Assessment Report Positive Weighing Solutions Ltd Assessment dates Assessment Location(s) Report author Assessment Standard(s)
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20/07/2018 to 20/07/2018 (Please refer to Appendix for details) Worcester (000) Ken Stafford ISO 9001:2015
Table of contents
Assessment Report.
Executive summary ......................................................................................................................................................3 Changes in the organization since last assessment ..................................................................................................... 4
NCR summary graphs ...................................................................................................................................................5 Your next steps............................................................................................................................................................. 6 NCR close out process.............................................................................................................................................. 6
Assessment objective, scope and criteria .................................................................................................................... 7 Assessment participants .............................................................................................................................................. 8 Assessment conclusion ................................................................................................................................................ 9 Findings from previous assessments .........................................................................................................................10
Findings from this assessment ...................................................................................................................................13
Quality Management System in Operation: ..........................................................................................................13 8 Operation: ...........................................................................................................................................................15
Next visit objectives, scope and criteria.....................................................................................................................17
Next visit plan .............................................................................................................................................................18
Appendix: Your certification structure & ongoing assessment programme..............................................................19 Scope of certification .............................................................................................................................................19
Assessed location(s) ...............................................................................................................................................19
Certification assessment programme ....................................................................................................................20 Expected outcomes for accredited certification....................................................................................................21
Definitions of findings: ...........................................................................................................................................21 How to contact BSI.................................................................................................................................................22
Notes ......................................................................................................................................................................22 Regulatory compliance ..........................................................................................................................................23
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Executive summary
Assessment Report.
In order to support the strategic direction and to give assurances to its customer base, the organisation maintains a management system to meet the requirements of ISO 9001 International Standard. The strategic vision was seen to be embedded in the organisation and provides confidence in the intended outcomes of the organisations management system.
The management system has demonstrated that it is supporting its strategic direction and delivery of the intended results. This was evidenced in the areas sampled and the organisations ability to provide quality assured products that meets its customer requirements.
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Assessment Report.
Changes in the organization since last assessment
There is no significant change of the organization structure and key personnel involved in the audited management system. No change in relation to the audited organization’s activities, products or services covered by the scope of certification was identified. The reference or normative documents applicable to the scope of certification were revised as follows: Quality policy has been amended to reflect NC raised at last assessment
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NCR summary graphs There have been no NCRs raised.
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Assessment Report.
Your next steps
Assessment Report.
NCR close out process Corrective actions with respect to nonconformities raised at the last assessment have been reviewed and found to be effectively implemented. No new nonconformities were identified during the assessment. Enhanced detail relating to the overall assessment findings is contained within subsequent sections of the report. Please refer to Assessment Conclusion and Recommendation section for the required submission and the defined timeline.
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Assessment objective, scope and criteria
Assessment Report.
The objective of the assessment was to conduct a surveillance assessment and look for positive evidence to verify that elements of the scope of certification and the requirements of the management standard are effectively addressed by the organization's management system; that the system is demonstrating the ability to support the achievement of statutory, regulatory and contractual requirements and the organization's specified objectives as applicable with regard to the scope of the management standard; to confirm the ongoing achievement and applicability of the forward strategic plan and where applicable to identify potential areas for improvement of the management system. The scope of the assessment is the documented management system with relation to the requirements of ISO 9001:2015 and the defined assessment plan provided in terms of locations and areas of the system and organization to be assessed. ISO 9001:2015 Positive Weighing Solutions Ltd management system documentation
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Assessment Report.
Assessment participants Name
Lucy Bennett-Poole Adam Grant
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Position
Managing Director Engineer
Opening meeting X
Closing meeting X
Interviewed (processes) X X
Assessment Report.
Assessment conclusion BSI assessment team Name
Ken Stafford
Position
Team Leader
Assessment conclusion and recommendation The audit objectives have been achieved and the certificate scope remains appropriate. The audit team concludes based on the results of this audit that the organization does fulfil the standards and audit criteria identified within the audit report and it is deemed that the management system continues to achieve its intended outcomes. RECOMMENDED - The audited organization can be recommended for continued certification to the above listed standards, and has been found in general compliance with the audit criteria as stated in the above-mentioned audit plan.
Use of certification documents, mark / logo or report The use of the BSI certification documents and mark / logo is effectively controlled.
