ASSESSMENT REVIEW REPORT ISO 9001 - Sovereign Cert. · PDF fileASSESSMENT REVIEW REPORT ISO 9001 Doc. Ref. Version Date Approved By Page . ASSESSMENT REVIEW REPORT ISO 9001 Doc. Ref

ASSESSMENT REVIEW REPORT

ISO 9001

Doc. Ref. Version Date Approved By Page ARR-FORM-9001 1.0 24/08/2004 M. Helm 1 of 24

© Sovereign Certification Limited

Name of Applicant (Organisation Name)

Date of Completion (or amendment date)

Notes:

1. Applicant to complete all shaded areas

2. The report is designed to be word processed but hand written responses are acceptable.

3. Provide brief explanations to explain conformance in all areas.

4. The reference numbers (in brackets) refer to the ISO 9001 clauses.

5. Clauses which are indicated as clause 7 (e.g. 7.3 Design) may be marked “Not Applicable” where appropriate but should include an explanation of why.

6. Detailed assistance in completing this report and ensuring you have the correct documentation can be found in guidance boxes.

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ISO 9001



Contents

1. Quality Policy & Objectives............................................................................................................ 3

2. Management Responsibilities ....................................................................................................... 4

3. Quality Manual.................................................................................................................................... 6

4. Management Review......................................................................................................................... 8

5. Internal Auditing ................................................................................................................................ 9

6. Communication ................................................................................................................................10

7. Non-conformance............................................................................................................................11

8. Customer Satisfaction ...................................................................................................................12

9. Human Resources ...........................................................................................................................13

10. Infrastructure & Environment......................................................................................................14

11. Product & Customer Requirements (including Service)....................................................15

12. Planning..............................................................................................................................................16

13. Design & Development ..................................................................................................................17

14. Procurement......................................................................................................................................19

15. Production..........................................................................................................................................21

Appendices

Assessment Review Report compliance with ISO 9001:2000......................................23 Amendment Record.............................................................................................................24




ISO 9001



1. Quality Policy & Objectives You are required to have a documented quality policy (statement of your commitment to quality) suitable for your organisation that includes (5.3.a / 4.2.1.a):

• A commitment “to comply with requirements” and “continually improve the effectiveness of the quality management system” (5.3.b)

• Provide a “framework for establishing and reviewing quality objectives” (When you set your quality objectives these must be consistent with the quality policy). (5.3.c)

Guidance Your quality policy will need to meet the requirements stated but you should also try to ensure it reflects what you want to tell your customers about your commitment to them. Quality Policy Sample (Available) MS Word QPY-Sample-9001 PDF QPY-Sample-9001

(Explain how you meet this requirement in this space)

You are required to define quality objectives which are measurable and consistent with the policy.(5.4.1)

Guidance Your quality objectives are probably the things you imagine your business doing better in the future. They can and should relate to overall aspects of improvement as well as product conformity. Quality Objectives Sample (Available) MS Word QOB-Sample-9001 PDF QOB-Sample-9001





ISO 9001



2. Management Responsibilities Is it evident that top management are committed to the development, implementation and improvement of the quality management system (5.1 / 5.4.2) and do they:

• Communicate the importance of meeting customer as well as statutory and regulatory requirements (5.1.a)

• Ensure the quality policy is adopted (5.1.b) • Ensuring that Quality Objectives are

meaningfully established (5.1.c) including in relation to the product (5.4.1)

• Ensure the availability of resources to meet customer requirements and implement the business processes and quality management system (5.1.e / 6.1.a, b)

Guidance A judgement needs to be made in each of the areas. This is a real measure of management’s commitment to the quality system.


Have top management ensured that responsibilities and authorities are defined and communicated within the organisation to such an extent that all personnel know there duties. (5.5.1).

Guidance You need to confirm that personnel know their positions and responsibilities. There may be a current organisation chart showing the position and job descriptions etc.





