development planning||7.3.1 Design and development planning|
|8.3.3 Design and development Inputs||7.3.2 Design and development inputs|
|8.3.4 Design and development controls||7.3.4 Design and development review 7.3.5 Design and development verification
7.3.6 Design and development validation
|The new clause aggregates of the three 2008 clauses, and emphasizes the nature, duration of design and development processes.|
|8.3.5 Design and development outputs||7.3.3 Design and development outputs|
|8.3.6 Design and development changes||7.3.7 Control of design and development changes|
|8.4 Control of externally provided products and services||7.4.1 Purchasing process|
|8.4.1 General||7.4.1 Purchasing process|
|8.4.2 Type and extent of control of external provision||7.4.1 Purchasing process 7.4.3 Verification of purchased product|
|8.4.3 Information for external providers||7.4.2 Purchasing information||The 2015 version emphasizes monitoring and control of external providers.|
|8.5 Production and service||7.5 Production and service provision|
|8.5.1 Control of production and service provision||7.5.1 Control of production and service provision|
|8.5.2 Identification and traceability||7.5.3 Identification and traceability|
|8.5.3 Property belonging to customers or external providers||7.5.4 Customer property||Describes extending requiments for property belonging to external providers (as well as customers).|
|8.5.4 Preservation||7.5.5 Preservation of product|
|8.5.5 Post-delivery activities||7.5.1 Control of production and service provision||The new standard separates to a new clause.|
|8.5.6 Control of changes||7.3.7 Control of design and development changes||A new separate clause is used to highlight the importance of change control.|
|8.6 Release of products and services||8.2.4 Monitoring and measurement of processes 7.4.3 Verification of purchased product|
|8.7 Control of nonconforming process outputs, products and services||8.3 Control of nonconforming product|
|9 Performance evaluation||New|
|9.1 Monitoring, measurement, analysis and evaluation||8 Measurement, analysis and improvement|
|9.1.1 General||8.1 General|
|9.1.2 Customer satisfaction||8.2.1 Customer satisfaction|
|9.1.3 Analysis and evaluation||8.4 Analysis of data|
|9.2 Internal audit||8.2.2 Internal audit||The new standard does not require a documented procedure|
|9.3 Management review||5.6 Management review|
|10 Improvement||8.5 Improvement|
|10.1 General||8.5.1 Continual improvement|
|10.2 Nonconformity and corrective action||8.3 Control of nonconforming product 8.5.2 Corrective action|
|10.3 Continual Improvement||8.5.1 Continual improvement||The 2015 standard emphasizes the use of all available information for continually improving the Quality Management System|
Benefits of ISO 9001:2015 Certificate
The new version of the standard brings the user a number of benefits:
- Addresses supply chain management more effectively
- Uses simplified language and a common structure and terms, which are particularly helpful to organizations using multiple management systems, such as those for the environment, health & safety, or business continuity
- Puts greater emphasis on leadership engagement
- Supports address organizational risks and opportunities in a structured manner
- Is more user-friendly for service and knowledge-based organizations
Section Changes in ISO 9001:2015
|SECTION NUMBER||CURRENT STANDARD SECTIONS||PROPOSED STANDARD SECTIONS|
|Section 2:||Normative Reference||Normative References|
|Section 3:||Terms and Definitions||Terms and Definitions|
|Section 4:||General Requirements||Context of the Organization|
|Section 5:||Management Responsibility||Leadership|
|Section 6:||Resource Management||Planning|
|Section 7:||Product Realization||Support|
|Section 8:||Measurement, Analysis and Improvement||Operation|
|Section 9:||Performance Evaluation|