{[Insert Logo and]{.underline}

[Name of Institute]{.underline}}

Quality Management System Report

{Type of CMC\[example: Dimensional Metrology\]}

Date:{yyyy-mm-dd}

# Instructions

Please look over this template and remove anything that does not apply.
The parts that should be changed in reference to your institution are
{[underlined and in brackets}]{.underline}. Please also add any relevant
information pertaining to your institution that is not already mentioned
below. Instructions or examples are included in \[brackets\], please
remove these before submission.

Please save all documents in the same folder. The following naming
convention is recommended: (Folder name:
{[Institution}]{.underline}\_QS_Date in year, month, day format) and
create a hyperlink to the related documentation, as indicated on this
master document. As an example, the folder name for NRC of Canada would
be: **NRC_QS_2008-06-13**

# 

Table of Content

[**Instructions 2**](#quality-system-structure)

[1. Quality System Structure 4](#quality-system-structure)

[1.1 Quality Policies 4](#quality-policies)

[1.2 Organizational Chart (link) 4](#organizational-chart-link)

[1.3 Quality Management Policies and Responsibilities
5](#quality-management-policies-and-responsibilities-policy)

[2. Quality Manual Components 7](#quality-manual-components)

[2.1 Table of Content (link) 7](#table-of-content-link)

[2.2 Cross-Reference Table between ISO/IEC 17025 and the Quality
Documentation of the {INSTITUTION or DI} (link)
7](#cross-reference-table-between-isoiec-17025-and-the-quality-documentation-of-the-institution-or-di-link)

[2.3 List of CMCs (link) 7](#list-of-cmcs-link)

[2.4 List of Type of CMC Documents and Procedures (link)
7](#list-of-type-of-cmc-documents-and-procedures-link)

[2.5 List of {INSTITUTION} Documents and Procedures (link)
7](#list-of-institution-documents-and-procedures-link)

[3. Quality System Implementation 7](#quality-system-implementation)

[3.1 Complaints and Appeals 7](#complaints-and-appeals)

[3.2 Control of Nonconforming Calibration or Measurement Work
9](#control-of-nonconforming-calibration-or-measurement-work)

[3.3 Corrective Actions 10](#corrective-actions)

[3.4 Internal Audits 11](#internal-audits)

[3.6 Management Reviews 13](#management-reviews)

[4. Assessment Process 15](#peer-reviewassessment-process)

[4.1 Current Status 15](#current-status)

[4.2 Assessment Report 15](#peer-reviewassessment-report)

# 1. Quality System Structure

## 1.1 Quality Policies

[{INSTITUTION}]{.underline} is committed to providing ......

The quality manual contains statements of the policies to be followed to
achieve these objectives and addresses the requirements of the
international standard ISO/IEC 17025:2005.

[{INSTITUTION}]{.underline} is committed to complying with the above
standard and requires all staff involved in calibration and measurement
services to familiarize themselves with the policies described in the
current issue of the quality manual and the associated procedures. Staff
must also ensure that their conduct conforms to the above mentioned
policies and procedures.\]

## *1.2 Organizational Chart (link)*

\[Link to document: {[INSTITUTION]{.underline}}\_OrgChart\]

## 1.3 Quality Management Policies and Responsibilities Policy

The {[INSTITUTION}]{.underline} quality system ensures that its
calibration and measurements services comply with the specified
requirements of ISO/IEC 17025. Quality-related activities are governed
by written procedures, where applicable, with emphasis on the following:

Prevention as well as detection of non-conformance;

Selection and monitoring of suppliers of materials and services that
affect the quality of service;

Procedures ensuring the safe and confidential handling, packaging,
storing, and delivery of materials;

Procedures to establish and monitor calibration and measurement
processes;

Regular internal audits and management reviews;

Continual improvement of the effectiveness of the quality system

Effective corrective and preventive action procedures for dealing with
client complaints and other instances of non-conformance; and

Appropriate techniques to monitor quality and seek clients' feedback.

### Scope

This policy applies to all functions of the calibration and measurement
services.

### Responsibilities

Calibration and measurement services personnel who manage, perform and
verify work affecting quality are responsible for the implementation of
the quality system.

The Quality System Coordinator is responsible for ensuring that the
quality system is implemented, properly documented and maintained. The
Quality System Coordinator may delegate certain responsibilities to
appropriate staff.

### Quality System Document Structure

The controlled version of the Quality Manual is available at \[[{enter
where the quality manual is available}\]]{.underline}.