ISO 9001



2. Management Responsibilities Have top management appointed a Management Representative (Quality Manager / Director etc) who (5.5.2):

• Ensures that the systems for quality management are established, implemented and maintained (5.5.2.a)

• Can report directly to top management regarding performance of the quality management system and identify areas which require attention (5.5.2.b)

• Is responsible for the promotion of customer requirements (5.5.2.c) and enhancing customer satisfaction (5.2)

• Ensures the integrity of the quality management system is maintained (5.4.2.b)

Guidance You must have appointed a Quality Manager (or other designation) who takes responsibilities for the listed activities.


You must ensure that the control and operation of the quality management system processes are effective (4.1.c) and are monitored (measured and analysed) for effectiveness (4.1.e) in producing the desired product / service (4.1.f)

Guidance You must have reviewed your processes and considered them effective when considering if they deliver the desired outputs to enable the desired product / service to be produced.





ISO 9001



3. Quality Manual You must prepare a quality manual (4.2.1.b) to include:

• The scope of the quality management system including the details and justification for any exclusion. (4.2.2.a)

• A flowchart or description of the “processes including the sequence and interaction needed for the quality management system to operate efficiently for the organisation. (4.1.a, b / 4.2.2.c)

(Quality Manual Continued – See Below)

Guidance You must have prepared, approved and implemented your quality manual. Use the sample listed below or other similar solution. Quality Manual Sample (Available) MS Word QML-Sample-9001 PDF QML-Sample-9001





ISO 9001



3. Quality Manual • You must prepare and include documented procedures (or

reference to) for: (4.2.1) o Control of Documents including the following aspects

(4.2.3): § Approve documents for adequacy prior to issue § Review, update and re-approve documents § How changes and current revision are identified § How relevant issues are available where required § How they remain legible and identifiable § To identify external documents and control their

distribution § How obsolete (superseded) documents are

controlled o Control of Records including to ensure the Identification,

storage, protection, retrieval, retention time and disposition (destruction) of records (4.2.4).

o Internal Auditing to describe how audits are planned and undertaken, reported and records maintained (8.2.2)

o Control of Nonconforming Product (i.e. things that go wrong) which will describe how non-conforming product is identified and controlled to prevent delivery including subsequent actions and records that must be maintained (8.3).

o Corrective Action which will describe how non-conformities are reviewed (including customer complaints) to determine the cause, and evaluate the action required to provide a remedial action as well as one to prevent reoccurrence of the problem and review the action taken. A record of the corrective action and its processing will be maintained (8.5.2)

o Preventive Action to provide a means of identifying and determining any actions required to prevent the occurrence of a problem and record the actions taken and a review of the action (8.5.3).

• Other procedures must be documented where they are deemed necessary for effective control of your processes (4.2.1.d)

See above for guidance and

sample file





ISO 9001



4. Management Review A regular (minimum annually) minuted management review meeting must be undertaken to discuss and define any actions required in a minuted meeting (5.1.d /5.6). The agenda must as a minimum cover the following issues:

• Review and report on actions from previous management review meeting (5.6.2.e)

• Review the effectiveness of the Quality Policy and the overall quality management system and including related processes (5.3.e / 5.6.2.c)

• Review resources for the management, operation and monitoring of the quality management system (4.1.d / 5.6.3.c)

• Review your quality objectives are (4.2.1.a) • Review all audit results (internal, external)

(5.6.2.a) • Review customer feedback including customer

satisfaction survey results (5.6.2.b) • Review the conformance of your product (or

service) i.e. including non-conformance and potential improvements to meet customer requirements (5.6.2.c / 5.6.3.b)

• Consider any outstanding actions you may have in relation to prevention of problems and correct those that have been detected 5.6.2.d)

• Discuss any forthcoming changes that may affect the performance of the quality management system (5.6.2.f)

• Discuss any recommendations for improvement (5.6.2.g)

• Review the data associated with the performance of your suppliers (in relation to 8.4.d)

Guidance You must undertake a meeting of management to discuss the agenda of the Management Review Meeting and keep minutes of the meeting including any action that must be completed (with dates). Management Review Agenda (Available) MS Word MRA-Template-9001 PDF MRA-Template-9001





ISO 9001



5. Internal Auditing You must ensure that internal audits are planned and executed to verify compliance with your systems and the requirements of ISO 9001. The audit frequencies in various areas will be dependent on the likelihood of those areas being problematic. The Internal Auditor undertaking the audits will be independent from the areas being audited. Audit Reports must be produced identifying any non-conformances detected and those managers responsible must take action to correct the problems and their causes (8.2.2)

