Positive Weighing Solution's Quality Management System ISO 17025/2017

PART A SECTION 1

1.0     Purpose:

1.1     To describe the organisation and management arrangements for the laboratory of Positive Weighing Solutions Limited, hereafter referred to as either the laboratory or PWS.

2.0     Scope:

2.1     This management system covers the UKAS accredited calibration activities performed by PWS and other activities associated with these accredited services, for example administrative and maintenance functions.  Some support activities may reference the ISO9001 management system and staff can be common to both systems but may have different roles for each.

Specific exclusions from this management system are:

  • Calibration, service, repairs, hire and sales which are covered within the PWS ISO9001 certification and associated management system and/or the UKWF Code of Practice.
  • Initial verification and re-verification of Non-Automatic Weighing Instruments (NAWI) as agents of Dini Argeo.
  • Human Resources matters, Health, Safety and Environmental - however, these may be referenced to within this management system to facilitate compliance.
  • Sampling - the laboratory does not utilise sampling, but if this changes a sampling plan will be implemented.
  • Design – PWS design service is only offered under ISO9001 certification.

2.2     UKAS accreditation to EN ISO/IEC 17025:2017

PWS is UKAS Accredited Calibration Laboratory No. XXXX and as a minimum the policies, procedures, and work instructions within this management system meet the requirements of this standard.  PWS scope is detailed on the current Schedule of Accreditation available at www.ukas.com.  In summary these are:

  • Permanent laboratory
    • Non-automatic weighing machines up to and including 1,500kg capacity
    • Customers’ premises
    • Non-automatic weighing machines up to and including 1,500kg capacity

2.3     Those non-accredited activities mentioned in 2.1 above are included within the PWS EN ISO 9001:2015 management system under current certification issued by BSI.

3.0     Responsibility

3.1     It is the responsibility of the Quality & Technical Consultant and Managing Director to approve and authorise all policies, procedures and work instructions as well as authorising any amendments to them.  Adherence to these ensures that the laboratory’s activities meet the requirements of ISO17025:2017 and customers, and the effective operation of the management system and any work, health and safety, or environmental instructions or information which supplement it to ensure that its activities.

3.2     It is the responsibility of all personnel who are involved in the delivery of services to follow this management system and any work, health and safety, or environmental instructions or information which supplement it

3.3     Individual responsibilities are detailed within the section titled Personnel and included within staff job descriptions.

4.0     Definitions:

4.1     MD – Managing Director

PWS – Positive Weighing Solutions Limited

QTC – Quality & Technical Consultant

SD – Sales Director

TM – Technical Manager

5.0     Organisation:

5.1     Positive Weighing Solutions Limited is registered with Companies House as Company Number 06442820 and is an entity that can be held legally responsible.  An organisation chart is depicted within this section.

5.2     Public liability and employer’s liability are held on an ongoing basis to cover all activities.

6.0     Management arrangements:

6.1     The MD is directly responsible and accountable for all aspects of PWS operations including, but not limited to, resources, budgets, and quality matters, supported by and deputised for by the Sales Director.  The management team and staff are committed to ensuring impartiality is maintained and conflict avoided.  Where consultants or subcontractors are employed (refer to Apart A Section 9), their impartiality is assessed as part of engagement, and where appropriate additional measures are put in place to manage the risk and documented.  Subcontractors are required to complete a form which includes a requirement to not disclose any information obtained or witnessed during activities to other parties.

The management and staff will not be influenced by customers or suppliers and any such requests or concerns will be escalated to the MD.  The management and its staff shall always remain impartial in matters that are brought to its attention from any party and remain committed to providing consistent competent services in an environment that is free from bias, prejudice, and conflicts of interest.

 

6.2     The MD is responsible for ensuring that no conflicts exist within operations and/or any activities and staff are aware of the company’s expectation in relation to standards of conduct and behaviour.  Where service and UKAS calibration are combined as part of a service contract, staff are suitably aware of the potential conflict and ensure that neither activity can influence the other.

Similarly, all staff are aware of the need for confidentiality (commercial in confidence, data protection etc.) of customer and PWS information (that is not in the public domain), and if uncertain will discuss it with the MD.

Staff training ensures that external influence or pressure, eg financial or commercial, cannot compromise impartiality or activities, and staff performing accredited activities are not renumerated based on performance or commission.