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Findings from previous assessments Finding Reference Certificate Standard Category
Area/process: Details:
Objective evidence: Cause
Correction / containment Corrective action Closed?:
Finding Reference Certificate Standard Category
Area/process: Details:
Objective evidence: Cause
Correction / containment Corrective action Closed?:
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1455063-201703-N1 ISO 9001:2015 Minor
Certificate Reference Clause
Assessment Report.
FS 567522
2015:10.2.1
Transition readiness review
No evidence that root causes were identified leading to actions to prevent recurrence.
1. There was no evidence (e. g. in the incident logs for customer complaints, audit non-conformances, workshop errors) that the root causes had been identified (e. g. in terms of the failing process) such that process improvements to prevent recurrence could be considered. 2. Also it was not clear whether sub-clauses b, d and e had been adequately addressed in the QMS. Terminology within Corrective Action did not relate to "Cause". Amend Corrective Action log to include Cause. Log amended, cause now present. Observed Corrective Action Log 2018. Yes
1533531-201709-N1 ISO 9001:2015 Minor
Certificate Reference Clause
FS 567522
2015:5.2.1
5 Leadership
"satisfy applicable requirements" not included in the quality policy.
The quality policy did not include a commitment to satisfy applicable requirements ref 5.2.1 c. Lack of awareness as to the requirements of ISO 9001:2015
1) Awareness of standard to be gained by Internal Auditor Training. 2) Amend policy to reflect the requirements of the new standard. 1) Internal auditor training undertaken Oct 2017. 2) Policy amended to satisfy the requirements of the new standard. Issues 26th September 2017. Yes
Assessment Report. Finding Reference Certificate Standard Category
Area/process: Details:
Objective evidence: Cause
Correction / containment Corrective action Closed?:
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1533531-201709-N2 ISO 9001:2015 Minor
Certificate Reference Clause
FS 567522 2015:9.2
9 Performance evaluation
The organisation internal audit programme was found not to meet the requirements of the international standard
The organisation internal audit programme was found not to meet the requirements of the international standard:1) Not all process were found to be audited. i.e Internal audit process. 9.2.2 a 2) Audit reports sampled did not indicated, conformance with the international standard. 9.2.1 a2 3) Audit criteria and scope not established for each audit. 9.2.2b Lack of awareness as to the requirements of ISO 9001:2015
1) Awareness of standard to be gained by Internal Auditor Training. 2) Audit reports to include reference to International Standard. 3) Criteria & scope to be included for 2018 audits. 1) 2) 3) 4)
Internal auditor training undertaken Oct 2017. Refer to main report for detail. Refer to main report for detail. All processes now included within audit plan.
Yes
Assessment Report. Finding Reference Certificate Standard Category
Area/process: Details:
Objective evidence: Cause
Correction / containment Corrective action Closed?:
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1533531-201709-N3 ISO 9001:2015 Minor
Certificate Reference Clause
FS 567522
2015:9.3.2
9 Performance evaluation
Not all inputs as required by the standard had been included within the management review process
Not all inputs as required by the standard had been included within the management review process. i.e. Internal & External Issues, Interested parties. Lack of awareness as to the requirements of ISO 9001:2015
1) Gain awareness of ISO 9001:2015 2) Include Internal External Issues & Interested parties within management review process.
1) Awareness of the standard gained from Internal Auditors course. 2) Internal External Issues & Interested parties now included within Management Review Process. Observed Management Review Minutes dated 07/07/18 Yes
Findings from this assessment
Assessment Report.
Quality Management System in Operation:
4.3 • The scope of the organization’s quality management system has been established, it is available and maintained as documented information within the organisations Quality Manual. • The scope states the types of products and services covered, and there are no declared exclusions. • In establishing the scope considerations have been given to:-
4.4 • The organization determines the processes needed for its quality management system in accordance with ISO 9001. • Processes included are those for Production & Service provision, along with those needed for the effective implementation and maintenance of the organisations quality management system. • Documented information of these processes is retained. 5.2 • The organisation has established a quality policy which aligns with the strategic direction of the organisation. • The quality policy describes the intentions and direction of the organisation. • The quality policy was available and documented within organisations QMS. • The quality policy is available to interested parties upon request. 6.2 • The organisation has established objectives along with appropriate actions to achieve them. • Objectives were targeted at products and services and enhancement of customer satisfaction. • Quality objectives were found to be measurable and reviewed during the management review • The Managing Director defines the responsibility for achieving the objectives. Target Actual YTD ~ Supplier Non-Conforming Products Monitor 8 ~ Warranty Return 0 7* ~ Work shop errors 0 5* ~ Late Deliveries 0 0 ~ Damage to Customer Property 0 0 ~ Customer Complaints 0 0
* Increased diligence by the organisation, in recording these aspects. ^ Enhanced skills matrix/training has led to this reduction.