Guidance You must undertake internal audits. The number or frequency is your decision but should be sufficient to enable you to be satisfied the system is operating to the requirements of ISO 9001. Audit Schedule (Available) MS Word AUS-Sample-9001 PDF AUS-Sample-9001 Audit Report (Available) MS Word AUR-Template-9001 PDF AUR-Template-9001 Discrepancy Report (Available) MS Word NCR-Template-9001 PDF NCR-Template-9001

(Please add your response in this space)




ISO 9001



6. Communication Communicate the quality policy to enable understanding within the organisation (5.3.d)

Guidance You must make sure personnel are aware of your quality policy and abide by it.


You must ensure that you have effective arrangements for communicating with customers in relation to product information and answering enquiries (7.2.3.a,b)

Guidance You must explain how you are able to communicate with the customer. E.g. brochure, web pages, individual job specification, help desk etc.


Is there a system organised by top management to ensure that internal communication (meetings / briefings / newsletters etc) can take place. Especially in relation to the effectiveness of the quality management system (5.5.3)

Guidance Does management communicate with personnel at all levels? E.g. monthly briefs, newsletters, informal meetings etc.





ISO 9001



7. Non-conformance You must ensure that all non-conformances are recorded including the corrective actions taken to prevent occurrence of the problem and any associated records (8.3)

Guidance You must record everything that goes wrong so that you can learn by the mistakes and avoid a repetition. Keep records of all problems and analyse for corrective action and report to management on results. Discrepancy Report (Available) MS Word NCR-Template-9001 PDF NCR-Template-9001 Or consider keeping a log.





ISO 9001



8. Customer Satisfaction You must establish a system for obtaining a measurement of the perception of your customers in relation to the products / services you provide. The data must be analysed and presented to management (8.2.1 / 8.4.a).

Guidance You must investigate what your customers think of your product / service and analyse results for management. Customer Satisfaction Questionnaire (Available) MS Word CSQ-Template-9001 PDF CSQ-Template-9001





ISO 9001



9. Human Resources You must ensure that all personnel performing work affecting the quality of the product (and service) are competent (by education, training, skills and experience as appropriate (6.2.1). This will be confirmed by:

• Reviewing the competence of personnel to ensure they are fully able to perform their duties.(6.2.2.a)

• Providing training or other steps as required to ensure competence for duties of personnel and review the actions taken to ensure competence has been achieved (6.2.2.b)

• Maintain records of education, training, skills and experience (6.2.2.e)

Guidance You may need to consider producing a competence matrix to demonstrate that you have reviewed personnel to ensure they are competent to do the work / tasks required. You should consider how you will demonstrate that you have appraised personnel to determine what, if any, further training is required. You must keep records of the training that has been undertaken.


Personnel will be made aware of the relevance and importance of their activities in meeting quality objectives (6.2.2.d)

Guidance You must ensure that your personnel understand the importance of their activities in meeting customer requirements and the objectives you have set for the organisation.





ISO 9001



10. Infrastructure & Environment Does the organisation have the appropriate environment (space, temperature, other environmental conditions etc.), buildings, workspaces, utilities, process equipment (hardware and software) and supporting services (e.g. transport and communications) necessary to achieve the conformity required of the product (6.3 / 6.4)

Guidance You must ensure that the infrastructure and environment is suitable for meeting the quality of the product and not detrimental to it.





ISO 9001



11. Product & Customer Requirements (including Service) Before offering and accepting an order (or change to an order) to supply do you:

• Ensure that you have a full understanding of the customer’s requirements without ambiguity (7.2.1.a, d / 7.2.2.a, b). as well as other needs of the customer as you become aware of them (7.2.1.b) and any Statutory and regulatory requirements (7.2.1.c)

• Ensure that you have the ability to meet all defined requirements (7.2.2.c)

• Confirm requirements with the customer where the customer has not documented them (7.2.2)

• Have some evidence that the above was achieved (7.2.2)

Guidance You must not accept work that you cannot fulfil and you must ensure that you have an unambiguous understanding of what the customer requires.