6.3     Certain parties could affect the ability of PWS to provide impartial services that meet customer and applicable regulatory requirements.  These parties and the potential risks are outlined within Section 4.1 of the ISO9001 management system as an internal and external risk matrix.

Contracts of employment reinforce expectations of all staff – see also A 1, 7.4 below.

6.4     PWS have systems in place to meet requirements relating to data protection and regulatory controls, eg GDPR.  PWS do not share information with any other person or organisation without the prior authorisation of the person or organisation in question – even if that person or organisation is the end user of an instrument that was submitted by a third party.  Neither will PWS place any information in the public arena appertaining to any person or organisation.  The only exception may be in promoting the laboratory services where an organisation is named as a customer, and this will only be undertaken if that organisation has given prior approval in writing and made aware of its purpose and content.  Any instances of this should be reported to the MD and a record made of the discussion.

By default, all information that is provided to PWS as part of activities performed on behalf of the customer is confidential, regardless of any information that the customer has placed in the public arena, as it is impractical to constantly monitor what a person or organisation has made publicly available.

6.5     If requests are received to release information relating to activities of the laboratory, advice will be sought from appropriate legal representatives.  Release will only be permitted if it is a legal requirement, with disclosure to the customer being provided if it is legal to do so.

All information obtained during the laboratory’s activities are held securely at the premises or on cloud-based storage.  Any electronic devices used to retain data are secured to prevent access to information that may be stored on them at any time.

Records are only retained for the period defined in Part A Section 3 Records and in compliance with the appropriate data protection regulations.  Electronic data is automatically backed up at regular intervals throughout the day using the cloud-based storage. Only PWS employees or consultants can access electronic data.

6.6     The MD & SD operate the business flexibly in a dynamic and complex environment, whilst ensuring that they are compliant with ISO17025 and this management system.  The management system is developed in conjunction with the Quality & Technical Consultant.

The MD has overall responsibility for ensuring that the laboratory is adequately resourced and that its personnel have appropriate training and authority to perform their duties.  Arrangements are in place within the company to ensure that authority is delegated where appropriate, and employees are clear in their roles, responsibilities, competencies, and any restrictions.

Where additional facilities or equipment are required, these are sourced in line with Part A Section 4 Approved Suppliers and Part B Section 4 Measuring and test equipment as some equipment may be on hire or loan to the laboratory.

For equipment that is hired by/loaned to the laboratory, the laboratory will maintain records of this equipment, including any certificates of calibration and drift analysis to ensure the continued validity of calibrations performed by the laboratory.

6.7     Staff are aware of the need to ensure quality and therefore where pressure is experienced, they can raise their concerns directly with MD immediately or via meetings.  Regular staff meetings provide opportunities for information exchange and highlighting issues or opportunities for improvement.

7.0     Quality Policy and Objectives – issued by the MD

7.1     PWS reviews its quality policies and objectives at least annually, normally at Management Review and being recorded within the minutes of Management Review.  Any amendments made at other times are recorded via evidence of change.  Quality Policy and objectives are communicated to PWS staff with these policies and objectives updated within this section as necessary.

7.2     Quality Policy from 15 May 2023

It is the policy of PWS management to:

  • Comply with the relevant legal and UKAS requirements and satisfy the applicable requirements of EN ISO/IEC 17025:2017, by implementing this management system and ensuring staff are familiar with and committed to compliance.
  • Ensure activities and services are provided consistently with good professional practice, excellent quality calibrations, continuous improvement and meeting or exceeding customers’ needs or expectations by implementing all aspects of this management system. The purpose of this is to maintain quality, effectiveness, efficiency and excellent customer care.
  • Ensure all staff, contractors and consultants are committed to impartiality and confidentiality in all activities, and that these activities are continually reviewed. Staff will raise any concerns with laboratory management.
  • Continually improve the management system through identification of risk and continuous review to ensure that:
    • The management system achieves its intended results,
    • Opportunities to achieve the purpose and objectives of the service are met,
    • Prevention or reduction of undesired impacts or potential failures within the service’s activities are achieved,
    • Continuous improvement is identified and embraced at every opportunity within all systems and processes, including the use of technological advances, and
    • Services provided to customers are efficient and effective and meet or exceed customer requirements within our capabilities/scope on a continual basis.
  • Ensure that the services provided meet or exceed PWS customer care standards and achieve the objectives described above
  • Continually improve and develop the services offered to meet with the long-term strategic direction of the business and the needs of the customers.

