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Compare ISO 9001:2015 to ISO 17025:2017

Although both ISO 9001:2015 and ISO 17025:2017 are quality management systems applicable to any industry, their scope is significantly different. ISO 17025 is only for calibration and testing laboratories whereas ISO 9001 can be applied to any organization.

There are a minimum set of QMS requirements that are needed for the ISO 17025:2017 standard, which are similar to those found in ISO 9001:2015. These are:

  • Improvement
  • Management reviews
  • Management system documents control
  • Documentation of management system
  • Corrective actions
  • Handling risks and opportunities
  • Records control
  • Internal audits

ISO/IEC 17025 standard allows for two options depending on your accreditation scheme:

  • Option A – If you have not implemented ISO 9001, you must include them as part of your ISO 17025 QMS Scope.
  • Option B – If your organization has ISO 9001 certification, these are already present.

Implementation of ISO 9001 can be beneficial for your lab and it doesn’t have to comply with ISO 17025:2017.

Compare ISO 9001:2015 to ISO 17025:2017 Chart

ISO 9001: 2015 ISO 17025:2017 Discussion
4  Context of the organization ISO 17025:2017 does not discuss identification of internal issues, establishing a QMS scope or interested parties.
4.1  Understanding the organization and its context 5.4  part of Structural requirements Organizations must determine the external and internal issues that affect its purpose and strategic direction as well as relevant interested parties and their requirements.
4.2  Understanding the needs and expectations of interested parties 4.1.3 for impartiality

4.2.1 for confidentiality

7.9.2 for complaints

Relevant interested parties and their requirements must be determined and this information is to be monitored and reviewed.
4.3  Determining the scope of the quality management system 5.3 part of Structural requirements The Quality Manual is no longer mandatory.  The requirement remains for determining and documenting the QMS scope.
4.4  Quality management system and its processes 5.6 for personnel

8.1.1 for management system

8.2.4 for documentation

This requirements remain, but now includes risks, opportunities, and assigning authority for processes.
5  Leadership ISO 17025:2017 does not include a leadership commitment list nor does it include quality policy.
5.1  Leadership and commitment 8.2.3 for management commitment
5.1.1  Leadership and commitment for the quality management system 8.2.3 The 2015 version requires top management to become accountable for the QMS’ effectiveness and integration with the organization’s business processes as well as ensuring the quality policy and objectives are compatible with the organization’s context and strategic direction.
5.1.2  Customer focus 8.2.3 The 2015 version includes services (along with products) and also addresses statutory and regulatory requirements.
5.2  Quality policy No longer required

But review policies at Mgmt Review (8.9.1)

The quality policy (9001)must now be appropriate to the purpose, strategic direction and context of the organization.

ISO 17025:2017 doesn’t include essential QMS goals but they are included in ISO 9001:2015.

5.3  Organizational roles, responsibilities and authorities 5.5   for structural requirements

5.6  for structural requirements

6.2.4  for personnel

7.10  for non-conforming work

8.2.5   for documentation

8.8.2  for internal audits

The 2015 version requires top management to assign responsibility and authority for ensuring processes delivering their intended outputs.
6 Planning for the quality management system 8.7.1 e

8.8.2

6.1  Actions to address risks and opportunities 4.1.4  related to impartiality

8.1.2  for the system

8.5  full element

8.7.1e for corrective actions

8.9.1m for management review

Preventative action has been replaced by risks and opportunities.
6.2  Quality objectives and planning to achieve them 8.2.1 and .2 related to documentation

8.5.1b  related to risks and opportunities

8.9.1 and .2 for management review

Quality objectives must now be monitored. There are also additional requirements for planning how the organization will achieve it’s objectives. 

ISO 17025:2017 doesn’t include essential QMS goals but they are included in ISO 9001:2015.

6.3  Planning of changes 5.7b / 7.1.8 / 7.11.2 (MIS) / 8.3.2c /

8.7.1f / 8.8.2a / 8.9.2l / 8.9.3c

7  Support 6.1

6.6.1

7.2.1.2

8.1.1

7.1  Resources 5.6

7.1.1b

7.2.1.6

8.9.2 l

8.9.3 c

7.1.1  General
7.1.2  People 6.2 (primary ref.) plus 14 other references
7.1.3  Infrastructure 6.3
7.1.4  Environment for the operation of processes 6.3 (primary) plus 7 other references
7.1.5  Monitoring and measuring resources 6.2.5f   for personnel monitoring

6.6.2b and d  for monitoring

8.9.2  

Most of clauses 6 and 7 generally

7.1.6  Organizational knowledge The 2015 version makes a distinction between knowledge specific to the organization and general training or competence.
7.2  Competence 6.2.2 and .3

6.2.5

7.1.3

Competence clause separated for clarity and focus.
7.3  Awareness Awareness clause separated for clarity and focus.
7.4  Communication 5.7a