The [{INSTITUTION}]{.underline} Quality System is designed around the
following document structure:{ }

**The {[INSTITUTION}]{.underline} Calibration and Measurement Services
Quality Manual**

This document states the quality policy and describes the quality system
within calibration and measurement services. It outlines the
philosophies and policies as well as the goals and objectives of
calibration and measurement services.

**[{INSTITUTION}]{.underline} Operating Procedures**

[{INSTITUTION}]{.underline} has procedures that describe how the quality
system functions and who is responsible for calibration and measurement
services. The procedures adhere to the principles and practices defined
in the Quality Manual and detail how the quality principles and
practices are applied and who is responsible.

**Calibration and/or Measurement Procedures**

Documented procedures are available which describe how a calibration or
measurement is performed. Detailed requirements of tasks which affects
the quality of output are defined. This is to ensure consistent
calibration or measurement methods in order to achieve the standard of
measurement required. Where appropriate, a direct link exists to a known
national or international standard method. Where no standard method
exists, the calibration and measurement is consistent with best
metrological and scientific practice.

Group/Scope Quality Procedures

A group/scope covering a specific area of metrology within
[{INSTITUTION}]{.underline} may develop its own procedures to describe
how their part of the quality system functions. These procedures must
adhere to the principles and practices defined in the Quality Manual and
meet at least the requirements outlined in the
[{INSTITUTION}]{.underline} Operation Procedures.

### Quality System Records include:

quality system documentation;

quality system files;

published standards;

statutory regulations;

training and qualification records of calibration and measurement
services personnel;

correspondence and agreements with clients;

internal audits and follow-ups;

complaints, follow-ups and clients feedback;

quality system reviews; and

documentation of the output from operating procedures and calibration or
measurement operating procedures.

### Strategic Planning Framework

### Long term strategic planning at *[{INSTITUTION}]{.underline}* is a quality system activity which is dictated by .......... policy. {[INSTITUTION}]{.underline}'s implementation of this policy is carried out under the leadership of the ...........

# 2. Quality Manual Components

##  2.1 Table of Content (link) {#table-of-content-link .Style-Heading-2-+-Not-Italic}

\[Link to document: INSTITUTION_Quality manual components\]

## **2.2 Cross-Reference Table between ISO/IEC 17025 and the Quality Documentation of the {***[INSTITUTION or DI}]{.underline}* **(link)**

\[Link to document: INSTITUTION_Cross-reference table\]

##  2.3 List of CMCs (link) {#list-of-cmcs-link .Style-Heading-2-+-Not-Italic}

\[Link to document: INSTITUTION_CMCList\]

## **2.4 List of** *[Type of CMC]{.underline}* **Documents and Procedures (link)**

\[Link to document: INSTITUTION_CMC Docs and procedures\]

## **2.5 List of {***[INSTITUTION}]{.underline}* **Documents and Procedures (link)**

\[Link to document: INSTITUTION_Docs and procedures\]

# 3. Quality System Implementation

##  3.1 Complaints and Appeals  {#complaints-and-appeals .Style-Heading-2-+-Not-Italic}

### Policy

[{INSTITUTION}]{.underline} calibration and measurement services records
and investigates client complaints. If a client's complaints are
substantiated the non-conformance is resolved and the resolution is
recorded. Non-substantiated complaints are also recorded and may be
identified as a preventive action. In cases where complaints are not
solved to the client's satisfaction, an appeal mechanism is available.

**3.2 Feedback**

This policy applies to feedback received from clients or other parties
regarding services offered by {Institution} calibration and measurement
services.

### Responsibilities

### *[{INSTITUTION}]{.underline} personnel are responsible for directing complaints to ....*

In the case of an appeal, the ....

The ............ is responsible for the general implementation of this
policy and for ensuring that records of complaints and appeals, results
of investigations and follow-ups are maintained. The
....................is responsible for ensuring that client complaints
and appeals are handled appropriately based on the nature of the
complaint and that handling of complaints is consistent ....

### Records

Complaints Log and Records {\[ insert where it available\]}

### Statistics

Since [{Date}]{.underline} : [{#}]{.underline} complaints

{ Description of complaint}, raised and resolved {Date}

### Quality Procedures for Handling Complaints and Client Feedback 

\[Link to document: INSTITUTION_Procedures for complaints\]

###  Quality Procedures for Handling Appeals

\[Link to document: INSTITUTION_Procedures for appeals\]

##  3.3 Control of Nonconforming Calibration or Measurement Work {#control-of-nonconforming-calibration-or-measurement-work .Style-Heading-2-+-Not-Italic}

### Policy

[{INSTITUTION}]{.underline} calibration and measurement services
personnel ensure that nonconformities are identified, removed from use,
and corrected. Affected parties are notified of nonconformities if
deemed necessary.