SIGN HERE

Lucy Bennett-Poole

Managing Director

Dated: 15 May 2023

7.3     Quality Objectives from 15 May 2023

PWS objectives are to:

  • Provide suitably resourced services within its scope that are of the highest standards and as a minimum meet the needs of its customers. PWS customers are the driving force for service delivery and improvement, and PWS aims to always meet the needs of its customers, and where commercially possible exceed these to maintain and improve the commercial relationship.
  • Ensure current and future needs of PWS and customers are met on an ongoing basis where they align with the strategic direction of PWS, and as evidenced by customer feedback.
  • Focus on the needs of the customer and achieve this by ensuring PWS listens carefully to their needs, delivers the service that they require and keeps in touch with their developing needs following service delivery, as evidenced by customer feedback and complaints.
  • Auditing of the PWS service delivery ensures that the customer’s experience of the service is maintained and continuously improves, as evidenced by audit findings, corrective actions, customer feedback and complaints.
  • Ensure that justified complaints are acted upon and resolved to mutual satisfaction, whilst working to eliminate justified complaints. as evidenced by complaint levels, themes and feedback
  • Ensure effective communication exists within PWS and that all employees recognise the importance of customer care, quality, and compliance with the management system, as evidenced by customer feedback, complaints, corrective actions and non-conforming work records.
  • Log and review
  • Monitor and investigate, or assess, as necessary:
  • Accidents
  • Complaints
  • Warranty returns
  • Equipment repair errors
  • Supplier quality
  • Corrective and preventive actions
  • Damage to customer property
  • Suggestion Box opportunities for improvement
  • Continuous improvement activities and actions
  • Deliver 100% of goods and services on time and investigate any failings
  • Adhere to internal audit plan
  • Achieve business targets:
    • Achieve those stated in the current business year.
    • Justified complaints monitored and acted upon. See Part A Section 6 for definitions.
    • Excellent customer satisfaction is maintained.

7.4     Impartiality and Confidentiality Policy

          PWS management are committed to:

  • Complying with all impartiality, confidentiality, and proprietary rights requirements of EN ISO/IEC 17025:2017 through the implementation of this management system and ensuring staff are familiar with and committed to complying with it.
  • Ensuring all staff, contractors and consultants are committed to impartiality and confidentiality in all activities, and that these activities are continually reviewed.
  • Ensuring that staff can raise any concerns with laboratory management.
  • At all times keeping any information held secure through the security arrangements detailed within this management system.
  • Ensuring that all suppliers, including subcontractors and consultants, are committed to confidentiality, by using suppliers that meet the requirements of Part A Section 4 – Approved Suppliers.

 

SIGN HERE

Lucy Bennett-Poole

Managing Director

Dated: 15 May 2023

8.0     Structure of the Management System and Interaction

8.1     The aim of this management system is to ensure the performance of accredited calibration activities is in accordance with the Quality Policy and Objectives. This management system will support the delivery of the business aims and objectives through the identification of key requirements in service delivery and ensuring a process of continual improvement implemented.

This management system is available via the SharePoint site that is only accessible to PWS staff and the QTC. Control is operated as described within the section titled Document Control.

8.2     The management system is divided into sections as per the index which facilitates location of relevant policies, procedures, and work instructions.  Work instructions or operating procedures are formulated to facilitate consistency and quality in the delivery of the process being described.

Further documentation required for technical reasons is issued by the TM or QTC and is accessible and controlled as described in Document Control.

Attachments to any part of the management system exist to identify and control other documents that require referring to.

8.3     The basic structure is:

  • Part A - Management requirements
  • Part B - Technical requirements
  • Part C - Work instructions

 

 

9.0 Organisation Chart

PART A SECTION 2

1.0     Purpose:

1.1     To describe the procedures PWS uses to control all documents that form part of the management system and other documents used within performance of accredited activities.

2.0     Scope

2.1     Document control is limited to all documents that form part of this management system for accredited activities, including items such as internally or externally sourced documents, and software, including Excel spread sheets used to calculate results.  Generic documents are controlled within this management system or the ISO9001 management system.