6.2.4

6.6.3

7.1.3

7.9.6  for complaints

Communication expanded in the 2015 revision to include eternal communication.
7.5  Documented information Mostly 7.5 and 8.4 for records and

8.2 and 8.3 for documents

Documents and records are now referred to as “documented information“. Where “retain” is used this refers to records and where “maintain” is used this refers to documents.
7.5.1  General
7.5.2  Creating and updating 5.5c

6.2.2 plus 21 other references

7.5.3  Control of documented Information 8.3   New requirement to protect records from unintended alterations.
8  Operation
8.1  Operational planning and control 6.4.3  for equipment

7.2.1.6 for test methods

7.3  for sampling

7.7.1. and .2 for QA and PT/ILC

8.5.2  for risks

New requirement to review the consequences of unintended changes and take actions to mitigate any adverse effects.
8.2  Determination of requirements for products and services 7.1 / 7.2 and 7.4  for process requirements
8.2.1  Customer communication 7.1  for contract review
8.2.2  Determination of requirements related to products and services 7.1  for contract review

7.8  for reporting of results

8.2.3  Review of requirements related to the products and services 7.1  for contract review

7.7  for quality assurance

8.3  Design and development of products and services N/A
8.3.1  General N/A Establish, implement and maintain a design and development process that is appropriate for your organization.
8.3.2  Design and development planning N/A Organization’s must now consider the need for involvement of customers and users in the design and development process.
8.3.3  Design and development Inputs N/A
8.3.4  Design and development controls N/A
8.3.5  Design and development outputs N/A
8.3.6  Design and development changes N/A
8.4  Control of externally provided products and services 6.6
8.4.1  General 6.6.1
8.4.2  Type and extent of control of external provision 6.6.2
8.4.3  Information for external providers 6.6.3
8.5  Production and service provision 7.1 through 7.8
8.5.1  Control of production and service provision
8.5.2  Identification and traceability 6.5 and Annex A

7.4

Metrological traceability is unique for 17025
8.5.3  Property belonging to customers or external providers 6.3

6.4

6.6

Extends requirements for property belonging to external providers (as well as customers).
8.5.4  Preservation 6.3
8.5.5  Post-delivery activities N/A The new standard separates post-delivery activities into its own sub-clause.
8.5.6  Control of changes See 9001 line item for 6.3
8.6  Release of products and services 7.8
8.7  Control of nonconforming process outputs, products and services 7.10
9  Performance evaluation 6.2.3  
9.1  Monitoring, measurement, analysis and evaluation 6.2.5
9.1.1  General
9.1.2  Customer satisfaction 8.6.2
9.1.3  Analysis and evaluation 8.6.2
9.2  Internal audit 8.8 The new standard does not require a documented procedure for internal audit, but an internal audit program must be established.
9.3  Management review 8.9 Management reviews now include review the QMS for alignment with the organization’s strategic direction. In addition, review inputs must include changes to internal and external issues, feedback from interested parties and the extend to which quality objectives have been met.
10   Improvement 8.6.1  for improvement
10.1  General
10.2  Nonconformity and corrective action 7.9  for complaints

7.10  for non-conforming

8.7  for corrective action

New requirement to review the effectiveness of correction actions and to update risks and opportunities.
10.3  Continual Improvement 8.6.1  for improvement

8.9.1  for management review

AND . . .
N/A 5.4 – meet regulatory and recognition body requirements
N/A 5.5 – outline lab in management structure
N/A 6.2.1 – competence
N/A 6.2.2 – competence requirements
N/A 6.2.3 – evaluate significance of deviations
N/A 6.2.5 – determine competence requirements
N/A 6.2.6 – authorize personnel for lab activities
N/A 6.3.1 – suitable facilities
N/A 6.3.2 – restrict access to lab facilities
N/A 6.3.3 – prevent lab contamination
N/A 6.3.4 – separation of activities
N/A 6.4.1 to 6.3.13 – lab equipment adequate access to equipment, use of external equipment, handling and maintenance of equipment, and 10 other sub-elements
N/A 6.5.1 to 6.5.3 – metrological traceability
N/A 7.1.1 – assure appropriate test methods
N/A 7.1.2 – inform customer of improper methods
N/A 7.1.3 – info for statements of conformity
N/A 7.2.1.1 to 7.2.2.4 – selection and validation of test methods
N/A 7.3.1 to 7.3.3 – sampling methods
N/A 7.4.1 to 7.4.4 – handling of test and calibration items
N/A 7.5.1 to 7.5.2 – technical records
N/A 7.6.1 to 7.6.3 — evaluation of measurement uncertainty
N/A 7.7.1 to 7.7.3 – ensuring validity of results (QA)
N/A 7.8.1 to 7.8.8 —  reporting of results
N/A 7.11.1 to 7.11.6 – control of data and information systems

 

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