ISO 9001 Evidence Checklist

Please click the link above to download our ISO 9001 Evidence Checklist

Bywater – Quality Matters

Please click the link above to download our Quality Matters Employee Handbook – An Introduction to ISO 9001.

Bywater – Environmental Matters

Please click  the link above to download our Environmental Matters Employee Handbook – An Introduction to ISO 14001.  We hope you and your colleagues find these booklets useful and informative.

An updated edition of the auditing standard ISO 19011 has just been published. This revision (November 2011) provides a uniform approach to various management system audits.

Many organisations operate a number of management systems, such as Quality, Environmental, Health and Safety and Information Security. These could be combined into an Integrated Management System, but whether they’ve done this or not, they should integrate auditing of the systems.

The first edition, ISO 19011:2002, applied only to Quality and Environmental Management Systems. The scope of ISO 19011:2011, Guidelines for Auditing Management Systems, has been extended to auditing multiple management systems.

ISO 19011:2011 continues to provide guidance on the conduct of internal and external management system audits. Intended users of the standard include auditors, audit team leaders, audit programme managers, organisations implementing management systems and organisations needing to conduct management system audits for contractual or regulatory reasons.

Compared to the 2002 version, ISO 19011:2011 now recognises:

• the concept of risk
• more explicitly the competence of the audit team and individual auditors
• the use of technology in auditing.

The relationship between ISO 19011:2011 and ISO 17021:2011 (Conformity assessment – Requirements for bodies providing audit and certification of management systems) is also clarified.

Bywater auditor courses have all been updated to reflect the revision. These changes do not require action by existing Bywater trained auditors.

Good nonconformity writing is probably the most important skill of an auditor and yet is commonly neglected by auditors at all levels. A Nonconformity Report or Corrective Action Request is left behind after the audit with the expectation that the auditee reviews the activity concerned, investigates the cause then establishes, implements and ensures the effectiveness of corrective action.

It is not only a courtesy, but imperative that the Nonconformity is properly written to allow the auditee to fulfil the corrective action process.

• A requirement is defined as: – “need or expectation that is stated, generally implied or obligatory”
• A Nonconformity is defined as “non-fulfilment of a requirement”.

It follows that nonconformity cannot exist if there is no requirement.

There is no room for opinion or speculation in a Nonconformity and words such as could, might and possible have no place.

This is not to say that an Auditor’s opinion is not valid. It might be useful for the auditee to consider an opinion, but other forms of categorisation should be used, e.g. Observation, and it must be made clear that there is no requirement to take action.

For a Nonconformity to exist two factors must be present. There must be a requirement and there must be factual objective evidence of failure. Factual objective evidence can consist of:

1. An action an Auditor has seen take place
2. A record of a past action
3. Something the Auditor is told by somebody who performs or is responsible for an action
4. The non-existence of required controls
5. The non-existence of required records

The writing of a Nonconformity must provide enough information for the person responsible to understand it after the audit and perhaps several days or weeks later. It must contain the requirement AND the objective evidence of failure. The style of writing must ensure the Nonconformity is written in a clear, concise and precise manner.

The auditee must be afforded the opportunity to revisit the specific evidence observed by the Auditor; hence, the actual reference numbers or other means of locating the Nonconformity must be recorded.

A Nonconformity written in two clear sentences will assist clarity. One sentence will contain the requirement, the other, the evidence of failure. The easiest way to record the requirement is to use the exact words from the audit criteria. This avoids error and negates the need for any creative writing, which might alter the meaning. Where the paragraph or sentence is lengthy it is reasonable to use a series of dots, the specific words required, and then another series of dots to indicate it is an extract.

An example of a requirement might be:

“…..measuring equipment shall be calibrated or verified at defined intervals…..”

An example of evidence of failure might be:

 “Micrometers X56, Y67 and Z78 have not been calibrated within the twelve month interval defined.”

Exams can be a daunting prospect, especially for those of us who haven’t taken an exam for many years. After a five day training course, the need to pass an exam, often with the added pressure of having to succeed to satisfy your employer or job role, can be a pressure situation.

At Bywater we do everything we can to help our delegates pass first time.

Below are 6 handy tips to help make your Lead Auditor exam as painless and successful as possible:

1. Know your standard

Prior training is not needed before attending a Lead Auditor course, however, some knowledge and understanding of the relevant standard will assist your learning right from the start. The more you know, the more of a head start you will have for the course leading to lots of extra confidence for the exam.

2. Read the questions carefully

Sometimes delegates write an excellent answer, that is well thought out and carefully argued, but the answer is to a completely different question entirely. Make sure you read each question carefully and that you have fully understood it before answering. Just to be sure, check the question again after you have written your answer.

3. Answer each question sufficiently

Look to see how many marks are available for each question; this will give you a good indication of the level and depth required for each answer. A question with a possible 5 marks available will need  more time and attention than a question with 1 mark available.

If the exam is “open book” you will have access to any notes that you have prepared throughout the course. Keep your notes tidy! If your notes are scruffy and difficult to read, you may spend more time trying to decipher these than answering the questions.

4. Attempt all questions

Scan through the exam paper before answering your first question and establish how many questions you have to tackle. By doing this and bearing in mind tip 3, you can plan your time and not be caught out at the end with unfinished answers. Where required, attempt every question, even if you are not sure of the answer. A question unanswered is worth 0 marks.  But a question attempted that has a well argued case can still score marks, which could make all the difference to your final result.

5. Review your answers

Once you have completed your exam paper, review your answers. Make sure you have answered each question directly and have given a logical, worked through explanation of how you have reached your conclusion. If you still have time to add to your answers, you might gain valuable extra marks.

6. Be prepared

Eat sufficiently before the test and have a drink to hand. This will keep your mind sharp and keep your concentration throughout the exam!