3.0     Responsibilities

3.1     The QTC is responsible for authorisation, compilation, amendment, and maintenance of the management system.

The management system is controlled via all current documents (identified also by issue status) being available on the PWS Share Point site.  A master issue control record is provided by way of the current Index issued on Master Issue Control Form & Index QF A2.1. Current documents are identifiable as per this section of the Management System.

3.2     It is the responsibility of all PWS staff to comply with the requirements of this management system and associated documentation to ensure compliance with standards and regulations.

4.0     References

4.1     Section: Records

Sales Force – Beacon for recording of activities and work contracts

5.0     Document approval and issue

5.1     The authorised Management System is available:

  1. a) On the UKAS 17025 SharePoint site as an electronic read only document
  2. b) Via one each of an electronic and a hard copy retained by the QTC for business continuity purposes
  3. c) In part, via electronic or hard copy of the sections relevant to onsite calibrations being obtained by staff prior to onsite work. These copies are to be deleted/destroyed after use.

5.2     Management system documents are reviewed at least annually by the QTC, or a nominated person, and where appropriate they are revised to ensure continuing suitability and compliance with applicable requirements.

Annual review may occur at management review, or any other time and it is an integral part of quality audits, preventive actions, improvement opportunities etc and at the time of any change to a document or part of, that document/section is reviewed in its entirety to ensure it remains current and correct.

5.3     Invalid or obsolete documents, including those retained for either legal or knowledge preservation purposes, are removed from all points of issue or use, and retained as superseded documents in an appropriate format for the period defined in Records.

5.4 Each document which forms part of the management system bears:

  • "Positive Weighing Solutions Limited Management System” or similar
  • Unique identification – Part and Section
  • Page x of y
  • Issue number eg 1.00 (highlighted in yellow)
  • Issue date (highlighted in yellow)
  • Issuing authority ie QTC

5.5

5.6     Each form from the management system bears:

  • " Positive Weighing Solutions Limited Management System " or similar
  • QF identification unique to the management system
  • Numeric: is the section of the management system the form relates to
  • Sub-numeric: form number of the section
  • Issue number (highlighted in yellow)
  • Issue date (highlighted in yellow)
  • Page x of y
  • Issuing authority ie QTC

eg QF A2.1/1.00 is the first form from Part A Section 2 and issue 1.00.

5.7     When a need arises for an amendment this shall be proposed to the QTC who will investigate its technical and quality implications and consult with others as appropriate.  Where the proposals are accepted, they shall be implemented via the process detailed within this section.

Colour coding:

Highlighted in yellow (text): Changes have been made and the yellow highlighter tool is used identify the latest inclusions.  In cases where changes include replacement the previous text is to be formatted as double strikethrough, highlighted in yellow and suffix the new text.  The new text is to be highlighted in yellow as above.  In some cases, it may be more appropriate to do this to the complete paragraph.

Blue (text): Highlights hyperlinks and/or forms within sections

Green (text): Highlights changes that have been made, but these changes are non-critical amendments that can be made by the QTC without reissuing the whole section unless it could lead to any errors etc. Such examples may include typographical errors or incorrect section references eg where a reference refers to a section that no longer exists or has moved and is found during audit.  The issue number remains the same as currently in place.

Black (text): All text in its normal font that has not changed.  Any previous amendments that have been highlighted in yellow highlighter or green text will be changed to black when the section is reissued – green text staying green until a section is reissued in full.

6.0     Process for any changes to the management system

A)  The existing master document/form shall be copied and saved as the same file name but the next issue status. Where a new section is required, this will be created.  These electronic documents are retained securely in a specific area for draft procedures.

b)  The “new” document will have any previous amendments that have been highlighted in line with the process in place at time of update changed to normal text font colour (ie black), the date of issue removed and replaced with DRAFT and issue number increased (e.g. 1.00 becomes 1.01) and these are highlighted by the highlighter tool in yellow to prevent any unapproved documents entering the workplace.

c)  The new section will be produced or amended as required with any changes highlighted using the yellow highlighter and checked thoroughly for accuracy, and compliance with the relevant standards and/or regulations, and impact on any other activities or sections of the management system.

d) Where appropriate, staff will be consulted on the changes to the section or form to ensure that any further improvement opportunities are identified, and no errors exist.

e) For operating procedures and work instructions a complete section will be issued with the new issue number and date of issue being entered in the header on each page. For forms a new form is created with the new issue number and date of issue being entered in the header on each page.