process. 2017 5 2 4 2 0 7^
7.5 Documented information required by the standard was available. • Documented information determined by the organisation as being necessary for the effectiveness of the QMS was included. • The aforementioned were available and suitable for use where and when required, and was found to be adequately protected. • Appropriate controls were in place for creating and updating documents.
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Assessment Report.
9.1.2 • The organisations monitors customer feedback to evaluate customer satisfaction and to determine opportunities for improvement. • The aforementioned provides information on customers’ perceptions about the products and services of the organization, and whether needs and expectations have been met. • Methods used for obtaining customer feedback include:- Testimonials - Satisfaction Surveys; - Customer Retention - Product Conformance Observed o Bostik; rated between Very Good & Good, Calibration & Repair o National Refrigerants; Average o Capital Coated Skill; Positive comments relating to engineer o Alfaplas; Very Good
9.2 Internal audits are conducted at planned intervals to determine whether the quality management system • Conforms to its own requirements • The requirements of the standards it operates under • Is effectively implemented and maintained. Observed o Documentation Control; No. 2018 Q2-8, report included ref to clause 7.5 of the standard, there were no findings arising from the audit. Auditor Lucy Bennett-Poole. o Supplier Management; No. 2018 Q2-9, report included ref to clause 8.4 of the standard, there was one opportunity for improvement identified. o Emergency Call Out; 2018 Q1-02, report included ref to clause 8.4 of the standard, there was one opportunity for improvement identified.
9.3 • The organisation plans and conducts management reviews at least 4 times per year, to ensure its QMS continuing suitability, adequacy and effectiveness with its strategic direction. • The review includes the inputs required by the standard and the subsequent outputs. • Documented information of management reviews is maintained; management review minutes dated 07/07/18. 10.2 There has been no customer complaints received YTD. • The organization has established a process to take action to investigate what has gone wrong, to correct it if possible, and to avoid similar issues from recurring in the future. • The scope of the process includes Customer Feedback, Internal & Supplier Issues. • The organization seeks to eliminate the causes and consequent effects of problems that could have a negative impact on its products and services. • The organization retains documented information in order to provide evidence that correction or corrective action has been identified. Observed o Corrective Action #10, ATEX certificate not saved on "ACT". o Internal Audit Action #08, Information on "ACT" not being updated.
Planned activities have been realized. The aspects of the process sampled, were found to meet the requirements of ISO 9001:2015. Planned results have been realized. Page 14 of 23
8 Operation:
Assessment Report.
8.3 8.3.1 The organization has established, implement and maintain a design process that is appropriate to ensure the subsequent provision of products and services. 8.3.2 The organisations Design and development planning takes the format of a Project Briefing Form. Observed o Alfaplas, dated 01/02/18 8.3.3 Design inputs included:• FLT application; weighing only • Capacity 2000Kg x 1Kg • FLT Type; Toyota 8FDF25 • Third party supply • Consumable & Sundry Items • Location • Environmental Constraints • Configuration Options • Timings • Regulatory Requirements 8.3.4 Design and development controls:• Understanding of Customer & Regulatory requirements • Confirmation of input requirements and can these be achieved under the aforementioned. • Verification & Validation activities • Retention of information • Completion against timings 8.3.5 Design and development outputs:• The design output can be considered the product or service provided, in the example assessed this was the "FLT Scale" that satisfied the design inputs. • Customer acceptance payment after installation 16/03/18 Ref Invoice 5442. 8.3.6 Design and development changes • Where change is required these are implemented in a control manner. • The organisation retains documented information on design changes.
Planned activities have been realized. The aspects of the process sampled, were found to meet the requirements of ISO 9001:2015. Planned results have been realized.
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Assessment Report.