ISO 9001



12. Planning Do you plan and develop the methodology necessary to ensure you are able to deliver your product to you customers taking into account all the steps (processes) necessary to achieve the correct product and service. In particular:

o Do you set the requirements for the product

o Do you ensure that all necessary documentation is available

o Where necessary to ensure quality do you inspect or test the product against the requirements

o Do you keep records as evidence that you did the necessary processes?

(7.1.a,b,c,d)

Guidance A sophisticated response may include the use of a documented quality plan to show what, who and when etc. You will need to show that you plan the way you do work to ensure the product is correctly completed and what records ought to be kept to record this where appropriate.


Personnel will be made aware of the relevance and importance of their activities in meeting quality objectives (6.2.2.d)

Guidance Explain how staff are made aware of how their role in meeting customer requirements is done. E.g. discussion, training etc?





ISO 9001



13. Design & Development You must plan how you will review, verify and validate the design in appropriate stages ensuring that there are designated responsibilities including the interfaces with other groups as necessary (7.3.1.a,b,c)

Guidance Ensure that you have a clear understanding of the stages that the design will go through and when you will undertake reviews and who you will interface with.


You must determine and maintain records of the design input (all information that is required to prepare the design including changes) (7.2.2 / d / 7.3.7). These must include:

• Functional and performance requirements (7.2.2.a)

• Applicable statutory and regulatory requirements (7.3.2.b)

• References to similar designs (7.3.2.c)

Guidance You must be able to identify all inputs for the design including any initial brief, specification and any further amendments such as email, letters or faxes and telephone conversations that change or add to the input.





ISO 9001



13. Design & Development You must be able to provide the design output (drawings, specifications etc.) to meet the requirements for design input (7.3.3). In particular:

• The output must provide appropriate information for further activities such as purchasing, manufacture, construction etc. (7.3.3.a)

• The output (including changes of version / revision) must be checked and approved prior to release and records retained. (7.3.3 / 7.3.5 / 7.3.7)

• Changes must be reviewed and their impact on previous work evaluated and suitable action taken (7.3.7).

• There must be evidence that the design reviews, including all relevant participants, have been undertaken at suitable stages to ensure that the design is meeting the design input requirements and any action taken to resolve problems (7.3.4).

Guidance Is the design work such as drawing etc. suitable for the requirement? E.g. construction or fabrication. You will need to be able to demonstrate that you have checked the design work. In particular, prior to issue for any other purpose.


You must ensure that the final design (including planned stages) is able to meet the requirements of its application / intended use, where known (7.3.6).

Guidance Have you reviewed the customer requirement and satisfied your selves that the design meets them.





ISO 9001



14. Procurement Outsourcing will be controlled in a defined manner to ensure control over these processes (4.1)

Guidance What steps do you take to ensure that your subcontractors and suppliers where impacting upon the requirements of this report (and hence ISO9001) are managed to ensure they conform to requirements.


You must ensure that the products and services you purchase for inclusion in your products and services and able to meet requirements. (7.4.1). In particular you must:

• Evaluate your suppliers against defined criteria and re-evaluate them on an on-going basis and retain records (7.4.1)

• Data pertaining to their performance will be collected and analysed for presentation to management (8.4.d)

Guidance How do you evaluate your suppliers to ensure that they can do the job you ask of them initially and on-going? What records do you keep to demonstrate that they are evaluated for approval and performance? Supplier Evaluation (Available) MS Word SEQ-Template-9001 PDF SEQ-Template-9001


When purchasing you must ensure that the description of the product or service is described and reviewed to ensure that there cannot be any misinterpretation (7.4.2.a, b, c).

Guidance When you place an order it must be unambiguous. E.g. catalogue number, detailed specification or chosen directly to ensure correct product.





ISO 9001



14. Procurement (Explain how you meet this requirement in this space)

You must ensure that you inspect the products and services to an extent where your can be satisfied that they will not lead to a quality issue within the overall supply to the customer (7.4.3).

Guidance Explain how you make sure that the products (and services) are reviewed (inspected) to make sure that they are okay for your product or services or what safeguards are needed.