f) The revised document will be loaded onto the SharePoint site.

g) The QTC retains one copy of each superseded section or form and a copy of the amendment details for the period defined in section titled Records.

h) The QTC controls issue status within the management system by way of the SharePoint site and the Master Issue Control Form & Index QF A2.1.

i) The Index is updated whenever changes are made with the new issue number and date for any affected sections/forms being highlighted in yellow. This assists in identifying the last review and therefore where attention should be refocused in reviewing the management system and ensuring work instructions remain current.

j) All staff will be notified of the changes, either by:

    1. Electronic means containing details of the changes and/or
    2. Staff briefing/meeting

Confirmation of assimilation is by way of an entry made on staff records and ongoing competence assessments.

 

k) All retained documents are only accessible to PWS staff and the QTC, and all are made read only at time of issue to prevent inadvertent changes and provide an audit trail.

7.0     Electronic documents holding data

7.1     Electronic documents used for observations utilise Excel spread sheets which are generated from Excel templates.  The documents are used for collecting data including observations in relation to the calibration and full details of the equipment.  These documents are only available to laboratory staff with backups retained in case of overwrite.

7.2     Excel templates are used to issue certificates, and these are issued in the same way as the management system with their control via the templates and Master Issue Control & Index.

7.3     If any amendments are made to any form/document etc. within the management system, the form/document will be reissued as per this section.

7.4     Update of electronic spread sheets

These forms hold key information that is required for calibrations, and this requires regular updates, eg when reference standards have been recalibrated.  Changes to these forms are highlighted, as detailed within this section, wherever possible, but on occasions, eg where cells are yellow under conditional formatting, an exception will be made and communicated at the time of the update. Similarly, with changes in measured values, these are just updated with verification being via date of calibration etc.

  1. Change proposed to QTC and assessed – where agreed QTC effects changes.
  2. Current master document is copied and saved with a new issue number and issue date in the same manner as all management system documents.
  3. Relevant changes made to draft document with cells protected where necessary and read only properties implemented.
  4. Once checks have validated the document it is moved to the working file and a backup copy saved in the relevant location.
  5. Issue control is managed in the same manner as the rest of the management system – as per Part A Section 2, 6.0 above.
  6. Any superseded document is filed in the superseded section of SharePoint.
  7. All staff informed of changes as per the management system update process.

7.5     PDF documents are retained as part of the original observations and are scanned post completion of calibration activities as part of the permanent record.

8.0     Documents - issue of external documents

8.1     Documents referred to in the management system can only be issued by the QTC and these are controlled via the Master Issue Control Form and Index.

The Master Issue Control Form & Index QF A2.1 is utilised for identifying reference materials etc required for delivery of services, either in hard copy, electronic copy or both.   The current issue status of these is also recorded on the form.

Where hard copy documents are required for reference, these are marked as “Reference Material” together with the date of issue by the laboratory and issuing authority.

8.2     The QTC shall check for any updated standards etc at least monthly to ensure that any action required is undertaken in a timely manner and staff/systems/management system are updated as appropriate. This is achieved via a simple Outlook reminder and sign up to UKAS notifications.

8.3     Externally sourced documents listed in the Master Issue Control Form & Index UKAS publications are available via the UKAS website to all staff to facilitate the effective and efficient operation of the laboratory, with hard copies not retained by staff.

9.0     Exceptions

9.1     In some instances it may be more appropriate to continue to use an existing form and this is permitted in the following circumstances:

  • Where there have been no material changes to the form and
  • Where the form contains data that cannot easily be transferred to a new document and
  • The form is not part of any accredited process for obtaining or reporting calibration or testing results.

10.0   Review program

10.1   The suitability of the management system and its policies are discussed at Management Review (Refer to Part A Section 8) and any requirements for updates in advance of next planned reviews are notes as outputs/actions.

10.2   Additionally periodic review is managed for the Master Issue Control Form & Index – sections and forms within the management are nominated for review based on a predetermined schedule built into the formulae within the spreadsheet and use of conditional formatting. Sections of the management system are reviewed on an ongoing basis with formal review at Management Review meetings.

The periodic review is to ensure that the procedure, work instruction etc remains current and reflecting current practice, but also facilitates inclusion of improvement opportunities.

 

END OF SECTION

PART A SECTION 3