8.5 Off site calibration visit to Clients customer "Morgan Cars Ltd" Malvern. • Calibration request for Sartorius Scales, serial No. 25902271 (7.1) • Technicians performing the task Adam Grant o Training records for Adam Grant; , Signal Injector Training, Load Cell Fault Finding, Comm`s, Training, Competence demonstrated at Interview (7.2) • Equipment to be used to perform calibration:- (7.1.5) o Set 2, Iron Weights, 10Kg, 5Kg, 2Kg, 1Kg, 500g, 200g & 100g. o Calibration certificate of the above 232081, dated 10/01/18. o The above certificate was traceable to National Standards. • Site rules complied with. • Necessary PPE worn. • Calibration Checklist defined parameters to be achieved:- (8.6) o Calibration loads 500g, 1000g, 2000g, 5000g & 7500g o Calibration checklist used to record results, "as found" and any "adjustments". (8.6) • Customer is informed of any results that do not conform before leaving site. (8.7) • It was observed that care is taken with customers property. (8.5.3) • Recorded information is returned to office for Calibration Certificate to be issued, ref 25902272. (8.5.2) • Post activities relate only to providing a Calibration Certificate. (8.5.5)
Planned activities have been realized. The aspects of the process sampled, were found to meet the requirements of ISO 9001:2015. Planned results have been realized.
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Next visit objectives, scope and criteria
Assessment Report.
The objective of the assessment is to ascertain the integrity of the organization's management system over the current assessment cycle to enable recertification and confirm the forward strategic assessment plan. The scope of the assessment is the documented management system with relation to the requirements of BS EN ISO 9001 and the defined assessment plan provided in terms of locations and areas of the system and organization to be assessed. BS EN ISO 9001 Positive Weighing Solutions Ltd management system documentation Please note that BSI reserves the right to apply a charge equivalent to the full daily rate for cancellation of the visit by the organization within 30 days of an agreed visit date. It is a condition of registration that a deputy management representative be nominated. It is expected that the deputy would stand in should the management representative find themselves unavailable to attend an agreed visit within 30 days of its conduct.
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Assessment Report.
Next visit plan Date
16/07/2019
Auditor
Ken Stafford
Time
Area/process
9:15
Strategic Review/Top management interview
9:00
Opening Meeting 4.3 Scope
4.4 QMS & its processes
5.2 & 7.3 Policy & Awareness
6.2 & 7.3 Objectives & Awareness 7.5 Documented Information 9.1.2 Customer Satisfaction 9.2 Internal audit
9.3 Management Review
10.2 Non-conformity & C/A
4.1 & 4.2 External/Internal issues & Interest parties 11:15 12:15 12:30
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6.1 & 6.3 Risk & Opportunities, Planning for Change Report Preparation Closing Meeting
End of assessment
Clause
Assessment Report.
Appendix: Your certification structure & ongoing assessment programme Scope of certification
FS 567522 (ISO 9001:2015) The provision, supply, including partial assembly, packaging, installation management and ongoing support for the quality management system for the calibration, maintenance and repair for weighing, bagging, bag-stitchers, liquid filling and related products and spares.
Assessed location(s) The audit has been performed at Central Office. Worcester / FS 567522 (ISO 9001:2015) Location reference 0047396596-000 Address Positive Weighing Solutions Ltd Unit 8 The Clifton Centre Spring Lane South Malvern Worcester WR14 1BJ United Kingdom Visit type Assessment reference Assessment dates Deviation from audit plan
Total number of Employees Effective number of Employees Scope of activities at the site Assessment duration
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Continuing assessment (surveillance) 8807636 20/07/2018 No 9 5
Main certificate scope applies. 1 day(s)
Assessment Report.
Certification assessment programme Certificate number - FS 567522 Location reference - 0047396596-000 Business area/location Transition to ISO 9001:2015
Date (mm/yy):
Duration (days):
