Guidelines vs. Requirements – Providing Clarity
ISO 9001 Lead Auditor training should enable auditors to focus on the requirements when auditing and to stay away from the pitfall of guidelines. Take the case of ISO 9001 or for that matter any standard. The standard has notes to explain the clauses. Clause 4.1 of ISO 9001 e.g. has 3 notes. Are these notes integral to the clause? Yes and no! Yes, because they are explaining important aspect of the clause. No because though these are valuable inputs in designing questions and an in implementing the ISO 9001, they can not be used as requirements. Afterall, Non-Conformities (NCs), as the drivers of correction and corrective action (CA) are fundamental to the implementation of ISO 9001. ISO 9001 Lead Auditor training must clearly outline for the students that a NC is the nonfulfillment of a Requirement. Notes per say are not a requirement per the clause.
Similarly, guidelines issued by organizations can never be requirements. Often the success attributed to good guidelines is taken by leadership, but if the guidelines result in any failure the Top Management (TM), is bound to challenge the competence of the mid-level by reminding them guidelines are just guidelines! It is therefore most important that those who design MSs and those who audit them remember this fine line. ISO 9001 lead auditor training certified by exemplar global clarifies the need for auditors to focus on the requirements when auditing.
The author is a member of TAG-176 the group feeding to TC-176. TC-176 is the ISO technical committee that works to monitor ISO 9001 and update it when the time comes to do so. Annex B to ISO 9001 provides the TC-176 developed guidance to organizations in implementing the ISO 9001. It is again to be remembered that these can not be used to add or modify the clauses of ISO 9001 and for that matter to interpret any standard. ISO 9001 auditors completing QMII’s ISO 9001 Lead Auditor training will be familiar with the development process of standards and how to get certified to them.
Auditors having completed their ISO 9001 Lead Auditor training, in looking at and in interpreting ISO 9001 Clause 8.5.5 post-delivery activities and for that matter, ISO 9001 Clause 9.1.2 customer satisfaction may consider the wisdom of ISO 10001 QM (quality management), customer satisfaction guidelines. However, if the organization is not conforming to these guidelines a non-conformity cannot be issued.
Similarly, ISO 10002 QM, guidelines for complaints handling are useful as also ISO 10003 QM guidelines for dispute resolution external to organizations and so on to ISO 10004, ISO 10005 right through to ISO 10019 are a very important input and yet, nevertheless guidelines. ISO 19011:2018 guidelines for auditing management systems is more widely used as the guidance on management of an audit program. This standard also forms a core part of the curriculum for ISO 9001 Lead auditor training. The basics of planning and conducting an audit as also evaluating auditor’s competence is part of this guideline. Again, it is to be remembered these are but guidelines. It is for TM/ Leadership to correctly interpret and apply the guidelines wisely to their organizations. Auditors having completed their ISO 9001 Lead Auditor training must conduct their audits in an objective manner and provide useful inputs to management to make wise decisions.
ISO 9001 as also other standards as applicable, are as good and useful as the implementation that is carried out. ISO 9001 auditors too need a good ISO 9001 lead Auditor training foundation to assess the implementation based on interpretations of the clauses of the selected standard. Leadership may choose to implement an integrated MS based on several standards. In auditing and using the various guidelines it is important that the purport of guidelines be not mixed with requirements.
This of course does not take away a leadership prerogative of converting any selected guidelines to requirements by so stating it in the MS. The point here is do not mix guidelines and requirements. When these are mixed it makes a potent mixture for the failure of a MS. ISO 9001 Lead Auditor training should ensure that your auditors steer clear of auditing to guidelines. For guidelines confuse the users, auditors, leadership et al resulting in poor implementation of ISO 9001 or any other ISO standard or industry specific standard. Mixing of guidelines and requirements is enemy number two of a MS. Enemy number one being the writing of a MS to the clauses of standard, ISO 9001 or any other standard.
Over the 30 plus years that QMII (www.qmii.com ) has helped clients, our experience is that management systems that mix guidelines worsen it further by contravening the caution in ISO 9001 Introduction 0.1 paragraph 3second bullet, where it says clearly it is not the intend of the Standard to align the MS documentation to the clause structure of the standard. Yet, in my 20 years of experience I see 70% of MSs based on ISO 9001 aligned to clauses! I often ask why? The answer is it easy for auditors to audit! Managements forget that MS is written for employees for users, who work per processes and not per clauses! QMII’s ISO 9001 Lead Auditor training, used and improved since 80’s, enable auditors to prepare for systems that are unique and developed around the users and not aligned to the clauses