When products are received whether received from purchasing or provided by the customer they will be identified and protected from damage (7.5.4, 7.5.5)

Guidance Explain how the material is looked after.





ISO 9001



15. Production You must ensure the following:

• The processes shall be monitored by suitable means (statistics etc.) for demonstration of conformance, confidence in the quality management system and for improvement purposes and corrective action (8.1 / 8.2.3)

• Availability of information to define the product or service (e.g. necessary for manufacture etc.) (7.5.1.a)

• Availability of any instructions necessary to ensure the processes can be adequately managed (7.5.1.b)

• Availability and use of suitable equipment including measurement (7.5.1.c, d)

o A system must be in place to ensure that the equipment is suitably maintained and calibrated (7.6)

o Where problems with equipment are discovered the impact on any previous results must be reviewed and acted upon (7.6)

• Take steps to ensure that the status of products and services is managed and if required traceability (by means of unique references etc.) is considered (7.5.3)

• Take steps to control the release and supply activities. E.g. final inspection prior to delivery etc. (7.5.1.f)

Guidance You must be confident that the production of your product / service is undertaken in view of the adjacent requirements.


You must ensure that the methods that are employed to achieve your product or service are reliable to achieve the desired results (7.5.2). In particular:

• Define what methods are to be employed and how the methods can be approved and re-approved as required (7.5.2.a, e)

• Approve the equipment and qualification of personnel (7.5.2.b)

• Establish what methods, procedures and records are required (7.5.2.c, d)

Guidance Do you consider the most appropriate way to achieve you product or service and set out the ways that people should work ensuring the correct equipment. What procedures and records (where appropriate) do you need to show that this has been achieved




ISO 9001



15. Production (Explain how you meet this requirement in this space)

Performance in relation to the conformance of the products and services must be analysed and presented to management. (8.4.b, c)

Guidance What feedback to management can be given to demonstrate the success of the methods used for production? Are there any statistical or simple measurements that it would be beneficial to analyse in order to make decisions on things that could be improved?





ISO 9001



Assessment Review Report compliance with ISO 9001:2000

ISO 9001 Clause Description Assessment Review

Report Section 4.1 General requirements 2, 3, 4, 14 4.2.1 General 1, 3, 4 4.2.2 Quality manual 3 4.2.3 Control of documents 3 4.2.4 Control of quality records 3 5.1 Management commitment 2, 4 5.2 Customer focus 2 5.3 Quality policy 1, 4, 6 5.4.1 Quality objectives 1, 2 5.4.2 Quality management system planning 2, 5.5.1 Responsibility and authority 2 5.5.2 Management representative 2 5.5.3 Internal communication 6 5.6.1 General 4 5.6.2 Review input 4 5.6.3 Review output 4 6.1 Provision of resources 2 6.2.1 General 9 6.2.2 Competence, awareness and training 9, 12 6.3 Infrastructure 10 6.4 Work environment 10 7.1 Planning of product realization 12 7.2.1 Determination of requirements related to the product 11 7.2.2 Review of requirements related to the product 11, 13 7.2.3 Customer communications 6 7.3 Design and development 13 7.4.1 Purchasing process 14 7.4.2 Purchasing information 14 7.4.3 Verification of purchased product 14 7.5.1 Control of production and service provision 15 7.5.2 Validation of processes for production and service provision 15 7.5.3 Identification and traceability 15 7.5.4 Customer property 14 7.5.5 Preservation of product 14 7.6 Control of monitoring and measuring devices. 15 8.1 General 15 8.2.1 Customer satisfaction 8 8.2.2 Internal audit 3, 5 8.2.3 Monitoring and measurement of procedures 15 8.2.4 Monitoring and measurement of product (15) 8.3 Control of nonconforming product 3, 7 8.4 Analysis of data 4, 8, 14, 15 8.5.1 Continual improvement (1, 2, 4, 5, 7, 8) 8.5.2 Corrective action 3, 8.5.3 Preventive action 3,




ISO 9001



Amendment Record

Note: To be completed by applicant organisation for minor changes to the report contents. Major changes would result in an amendment to the report.

Date Description of the changes (refer to relevant sections of the Assessment Review Report)