4.3 Scope
4.4 QMS & its processes
5.2 & 7.3 Policy & Awareness
6.2 & 7.3 Objectives & Awareness
Audit1
09/17 1
X
X
X
X
X
X
X
10.2 Non-conformity & C/A
X
X
X
X
X
7.4 Communication
X
8.4 Control of externally provided processes, products & services
X X
8.6 Release of products & services
X
9.1.1 & 9.1.3 Performance evaluation
X
8.7 Control of Non-conforming product 10.1 & 10.3 Improvement
Strategic Review/Top management interview Page 20 of 23
X
X
X
X
X
X
X
X
X
8.5 Repair, service, hire and calibration
8.5 Site Visit, timing dependant on client’s availability. PWS to advise BSI 4 weeks prior to assessment.
X
X
X
8.3 Design & Development
X
X
7.1.5 Monitoring & measuring
8.2 Requirements for products & services
X
X
6.1 & 6.3 Risk & Opportunities, Planning for Change
8.1 Operational planning & control
X
X
X
X
7.2 Competence
X
X
X
4.1 & 4.2 External/Internal issues & Interest parties
7.1.3 & 7.1.4 Infrastructure Inc. Maintenance & Environment
0.5
X
X
9.2 Internal audit
5.1 & 5.2 Leadership, Roles & Responsibilities
1
07/19
X
X
9.3 Management Review
07/18
Audit3
X
7.5 Documented Information 9.1.2 Customer Satisfaction
Audit2
X
X
X
X
X
Expected outcomes for accredited certification
Assessment Report.
What accredited certification to ISO 9001 means ISO 9001:2015 specifies requirements for a quality management system when an organization: needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements; and aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. What accredited certification to ISO 9001 does not mean 1) It is important to recognize that ISO 9001 defines the requirements for an organization’s quality management system, not for its products and services. Accredited certification to ISO 9001 should provide confidence in the organization’s ability to “consistently provide product that meets customer and applicable statutory and regulatory requirements”. It does not necessarily ensure that the organization will always achieve 100% product conformity, though this should of course be a permanent goal. 2) ISO 9001 accredited certification does not imply that the organization is providing a superior product or service, or that the product or service itself is certified as meeting the requirements of an ISO (or any other) standard or specification.
Definitions of findings: Nonconformity: Non-fulfilment of a requirement. Major nonconformity: Nonconformity that affects the capability of the management system to achieve the intended results. Nonconformities could be classified as major in the following circumstances: • If there is a significant doubt that effective process control is in place, or that products or services will meet specified requirements; • A number of minor nonconformities associated with the same requirement or issue could demonstrate a systemic failure and thus constitute a major nonconformity. Minor nonconformity: Nonconformity that does not affect the capability of the management system to achieve the intended results. Opportunity for improvement: It is a statement of fact made by an assessor during an assessment, and substantiated by objective evidence, referring to a weakness or potential deficiency in a management system which if not improved may lead to nonconformity in the future. We may provide generic information about industrial best practices but no specific solution shall be provided as a part of an opportunity for improvement.
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How to contact BSI
Assessment Report.
'Just for Customers' is the website that we are pleased to offer our clients following successful registration, designed to support you in maximising the benefits of your BSI registration - please go to www.bsigroup.com/j4c to register. When registering for the first time you will need your client reference number and your certificate number (47396596/FS 567522). Should you wish to speak with BSI in relation to your registration, please contact our Customer Engagement and Planning team: Customer Services BSI Kitemark Court, Davy Avenue, Knowlhill Milton Keynes MK5 8PP
Tel: +44 (0)345 080 9000
Email: MK.Customerservices@bsigroup.com
Notes This report and related documents are prepared for and only for BSI’s client and for no other purpose. As such, BSI does not accept or assume any responsibility (legal or otherwise) or accept any liability for or in connection with any other purpose for which the Report may be used, or to any other person to whom the Report is shown or in to whose hands it may come, and no other persons shall be entitled to rely on the Report. If you wish to distribute copies of this report external to your organization, then all pages must be included. BSI, its staff and agents shall keep confidential all information relating to your organization and shall not disclose any such information to any third party, except that in the public domain or required by law or relevant accreditation bodies. BSI staff, agents and accreditation bodies have signed individual confidentiality undertakings and will only receive confidential information on a 'need to know' basis. This audit was conducted on-site through document reviews, interviews and observation of activities. The audit method used was based on sampling the organization’s activities and it was aimed to evaluate the fulfilment of the audited requirements of the relevant management system standard or other normative document and confirm the conformity and effectiveness of the management system and its continued relevance and applicability for the scope of certification. As this audit was based on a sample of the organization’s activities, the findings reported do not imply to include all issues within the system.
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Regulatory compliance
Assessment Report.
BSI conditions of contract for this visit require that BSI be informed of all relevant regulatory noncompliance or incidents that require notification to any regulatory authority. Acceptance of this report by the client signifies that all such issues have been disclosed as part of the assessment process and agreement that any such non-compliance or incidents occurring after this visit will be notified to the BSI client manager as soon as practical after the event.
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