### Scope

This policy applies to any aspect of the calibration and measurement
services work, or its results which do not conform to procedures or to a
client's agreed upon requirements.

### Responsibilities

[{INSTITUTION}]{.underline} personnel are responsible for identifying
and reporting nonconformities to the Technical Supervisor for review and
action, and for informing the Quality System Coordinator.

The Quality System Coordinator is responsible for the general
implementation of this policy and for ensuring that records of
nonconformities and how they were resolved are maintained. The Quality
System Coordinator is responsible for ensuring that resolution of
nonconformities is handled appropriately based on the nature of the
nonconformities and that handling of nonconformities is consistent
throughout [{INSTITUTION}]{.underline} calibration and measurement
services.

The Quality System Coordinator is responsible for ensuring that
corrective action is initiated when an evaluation of a nonconformity
indicates it could recur or that [{INSTITUTION}]{.underline} calibration
and measurement services is not in compliance with quality system
policies and procedures.

### Records

Complaints Log and Records

### Statistics

Since [{Date}]{.underline} : [{#}]{.underline} nonconformities

{ Description of nonconformity},, raised and resolved {Date}

### Quality Procedures for Handling nonconformities 

\[Link to document: INSTITUTION_Procedures for nonconformities\]

##  3.4. Corrective Actions {#corrective-actions .Style-Heading-2-+-Not-Italic}

### Policy

[{INSTITUTION}]{.underline} calibration and measurement services
implements corrective actions when the evaluation of a non-conformance
indicates it could recur or that [{INSTITUTION}]{.underline} calibration
and measurement services is not in compliance with quality system
policies and procedures.

### Scope

This policy applies to the [{INSTITUTION}]{.underline} calibration and
measurement services.

### Responsibilities

The ................. is responsible for ensuring that corrective action
is initiated when an evaluation of a non-conformance indicates it could
recur or that [{INSTITUTION}]{.underline} calibration and measurement
services is not in compliance with quality system policies and
procedures.

The ............... is responsible for the general implementation of
this policy and for ensuring that records of corrective actions and
follow-ups are maintained.

### Corrective action

The {[INSTITUTION}]{.underline} calibration and measurement services
procedures for corrective action include:

effective review of reports of nonconformities to identify when a
corrective action is initiated;

investigating the root cause of a nonconformities;

recording the results of the investigation;

determining the corrective action needed to eliminate or manage the
cause of the nonconformities;

documenting required changes;

applying controls to ensure that effective, corrective action is taken ;

auditing the appropriate areas of activity, when necessary, to ensure
the laboratory continues to comply with required criteria; and

ensuring that relevant information on actions taken is submitted for
management review.

### Records

Corrective/Preventive and Improvement Action Log and Records

Records of responses to Internal Audits and External Assessments

### Statistics

Since [{Date}]{.underline} : [{#}]{.underline} Corrective Action
[{]{.underline} [Description of Corrective Action}]{.underline},,
carried out and reviewed for effectiveness [{Date}]{.underline}

### Quality Procedures for Corrective and Preventive Action 

\[Link to document name: INSTITUTION_Procedures for corrective action\]

##   {#section-1 .Style-Heading-2-+-Not-Italic}

## 3.5. Internal Audits {#internal-audits .Style-Heading-2-+-Not-Italic}

### Policy

{[INSTITUTION}]{.underline} carries out internal audits to determine
whether the calibration and measurement services\' activities, and
documented policies and procedures meet the requirements of the quality
system and are effective in achieving the stated quality objectives.

When auditing calibration procedures, every effort is made to balance
the need for a conflict of interest-free process with the need to ensure
the participation of auditors with the highest level of technical
knowledge in order to compare the written calibration procedures to the
internationally validated methods.

### Scope

This policy applies to internal audits for the quality system.

### Responsibilities

The ...................... is responsible for:

scheduling and coordinating internal audits,

maintaining audit records,

initiating corrective actions on the basis of the audit results,

communicating audit results.

specifying qualification requirements of internal auditors and
coordinating training activities for internal auditing.

The .............. authorizes the Quality System Coordinator to schedule
and coordinate internal audits and to initiate corrective actions. The
................. also identifies areas of importance for auditing,
reviewing audit results and for monitoring results of corrective action.

### Audit 

Calibration and measurement services have documented procedures for
planning and implementing internal audits. These audits verify
compliance of quality and technical activities and results, with the
requirements of the quality system.

The ........................... proposes an audit plan for approval by
the................ .

Internal audits are conducted by qualified personnel who are independent
of the activity audited.

Records are maintained of all audits. Audit findings are documented and
communicated to the accountable personnel as well as to the
................. for timely, corrective action.

### Procedures for Performing Internal Audits 

\[Link to document: INSTITUTION_Procedures for Internal Audits\]

### Bios of Internal Auditors 

[{#}]{.underline} staff members are formally trained in conducting
internal audits to ISO/IEC 17025, of whom [{#}]{.underline} are trained
as Team Leaders.

The Internal Auditing training was provided by [{Name}]{.underline}.

\[Link to document: INSTITUTION_Bios of internal auditors\]

###  Summary of Current Cycle of Internal Audits

  ------------------- ------------------- ----------------- ----------------
  Scope               Audit dates         Number of         Date resolved
                                          nonconformities   

                                                            

                                                            

                                                            

                                                            

                                                            

                                                            

                                                            

                                                            

                                                            

                                                            

                                                            

                                                            
  ------------------- ------------------- ----------------- ----------------

###  

##  3.6 Management Reviews {#management-reviews .Style-Heading-2-+-Not-Italic}

### Policy

{[INSTITUTION}]{.underline} Quality System and its calibration and
measurement activities are reviewed at sufficient intervals to ensure
their continuing suitability and effectiveness in satisfying ISO/IEC
17025 and stated quality policy and objectives.

### Scope

This policy applies to all activities within the calibration and
measurement services.

### Responsibilities

The {[INSTITUTION}]{.underline} Management Team reviews the Quality
Management System for calibration and measurement activities.

Formal audit action items and corrective action items are included, when
appropriate, as agenda items for {Institution} Management Team meetings.

Minutes of the review meetings are maintained to ensure that actions
arising from the reviews are discharged as required.

### Frequency

Management reviews are held at least once a year and are scheduled well
in advance to ensure full attendance.

### Guidelines for the Preparation and Implementation of Management Reviews 

\[Link to document: INSTITUTION_Guidelines for management review\]

### Management Review - 

Reviews include at least the following:

Complaints;

Client feedback;

Corrective and preventive action requests;

Internal Audit reports;

Assessments by external bodies;

Results of intercomparisons;

Changes in the volume and type of the calibration and measurement work;

Performance parameters including the identification and acquisition of
physical resources and qualified personnel needed to achieve the
required quality level; and

Amendments to the quality system, including the quality manual, to
ensure future requirements are addressed.

### Summary of Management Review 

Present

Absent

Minutes

# 

# 4. Peer Review/Assessment Process

##  4.1 Current Status {#current-status .Style-Heading-2-+-Not-Italic}

\[{Please insert current status of assessment process}\]

##  4.2 Peer Review/Assessment Report {#peer-reviewassessment-report .Style-Heading-2-+-Not-Italic}

A Peer Review/Assessment visit to {Type of CMC} was carried out by {Name
of external Peer Reviewers/Assessors} from {Date} to {Date}.

The purpose of the visit was to confirm conformance of the laboratory's
quality management system to the requirements of ISO/IEC 17025:2005.

The Team Leader was [{Name}]{.underline}.

The Technical Experts were:

{Name}

{Name}

{Name}

The short bios of the members of the Peer Review/Assessment team are
given in the attached document:

\[Link to document: \_Peer review/Assessment Team biosReport\]

The report of the Peer Review/Assessment, and initial responses, are
given in the attached document:

\[Link to document: MI\_ Peer Review/Assessment t Report\]

In parallel with the Peer Review/Assessment visit, the Technical
Assessors carried out a peer review of [{Type of CMC}]{.underline}
activities with the objective of establishing that:

The applicant {[INSTITUTION}]{.underline} has adequate competence to
disseminate national standards to clients with its claimed Calibration
and Measurement Capabilities; and

The {[INSTITUTION}]{.underline} meets the technical requirements of
ISO/IEC 17025, General Requirements for the Competence of Testing and
Calibration Laboratories, and ISO Guide 34, General requirements for the
competence of reference material producers.

The report of the peer review is given in the attached document:

\[Link to document : INSTITUTION_Peer Review\]

3.  **Action Plan for addressing findings** \[include actions and
    indication of completions dates (yyyy-mm-dd) and any follow-up
    applicable\]

**\[**Link to document: INSTITUTION_Action Plan\]